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protocolSection identificationModule nctId: NCT06344559, orgStudyIdInfo id: 2023001006, briefTitle: Brain Criticality, Oculomotor Control, and Cognitive Effort, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, descriptionModule briefSummary: The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study will involve three sessions of within-subject, crossover, double-blind transcranial magnetic stimulation with either 1) active intermittent theta burst stimulation, 2) active continuous theta burst stimulation or 3) sham intermittent or continuous theta burst stimulation., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Participants numbers will be assigned three blinded codes which are linked with either sham, active continuous, or active intermittent theta burst stimulation in the stimulator protocol. The investigator will enter the code to initiate the corresponding stimulator protocol, but will not know which protocol is active.Half of participants will be assigned a sham code corresponding to sham continuous theta burst stimulation and half will be assigned a sham code corresponding to sham intermittent theta burst stimulation. So, for any given session, either continuous or intermittent theta burst stimulation will be used, but it will be unclear whether the stimulation is active or sham., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Critical dynamics - immediate effects of cTBS versus sham stimulation, primaryOutcomes measure: Functional E/I balance - immediate effects of cTBS versus sham stimulation, primaryOutcomes measure: Avalanche branching ratio - immediate effects of cTBS versus sham stimulation, primaryOutcomes measure: Critical dynamics - immediate effects of iTBS versus sham stimulation, primaryOutcomes measure: Functional E/I balance - immediate effects of iTBS versus sham stimulation, primaryOutcomes measure: Avalanche branching ratio - immediate effects of iTBS versus sham stimulation, primaryOutcomes measure: Memory-guided saccade accuracy - effects of cTBS versus sham stimulation, primaryOutcomes measure: Memory-guided saccade accuracy - effects of iTBS versus sham stimulation, primaryOutcomes measure: Anti-saccade accuracy - effects of cTBS versus sham stimulation, primaryOutcomes measure: Anti-saccade accuracy - effects of iTBS versus sham stimulation, primaryOutcomes measure: Subjective effort discounting - cTBS versus sham stimulation, primaryOutcomes measure: Subjective effort discounting - iTBS versus sham stimulation, primaryOutcomes measure: Subjective effort rating - cTBS versus sham stimulation, primaryOutcomes measure: Subjective effort rating - iTBS versus sham stimulation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-03-17, uploadDate: 2024-03-27T17:23, filename: Prot_000.pdf, size: 1099938, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-30, uploadDate: 2024-03-27T17:01, filename: ICF_001.pdf, size: 711815, hasResults: False
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protocolSection identificationModule nctId: NCT06344546, orgStudyIdInfo id: K 2023-10247, briefTitle: Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Karolinska University Hospital, class: OTHER, descriptionModule briefSummary: The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS., conditionsModule conditions: Critical Illness, conditions: Refeeding Syndrome, conditions: Hypophosphatemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Metabolomics, outcomesModule primaryOutcomes measure: Metabolomics, secondaryOutcomes measure: Metabolomics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Královské Vinohrady, city: Prague, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: University Hospital Policlinico of Foggia, city: Foggia, country: Italy, geoPoint lat: 41.45845, lon: 15.55188, locations facility: Karolinska University Hospital, city: Huddinge, state: Stockholm, zip: 14186, country: Sweden, contacts name: Martin Sundström Rehal, MD PhD, role: CONTACT, phone: +46-8-12381507, email: martin.sundstrom@gmail.com, contacts name: Olav Rooyackers, PhD, role: CONTACT, email: olav.rooyackers@ki.se, geoPoint lat: 59.23705, lon: 17.98192, locations facility: Karolinska Universitetssjukhuset Solna, city: Stockholm, country: Sweden, contacts name: Jonas Blixt, MD PhD, role: CONTACT, email: jonas.blixt@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Södersjukhuset, city: Stockholm, country: Sweden, contacts name: Rebecka Rubenson Wahlin, MD PhD, role: CONTACT, email: rebecka.rubenson-wahlin@regionstockholm.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06344533, orgStudyIdInfo id: JMKX003142iv-101, briefTitle: Study of JMKX003142 Injection in Chinese Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Jemincare, class: INDUSTRY, collaborators name: Zhejiang Hangyu Pharmaceutical Co., Ltd, descriptionModule briefSummary: To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects, conditionsModule conditions: Healthy Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: JMKX003142 Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of the Adverse Events that are related to the single dose treatment, primaryOutcomes measure: Number of the Adverse Events that are related to the multiple dose treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Haiyan Li, role: CONTACT, contacts name: Haiyan Li, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Dongyang Liu, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06344520, orgStudyIdInfo id: IsiU, briefTitle: Pectoralis Minor Shorthening and Swimming Performance, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-29, primaryCompletionDateStruct date: 2023-08-30, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Istinye University, class: OTHER, descriptionModule briefSummary: Swimming is one of the sports branches that includes many factors such as aerobic and anaerobic endurance, strength, flexibility, speed, quickness, rhythm, coordination as well as sportive performance and technical skills.Athletes must have a high level of fitness, strength, coordination, agility, speed and motor control to perform at an elite level with minimal injury risk.Repetitive upper extremity movements imposed by freestyle swimming may lead to changes in muscle length and tension by paving the way for postural misalignment in adolescent swimmers.As can be seen in the studies, young swimmers who are preparing for the competition have postural disorders and injuries related to use, such as decreased posture, shoulder joint range of motion and subacromial distance.Pectoralis minor stretching exercise to be performed in swimmers is aimed to improve swimming performance and prevent possible postural disorders by contributing to the increase of maximal shoulder muscle strength as well as correcting the incorrectly developed posture in children., conditionsModule conditions: The Study Will Not be Based on Any Disease, conditions: Ability to Swim 100m Independent Freestyle, conditions: Be Between the Ages of 9-16, conditions: Continuing Running as Part of a Sports Club, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: three groups as intervention, exercises group non- exercises group and scham, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 91, type: ACTUAL, armsInterventionsModule interventions name: pektoralis minor shortnes, interventions name: Group in which the Pectoralis Minor stretching exercise was performed in a sham manner, interventions name: The group in which Pectoralis Minor stretching exercise was not applied, outcomesModule primaryOutcomes measure: Speed Tests, primaryOutcomes measure: Apley test, primaryOutcomes measure: Round Shoulder, primaryOutcomes measure: Anthropometric Measurement:, primaryOutcomes measure: Posture analysis: (ANNEX2), primaryOutcomes measure: Anthropometric Measurement 2, primaryOutcomes measure: Y Balance Test, primaryOutcomes measure: Eurofit Test Battery, primaryOutcomes measure: Eurofit Test Battery 2, primaryOutcomes measure: Eurofit Test Battery 3, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Galatasaray Ergün Gürsoy Olympic Swimming Pool, city: Üsküdar, state: Nuhkuyusu, zip: 34662, country: Turkey, geoPoint lat: 41.02252, lon: 29.02369, hasResults: False
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protocolSection identificationModule nctId: NCT06344507, orgStudyIdInfo id: TAILOR-EUS, briefTitle: Iconographic Registry of Pancreatobiliary Endoscopy Procedures, acronym: TAILOR-EUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-28, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027.Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases., conditionsModule conditions: Pancreas Neoplasm, conditions: Cancer of Pancreas, conditions: Pancreatitis, conditions: Neuroendocrine Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 12000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Registry for images and videos, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele Hospital, status: RECRUITING, city: Milan, zip: 20132, country: Italy, contacts name: Matteo Tacelli, MD, role: CONTACT, email: tacelli.matteo@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06344494, orgStudyIdInfo id: INTELICE-CTP-2401, briefTitle: Cardiac Interventional ICE Imaging Trial, acronym: INTELICE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: ICE Intelligent Healthcare Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process., conditionsModule conditions: Structural Heart Diseases, conditions: Atrial Septal Defect, conditions: Patent Foramen Ovale, conditions: Arrhythmias, Cardiac, conditions: Atrial Fibrillation, conditions: Supraventricular Tachycardia, conditions: Valve Disease, Heart, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, interventions name: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system, outcomesModule primaryOutcomes measure: Image quality, secondaryOutcomes measure: Image quality, secondaryOutcomes measure: Procedure success, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Procedure time, otherOutcomes measure: Device performance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, Capital Medical University, city: Beijing, state: Bejing, zip: 100011, country: China, contacts name: Deyong Long, MD, PhD, role: CONTACT, phone: 64412431, phoneExt: 0086010, email: dragon2008@vip.sina.com, contacts name: Ribo Tang, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First People's Hospital of Changzhou, city: Changzhou, state: Jiangsu, zip: 213004, country: China, contacts name: Ling Yang, MD, role: CONTACT, phone: 68873108, phoneExt: 00860519, email: Yangling369@czfph.com, contacts name: Ling Yang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Bo Qian, MD, role: SUB_INVESTIGATOR, geoPoint lat: 31.77359, lon: 119.95401, locations facility: The First Hospital Of Jilin University, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Shuyan Li, MD, PhD, role: CONTACT, phone: 88782222, phoneExt: 00860431, email: shuyanli1992@163.com, contacts name: Shuyan Li, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Hongbo Meng, role: SUB_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: Shanghai General Hospital, city: Shanghai, state: Shanghai, zip: 200081, country: China, contacts name: Songwen Chen, MD, PhD, role: CONTACT, phone: 18017638339, phoneExt: 0086, contacts name: Songwen Chen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Juan Sun, role: SUB_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06344481, orgStudyIdInfo id: CL-00003, briefTitle: The Hyalex First-in-Human Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Hyalex Orthopaedics, Inc., class: INDUSTRY, descriptionModule briefSummary: The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment., conditionsModule conditions: Cartilage Injury, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Surgical (Hyalex Cartilage Knee Implant), outcomesModule primaryOutcomes measure: Freedom from implant rejection and infection., primaryOutcomes measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months., eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SPORTO, status: RECRUITING, city: Łódź, zip: 09-038, country: Poland, contacts name: Klaudia Marchewa, role: CONTACT, email: marchewa.klaudia@gmail.com, contacts name: Marcin Domzalski, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.75, lon: 19.46667, hasResults: False
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protocolSection identificationModule nctId: NCT06344468, orgStudyIdInfo id: 531393, briefTitle: The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-12, primaryCompletionDateStruct date: 2023-06-05, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).The hypothesis are:Hypothesis I: Early mobilization positively affects the sleep quality of patients.Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure\>160 mmHg), or hypotension (systolic pressure\<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.Control Group:After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded., conditionsModule conditions: Early Mobilization, conditions: Sleep Quality, conditions: Critical Care, conditions: Nursing Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 82, type: ACTUAL, armsInterventionsModule interventions name: Early Mobilization, outcomesModule primaryOutcomes measure: The length of stay of patients in the intensive care unit, secondaryOutcomes measure: The Richards-Campbell Sleep Questionnaire (RCSQ), secondaryOutcomes measure: The Glasgow Coma Scale (GCS), secondaryOutcomes measure: Physiological Parameter - for the experimental group, secondaryOutcomes measure: Physiological Parameter - for the control group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06344455, orgStudyIdInfo id: RCT Delay Discounting, briefTitle: Influence of Educational Stimuli From the Pé-de-Meia Program on Delay Discounting Propensity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Federal Institute of Education, Science and Technology of the State of Mato Grosso, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to investigate how the Stay-and-Complete School Incentive Savings, part of the Pé-de-Meia Program, affects decision-making among low-income high school students, particularly their tendency towards delay discounting. This concept describes the preference for immediate gratifications over larger future rewards. The main questions it seeks to answer are:Can exposure to the specific educational stimuli of the Pé-de-Meia Program alter students' propensity for delay discounting? How do different levels of delay discounting influence students' decision-making regarding their studies and the utilization of the program's incentives?Participants will:Engage in a modified version of the Iowa Gambling Task (IGT), a computerized game that simulates decision-making under uncertainty, adapted to reflect the stimuli and choices related to the Pé-de-Meia Program.Complete questionnaires that measure their propensity for delay discounting and gather demographic and socioeconomic information.Researchers will compare the outcomes among groups of students exposed to different types of stimuli (aligned with the program's objectives, contrasting, and a control group without modifications) to see if the specific financial and educational incentives of the Pé-de-Meia Program influence how students value immediate rewards compared to future benefits. This study is expected to contribute to the improvement of public educational policies, encouraging school retention and promoting the educational success of low-income adolescents., conditionsModule conditions: Delay Discounting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: School Retention and Completion Incentive Savings via Modified Iowa Gambling Task A, interventions name: Iowa Gambling Task, interventions name: School Retention and Completion Incentive Savings via Modified Iowa Gambling Task B, outcomesModule primaryOutcomes measure: Delay Discounting 1, primaryOutcomes measure: Delay Discounting 2, secondaryOutcomes measure: decision-making performance under risk and uncertainty, secondaryOutcomes measure: loss aversion, secondaryOutcomes measure: Loss Frequency-Based Decision Strategy, secondaryOutcomes measure: Learning, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06344442, orgStudyIdInfo id: APHP220827, briefTitle: Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2026-06-05, completionDateStruct date: 2026-06-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality.Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtrationThe hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation., conditionsModule conditions: Acute Kidney Injury Post Liver Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, national multicentre, double-blinded, randomized ,controlled superiority trial with two parallel arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All the clinical teams involved intraoperatively (anaesthetists, nurse anaesthetists and surgeons) and postoperatively (doctors and nurses who will take care of the patient postoperatively) and the families will ignore the allocation of treatments for the duration of the trial,except the nurse in charge of preparing the infusions ,She will ensure respect for the blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 304, type: ESTIMATED, armsInterventionsModule interventions name: Arginine vasopressin, interventions name: Norepinephrine, outcomesModule primaryOutcomes measure: The primary objective is to compare the effect of intraoperative low-dose supplementation of AVP vs norepinephrine infusions on post-transplant Acute Kidney Injury after liver transplantation., secondaryOutcomes measure: To compare into the two arms the number of packed red blood cellsand fresh frozen plasma transfused, secondaryOutcomes measure: To compare into the two arms the number of the Number of AKI KDIGO 1, secondaryOutcomes measure: To compare into the two arms the Number of AKI KDIGO 2, secondaryOutcomes measure: To compare into the Number of AKI KDIGO 3, secondaryOutcomes measure: The need for renal replacement for replacement therapy (RRT) in ICU, secondaryOutcomes measure: The number of patients remaining on dialysis at the end of the study, secondaryOutcomes measure: Average intraoperative norepinephrine concentrations, secondaryOutcomes measure: Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine), secondaryOutcomes measure: Number of platelets transfused intraoperatively, secondaryOutcomes measure: Amount of vascular filling solutions intraoperatively, secondaryOutcomes measure: Sequential Organ Failure Assessment (SOFA score), secondaryOutcomes measure: Number of days alive outside intensive care unit, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: URC Lariboisière-Fernand Widal-saint Louis, city: Paris, zip: 75010, country: France, contacts name: Nabila PIZZI, role: CONTACT, phone: 01 40 05 49 83, phoneExt: +33, email: nabila.pizzi@aphp.fr, contacts name: Jaques DURANTEAU, Pr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06344429, orgStudyIdInfo id: STL_CT_0001, briefTitle: Stellest Lenses and Low-concentration Atropine Myopia Control Among Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-20, primaryCompletionDateStruct date: 2024-08-20, completionDateStruct date: 2025-08-20, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Essilor-Polylite Taiwan Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the young population suffers from myopia, and almost 20% have high myopia. High myopia can easily lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma. In Taiwan, according to a survey by the National Health Administration, the proportion of myopia among Grade 1 students has exceeded 81%.There are many ways to control myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine.Multiple animal experiments have confirmed that giving retinal myopia defocus signals can effectively decrease the growth of the eye, thereby inhibiting the progression of myopia. Therefore, regarding lens design, myopic defocus does play an important role in myopia control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral defocus lenses.Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest significantly slowed down the myopia progression reaching 67% and retard axial elongation reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in controlling myopia in Taiwanese children and whether Stellest Lenses combined with low-concentration atropine eye drops can increase the effect of myopia control., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Stellest Lenses, interventions name: Stellest Lenses+0.05% atropine, interventions name: Single vision Lenses+0.05% atropine, outcomesModule primaryOutcomes measure: Spherical equivalent refraction power, primaryOutcomes measure: Axial length, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Kaohsiung Chang Gung Memorial Hospital, status: RECRUITING, city: Kaohsiung, zip: 833401, country: Taiwan, contacts name: Pei-Chang Wu, role: CONTACT, contacts name: Pei-Chang Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06344416, orgStudyIdInfo id: RXG-001-2024-CLP (Rex-002), briefTitle: Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Dosentrx Ltd., class: INDUSTRY, descriptionModule briefSummary: Primary Objective:• To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation.Secondary Objective:• To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group., conditionsModule conditions: Any Solid Oral Medication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Study groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group., whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Use of ReX to dispense and monitor solid oral medication therapy., outcomesModule primaryOutcomes measure: Outcome MeasureReX Platform Study Group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OHC, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, hasResults: False
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protocolSection identificationModule nctId: NCT06344403, orgStudyIdInfo id: KY2024-045-02, briefTitle: Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only., conditionsModule conditions: Herpes Zoster, conditions: Local Infiltration, conditions: Acute Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: analgesic, interventions name: Tender point infiltration, outcomesModule primaryOutcomes measure: The presence of postherpetic neuralgia using VAS score, secondaryOutcomes measure: visual analogue scale score at each time point, secondaryOutcomes measure: Proportion of patients receiving repeated TPIs and block points, secondaryOutcomes measure: Consumption of oral drugs at each time point, secondaryOutcomes measure: The presence of PHN 3 and month 6 post treatment, secondaryOutcomes measure: Patient satisfaction scores on the 5-point Likert scale, secondaryOutcomes measure: Quality of life on the Scores on the WHOQOL-BREF, secondaryOutcomes measure: Adverse reactions through study completion, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100070, country: China, contacts name: Luo Fang, M.D, role: CONTACT, phone: +86 13611326978, email: 13611326978@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06344390, orgStudyIdInfo id: 20210327, briefTitle: Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Hebei Medical University, class: OTHER, descriptionModule briefSummary: Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function. The patients with cognitive impairment and non-dementia PSCIND after ischemic stroke were randomly divided into two groups. In addition to the basic drugs of ischemic stroke, the patients were given pentothemine sustained release tablets and blank control respectively to observe the effects of pentothemine on cognitive function and neuronal electrical signals in the patients with ischemic PSCIND. It is expected to explore the possible internal biological mechanism by using transcranial Doppler, oxygen-dependent functional magnetic resonance imaging and craniocerebral magnetic resonance pop analysis. Finally, statistical correlation analysis was used to elucidate the specific mechanism of pentoxifylline in improving cognitive function of non-dementia patients with cognitive impairment after ischemic stroke., conditionsModule conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pentoxifylline, outcomesModule primaryOutcomes measure: Pentoxifylline can improve cognitive impairment after ischemic stroke, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: BHan, status: RECRUITING, city: Shijiazhuang, country: China, contacts name: Jiaying Rong, role: CONTACT, phone: 15241876265, email: rjy19982023@163.com, geoPoint lat: 38.04139, lon: 114.47861, hasResults: False
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protocolSection identificationModule nctId: NCT06344377, orgStudyIdInfo id: BETadiposeWOMEN, briefTitle: Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-21, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Poznan University of Life Sciences, class: OTHER, descriptionModule briefSummary: Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity.This study is designed in a placebo-controlled, double-blinded, randomized fashion. The participants will be overweight or obese pre-menopausal females. Upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. The supplementation period will last for 8 weeks. There will be three study meetings: T1 before supplementation, T2 after 4 weeks of supplementation, and T3 after 8 weeks of supplementation. Blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings T1 and T3. The T2 meeting will involve only body composition measurement. Study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Betaine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Body composition, primaryOutcomes measure: Body mass, primaryOutcomes measure: Waist and hips circumference, primaryOutcomes measure: Lipid profile, primaryOutcomes measure: Gene expression, secondaryOutcomes measure: Liver function test, secondaryOutcomes measure: Dietary intake, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Poznan University of Life Sciences, city: Poznań, zip: 60-637, country: Poland, contacts name: Agata Chmurzynska, role: CONTACT, phone: +48 618466181, email: agata.chmurznska@up.poznan.pl, contacts name: Agata Chmurzynska, role: PRINCIPAL_INVESTIGATOR, contacts name: Emilia Zawieja, role: SUB_INVESTIGATOR, contacts name: Monika Młodzik-Czyżewska, role: SUB_INVESTIGATOR, contacts name: Paweł Juszczak, role: SUB_INVESTIGATOR, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False
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protocolSection identificationModule nctId: NCT06344364, orgStudyIdInfo id: PHN 1-080-23, briefTitle: Digital Pathology and AI for Liver Outcomes in MASLD, acronym: DPAILO-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: PharmaNest, Inc, class: INDUSTRY, collaborators name: Chinese University of Hong Kong, collaborators name: University of Edinburgh, collaborators name: University of Seville, collaborators name: Imperial College London, collaborators name: Icahn School of Medicine at Mount Sinai, collaborators name: Fundacio Clinic Barcelona, descriptionModule briefSummary: The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH)., conditionsModule conditions: Metabolic Dysfunction-associated Steatotic Liver Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), outcomesModule primaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS, secondaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the FIB-4 biomarker, a non-invasive test, secondaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test, secondaryOutcomes measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Parenchymal Tissue Adjusted Phenotypic Fibrosis Composite Score (Pt-Ph-FCS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Icahn School of Medicine at Mount Sinai, city: New York, state: New York, zip: 10029, country: United States, contacts name: Meena Bansal, MD, role: CONTACT, email: meena.bansal@mssm.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: The Chinese University of Hong Kong, city: Sha Tin, country: Hong Kong, contacts name: Vincent Wong, PhD, role: CONTACT, email: wongv@cuhk.edu.hk, geoPoint lat: 22.38333, lon: 114.18333, locations facility: Fundació de Recerca Clinic Barcelona, city: Barcelona, country: Spain, contacts name: Isabel Graupera, PhD, role: CONTACT, email: igraupera@hsph.harvard.edu, geoPoint lat: 41.38879, lon: 2.15899, locations facility: University of Seville, city: Sevilla, zip: 41004, country: Spain, contacts name: Manuel R Gómez, PhD, role: CONTACT, email: mromerogomez@us.es, geoPoint lat: 37.38283, lon: -5.97317, locations facility: University of Edinburgh, city: Edinburgh, state: Scotland, country: United Kingdom, contacts name: Jonathan Fallowfield, PhD, role: CONTACT, email: Jonathan.Fallowfield@ed.ac.uk, contacts name: Timothy Kendall, PhD, role: CONTACT, email: Tim.Kendall@ed.ac.uk, geoPoint lat: 55.95206, lon: -3.19648, locations facility: University of Edinburgh, city: Edinburgh, state: Scotland, country: United Kingdom, contacts name: Quentin Anstee, PhD, role: CONTACT, email: quentin.anstee@newcastle.ac.uk, contacts name: Jo Boyle, role: CONTACT, email: jo.boyle@newcastle.ac.uk, geoPoint lat: 55.95206, lon: -3.19648, locations facility: Imperial College London, city: London, country: United Kingdom, contacts name: Pinelopi Manousou, PhD, role: CONTACT, email: p.manousou@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06344351, orgStudyIdInfo id: TQB3006-I-01, briefTitle: A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer., conditionsModule conditions: Advanced Malignant Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: TQB3006 tablets, outcomesModule primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Maximum tolerated dose (MTD), primaryOutcomes measure: Recommended phase II dose (RP2D), secondaryOutcomes measure: Adverse events (AE), secondaryOutcomes measure: Serious adverse events (SAE), secondaryOutcomes measure: Time to reach maximum plasma concentration (Tmax), secondaryOutcomes measure: Peak concentration (Cmax), secondaryOutcomes measure: Half-life (t1/2), secondaryOutcomes measure: Area under the concentration-time curve (AUC [0-infinity]), secondaryOutcomes measure: Area under the concentration-time curve (AUC [0-t]), secondaryOutcomes measure: Apparent clearance (CL/F), secondaryOutcomes measure: Apparent volume of distribution (Vd/F), secondaryOutcomes measure: Objective response rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Harbin Medical University Cancer Hospital, status: RECRUITING, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Tongsen Zheng, Doctor, role: CONTACT, phone: 15134569619, email: zhengtongsen@126.com, geoPoint lat: 45.75, lon: 126.65, hasResults: False
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protocolSection identificationModule nctId: NCT06344338, orgStudyIdInfo id: Z211100002921030, briefTitle: Application of tDCS Stimulation in Controlling Refractory Status Epilepticus, acronym: tDCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Xuanwu Hospital, Beijing, class: OTHER, descriptionModule briefSummary: The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus, conditionsModule conditions: Refractory Status Epilepticus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: tDCS stimulation, interventions name: TDCS sham-stimulation, outcomesModule primaryOutcomes measure: Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus, secondaryOutcomes measure: Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xuanwu Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Weibi Chen, role: CONTACT, phone: +8615010255903, email: chenweibi@126.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06344325, orgStudyIdInfo id: EDPP, briefTitle: ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, descriptionModule briefSummary: Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia, conditionsModule conditions: Elective Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: fospropofol, outcomesModule primaryOutcomes measure: Sedation score, secondaryOutcomes measure: Postoperative adverse reactions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji hospital, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Aijun Xu, Dr., role: CONTACT, phone: +8618627784217, email: ajxu@tjh.tjmu.edu.cn, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06344312, orgStudyIdInfo id: M2023551, briefTitle: Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism, conditionsModule conditions: Stroke, Acute Ischemic, 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: 60, type: ESTIMATED, armsInterventionsModule interventions name: Yangxue Qingnao Granules, outcomesModule primaryOutcomes measure: The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06344299, orgStudyIdInfo id: HuaDong Hosiptal of FUDAN, briefTitle: Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-06-30, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 5302, type: ACTUAL, armsInterventionsModule interventions name: potential predictors, outcomesModule primaryOutcomes measure: ORs of potential predictors, secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 75 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huadong Hospital affiliated to Fudan University, city: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06344286, orgStudyIdInfo id: IstanbulTRH-DArman-002, briefTitle: The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2022-08-31, completionDateStruct date: 2022-10-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Istanbul Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo., conditionsModule conditions: Hypoxic-Ischemic Encephalopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: An enteral intake of breast milk with a volume of 10-20 mL/kg/day was defined as minimal enteral feeding. Minimal enteral feeding was initiated at postnatal 24 hours with breast milk via an orogastric tube. A total daily intake of 120 ml/kg/day was defined as full enteral feeding.The babies were randomized into two groups based on whether they received MEN during TH. While the babies fed with MEN during TH constituted the study group, the control group was composed of the babies who were given the same amount of distilled water according to the same protocol. Two groups were compared in terms of demographic characteristics, clinical outcomes, NIRS and Doppler measurements., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: The feeding materials were prepared inside an opaque syringe and serially numbered by Total Parenteral Nutrition Department in our institution. The investigators who made all measurements, examinations and collected data, and the nurses of the babies were blinded. All of the infants in the study group were fed with breast milk during the trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Minimal enteral nutrition, interventions name: Distilled water, outcomesModule primaryOutcomes measure: Cerebral and mesenteric blood flow velocities and oxygenation, primaryOutcomes measure: Cerebral and mesenteric rSO2 values, secondaryOutcomes measure: Development of NEC, secondaryOutcomes measure: Feeding intolerance, secondaryOutcomes measure: Time to full enteral feeding, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 1 Day, stdAges: CHILD, contactsLocationsModule locations facility: IstanbulTRH, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06344273, orgStudyIdInfo id: Burcu01, briefTitle: The Effect of Lower Extremity ROM Exercises on Hypotension, Fatigue, and Hemodialysis Comfort in Individuals, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-10-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Duzce University, class: OTHER, descriptionModule briefSummary: Range of motion (ROM) is a term used to describe the amount of motion in each joint in our body. Every joint in the body has a normal range of motion. Maintaining the normal opening of the joints is achieved through movement. ROM exercises reduce contractures and are very important in terms of helping to preserve muscle movements. ROM exercises are an inexpensive method that can be applied in any environment, either as a group or individually, covering all muscle-joint groups. Individuals with disabilities can perform ROM exercises individually or receive support from healthcare professionals. It provides support to venous return by increasing muscle strength in patients who are immobilized for a long time.Based on this information, the aim of our study is to investigate the effect of lower extremity ROM exercises during hemodialysis on hypotension, fatigue and hemodialysis comfort.The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session., conditionsModule conditions: Hemodialysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: You are completely free to participate in the research or not. Not participating in this research will certainly not affect the service you receive. You have the right to withdraw from the study at any time by giving notice; you may also be excluded from the study by the investigator, if deemed necessary, provided that no harm is done to your medical condition.If you participate in the research, you will not be charged or paid any fees for the expenses to be made in the study. In addition, at the end of the research, your information will only serve scientific purposes without revealing your identity., whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: ROM exercises, outcomesModule primaryOutcomes measure: follow-up form, primaryOutcomes measure: Piper Fatigue Scale, primaryOutcomes measure: comfort condition, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duzce University, city: Düzce, zip: 81000, country: Turkey, geoPoint lat: 40.83889, lon: 31.16389, hasResults: False
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protocolSection identificationModule nctId: NCT06344260, orgStudyIdInfo id: hNSCALSII, briefTitle: Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS), acronym: STEMALS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Casa Sollievo della Sofferenza IRCCS, class: OTHER, collaborators name: Ministry of Health, Italy, descriptionModule briefSummary: A Not for Profit Phase II Study to Evaluate Safety, Efficacy and Biomarkers secondary endpoints of Human Neural Stem cell intracerebroventricular transplantation in amyotrophic lateral sclerosis patients: a randomized, placebo controlled, triple blind study.This is an approximate 24-months study (PHASE B) consisting, per patient, of a 30-day screening period, 12-month enrollment and follow up period. A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses. The study will be stopped when all the subjects included in the treatment period complete the study visits. The study uses an ATMP, for that reason all the patients follow up will be prosecuted long life., conditionsModule conditions: Amyotrophic Lateral Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is an approximate 24-months triple-blinded, randomized, controlled vs placebo, in three arms study (PHASE B). A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses.In the phase B three arms will be: 1) hNSCs 20 milion cells 2) hNSCs 40 milion cells 3) Saline (comparator), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: In order to blind also the statistician that will analyse the results the protocol has been designed as a triple-blinded protocol. This means that both the researchers, which include neurologist, neurosurgeon and biologist, as well as the patients and the statisticians are unaware of whether the participant received the treatment or the placebo (only IMP Manufacturer QP is unblinded since release the cell drug to the use in the surgery room), whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: human Neural Stem Cells (hNSC), interventions name: Saline (Placebo), outcomesModule primaryOutcomes measure: Safety of treatment, secondaryOutcomes measure: Biological Endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Casa Sollievo Della Sofferenza IRCCS, status: NOT_YET_RECRUITING, city: San Giovanni Rotondo, state: Foggia, zip: 71013, country: Italy, geoPoint lat: 41.70643, lon: 15.7277, locations facility: Centro SLA Azienda Ospedaliera Università Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Letizia Mazzini, MD, role: CONTACT, phone: +39 0321 3733962, email: ambulatorio.sla@maggioreosp.novara.it, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Azienda Ospedaliera di Padova, status: NOT_YET_RECRUITING, city: Padua, zip: 35128, country: Italy, contacts name: Gianni Sorarù, MD, role: CONTACT, phone: +39049-8213645/646, email: cl.neurologica@aopd.veneto.it, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Azienza Ospedaliera Universitaria - Policlinico "P. Giaccone" Università degli Studi di Palermo, status: NOT_YET_RECRUITING, city: Palermo, zip: 90129, country: Italy, contacts name: Vincenzo La Bella, MD, role: CONTACT, phone: +39 091 6555158, email: info@centroslapalermo.it, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06344247, orgStudyIdInfo id: IIT-2023-0253, briefTitle: Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to exploring the changes in 24-hour urinary protein and renal function in obese patients with kidney disease after the application of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon like peptide-1 receptor agonists (GLP-1RA).Eligible patients were randomly and non-blindly allocated to four groups in a 1:1:1:1 ratio.The first group is the optimized treatment group, and patients in this group maintain the maximum dose/maximum tolerated dose of RAS blocker therapy.The second group is the optimized treatment + SGLT2i group. Participants in this group are titrated to the target dose (10 mg qd) in combination with dapagliflozin on the basis of optimized treatment.The third group is the optimized treatment + GLP-1RA group. Participants in this group will be titrated to the target dose (1mg qw) in combination with semaglutide on the basis of optimized treatment.The last group is the optimized treatment + SGLT2i + GLP-1RA treatment group, that is, based on the optimized treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw)., conditionsModule conditions: Obesity, conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: RAS inhibitors：Losartan®️/Valsartan®️, interventions name: dapagliflozin：Forxiga®️, interventions name: simagliptin：Forxiga®️, outcomesModule primaryOutcomes measure: Change of 24-hour urine protein quantification, secondaryOutcomes measure: Decline in glomerular filtration rate, secondaryOutcomes measure: Changes in BMI, secondaryOutcomes measure: changes in fasting blood glucose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200127, country: China, contacts name: wei jin, role: CONTACT, phone: +8615026696535, email: jinwei_xj@126.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06344234, orgStudyIdInfo id: 0049191, briefTitle: Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE), acronym: INSPIRE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Bari, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.The main questions this trial aims to answer are:- Primary Outcome: whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.Secondary outcomes will include:* Statistic metric of association between P0.1, ΔP, PMI and ΔPes* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort.Participants will undergo the following tasks and treatments:* Complete written informed consent before enrollment.* Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks.* Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test)* Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer.* Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively.* Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS).* Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions., conditionsModule conditions: Respiratory Disease, conditions: Artificial Respiration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: End-inspiratory Maneuvers, outcomesModule primaryOutcomes measure: Statistic metric of association between ΔPocc and ΔPes, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔP, PMI and ΔPes, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%, secondaryOutcomes measure: Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort, otherOutcomes measure: Reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda ospedaliero-universitaria consorziale policlinico di Bari, status: RECRUITING, city: Bari, zip: 70124, country: Italy, contacts name: Salvatore Grasso, MD, Professor, role: CONTACT, email: salvatore.grasso@uniba.it, contacts name: Francesco Murgolo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Domenico Luca Grieco, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.11148, lon: 16.8554, hasResults: False
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protocolSection identificationModule nctId: NCT06344221, orgStudyIdInfo id: 2023-A00954-41, briefTitle: Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study, acronym: HapticS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier St Anne, class: OTHER, collaborators name: Brain & Spine Institute (ICM), collaborators name: Centre Hospitalier Régional d'Orléans, descriptionModule briefSummary: The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect., conditionsModule conditions: Stroke, conditions: Upper Extremity Paresis, conditions: Manual Dexterity, conditions: Sensory Integration Dysfunction, conditions: Vibration; Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Dextrain Manipulandum and haptic feedback device, outcomesModule primaryOutcomes measure: Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence, secondaryOutcomes measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index, secondaryOutcomes measure: Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity, secondaryOutcomes measure: Correlation between clinical assessment and haptic measure, secondaryOutcomes measure: Assessment of the feasibility of the haptic measures, secondaryOutcomes measure: Assessment of the benefits of the haptic measures, secondaryOutcomes measure: Study the test re-test reliability of the haptic device by comparing the haptic effect on dexterity assessed at the beginning and end of the session by the same evaluator, secondaryOutcomes measure: Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity), secondaryOutcomes measure: Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks), secondaryOutcomes measure: Transcranial magnetic stimulation (TMS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06344208, orgStudyIdInfo id: IEO 1647, briefTitle: Predicting Toxicity in Elderly Patients With Head and Neck Cancer, acronym: PREtoxEL, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Predicting toxicity in elderly patients with head and neck cancer:validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes., conditionsModule conditions: Head and Neck Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3, type: ESTIMATED, outcomesModule primaryOutcomes measure: Predicting toxicity in elderly patients with head and neck cancer, eligibilityModule sex: ALL, minimumAge: 70 Years, maximumAge: 99 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, state: MI, zip: 20141, country: Italy, contacts name: maria Cossu Rocca, MD, role: CONTACT, phone: 00390294372900, email: maria.cossurocca@ieo.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06344195, orgStudyIdInfo id: 2517, briefTitle: Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening, acronym: Antiviral, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Dow University of Health Sciences, class: OTHER, descriptionModule briefSummary: This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days, conditionsModule conditions: Acute Apical Abscess, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Valacyclovir 500 mg, interventions name: Naproxen Sodium 550mg, outcomesModule primaryOutcomes measure: Changes in pain score using Numeric Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Yumna Shaheen Ali, status: RECRUITING, city: Karachi, state: Sindh, zip: 75290, country: Pakistan, contacts name: Dr. Yumna Shaheen Ali, role: CONTACT, email: yumna.shaheen@duhs.edu.pk, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False
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protocolSection identificationModule nctId: NCT06344182, orgStudyIdInfo id: STarkan, briefTitle: Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2021-05-15, completionDateStruct date: 2021-05-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Validity was assessed that the 30s Chair Stand Test (30sCS), the Hospital for Special Surgery score (HSS) and Short Form-12 Quality Life Questionnaire (SF-12) were used as comparator instruments., conditionsModule conditions: Total Knee Arthroplasty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 47, type: ACTUAL, armsInterventionsModule interventions name: Step Up and Down Test, outcomesModule primaryOutcomes measure: Step Up and Down Test, secondaryOutcomes measure: 30 Seconds Chair Stand Test, otherOutcomes measure: Hospital for Special Surgery (HSS) Knee Score, otherOutcomes measure: 12-Item Short-Form Health Survey, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dokuz Eylul University, city: Izmir, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06344169, orgStudyIdInfo id: DTCRD112(2)-I-15, briefTitle: Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-06-14, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Dalin Tzu Chi General Hospital, class: OTHER, descriptionModule briefSummary: Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP., conditionsModule conditions: Postsurgical Pain, conditions: Cesarean Section, conditions: Chronic Post-surgical Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, open-label, non-inferiority trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Sebacoyl Dinalbuphine Ester, interventions name: Morphine, outcomesModule primaryOutcomes measure: Intensity of surgical pain after operation as assessed by visual analogue scale, primaryOutcomes measure: Rescue doses of analgesics administered after operation, secondaryOutcomes measure: Incidence of chronic post-surgical pain, secondaryOutcomes measure: Satisfaction of living after surgery as assessed by the HRQoL short-form (SF)-12, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06344156, orgStudyIdInfo id: PDAC-Neoantigen, briefTitle: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer, conditionsModule conditions: Pancreatic Cancer, conditions: Adjuvant Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy, outcomesModule primaryOutcomes measure: 18-month RFS, primaryOutcomes measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability], secondaryOutcomes measure: 18-month OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Zhong Wu, MD, role: CONTACT, phone: 028-85422851, email: wuzhong5555@126.com, contacts name: Zhong Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06344143, orgStudyIdInfo id: 24-324, briefTitle: Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma, acronym: MACS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2029-11-01, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, collaborators name: Recordati Rare Diseases, descriptionModule briefSummary: The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes., conditionsModule conditions: Mild Autonomous Cortisol Secretion (MACS), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Various labs and imaging tests, outcomesModule primaryOutcomes measure: Evaluate best diagnostic test(s), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Cleveland Clinic Foundation, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Maya Boyd, role: CONTACT, phone: 216-444-4919, email: boyda5@ccf.org, contacts name: jenkink@ccf.org Jenkins, role: CONTACT, phone: 216-445-4791, email: jenkink@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06344130, orgStudyIdInfo id: 10001859, secondaryIdInfos id: 001859-C, briefTitle: Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: Background:Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.Objective:To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.Eligibility:People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.Design:Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years., conditionsModule conditions: Astrocytoma, conditions: Glioma, conditions: Recurrent Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Radiation Therapy, outcomesModule primaryOutcomes measure: MTD of daily re-irradiation in participants with recurrent grade 4 gliomas, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Compliance and feasibility of administering PRO in this participant population, secondaryOutcomes measure: Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother, secondaryOutcomes measure: Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities, secondaryOutcomes measure: Meaningful change in disease and treatment-related symptoms by using anchors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: National Cancer Institute Referral Office, role: CONTACT, phone: 888-624-1937, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06344117, orgStudyIdInfo id: MF3 UHN (IA), briefTitle: Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients, acronym: UHN, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Owlstone Ltd, class: INDUSTRY, descriptionModule briefSummary: Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD)., conditionsModule conditions: Invasive Aspergillosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria., secondaryOutcomes measure: Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 2N2, country: Canada, contacts name: Shahid Husain, MD,MS, role: CONTACT, phone: (416) 340-3144, email: shahid.husain@uhn.ca, contacts name: Shahid Husain, MD,MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06344104, orgStudyIdInfo id: D6970C00008, briefTitle: A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension, acronym: BaxAsia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2026-05-20, completionDateStruct date: 2026-05-20, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets., conditionsModule conditions: Uncontrolled Hypertension, conditions: Resistant Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: placebo control, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Baxdrostat, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in siSBP at Week 12, secondaryOutcomes measure: Change from baseline in siSBP at Week 12, secondaryOutcomes measure: Change from RWD baseline (Week 24) in siSBP at Week 32, secondaryOutcomes measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM, secondaryOutcomes measure: Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM, secondaryOutcomes measure: Change from baseline in siDBP at Week 12, secondaryOutcomes measure: Achieving siSBP < 140 mmHg at Week 12, secondaryOutcomes measure: Change from baseline in siDBP at Week 12, secondaryOutcomes measure: Achieving siSBP < 140 mmHg at Week 12, secondaryOutcomes measure: Change from baseline in siSBP at Week 12, secondaryOutcomes measure: Change from baseline in siSBP at Week 12, otherOutcomes measure: Number of participants with adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Caba, zip: C1426, country: Argentina, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Research Site, city: Baotou, zip: 014010, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Research Site, city: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, city: Beijing, zip: 100044, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, city: Bengbu, zip: 233060, country: China, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Research Site, city: Changde, zip: 415003, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Research Site, city: Changsha, zip: 410015, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, city: Changsha, zip: 430033, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, city: Changzhou, zip: 272100, country: China, geoPoint lat: 31.77359, lon: 119.95401, locations facility: Research Site, city: Chengdu, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, city: Chongqing, zip: 400010, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, city: Chongqing, zip: 400042, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Research Site, city: Deyang, zip: 618000, country: China, geoPoint lat: 31.13019, lon: 104.38198, locations facility: Research Site, city: Guangzhou, zip: 510100, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, city: Ha'er Bin, zip: 150001, country: China, locations facility: Research Site, city: Hangzhou, zip: 310014, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, city: Hefei, zip: 230601, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Research Site, city: Heze, zip: 274099, country: China, geoPoint lat: 35.23929, lon: 115.47358, locations facility: Research Site, city: Jiujiang, zip: 332000, country: China, geoPoint lat: 29.70475, lon: 116.00206, locations facility: Research Site, city: Luoyang, zip: 471000, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Research Site, city: Meihekou, zip: 135022, country: China, geoPoint lat: 42.52722, lon: 125.67528, locations facility: Research Site, city: Nanchang, zip: 330009, country: China, geoPoint lat: 28.68396, lon: 115.85306, locations facility: Research Site, city: Nanchong, zip: 637900, country: China, geoPoint lat: 30.79508, lon: 106.08473, locations facility: Research Site, city: Nanjing, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, city: Ningbo, zip: 315020, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: Research Site, city: Panjin, zip: 124009, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: Research Site, city: Puyang, zip: 457000, country: China, geoPoint lat: 29.45679, lon: 119.88872, locations facility: Research Site, city: Qiqihar, zip: 161000, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: Research Site, city: Sanya, zip: 572000, country: China, geoPoint lat: 18.24306, lon: 109.505, locations facility: Research Site, city: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, city: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, city: Shenyang, zip: 110004, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, city: Shenyang, zip: 110016, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, city: Taiyuan, zip: 030024, country: China, geoPoint lat: 37.86944, lon: 112.56028, locations facility: Research Site, city: Tianjin, zip: 300457, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Research Site, city: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Research Site, city: Wuhan, zip: 430010, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Wuhan, zip: 430022, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Wuhan, zip: 430060, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, city: Xianyang, zip: 712000, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Research Site, city: Xianyang, zip: 750004, country: China, geoPoint lat: 34.33778, lon: 108.70261, locations facility: Research Site, city: Xuzhou, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Research Site, city: Yangzhou, zip: 225001, country: China, geoPoint lat: 32.39722, lon: 119.43583, locations facility: Research Site, city: Yinchuan, zip: 750001, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, city: Zhengzhou, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Research Site, city: Zigong, zip: 643021, country: China, geoPoint lat: 29.34162, lon: 104.77689, locations facility: Research Site, city: Hong Kong, zip: 00000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, city: Hong Kong, zip: 0000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, city: Bangalore, zip: 560 092, country: India, geoPoint lat: 12.97194, lon: 77.59369, locations facility: Research Site, city: Belgaum, zip: 590016, country: India, geoPoint lat: 15.85212, lon: 74.50447, locations facility: Research Site, city: Kanpur, zip: 208002, country: India, geoPoint lat: 26.46523, lon: 80.34975, locations facility: Research Site, city: New Delhi, zip: 110002, country: India, geoPoint lat: 28.63576, lon: 77.22445, locations facility: Research Site, city: New Delhi, zip: 110060, country: India, geoPoint lat: 28.63576, lon: 77.22445, locations facility: Research Site, city: Surat, zip: 395001, country: India, geoPoint lat: 21.19594, lon: 72.83023, locations facility: Research Site, city: Chuo-ku, zip: 103-0027, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, city: Chuo-ku, zip: 260-0804, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Research Site, city: Kagoshima-shi, zip: 890-8520, country: Japan, geoPoint lat: 31.56667, lon: 130.55, locations facility: Research Site, city: Minato-ku, zip: 108-0073, country: Japan, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Research Site, city: Tsukuba-shi, zip: 305-0861, country: Japan, geoPoint lat: 36.2, lon: 140.1, locations facility: Research Site, city: Utsunomiya-shi, zip: 320-8580, country: Japan, geoPoint lat: 36.56667, lon: 139.88333, locations facility: Research Site, city: Yokohama-shi, zip: 234-0054, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, city: Yokohama-shi, zip: 236-0004, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Research Site, city: Daejeon, zip: 35015, country: Korea, Republic of, geoPoint lat: 36.32139, lon: 127.41972, locations facility: Research Site, city: Seoul, zip: 02841, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 04763, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Seoul, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Research Site, city: Iloilo City, zip: 5000, country: Philippines, geoPoint lat: 10.69694, lon: 122.56444, locations facility: Research Site, city: Quezon City, zip: 1112, country: Philippines, geoPoint lat: 14.6488, lon: 121.0509, locations facility: Research Site, city: St Petersburg, zip: 197341, country: Russian Federation, geoPoint lat: 59.93863, lon: 30.31413, locations facility: Research Site, city: Ankara, zip: 06800, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Research Site, city: Kahramanmaras, zip: 46100, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, locations facility: Research Site, city: Kayseri, zip: 38039, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, locations facility: Research Site, city: Kocaeli, zip: 41380, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, locations facility: Research Site, city: Hanoi, zip: 100000, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Research Site, city: Ho Chi Minh, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, city: Hochiminh city, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, city: Hochiminh, zip: 70000, country: Vietnam, hasResults: False
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protocolSection identificationModule nctId: NCT06344091, orgStudyIdInfo id: ZYWB-ZM-AHP-A-003, briefTitle: A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2026-09-28, completionDateStruct date: 2026-10-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world., conditionsModule conditions: Local Analgesia Via Infiltration, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A single-arm study of liposomal bupivacaine injection, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 232, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine Liposome Injection, outcomesModule primaryOutcomes measure: The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system, secondaryOutcomes measure: The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration, secondaryOutcomes measure: Time to first rescue analgesia of opioid, secondaryOutcomes measure: The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration, secondaryOutcomes measure: The proportion of patients using patient-controlled intravenous analgesia (PCIA), secondaryOutcomes measure: Pain intensity score at rest after administration for children aged 6 to 7 years, secondaryOutcomes measure: Pain intensity score at rest after administration for children aged 8 years and older, secondaryOutcomes measure: Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years, secondaryOutcomes measure: Pain intensity score on movement (or cough) after administration for children aged 8 years and older, secondaryOutcomes measure: Length of Stay, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Guangzhou Women and Children's Medical Center, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Xingrong Song, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06344078, orgStudyIdInfo id: SIGMA-d, briefTitle: Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR)., acronym: SIGMA-D, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Societa Italiana di Chirurgia ColoRettale, class: NETWORK, descriptionModule briefSummary: This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months., conditionsModule conditions: Acute Diverticulitis, conditions: Stoma Colostomy, conditions: Stoma Ileostomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: sigmoid resection and anastomosis / stoma, outcomesModule primaryOutcomes measure: adhesion to guidelines, secondaryOutcomes measure: stoma reversal, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda ospedaliera universitaria paolo giaccone, status: RECRUITING, city: Palermo, country: Italy, contacts name: francesco ferrara, medicine and surgery, role: CONTACT, phone: +393343035829, email: frr.fra@gmail.com, contacts name: claudio guerci, role: CONTACT, phone: +393473898094, email: guerci.clau@gmail.com, geoPoint lat: 38.13205, lon: 13.33561, hasResults: False
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protocolSection identificationModule nctId: NCT06344065, orgStudyIdInfo id: 20220102C, briefTitle: Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2025-05-25, completionDateStruct date: 2028-12-25, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants., conditionsModule conditions: Healthy Volunteers, 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: 1584, type: ESTIMATED, armsInterventionsModule interventions name: Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed), interventions name: Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed), interventions name: Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine, outcomesModule primaryOutcomes measure: Immunogenicity results of experimental group and active control group (DTaP), primaryOutcomes measure: Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T), primaryOutcomes measure: Immunogenicity results of experimental group, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, status: RECRUITING, city: Nanning, state: Guangxi, zip: 530028, country: China, contacts name: Yi Mo, role: CONTACT, phone: +86-13788686968, email: 13647272@qq.com, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False
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protocolSection identificationModule nctId: NCT06344052, orgStudyIdInfo id: SP-002-004, briefTitle: To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2029-03-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Stamford Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy.Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms.* Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment.* Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment.* Arm 3 participants will receive daily hedgehog pathway inhibitor only., conditionsModule conditions: Basal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: SP-002, interventions name: Vismodegib, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Progressive free survival, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR), secondaryOutcomes measure: Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity., secondaryOutcomes measure: Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity., secondaryOutcomes measure: Incidence and severity of SP-002 and/or vismodegib related AEs., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85006, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lee's Summit, state: Missouri, zip: 64064, country: United States, geoPoint lat: 38.91084, lon: -94.38217, locations facility: Research Site, status: RECRUITING, city: Cedar Park, state: Texas, zip: 78613, country: United States, geoPoint lat: 30.5052, lon: -97.82029, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Humble, state: Texas, zip: 77346, country: United States, geoPoint lat: 29.99883, lon: -95.26216, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Longview, state: Texas, zip: 75601, country: United States, geoPoint lat: 32.5007, lon: -94.74049, hasResults: False
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protocolSection identificationModule nctId: NCT06344039, orgStudyIdInfo id: Floating hip, briefTitle: Epidemiological Study of Floating Hip Injuries in Assiut University Hospitals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Aim of the study is to describe and study the patterns of floating hip injuries and assess the current management in Assiut University Hospitals Trauma Centre to help reach the best approach to plan treatment for these severe and difficult injuries., conditionsModule conditions: Hip Fractures, conditions: Hip Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Incidence of floating hip injuries, primaryOutcomes measure: Patterns of injury, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06344026, orgStudyIdInfo id: ANPD001-02, briefTitle: Phase 1/2a Study of ANPD001 in Parkinson Disease, acronym: ASPIRO, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Aspen Neuroscience, class: INDUSTRY, collaborators name: California Institute for Regenerative Medicine (CIRM), descriptionModule briefSummary: This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open label, dose escalation of bilateral injection of ANPD001 dopaminergic precursor cells to the putamen, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: ANPD001, interventions name: Custom Device, outcomesModule primaryOutcomes measure: Incidence and severity of treatment emergent adverse events (Safety and Tolerability), secondaryOutcomes measure: "ON" time without troublesome dyskinesia, secondaryOutcomes measure: Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV), secondaryOutcomes measure: Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state, secondaryOutcomes measure: Post-injection change in the 18F-DOPA uptake in the putamen, secondaryOutcomes measure: Incidence and severity of treatment emergent adverse events during long term follow-up (Continued Safety and Tolerability), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Arizona - Banner Health, city: Tucson, state: Arizona, zip: 85724, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Scripps Health, city: La Jolla, state: California, zip: 92037, country: United States, geoPoint lat: 32.84727, lon: -117.2742, locations facility: University of California, Irvine, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Feinstein Institutes, city: Manhasset, state: New York, zip: 11030, country: United States, geoPoint lat: 40.79788, lon: -73.69957, hasResults: False
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protocolSection identificationModule nctId: NCT06344013, orgStudyIdInfo id: 29BRC24.0034 - BUNDLE ABCDEF, briefTitle: The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go!, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2022-07-31, completionDateStruct date: 2022-07-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital, Brest, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online., conditionsModule conditions: Delirium, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 341, type: ACTUAL, outcomesModule primaryOutcomes measure: knowledge and compliance of French intensive care units with the ABCDEF, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Brest, city: Brest, zip: 29609, country: France, geoPoint lat: 48.3903, lon: -4.48628, hasResults: False
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protocolSection identificationModule nctId: NCT06344000, orgStudyIdInfo id: RICU20240323, briefTitle: Study on Disease Progression and Nutritional Status in Bronchiectasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: Bronchiectasis is a common lung disease. The Bronchiectasis Severity Index (BSI) is a widely used assessment system. The body mass index (BMI) is a commonly used measure of nutritional status, but it has its limitations. To provide a more comprehensive assessment, the investigators also consider other nutrition-related indices such as upper arm circumference, calf circumference, skinfold thickness and grip strength. The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants' disease progression., conditionsModule conditions: Bronchiectasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: inapplicable, outcomesModule primaryOutcomes measure: Frequency of acute exacerbations of bronchiectasis, secondaryOutcomes measure: Deterioration of lung function, secondaryOutcomes measure: Severity of dyspnoea, secondaryOutcomes measure: Bhalla scores on CT of participants' lungs, secondaryOutcomes measure: Frequency of hospitalisation, secondaryOutcomes measure: Death, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wuhan Union Hospital, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Xiaorong Wang, role: CONTACT, phone: 18627195231, phoneExt: +86, email: rong-100@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06343987, orgStudyIdInfo id: 1-10-72-165-23, briefTitle: The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Aarhus University Hospital, class: OTHER, collaborators name: Danish Cancer Society, descriptionModule briefSummary: The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.The aim of the study is to assess the feasibility and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care.Participants will randomized 2:1 to either a physical activity program or care as usual., conditionsModule conditions: Metastatic Breast Cancer, conditions: Estrogen-receptor-positive Breast Cancer, conditions: Adiposity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Continuous inclusion. Randomized 2:1 - intervention group and observational group, respectively., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Physical Activity, outcomesModule primaryOutcomes measure: Adherence as assessed by attendance rate, primaryOutcomes measure: Metabolic efficacy assessed by change in metabolic score, secondaryOutcomes measure: Perceived satisfaction assessed by qualitative interviews, secondaryOutcomes measure: Health-related quality of life as assessed by EORTC-QLQ-30, secondaryOutcomes measure: Cancer coping as assessed by CBI-12, secondaryOutcomes measure: Sleep quality as assessed by PSQI, secondaryOutcomes measure: Insomnia as assessed by ISI, secondaryOutcomes measure: Change in C-reactive protein, secondaryOutcomes measure: Change in leukocytes, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in LDL cholesterol, secondaryOutcomes measure: Change in HDL cholesterol, secondaryOutcomes measure: Change in BMI, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Visceral fat, secondaryOutcomes measure: VO2 max, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Sit-rising, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oncology, Aarhus University Hospital, status: RECRUITING, city: Aarhus N, state: Central Denmark Region, zip: 8200, country: Denmark, contacts name: Signe Borgquist, MD, PhD, role: CONTACT, phone: + 45 22 62 45 25, email: signe.borgquist@auh.rm.dk, contacts name: May W Nielsen, Bsc.Med., role: CONTACT, phone: +45 29 90 66 05, email: maywni@gmail.com, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False
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protocolSection identificationModule nctId: NCT06343974, orgStudyIdInfo id: 0843, briefTitle: Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Turku University Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls.The main questions it aims to answer are:* Are fetal liver ultrasound radiomic features reproducible?* Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls?Participants will undergo ultrasound examination to collect ultrasound data for the analyses., conditionsModule conditions: Pregnancy in Diabetic, conditions: Diabetes Mellitus, Type 1, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Fetal liver ultrasound texture, secondaryOutcomes measure: Birth weight in grams, secondaryOutcomes measure: Birth weight centile, secondaryOutcomes measure: Large for gestational age (LGA), secondaryOutcomes measure: Interventricular septum (IVS) width, secondaryOutcomes measure: Number of pregnancies with neonatal hypoglycemia, secondaryOutcomes measure: Rate of neonatal hypoglycemia treated with oral dextrose gel, secondaryOutcomes measure: Rate of neonatal hypoglycemia treated with intravenous (IV) glucose, secondaryOutcomes measure: Length of treatment for neonatal hypoglycemia, secondaryOutcomes measure: Number of neonates admitted to neonatal intensive care unit (NICU), secondaryOutcomes measure: Length of NICU admission, secondaryOutcomes measure: Number of pregnancies with neonatal respiratory complications related to maternal diabetes, secondaryOutcomes measure: Number of pregnancies with neonatal hyperbilirubinemia, secondaryOutcomes measure: Maternal HbA1c concentration, secondaryOutcomes measure: Glucose management indicator (GMI), secondaryOutcomes measure: Time in glycemic range (TIR), secondaryOutcomes measure: Time above glucose range, secondaryOutcomes measure: Time below glucose range, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Turku University Hospital, city: Turku, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False
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protocolSection identificationModule nctId: NCT06343961, orgStudyIdInfo id: 2024-76, briefTitle: Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Jie Zhong, class: OTHER, descriptionModule briefSummary: The study used a new surgical technique: intraoperative fluorescence imaging,In the 1980s, some scholars proposed the concept of intraoperative fluorescein angiography.During vitrectomy, intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapy.Through this technology, the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery, providing effective imaging evidence support for the design of further treatment., conditionsModule conditions: Vascular Retinopathy of Left Eye (Disorder), conditions: Vascular Retinopathy of Right Eye (Disorder), conditions: Diabetic Retinopathy, conditions: Retinal Vein Occlusion, conditions: Retinal Vasculitis, conditions: Vitreous Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of 80 patients with vitreous hemorrhage diagnosed in Sichuan Provincial People's Hospital from January 2024 to December 2025 were selected. The number of included cases was calculated according to the minimum sample size of 200 patients with vitreous hemorrhage in our hospital, 95% confidence level and 5% confidence interval, and the calculated result was 79. The included cases were equally divided by random number method. 40 patients in the control group were given vitrectomy and other conventional operations such as retinal laser photocoagulation. In contrast group, 40 patients were given vitrectomy combined with intraoperative fluorescein angiography and other conventional operations such as retinal laser photocoagulation. The diagnosis rate of primary disease cause, observation rate of neovascularization and non-perfusion area, visual acuity, visual field, thickness of macular fovea and postoperative complications (ciliary detachment, secondary vitreous hemorrhage, neovascu, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative Fluorescein Angiography, outcomesModule primaryOutcomes measure: best corrected visual acuity, primaryOutcomes measure: Central retinal thickness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343948, orgStudyIdInfo id: BL-B01D1-306, briefTitle: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sichuan Baili Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd., descriptionModule briefSummary: This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy., conditionsModule conditions: HR+HER2- Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 382, type: ESTIMATED, armsInterventionsModule interventions name: BL-B01D1, interventions name: Eribulin, interventions name: Vinorelbine, interventions name: Gemcitabine, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Treatment Emergent Adverse Event (TEAE), secondaryOutcomes measure: Anti-drug antibody (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, city: Beijing, state: Beijing, country: China, contacts name: Binghe Xu, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06343935, orgStudyIdInfo id: YY-20394-014, briefTitle: A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Shanghai YingLi Pharmaceutical Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode)., conditionsModule conditions: Indolent B-cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Linperlisib, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Adverse event, secondaryOutcomes measure: Serious adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343922, orgStudyIdInfo id: Sadaf Riphah, briefTitle: Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21., conditionsModule conditions: Cerebral Palsy (CP), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1 will receive exercises by using oral motor facilitation technique protocol three times a week Group 2 will receive traditional oral motor exercises three times per week, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: oral motor facilitation technique group, interventions name: traditional oral motor exercises group, outcomesModule primaryOutcomes measure: Change in Drooling, primaryOutcomes measure: Change in feeding skills, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Mobilty Quest, status: RECRUITING, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: Mobility Quest, role: CONTACT, phone: 03336596656, email: mobilityquest@outlook.com, contacts name: Nazia Mumtaz, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Sadaf Safdar, BS, role: SUB_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06343909, orgStudyIdInfo id: REC/RCR & AHS/23/0197Ayesha, briefTitle: Foot and Hip Abductor Strengthening in Patients With Knee Osteoarthritis., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore, conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Hip abductor strengthening exercise, interventions name: Intrinsic foot muscle strengthening along with conventional exercises, outcomesModule primaryOutcomes measure: Knee Osteoarthritis Outcome Score (KOOS), primaryOutcomes measure: Berkemann foot prints, secondaryOutcomes measure: Frontal plane projection, secondaryOutcomes measure: Goniometer, secondaryOutcomes measure: 30 seconds chair stand test, secondaryOutcomes measure: Overall self-perception by Global Rating of Change Score, secondaryOutcomes measure: 9 step stairs climb test., secondaryOutcomes measure: 40-m fast-paced walk test, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: THQ hospital KRK., status: RECRUITING, city: Lahore, state: Punjab, country: Pakistan, contacts name: Ayesha Anwar, DPT, role: CONTACT, phone: 03340003448, email: ayeshaanwarali123@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06343896, orgStudyIdInfo id: AnkaraCHBilkent-tntaygurt, briefTitle: Evaluation of Sedation Depth and Reliability With Integrated Pulmonary Index (IPI) Follow-up in Pediatric Radiological Interventions, acronym: IPI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: In this study, we aimed to investigate the predictability of possible respiratory complications and the effect of the addition of the integrated pulmonary (EPI) score to the evaluation of the patient's respiratory index status in addition to the SPO2 measurement available in standard ASA monitoring in pediatric patients undergoing interventional radiological procedures under sedoanesthesia., conditionsModule conditions: Sedation, conditions: BIS, conditions: Integrated Pulmonary Index, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: monitorization reliability, outcomesModule primaryOutcomes measure: EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS, secondaryOutcomes measure: BİS correlation with the IPI, secondaryOutcomes measure: pulse oximetry correlation with the IPI, secondaryOutcomes measure: noninvasive blood pressure, secondaryOutcomes measure: heart rate, secondaryOutcomes measure: respiratory rate, secondaryOutcomes measure: end tidal carbondioxide, secondaryOutcomes measure: apnea and hypoxia conditions that develop in the patient during anesthesia, secondaryOutcomes measure: postoperative recovery time, secondaryOutcomes measure: intraoperative total dose of medication used, secondaryOutcomes measure: postoperative nausea and vomiting, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ankara City Hospital, Bilkent, status: RECRUITING, city: Ankara, country: Turkey, contacts name: tugbanur taygurt, role: CONTACT, phone: +905322005632, email: tugbanurtaygurt@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06343883, orgStudyIdInfo id: 24-353, briefTitle: Investigation of Low-intensity Focused Ultrasound Pressure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Virginia Polytechnic Institute and State University, class: OTHER, descriptionModule briefSummary: Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI., conditionsModule conditions: Somatic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Primary cohort (safety) will be collected prior to full study collection. Primary collection will involve highest pressure application and follow-up safety scans (MRI) to be reviewed by a Neuroradiologist. Once cleared - parallel design will be utilized for eeg and fMRI cohorts. Both cohorts will receive 3 LIFU pressures randomized over 3 study visits. Electrical stimulations will be applied pre and post LIFU administration to induce somatosensory evoked potentials (SEPs)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: No masking, no sham. All subjects will receive all conditions, all of which are active., enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: low-intensity focused ultrasound - low pressure, interventions name: low-intensity focused ultrasound - medium pressure, interventions name: low-intensity focused ultrasound - high pressure, outcomesModule primaryOutcomes measure: Report of Symptoms Questionnaire, primaryOutcomes measure: MRI, secondaryOutcomes measure: EEG, secondaryOutcomes measure: fMRI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fralin Biomedical Research Institute at VTC, city: Roanoke, state: Virginia, zip: 24016, country: United States, contacts name: Jessica Florig, MPH, role: CONTACT, phone: 540-526-2261, email: jnw@vtc.vt.edu, contacts name: Wynn Legon, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.27097, lon: -79.94143, hasResults: False
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protocolSection identificationModule nctId: NCT06343870, orgStudyIdInfo id: ESTIME, briefTitle: Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME), acronym: ESTIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, descriptionModule briefSummary: Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment., conditionsModule conditions: Menopause, conditions: Testosterone Deficiency, conditions: Estrogen Deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: testosterone pellet (100 mg), interventions name: Placebo, outcomesModule primaryOutcomes measure: Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms, secondaryOutcomes measure: Evaluate response in quality of life and sexual function, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343857, orgStudyIdInfo id: CE-AVEC 878/2022/Oss/AOUFe, briefTitle: Joint Self-Assessment Forms for Knee, Ankle and Shoulder, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: The present study represents the pilot phase of the project aimed at developing anatomical site-specific self-assessment questionnaires (shoulder, knee and ankle) that can advise the subject of the need for an orthopaedic specialist examination.The pilot phase of the project involves the collection of data from questionnaires in a population of subjects who have requested an orthopaedic consultation for the anatomical site covered by the questionnaire. Each questionnaire consists of questions designed to collect information about the patient's subjective condition.The data collected from the questionnaires will be used to evaluate the statistical significance (p value) of each question in the questionnaire in relation to the outcome of the orthopaedic specialist visit. Through a multivariate logistic analysis of the answers given by the subject, it will be possible to 'weight' each answer to obtain a final value that gives an indication of an orthopaedic specialist visit., conditionsModule conditions: Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: self-assessment questionnaire, outcomesModule primaryOutcomes measure: Observation of the distribution of questionnaire responses for each anatomical site., secondaryOutcomes measure: Therapeutic indication of the orthopaedic specialist for each subject participating in the study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica II, city: Bologna, state: BO, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Unità Operativa di Chirurgia della Spalla I.R.C.C.S. Ospedale Galeazzi-Sant'Ambrogio, city: Milan, state: MI, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06343844, orgStudyIdInfo id: 49RC23_0070, briefTitle: Disparities in Myocardial Infarction Remodeling According to Gender, acronym: REMOVE 2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2039-09-01, completionDateStruct date: 2040-07-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University Hospital, Angers, class: OTHER_GOV, descriptionModule briefSummary: Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study., conditionsModule conditions: Myocardial Infarction, conditions: Ventricular Remodeling, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1650, type: ESTIMATED, armsInterventionsModule interventions name: cardiac imaging to assess left ventricular volumes and function, outcomesModule primaryOutcomes measure: Asses left ventricular remodeling disparities between genders, secondaryOutcomes measure: Evaluate the evolution of remodeling at Month 3, secondaryOutcomes measure: Assess remodeling changes between inclusion and Month 12, secondaryOutcomes measure: Assess the prevalence of comorbidities and their impact on the effect on the outcome: post-infarction cardiac remodeling with gender (cardiovascular risk factors, renal function, hepatic functionperipheral artery disease, way of life), secondaryOutcomes measure: Explore prognostic disparities between men and women., secondaryOutcomes measure: Evaluate lifestyle habits up to 10 years: outcome anxiety/depression, secondaryOutcomes measure: Evaluate lifestyle habits up to 10 years: outcome diet score, secondaryOutcomes measure: Evaluate lifestyle habits up to 10 years: outcome physical activity, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: date of first period, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: pregnancy, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: children, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event, secondaryOutcomes measure: Assess the risk of remodeling based on specific parameters in female subjects: menopause, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06343831, orgStudyIdInfo id: IRB23-1646, briefTitle: Quantitative Assessment of Autologous Fat Transfer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: University of Houston, descriptionModule briefSummary: This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6., conditionsModule conditions: Autologous Fat Grafting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, MRI, and US are routinely used in practice but will be performed for research purposes in this study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6), interventions name: 3-Dimensional (3-D) Photographs (Visit 1- 6), interventions name: Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6), interventions name: Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6), interventions name: BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6), outcomesModule primaryOutcomes measure: Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging., secondaryOutcomes measure: Change from baseline in quality of life as measured by the BREAST-QTM survey., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343818, orgStudyIdInfo id: NIHR301578, briefTitle: Compassion Project: Developing an Empathy-Based Stress Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Bath, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, collaborators name: Oxford Health NHS Foundation Trust, collaborators name: Central and North West London NHS Foundation Trust, descriptionModule briefSummary: Compassion is recognising that someone is suffering and wanting to help them. Compassion fatigue is a reduction in capacity to feel compassion for others. Secondary trauma is the experience of traumatic responses to hearing about someone else's trauma. Burnout is depersonalisation, emotional exhaustion, and feeling less good at one's job. Compassion fatigue, secondary trauma and burnout can all be referred to as empathy-based stress. This is a problem for healthcare staff and their patients.Staff experiencing empathy-based stress deliver less high quality care, which can lead to serious consequences for patients. Empathy-based stress is also associated with staff sickness, which is bad for staff and costly to the United Kingdom's National Health Service (NHS).Child and adolescent mental health (CAMHS) wards are busy, high-pressure environments where families and young people are often upset, resources are stretched, and staff are managing high levels of patient risk of self-harm or suicide.The principal investigator has already reviewed research on empathy-based stress and interventions to prevent and/or reduce it in mental health ward staff. This evidence has been presented to CAMHS ward staff, managers, commissioners, patients and families and these stakeholders have co-designed an intervention for wards, to reduce empathy-based stress. The intervention aims to help staff to feel better and care better.This pilot study aims to test and improve our intervention on two CAMHS wards, measuring how useful and well-liked it is, and how feasible it would be to use it and to test it on more wards. Staff on CAMHS wards will be offered a modular intervention including psychoeducation about empathy based stress and ways of combatting it, and workplace stressor and management toolkits. NHS CAMHS ward staff and patients will be asked to complete questionnaires and a subsample of staff will be asked to complete interviews about the process of the intervention., conditionsModule conditions: Reduction of Empathy-Based Stress in Healthcare Staff, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The study uses a repeated AB design on two ward sites to assess feasibility, acceptability and usefulness of a novel intervention for empathy-based stress in staff, and to test feasibility of this study design. It is not assessing efficacy. The extended baseline measure is the control, there is no control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff, outcomesModule primaryOutcomes measure: Acceptability of intervention, primaryOutcomes measure: Feasibility of intervention, primaryOutcomes measure: Perceived usefulness of intervention, primaryOutcomes measure: Feasibility of Study, primaryOutcomes measure: Feasibility of gathering data on staff empathy-based stress using the Professional Quality of Life Scale at multiple timepoints, secondaryOutcomes measure: Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire, secondaryOutcomes measure: Process measures to assess potential mechanisms of change, secondaryOutcomes measure: Feasibility of gathering young person and parent/carer data on compassionate care, secondaryOutcomes measure: Feasibility of gathering young person and parent/carer data on experience of service, otherOutcomes measure: Ward-level contextual factors, eligibilityModule sex: ALL, minimumAge: 13 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343805, orgStudyIdInfo id: AJX-101, briefTitle: A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-15, primaryCompletionDateStruct date: 2026-08-15, completionDateStruct date: 2027-02-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ajax Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor., conditionsModule conditions: Primary Myelofibrosis, conditions: Post-Essential Thrombocythemia Myelofibrosis, conditions: Post-Polycythemia Vera Myelofibrosis, conditions: PMF, conditions: PPV-MF, conditions: PET-MF, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This dose escalation study will follow a 3+3 cohort design until the RP2D and/or MTD is determined., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: AJ1-11095, outcomesModule primaryOutcomes measure: Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0., primaryOutcomes measure: Number of patients with Dose Limiting Toxicities (DLTs), primaryOutcomes measure: To establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AJ1-11095, secondaryOutcomes measure: To assess clinical response to AJ1-11095 evaluated by the Total Symptom Score (TSS)., secondaryOutcomes measure: To assess clinical response to AJ1-11095 evaluated by spleen volume assessments., secondaryOutcomes measure: To assess clinical response to AJ1-11095 evaluated by spleen length assessments., secondaryOutcomes measure: To assess clinical response to AJ1-11095 evaluated through spleen size improvement., secondaryOutcomes measure: To evaluate the Area Under the Curve (AUC) of AJ1-11095, secondaryOutcomes measure: To evaluate the Cmax of AJ1-11095, secondaryOutcomes measure: To evaluate the Tmax of AJ1-11095, secondaryOutcomes measure: To evaluate the half-life of AJ1-11095, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Cancer Center, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Andrew Kuykendall, MD, role: CONTACT, phone: 813-745-4639, email: Andrew.Kuykendall@moffitt.org, geoPoint lat: 27.94752, lon: -82.45843, locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Abdulraheem Yacoub, MD, role: CONTACT, email: ayacoub@kumc.edu, geoPoint lat: 39.11417, lon: -94.62746, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: Gabriela Hobbs, MD, role: CONTACT, phone: 617-724-1124, email: ghobbs@partners.org, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Jacqueline Garcia, MD, role: CONTACT, phone: 617-632-1906, email: jacqueline_garcia@dfci.harvard.edu, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Stephen Oh, MD, role: CONTACT, phone: 314-362-8814, email: stoh@wustl.edu, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Icahn School of Medicine at Mount Sinai, city: New York, state: New York, zip: 10029, country: United States, contacts name: John Mascarenhas, MD, role: CONTACT, phone: 212-241-8839, email: john.mascarenhas@mssm.edu, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Levine Cancer Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, contacts name: Michael Grunwald, MD, role: CONTACT, phone: 980-442-4363, email: michael.grunwald@atriumhealth.org, geoPoint lat: 35.22709, lon: -80.84313, locations facility: The Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Uma Borate, MD, role: CONTACT, phone: 614-685-9828, email: uma.borate@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Prithviraj Bose, MD, role: CONTACT, phone: 713-792-7747, email: PBose@mdanderson.org, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06343792, orgStudyIdInfo id: RLS-0071-203, briefTitle: Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease, acronym: AURORA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: ReAlta Life Sciences, Inc., class: INDUSTRY, descriptionModule briefSummary: This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory., conditionsModule conditions: Steroid Refractory GVHD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: RLS-0071, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs), primaryOutcomes measure: Overall Response Rate (ORR) of RLS-0071, secondaryOutcomes measure: Incidence of refractoriness (to RLS-0071 +/- ruxolitinib), secondaryOutcomes measure: Overall corticosteroid use, secondaryOutcomes measure: Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent), secondaryOutcomes measure: Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria, secondaryOutcomes measure: Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD, secondaryOutcomes measure: Change or shift in overall Grade of aGvHD, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Non-relapse mortality, secondaryOutcomes measure: Duration of hospital stay, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06343779, orgStudyIdInfo id: PHA022121-C306, briefTitle: Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema, acronym: RAPIDe-3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Pharvaris Netherlands B.V., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE., conditionsModule conditions: Hereditary Angioedema, conditions: Hereditary Angioedema Type I, conditions: Hereditary Angioedema Type II, conditions: Hereditary Angioedema Types I and II, conditions: Hereditary Angioedema Attack, conditions: Hereditary Angioedema With C1 Esterase Inhibitor Deficiency, conditions: Hereditary Angioedema - Type 1, conditions: Hereditary Angioedema - Type 2, conditions: C1 Esterase Inhibitor [C1-INH] Deficiency, conditions: C1 Esterase Inhibitor Deficiency, conditions: C1 Esterase Inhibitor, Deficiency of, conditions: C1 Inhibitor Deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Deucrictibant, Placebo, outcomesModule primaryOutcomes measure: Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment., secondaryOutcomes measure: Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment., secondaryOutcomes measure: Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment., secondaryOutcomes measure: Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S)., secondaryOutcomes measure: Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment., secondaryOutcomes measure: Time to End of Progression (EoP) in attack symptoms within 12 hours., secondaryOutcomes measure: Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment., secondaryOutcomes measure: Proportion of attacks achieving symptom resolution., secondaryOutcomes measure: Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA)., secondaryOutcomes measure: Time to almost complete or complete symptom relief by AMRA., secondaryOutcomes measure: Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA., secondaryOutcomes measure: Time to EoP in attack symptoms within 12 hours., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Study Site, status: RECRUITING, city: Paradise Valley, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.53115, lon: -111.94265, locations facility: Study Site, status: RECRUITING, city: Walnut Creek, state: California, zip: 94598, country: United States, geoPoint lat: 37.90631, lon: -122.06496, locations facility: Study Site, status: RECRUITING, city: Madison, state: Mississippi, zip: 39110, country: United States, geoPoint lat: 32.46181, lon: -90.11536, hasResults: False
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protocolSection identificationModule nctId: NCT06343766, orgStudyIdInfo id: RECO6U/24-2022, briefTitle: Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-06, primaryCompletionDateStruct date: 2023-11-05, completionDateStruct date: 2023-11-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Amina Fouad Farag, class: OTHER, descriptionModule briefSummary: A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries., conditionsModule conditions: Dental Caries Secondary to Polymorphisms, conditions: Polymorphisms in Enamel Encoding Genes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 204, type: ACTUAL, armsInterventionsModule interventions name: DNA collation and genotyping, outcomesModule primaryOutcomes measure: Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility., eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 22 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, October 6 University, city: Giza, zip: 12511, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06343753, orgStudyIdInfo id: FMASU MD46/2024, briefTitle: Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale (QoR-15) for participant's receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy., conditionsModule conditions: Quality of Recovery, conditions: Pain, Postoperative, conditions: Elective Laparoscopic Cholecystectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Opioid free analgesia, interventions name: Opioid based Anesthesia, outcomesModule primaryOutcomes measure: Quality of recovery, secondaryOutcomes measure: Post operative pain, secondaryOutcomes measure: Postoperative Hypoxia, secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Postoperative bradycardia, secondaryOutcomes measure: Postoperative hypotension, secondaryOutcomes measure: Postoperative hypertension, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain Shams University, city: Cairo, country: Egypt, contacts name: Ahmed El-ghanam, role: CONTACT, phone: 201116171706, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06343740, orgStudyIdInfo id: PSY-2324-S-0136, briefTitle: First Evaluation of COMET-Y, acronym: COMET-Y, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Accare, class: OTHER, descriptionModule briefSummary: The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training., conditionsModule conditions: Self Esteem, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This pilot study is a pre-post study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: COMET-Y, outcomesModule primaryOutcomes measure: Self Esteem, secondaryOutcomes measure: Domain-specific Self Esteem, secondaryOutcomes measure: Mental Health Problems, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Affect, secondaryOutcomes measure: Resilience, secondaryOutcomes measure: Ecological Momentary Assessments - Global self-esteem, secondaryOutcomes measure: Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people, secondaryOutcomes measure: Ecological Momentary Assesments - Domain-specific self-esteem, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343727, orgStudyIdInfo id: HS25870 (H2023:026), briefTitle: A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Seven Oaks Hospital Chronic Disease Innovation Centre, class: NETWORK, collaborators name: University of Manitoba, collaborators name: Manitoba Egg Farmers, descriptionModule briefSummary: The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:* To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.* To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.* To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks., conditionsModule conditions: Kidney Failure, conditions: Frailty, conditions: Kidney Disease, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is an open-label randomized controlled parallel arm feasibility tria, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Egg white protein pudding, interventions name: : Ensure Plus, outcomesModule primaryOutcomes measure: Eligibility to randomization ratio, primaryOutcomes measure: Weekly recruitment rate, primaryOutcomes measure: Adherence to Egg pudding, secondaryOutcomes measure: Serum albumin, secondaryOutcomes measure: Hand grip strength, secondaryOutcomes measure: Change in gait speed, secondaryOutcomes measure: Five rep chair stand time, secondaryOutcomes measure: Tandem balance time, secondaryOutcomes measure: Serum bicarbonate, secondaryOutcomes measure: Calcium, secondaryOutcomes measure: Urine albumin, secondaryOutcomes measure: chloride, secondaryOutcomes measure: phosphorus, secondaryOutcomes measure: Potassium, secondaryOutcomes measure: Sodium, secondaryOutcomes measure: HbA1c, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343714, orgStudyIdInfo id: FB1003-04-101, briefTitle: A Study of FB1003 in Healthy Subject, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: 4B Technologies Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: FB1003, interventions name: Placebo, outcomesModule primaryOutcomes measure: The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo., secondaryOutcomes measure: FB1003 serum concentrations over time, secondaryOutcomes measure: PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of FB1003, secondaryOutcomes measure: Presence of anti-FB1003 antibodies over time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343701, orgStudyIdInfo id: BAİBÜ-SAT4, briefTitle: Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-18, primaryCompletionDateStruct date: 2024-05-05, completionDateStruct date: 2024-06-25, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:* There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.* There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.* There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.* There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children., conditionsModule conditions: Cerebral Palsy, Spastic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Implicit motor imagery, interventions name: Explicit motor imagery, outcomesModule primaryOutcomes measure: Explicit motor imagery -1, secondaryOutcomes measure: Explicit motor imagery - 2, secondaryOutcomes measure: Explicit motor imagery - 3, secondaryOutcomes measure: Implicit motor imagery, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi, status: RECRUITING, city: Zonguldak, state: Ereğli, zip: 67300, country: Turkey, contacts name: Seda AYAZ TAŞ, Phd, role: CONTACT, phone: 05495458040, email: seda.ayaztas@ibu.edu.tr, geoPoint lat: 41.45139, lon: 31.79305, locations facility: Bolu Abant İzzet Baysal University, status: RECRUITING, city: Bolu, state: Gölköy/ Bolu, zip: 14030, country: Turkey, contacts name: Seda Ayaz Taş, Phd, role: CONTACT, phone: 05495458040, email: seda.ayaztas@ibu.edu.tr, geoPoint lat: 40.73583, lon: 31.60611, locations facility: Düzce Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi, status: RECRUITING, city: Düzce, state: Merkez, zip: 81100, country: Turkey, contacts name: Seda AYAZ TAŞ, Phd, role: CONTACT, phone: 05495458040, email: seda.ayaztas@ibu.edu.tr, geoPoint lat: 40.83889, lon: 31.16389, hasResults: False
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protocolSection identificationModule nctId: NCT06343688, orgStudyIdInfo id: BAIBU-FTR-SAT-5, briefTitle: "Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: " Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval.", conditionsModule conditions: Diplegic Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO", outcomesModule primaryOutcomes measure: Wii Balance Board, primaryOutcomes measure: "The Gross Motor Function Measure-88 (D-E) (GMFM-88), primaryOutcomes measure: The Functional Reach Test, primaryOutcomes measure: "The Pediatric Berg Balance Scale (PBBS), secondaryOutcomes measure: "The Eating and Drinking Ability Classification System (EDACS), secondaryOutcomes measure: "The Manual Abilities Classification System (MACS), secondaryOutcomes measure: "The Gross Motor Function Classification System (GMFCS), secondaryOutcomes measure: "The Communication Function Classification System (CFCS), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343675, orgStudyIdInfo id: Dnr 2024-00620-01, briefTitle: Systematic Health-promoting Work Environment Management in Dentistry, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Linkoeping University, class: OTHER_GOV, descriptionModule briefSummary: Research shows that the workplace is an important arena where much can be done to promote a sustainable working life while maintaining health. However, there is a lack of knowledge that is specific to dental care with regard to managers' and employees' perceptions of the work environment, systematic work environment management and work adaptations, as well as what measures in the workplace are necessary to create a health-promoting and sustainable work environment. There is also a lack of knowledge regarding what support employees and managers need in the systematic work environment management and what individual workplace adaptations that can work within dental care organizations., conditionsModule conditions: Occupational Health, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: There is no intervention, outcomesModule primaryOutcomes measure: Work Ability Single Item Scale (WAS), primaryOutcomes measure: Work Ability physical demands, primaryOutcomes measure: Work Ability mental demands, primaryOutcomes measure: Sick leave, secondaryOutcomes measure: Structured Multidisciplinary Work Evaluation Tool (SMET), secondaryOutcomes measure: Satisfaction with work, secondaryOutcomes measure: Global Health, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Health problems related to work, secondaryOutcomes measure: Pain during last 7 days, secondaryOutcomes measure: Psychological safety, secondaryOutcomes measure: Work environment problems, secondaryOutcomes measure: Health related problems, secondaryOutcomes measure: Questions about workplace improvements, work adjustments, and support in the workplace, secondaryOutcomes measure: Work adjustment and discomfort, secondaryOutcomes measure: Support and meaning in work, secondaryOutcomes measure: Sustainable work life, secondaryOutcomes measure: Systematic work environment management and safety, secondaryOutcomes measure: Targeted questions to managers, secondaryOutcomes measure: Work environment responsibility and measures, secondaryOutcomes measure: Work environment management support and education, otherOutcomes measure: Background data, otherOutcomes measure: Semi-structured individual interview study with managers, sub-study 2, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Occupational and Environmental Medicine Centre, status: RECRUITING, city: Linköping, zip: 581 85, country: Sweden, contacts name: Anneli Peolsson, Prof., PhD, role: CONTACT, phone: +46700850599, email: Anneli.Peolsson@regionostergotland.se, contacts name: Carlotte Wåhlin, Assoc. Prof, PhD, role: CONTACT, phone: +46101036267, email: Charlotte.Wahlin@regionostergotland.se, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False
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protocolSection identificationModule nctId: NCT06343662, orgStudyIdInfo id: Meraki_Acquired Brain Injury, briefTitle: Group Music Therapy for Acquired Brain Injury, acronym: Meraki_ABI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI., conditionsModule conditions: Acquired Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: MERAKI_ABI, outcomesModule primaryOutcomes measure: Change in Discomfort ( Baseline (3 Assessments), Pre- Post), secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ, secondaryOutcomes measure: Charlson Comorbidity Index (CCI),, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Dr. Moliner, status: RECRUITING, city: Serra, state: Valencia, country: Spain, contacts name: Miguel Fombuena, PhD, role: CONTACT, email: fombuena_mig@gva.es, contacts name: Selene Valero-Moreno, PhD, role: SUB_INVESTIGATOR, contacts name: Isabel Bellver Vercher, role: SUB_INVESTIGATOR, contacts name: Ana Alegre Soler, role: SUB_INVESTIGATOR, contacts name: José Jorge Botella Trellis, Dr., role: SUB_INVESTIGATOR, contacts name: Cristina Rocío Espejo Fernández, Dra., role: SUB_INVESTIGATOR, contacts name: María Carmen Badía Picazo, Dra., role: SUB_INVESTIGATOR, geoPoint lat: 39.68333, lon: -0.43333, hasResults: False
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protocolSection identificationModule nctId: NCT06343649, orgStudyIdInfo id: CEUMA 187-2023-H, briefTitle: Explicit Motor Imagery in Persistent Pelvic Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:• Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain., conditionsModule conditions: Pelvic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 49, type: ACTUAL, armsInterventionsModule interventions name: Visual, interventions name: Auditory, outcomesModule primaryOutcomes measure: Numerical Rating Scale, primaryOutcomes measure: Pain Vigilance and Awareness Questionnaire, secondaryOutcomes measure: Movement Imagery Questionnaire-Revised, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06343636, orgStudyIdInfo id: VG3927-02.101, briefTitle: A Phase 1 Study of VG-3927 in Healthy Adults, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Vigil Neuroscience, Inc., class: INDUSTRY, descriptionModule briefSummary: A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: VG-3927, interventions name: Placebo, outcomesModule primaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Pharmacology of Miami, city: Miami, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
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protocolSection identificationModule nctId: NCT06343623, orgStudyIdInfo id: fac.med.2018.15, briefTitle: Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-12, primaryCompletionDateStruct date: 2022-10-16, completionDateStruct date: 2022-10-16, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Minia University, class: OTHER, descriptionModule briefSummary: Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall, conditionsModule conditions: Velopharyngeal Insufficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: myomucosal resection and direct closure, interventions name: superiorly based flap, outcomesModule primaryOutcomes measure: Improvement in the speech outcome, secondaryOutcomes measure: obstructive sleep apnea, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Faculty of medicine, city: Minya, zip: 61511, country: Egypt, geoPoint lat: 28.10988, lon: 30.7503, hasResults: False
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protocolSection identificationModule nctId: NCT06343610, orgStudyIdInfo id: VIST TO-UV 01-2024, briefTitle: The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose, acronym: VIST-TO-UV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: VIST - Faculty of Applied Sciences, class: OTHER, descriptionModule briefSummary: This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters., conditionsModule conditions: Minimal Erythema Dose, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Active product, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change of minimal erythema dose, secondaryOutcomes measure: Change of redness formation, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VIST - Faculty of Applied Sciences, Institute of Cosmetics, status: RECRUITING, city: Ljubljana, zip: 1000, country: Slovenia, contacts name: Katja Zmitek, PhD, role: CONTACT, phone: 002831700, email: katja.zmitek@vist.si, contacts name: Katja Žmitek, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Tina Pogačnik, MSc, role: SUB_INVESTIGATOR, contacts name: Petra Keršmanc, MSc, role: SUB_INVESTIGATOR, contacts name: Sara Jereb, Msc, role: SUB_INVESTIGATOR, geoPoint lat: 46.05108, lon: 14.50513, hasResults: False
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protocolSection identificationModule nctId: NCT06343597, orgStudyIdInfo id: 037.HPB.2020.R, briefTitle: Volume Outcome Relationships and Effects, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-06-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities., conditionsModule conditions: Esophageal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Esophageal Cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Richardson Medical Center, status: RECRUITING, city: Richardson, state: Texas, zip: 75082, country: United States, contacts name: Crystee Cooper, DHEd, role: CONTACT, phone: 214-947-1280, email: clinicalresearch@mhd.com, contacts name: Zaid Haddadin, MS, role: CONTACT, phone: 2149471280, email: clinicalresearch@mhd.com, contacts name: Dhiresh Jeyarajah, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.94818, lon: -96.72972, hasResults: False
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protocolSection identificationModule nctId: NCT06343584, orgStudyIdInfo id: 023.NUR.2021.M, briefTitle: Are Personal Smartphones Hurting Work-Life Balance for Nurse Managers?, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2022-05-06, completionDateStruct date: 2022-05-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: For leadership positions with only a handful of staff under their direct chain of command, this may not be all-consuming and detrimental to work-life balance. But for NMs with upwards of 100 direct reports, this can make for a never-ending stream of contact points. This study will implement several communication and behavioral strategies to determine how using provided smartphone tools impact work-life balance and professional burnout., conditionsModule conditions: Burnout, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Study will conducted over a six-month period using a quasi-experimental Pre-test/Post-test design using Stamm's (2009) ProQOL Scale., outcomesModule primaryOutcomes measure: • Impact of smartphone tool utilization will be measured using a pre-study survey and post-study survey using the Professional Quality of Life (ProQOL) Scale (Stamm, 2009)., secondaryOutcomes measure: • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the number of tools implemented during the study duration., secondaryOutcomes measure: • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the frequency of tool utilization during the study duration using a Likert scale., secondaryOutcomes measure: • Participants in Group 2 will self-report on the post-study survey (Appendix D2) using the ProQOL Scale., secondaryOutcomes measure: • Responses to the post-study survey from participants in Group 2 will be compared to participants in Group 1 to determine if utilizing a separate work smartphone during business hours has a greater improvement on work-life balance and burnout., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Mansfield Medical Center, city: Mansfield, state: Texas, zip: 76063, country: United States, geoPoint lat: 32.56319, lon: -97.14168, hasResults: False
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protocolSection identificationModule nctId: NCT06343571, orgStudyIdInfo id: MED-EL_CRD_2022_12, briefTitle: Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode, acronym: LOTOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: MED-EL Elektromedizinische Geräte GesmbH, class: INDUSTRY, descriptionModule briefSummary: This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array., conditionsModule conditions: Cochlear Implants, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343558, orgStudyIdInfo id: 24C302, briefTitle: Gait and Balance Impairment in Rare and Very Rare Neurological Diseases, acronym: GALVANISE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: IRCCS Istituto Neurologico Carlo Besta, descriptionModule briefSummary: Rare and very rare neurological diseases primarily or exclusively affect the nervous system with a prevalence of \< 5 out of 10'000 and 100'000 people, respectively. Besides these, there are undiagnosed neurological diseases: neurological conditions without a diagnosis after completing a full diagnostic examination.Rare, very rare, and undiagnosed neurological diseases are complicated and progressive and often cause variegated motor signs, impairments, and syndromes.Balance and gait are frequently affected in these conditions, already at the clinical examination. These balance and gait impairments limit activities and cause an increased risk of falling. Falls can eventually result in injuries, even severe.There are only a few studies about these diseases, likely because of their rarity. Hence, the clinical presentation and the course of rare and very rare diseases are poorly known or even unknown. Essential information for these conditions' diagnosis, prognosis, treatment and rehabilitation is missing.MaNeNeND is an observational study underway at the Fondazione IRCCS Istituto Neurologico "Carlo Besta" (Milano) aimed at detailing the clinical and biological features of very rare and undiagnosed neurological diseases.Research questions:1. Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?2. Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?3. Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?4. Do the balance and gait impairments in RaVU neurological diseases worsen in time?The current project aims at diagnosing, quantifying and detailing the balance and gait impairment in rare, very rare and undiagnosed neurological diseases.To this aim, questionnaires, clinical scales and instrumental tests will be administered to these patients to collect a wide range of balance and gait measures.These measures will also integrate those collected with MaNeNeND to provide a more detailed description of patients with rare, very rare and diagnosed neurological diseases.Participants will complete two questionnaires: the Dizziness Handicap Inventory - short form (DHI-sf, an ordinal score of self-perceived balance) and the Modified Fatigue Impact Scale (MFIS, an ordinal score of self-perceived fatigue).Moreover, a clinician will administer the Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance), the 10 m walking test (for measuring the gait speed and other gait parameters) and the Timed Up and Go test (an instrumental measure of mobility and balance). Walking and the Timed Up and Go tests will be recorded with a trunk-worn inertial measurement unit.Finally, participants will be asked to complete an instrumental upright stance and gait assessment, the first consisting of standing on posturographic plates and the second of walking on a treadmill equipped with force sensors. When walking on the treadmill, an optoelectronic system will also record the position in time of limbs and trunk.The quantification of the severity of the balance and gait impairment of the patients suffering a rare, very rare or undiagnosed neurological disease will highlight these persons' therapeutic and rehabilitative needs.Comparing the balance and gait impairment of rare, very rare and undiagnosed diseases with those of multiple sclerosis, Parkinson's disease and peripheral neuropathy will highlight if the formers' balance and gait impairment has unique characteristics that could help ease the diagnosis of these uncommon conditions.The longitudinal measurements on rare, very rare and undiagnosed diseases will be paramount to identifying prognostic factors.In addition, the data collected in the current study will be crucial for future studies, for example, for estimating the sample size in clinical trials., conditionsModule conditions: Multiple Sclerosis, conditions: Parkinson Disease, conditions: Peripheral Neuropathy, conditions: Rare Diseases, conditions: Healthy, conditions: Healthy Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires, clinical scales and instrumental tests, outcomesModule primaryOutcomes measure: Balance (Mini-BESTest), primaryOutcomes measure: Balance (Timed Up and Go test), primaryOutcomes measure: Gait speed, primaryOutcomes measure: Gait analysis - kinematic - stride length, primaryOutcomes measure: Gait analysis - kinematic - duration, primaryOutcomes measure: Gait analysis - kinematic - width of the base of support, primaryOutcomes measure: Gait analysis - kinematic - dorsal ankle angle, primaryOutcomes measure: Gait analysis - dynamic - reaction force, primaryOutcomes measure: Gait analysis - dynamic - ankle power, primaryOutcomes measure: Gait analysis - dynamic - energy, primaryOutcomes measure: Posturography - static - centre of pressure position, primaryOutcomes measure: Posturography - static - centre of mass position, primaryOutcomes measure: Posturography - dynamic - centre of pressure position, primaryOutcomes measure: Posturography - dynamic - centre of mass position, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano, status: RECRUITING, city: Milano, state: Milan, country: Italy, contacts name: Antonio Caronni, MD, PhD, role: CONTACT, phone: 02 619111, email: a.caronni@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Istituto Neurologico Carlo Besta, status: ACTIVE_NOT_RECRUITING, city: Milano, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06343545, orgStudyIdInfo id: Rehab_PROADI, briefTitle: Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure, acronym: Rehab, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Hospital Israelita Albert Einstein, class: OTHER, descriptionModule briefSummary: To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, Ward and post-discharge), on health-related quality of life and other long- and short-term outcomes in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19., conditionsModule conditions: Acute Respiratory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Cluster crossover randomized trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Standard of Care, interventions name: Rehabilitation, outcomesModule primaryOutcomes measure: Quality of life, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Days alive and free of hospital, secondaryOutcomes measure: Rehospitalization, secondaryOutcomes measure: Return to work, secondaryOutcomes measure: Anxiety and Depression, secondaryOutcomes measure: New disability, secondaryOutcomes measure: Disability, secondaryOutcomes measure: Clinical Status, secondaryOutcomes measure: Cognitive impairment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343532, orgStudyIdInfo id: NIDA-SXC-Ph1b-001, briefTitle: SXC-2023 Cocaine Interaction Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: National Institute on Drug Abuse (NIDA), class: NIH, collaborators name: Promentis Pharmaceuticals, Inc., collaborators name: Altasciences Company Inc., collaborators name: Technical Resources International, Inc., descriptionModule briefSummary: The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo., conditionsModule conditions: Cocaine Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: SXC-2023, interventions name: SXC-2023 Placebo, outcomesModule primaryOutcomes measure: Determine Safety and Tolerability of Oral SXC-2023 Co-administered with Intravenous Cocaine by Collecting Vital Signs and Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Altasciences Clinical Kansas, Inc., city: Overland Park, state: Kansas, zip: 66212, country: United States, contacts name: Debra J Kelsh, MD, role: CONTACT, phone: 913-696-1601, email: DKelsh@altasciences.com, contacts name: Debra J Kelsh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98223, lon: -94.67079, hasResults: False
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protocolSection identificationModule nctId: NCT06343519, orgStudyIdInfo id: Shocked Patients Monitoring, briefTitle: Echocardiographic and Laboratory Findings in Hemodynamic Monitoring of Shocked Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Shocked patients require prompt and accurate assessment of their hemodynamic status to guide appropriate management. Echocardiography is a valuable tool for assessing cardiac function, while laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate provide insights into tissue perfusion and oxygen metabolism. This study aims to compare echocardiographic findings, including cardiac index, speckle tracking parameters, and tissue Doppler indices, with laboratory findings in the evaluation of hemodynamic monitoring in shocked patients., conditionsModule conditions: Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography, outcomesModule primaryOutcomes measure: Change in Shock Status After Fluid Therapy Based on Echocardiographic Assessment of Fluid Responsiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343506, orgStudyIdInfo id: 2023-929-EXPEDITED, briefTitle: Ankle Dorsiflexion Changes With Assisted Stretching Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-30, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Montana State University, class: OTHER, descriptionModule briefSummary: Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion., conditionsModule conditions: Physical Therapy Modality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Grassroots Ankle Flex, outcomesModule primaryOutcomes measure: Ankle Range of Motion, secondaryOutcomes measure: Ankle Strength, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neuromuscular Biomechanics Laboratory, status: RECRUITING, city: Bozeman, state: Montana, zip: 59717, country: United States, contacts name: Corey Pew, PhD, role: CONTACT, phone: 406-994-6769, email: Corey.Pew@montana.edu, geoPoint lat: 45.67965, lon: -111.03856, hasResults: False
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protocolSection identificationModule nctId: NCT06343493, orgStudyIdInfo id: JALTAF, briefTitle: Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-16, primaryCompletionDateStruct date: 2023-12-15, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Rawalpindi Medical College, class: OTHER, descriptionModule briefSummary: Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.KEY WORDS:* Chronic rhinosinusitis (CRS)* Endoscopic sinus surgery* Boezaart score, conditionsModule conditions: Rhinosinusitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Normal saline heated up to 50 °C, outcomesModule primaryOutcomes measure: Boezaart Score, secondaryOutcomes measure: Bleeding in ml, secondaryOutcomes measure: Duration of Surgery, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Benazir Bhutto Hospital, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, geoPoint lat: 33.6007, lon: 73.0679, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-16, uploadDate: 2024-03-29T12:12, filename: Prot_SAP_000.pdf, size: 142077, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-06-16, uploadDate: 2024-03-24T04:58, filename: ICF_001.pdf, size: 48384, hasResults: False
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protocolSection identificationModule nctId: NCT06343480, orgStudyIdInfo id: SMVOT2024CT, briefTitle: Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2021-08-31, completionDateStruct date: 2021-11-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Federal Teaching Hospital Abakaliki, class: OTHER_GOV, descriptionModule briefSummary: Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes., conditionsModule conditions: Labor Onset and Length Abnormalities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Labour Induction, outcomesModule primaryOutcomes measure: Mean induction delivery interval, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 44 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Alex Ekwueme Federal University Teaching Hospital, city: Abakaliki, state: Ebonyi, zip: 480001, country: Nigeria, geoPoint lat: 6.32485, lon: 8.11368, locations facility: Federal Teaching Hospital, Abakaliki, city: Abakaliki, state: Ebonyi, zip: 480001, country: Nigeria, geoPoint lat: 6.32485, lon: 8.11368, hasResults: False
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protocolSection identificationModule nctId: NCT06343467, orgStudyIdInfo id: A17-376, briefTitle: Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost?, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: HealthPartners Institute, class: OTHER, descriptionModule briefSummary: Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review., conditionsModule conditions: Distal Radius Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Surgeons alternated between using generic implants and conventional implants in their distal radius fracture patients over the course of six months., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients underwent the standard surgical consent, however the specific plate vendor that was used, was not specified by the physician., whoMasked: PARTICIPANT, enrollmentInfo count: 101, type: ACTUAL, armsInterventionsModule interventions name: Generic Volar Locking Plate, interventions name: Conventional Volar Locking Plate, outcomesModule primaryOutcomes measure: 90-day reoperation rate, primaryOutcomes measure: 90-day readmission rate, primaryOutcomes measure: 90-day mortality rate, secondaryOutcomes measure: Implant Cost, secondaryOutcomes measure: Tourniquet Time, secondaryOutcomes measure: Estimated Blood Loss, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Regions Hospital, city: Saint Paul, state: Minnesota, zip: 55101, country: United States, geoPoint lat: 44.94441, lon: -93.09327, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-08-16, uploadDate: 2024-03-14T00:31, filename: Prot_SAP_000.pdf, size: 218626, hasResults: False
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protocolSection identificationModule nctId: NCT06343454, orgStudyIdInfo id: 2023/04-03(KA-22111), briefTitle: The Effect of Different Head Positions on Occlusal Contacts During Digital Interocclusal Bite Registration, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2024-01-27, completionDateStruct date: 2024-03-03, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is:• Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken.Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts., conditionsModule conditions: Occlusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Digital Interocclusal Record In Different Head Positions, outcomesModule primaryOutcomes measure: Number of Occlusal Contacts, primaryOutcomes measure: Density of Occlusal Contacts, primaryOutcomes measure: Location of Occlusal Contacts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, 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: 2023-04-17, uploadDate: 2024-03-29T04:39, filename: Prot_SAP_000.pdf, size: 212403, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-04-17, uploadDate: 2024-03-29T04:39, filename: ICF_001.pdf, size: 97067, hasResults: False
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protocolSection identificationModule nctId: NCT06343441, orgStudyIdInfo id: SH9H-2024-T29-2, briefTitle: Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis, conditionsModule conditions: Edentulous Jaw, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: intraoral scan, interventions name: open tray impression, outcomesModule primaryOutcomes measure: Grade of framework passive fit, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06343428, orgStudyIdInfo id: IEO 1519, briefTitle: Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients, acronym: TAPIOCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-19, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2026-07-19, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed., conditionsModule conditions: Neuroendocrine Neoplasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Immunohistochemical characteristics analysis, secondaryOutcomes measure: Review of the functional imaging, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, zip: 20141, country: Italy, contacts name: Francesca Spada, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06343415, orgStudyIdInfo id: H-23052844, briefTitle: Robot-assisted Training After Traumatic Brain Injury and Disorders of Consciousness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Christina Kruuse, class: OTHER, descriptionModule briefSummary: The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after traumatic brain injury and disorders of consciousness. The main questions it aims to answer are:* Is the protocol feasible concerning inclusion in the study?* Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail., conditionsModule conditions: Traumatic Brain Injury, conditions: Disorders of Consciousness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: AB - BA, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Assessors are blinded to allocation for the following exploratory clinical outcome scales: "Disability Rating Scale" and "Coma Recovery Scale-Revised".Data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: GAIT-assisted training, interventions name: STEP-assisted training, outcomesModule primaryOutcomes measure: Inclusion Rate, primaryOutcomes measure: Completion Ratio of protocols, secondaryOutcomes measure: Exploratory Safety Outcomes, otherOutcomes measure: Disability Rating Scale (DRS), otherOutcomes measure: Coma Recovery Scale-Revised (CRS-R) and level of consciousness, otherOutcomes measure: Early Functional Abilities (EFA), otherOutcomes measure: Functional Independence Measure (FIM), otherOutcomes measure: Physical activity intensity, otherOutcomes measure: Mean arterial pressure (MAP), otherOutcomes measure: Heart Rate Variability (HRV), otherOutcomes measure: Behavioural Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of brain and spinal cord injury, status: RECRUITING, city: Glostrup, state: Greater Copenhagen, zip: 2600, country: Denmark, contacts name: Christina Kruuse, Professor, role: CONTACT, email: christina.kruuse@regionh.dk, contacts name: Vibeke Wagner, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.6666, lon: 12.40377, hasResults: False
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protocolSection identificationModule nctId: NCT06343402, orgStudyIdInfo id: TBBO8520-101, secondaryIdInfos id: ONKORAS-101, type: OTHER, domain: TheRas, briefTitle: Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-02, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: TheRas, Inc, class: INDUSTRY, descriptionModule briefSummary: A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer, conditionsModule conditions: Non-small Cell Lung Cancer, conditions: Metastatic Non-Small Cell Lung Cancer, conditions: NSCLC, conditions: KRAS G12C, conditions: Metastatic Lung Cancer, conditions: Advanced Lung Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Phase 1a: sequential/parallel, Phase 1b: parallel, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: BBO-8520, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Adverse Events, primaryOutcomes measure: Dose-limiting toxicities (DLTs), secondaryOutcomes measure: To evaluate preliminary antitumor activity of BBO-8520, secondaryOutcomes measure: To evaluate preliminary antitumor activity of BBO-8520, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: To characterize the pharmacokinetics (PK) of BBO-8520, secondaryOutcomes measure: To characterize the pharmacokinetics (PK) of BBO-8520, secondaryOutcomes measure: To characterize the pharmacokinetics (PK) of BBO-8520, secondaryOutcomes measure: To characterize the pharmacokinetics (PK) of BBO-8520, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, locations facility: SCRI Oncology Partners, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: NEXT Oncology, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, locations facility: Peter MacCallum Cancer Centre, status: RECRUITING, city: Melbourne, state: Victoria, zip: 3051, country: Australia, geoPoint lat: -37.814, lon: 144.96332, hasResults: False
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protocolSection identificationModule nctId: NCT06343389, orgStudyIdInfo id: Soh-Med-24-03-14MS, briefTitle: Acute Kidney Injury in Patients With Liver Cirrhosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital., conditionsModule conditions: Acute Kidney Injury in Patients With Liver Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: serum creatinine, outcomesModule primaryOutcomes measure: Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06343376, orgStudyIdInfo id: I-3641523, secondaryIdInfos id: NCI-2024-01818, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3641523, type: OTHER, domain: Roswell Park Cancer Institute, briefTitle: Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2029-04-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies., conditionsModule conditions: Recurrent Chronic Lymphocytic Leukemia, conditions: Recurrent Diffuse Large B-Cell Lymphoma, conditions: Recurrent Follicular Lymphoma, conditions: Recurrent High Grade B-Cell Lymphoma, conditions: Recurrent Mantle Cell Lymphoma, conditions: Recurrent Transformed Chronic Lymphocytic Leukemia, conditions: Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, conditions: Refractory Chronic Lymphocytic Leukemia, conditions: Refractory Diffuse Large B-Cell Lymphoma, conditions: Refractory Follicular Lymphoma, conditions: Refractory High Grade B-Cell Lymphoma, conditions: Refractory Mantle Cell Lymphoma, conditions: Refractory Transformed Chronic Lymphocytic Leukemia, conditions: Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Cyclophosphamide, interventions name: Echocardiography, interventions name: EGFRt/19-28z/IL-12 CAR T-lymphocytes, interventions name: Fludarabine Phosphate, interventions name: Leukapheresis, interventions name: Multigated Acquisition Scan, interventions name: Positron Emission Tomography, outcomesModule primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells, secondaryOutcomes measure: Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi), secondaryOutcomes measure: Incidence of CR/CRi + partial response (PR) (ORR), secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Modified T-cell persistence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Francisco J. Hernandez-ILizaliturri, role: CONTACT, phone: 716-845-1642, email: Francisco.Hernandez@RoswellPark.org, contacts name: Francisco J. Hernandez-ILizaliturri, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
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protocolSection identificationModule nctId: NCT06343363, orgStudyIdInfo id: 318352, briefTitle: Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety, acronym: EARLY-Edge, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Oxford University Hospitals NHS Trust, class: OTHER, collaborators name: Edwards Lifesciences, descriptionModule briefSummary: Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.This prospective, observational cohort study will examine the safety and feasibility of this practice., conditionsModule conditions: Mitral Regurgitation, conditions: Tricuspid Regurgitation, conditions: Mitral Repair, conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Early discharge protocol, outcomesModule primaryOutcomes measure: Proportion of patients discharged 'early' after edge -to-edge repair, primaryOutcomes measure: All - cause rehospitalisation after completion of procedure, primaryOutcomes measure: All cause death after completion of procedure, secondaryOutcomes measure: Hospital length of stay, secondaryOutcomes measure: Proportion of patients requiring intensive care unit care, secondaryOutcomes measure: Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days, secondaryOutcomes measure: Symptomatic improvement, secondaryOutcomes measure: Heart failure hospitalisation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: John Radcliffe Hospital, status: RECRUITING, city: Oxford, state: Oxfordshire, zip: OX3 9DU, country: United Kingdom, contacts name: Sam Dawkins, MBBS MRCP BSc DPhil, role: CONTACT, email: Sam.Dawkins@ouh.nhs.uk, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False
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protocolSection identificationModule nctId: NCT06343350, orgStudyIdInfo id: OPTDR01P, briefTitle: OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Optain Health, class: INDUSTRY, descriptionModule briefSummary: In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR., conditionsModule conditions: Diabetic Retinopathy, conditions: Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: OPTDR01 software application, outcomesModule primaryOutcomes measure: Enrollment rate of eligible participants at clinical site, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Precision Research Institute, city: San Diego, state: California, zip: 92114, country: United States, contacts name: Marie Inocentes, role: CONTACT, phone: 619-501-0371, phoneExt: 310, email: marie@prisandiego.com, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
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protocolSection identificationModule nctId: NCT06343337, orgStudyIdInfo id: MSKUDİSCLİNİCALTRİALS_FYİLMAZ., briefTitle: The Effects of Pregnancy on Oral Health, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-20, primaryCompletionDateStruct date: 2023-04-01, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Muğla Sıtkı Koçman University, class: OTHER, descriptionModule briefSummary: The aim of this study was to evaluate the effects of pregnancy on salivary pH, flow rate, caries experience and periodontal status.The main questions it aims to answer are:* Does pregnancy affect caries experience and periodontal status?* Does pregnancy affect salivary pH and flow rate?* Is there a difference between pregnant and non-pregnant woman with respect to caries experience, periodontal status, salivary pH and flow rate?* Is there a difference among first, second and third trimester with respect to caries experience, periodontal status, salivary pH and flow rate?, conditionsModule conditions: Pregnancy Related, conditions: Dental Caries, conditions: Periodontal Diseases, conditions: Saliva Altered, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: The individual who evaluates the salivary pH and flow rate., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 198, type: ACTUAL, armsInterventionsModule interventions name: Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman, outcomesModule primaryOutcomes measure: The effects of pregnancy on caries experience, primaryOutcomes measure: The effects of pregnancy on periodontal status., primaryOutcomes measure: The effects of pregnancy on salivary pH., primaryOutcomes measure: The effects of pregnancy on salivary flow rate., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fatma Yilmaz, city: Mentese, state: Mugla, zip: 48000, country: Turkey, hasResults: False
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protocolSection identificationModule nctId: NCT06343324, orgStudyIdInfo id: 2023/012, briefTitle: Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, descriptionModule briefSummary: Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV., conditionsModule conditions: Noninvasive Ventilation, conditions: COPD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Web-based education, outcomesModule primaryOutcomes measure: Patient Identifiable Characteristics Form, secondaryOutcomes measure: S³-NIV Questionnaire, otherOutcomes measure: insomnia severity index, otherOutcomes measure: Expected behavioral changes in the individual survey, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences University Konya Beyhekim Training and Research Hospital, city: Konya, state: Selçuklu, zip: 42060, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06343311, orgStudyIdInfo id: EBUS22CD19AR100, briefTitle: T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL), acronym: Starlight-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Estrella Biopharma, Inc., class: INDUSTRY, collaborators name: Eureka Therapeutics Inc., descriptionModule briefSummary: This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase., conditionsModule conditions: B-Cell Non-Hodgkin's Lymphoma (NHL), conditions: Lymphoma, Non-Hodgkins, conditions: Lymphomas Non-Hodgkin's B-Cell, conditions: Non-Hodgkin Lymphoma, conditions: Non-Hodgkin's Lymphoma, conditions: Large B-Cell Lymphoma, conditions: Lymphoma, Non-Hodgkin's, Adult, conditions: Lymphoma, conditions: Refractory Non-Hodgkin Lymphoma, conditions: Relapsed Non-Hodgkin Lymphoma, conditions: Lymphoma, Non-Hodgkin, conditions: HIV Associated Lymphoma, conditions: CNS Lymphoma, conditions: High-grade B-cell Lymphoma, conditions: Refractory B-Cell Non-Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: EB103, outcomesModule primaryOutcomes measure: To assess the Dose Limiting Toxicities of EB103., primaryOutcomes measure: Incidence rates of Treatment-Emergent Adverse Events of EB103., primaryOutcomes measure: Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103., primaryOutcomes measure: To determine the Recommended Phase II Dose (RP2D) of EB103., secondaryOutcomes measure: To assess the Overall Response Rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Disease Control Rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Duration of Response of EB103 in our study subject population., secondaryOutcomes measure: To assess the Progression-Free Survival rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Event-Free Survival rate of EB103 in our study subject population., secondaryOutcomes measure: To assess the Overall Survival rate of EB103 in our study subject population., secondaryOutcomes measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax)., secondaryOutcomes measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax)., secondaryOutcomes measure: To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343298, orgStudyIdInfo id: ES_MANP_2001, briefTitle: To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: E-Star BioTech, LLC, class: INDUSTRY, collaborators name: Mayo Clinic, collaborators name: PPD, descriptionModule briefSummary: This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action., conditionsModule conditions: Difficult to Control Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: MANP, interventions name: Placebo Matched control, outcomesModule primaryOutcomes measure: Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42., primaryOutcomes measure: Incidence and severity of Adverse events through 4- weeks post end of treatment., primaryOutcomes measure: Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment., primaryOutcomes measure: Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment., secondaryOutcomes measure: Change in Clinic sitting systolic blood pressure, secondaryOutcomes measure: Pharmacokinetics - Cmax, secondaryOutcomes measure: Pharmacokinetics - Tmax, secondaryOutcomes measure: Anti-drug Antibody, otherOutcomes measure: Differential Outcomes in African-American Subject versus Non-African American Subjects, otherOutcomes measure: Metabolic biomarkers - Glucose, otherOutcomes measure: Metabolic biomarkers - Insulin, otherOutcomes measure: Metabolic biomarkers - HbA1C, otherOutcomes measure: Lipid biomarkers - HDL, otherOutcomes measure: Lipid biomarkers - LDL, otherOutcomes measure: Lipid biomarkers - TG, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06343285, orgStudyIdInfo id: 20231215, briefTitle: Upper Limb Tremor Reduction in Essential Tremor Patients, acronym: ULTRE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Encora, Inc., class: INDUSTRY, descriptionModule briefSummary: This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor., conditionsModule conditions: Essential Tremor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Three different arms in a randomized order, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization schedule maintained by non-Clinical personnel, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Encora Therapeutics Tremor Reduction Device, outcomesModule primaryOutcomes measure: Tolerability, primaryOutcomes measure: Safety, secondaryOutcomes measure: Bain & Findley Activity of Daily Living (BF-ADL) #2, secondaryOutcomes measure: BF-ADL #4, secondaryOutcomes measure: BF-ADL #17, secondaryOutcomes measure: BF-ADL #21, secondaryOutcomes measure: Patient Global Impression of Change (PGI-C), secondaryOutcomes measure: Clinician Global Impression of Change (CGI-C), secondaryOutcomes measure: Tremor power as measured by gyroscope, otherOutcomes measure: The Essential Tremor Rating Scale (TETRAS) #2.4, otherOutcomes measure: TETRAS #2.6, otherOutcomes measure: TETRAS #2.8, otherOutcomes measure: Patient Global Impression of Severity (PGI-S), otherOutcomes measure: Clinician Global Impression of Severity (CGI-S), otherOutcomes measure: Tremor power as measured by accelerometer, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Encora Therapeutics, status: RECRUITING, city: Cambridge, state: Massachusetts, zip: 02139, country: United States, contacts name: Kristi Winterfeldt, MSHS, role: CONTACT, phone: 763-248-1210, email: kristi@encoratherapeutics.com, contacts name: Taylor Robertson, role: CONTACT, phone: 7814221105, email: taylor@encoratherapeutics.com, contacts name: Kristi Winterfeldt, MSHS, role: PRINCIPAL_INVESTIGATOR, contacts name: Fatta Nahab, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.3751, lon: -71.10561, hasResults: False
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protocolSection identificationModule nctId: NCT06343272, orgStudyIdInfo id: LEGO, briefTitle: Lymphocyte Enhancement in Gastroenteric Oncology, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-22, primaryCompletionDateStruct date: 2024-12-22, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, collaborators name: University of Pavia, descriptionModule briefSummary: LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens., conditionsModule conditions: Advanced Gastrointestinal Cancers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: EAA supplementation, interventions name: Isocaloric placebo, outcomesModule primaryOutcomes measure: Exit from lymphopenia, secondaryOutcomes measure: The change in the % of lymphocytes over time, secondaryOutcomes measure: The proportion of patients with G3-G5 toxicity, secondaryOutcomes measure: The percentage of chemotherapy dose administered compared to that expected for the patients., secondaryOutcomes measure: plasma aminoacids composition chang during treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, zip: 27100, country: Italy, contacts name: Alessandra Ferrari, role: CONTACT, phone: 0382.503689, phoneExt: +39, email: alessandra.ferrari@smatteo.pv.it, contacts name: Salvatore Corallo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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