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protocolSection identificationModule nctId: NCT06271733, orgStudyIdInfo id: 21110503, briefTitle: TMS for Veterans Attending a 2-week Intensive Outpatient Program for PTSD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-01-11, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Rush University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this study is to determine whether complementing regular intensive PTSD treatment with intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) can improve treatment response for individuals attending a 2-week intensive outpatient program (IOP) for PTSD. Specifically, the present study will compare iTBS versus a sham condition during the second week of the 2- week IOP for veterans who have not experienced PTSD symptom reductions over the course of the first week of the Road Home Program intensive PTSD treatment program., conditionsModule conditions: PTSD, 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: 30, type: ESTIMATED, armsInterventionsModule interventions name: TMS, interventions name: Sham, outcomesModule primaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University Medical Center, city: Chicago, state: Illinois, zip: 60612, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06271720, orgStudyIdInfo id: faculty of physical therapy, briefTitle: Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Noha Elserty, class: OTHER, descriptionModule briefSummary: This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome, conditionsModule conditions: Shoulder Impingement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: visceral manipulation, interventions name: integrated neuromuscular inhibition, outcomesModule primaryOutcomes measure: pain intensity, primaryOutcomes measure: pain pressure threshold, primaryOutcomes measure: shoulder range of motion, primaryOutcomes measure: shoulder functional level, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06271707, orgStudyIdInfo id: ANES-2024-32720, briefTitle: Stellate Ganglion Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine if the addition of an ultrasound guided left sided stellate ganglion block with bupivacaine in patients undergoing esophagectomy, pneumonectomy, or lobectomy will result in lower rates of postoperative atrial fibrillation as compared to standard of care., conditionsModule conditions: Esophagectomy, conditions: Pneumonectomy, conditions: Lobectomy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: This is a double blind randomized prospective controlled trial. Randomization will be 1:1., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: 0.5% bupivacaine, interventions name: Saline, outcomesModule primaryOutcomes measure: an ultrasound guided left stellate ganglion block with 5 mL of saline., primaryOutcomes measure: Atrial fibrillation; Other arrhythmias; Adverse events., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271694, orgStudyIdInfo id: STUDY22020027, secondaryIdInfos id: 1K23DC020215-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23DC020215-01, briefTitle: Activity and Participation in Vestibular Disorders, acronym: APV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-11-29, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Pittsburgh, class: OTHER, collaborators name: National Institute on Deafness and Other Communication Disorders (NIDCD), descriptionModule briefSummary: This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation., conditionsModule conditions: Vestibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Vestibular Rehabilitation, outcomesModule primaryOutcomes measure: Late-life Function and Disability Instrument, primaryOutcomes measure: Dizziness Handicap Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC-Rehab Institute, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15206, country: United States, contacts name: Chelsea Behling, role: CONTACT, phone: 412-624-8811, email: [email protected], geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06271681, orgStudyIdInfo id: 2120135-1, briefTitle: Evaluation of PCV15 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: VA Sierra Nevada Health Care System, class: FED, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster series of 15-valent pneumococcal conjugate vaccine followed by 23-valent pneumococcal polysaccharide vaccine 8 weeks later. Immune response will be assessed by opsonophagocytic assay reactivity and IgG Geometric mean concentration changes., conditionsModule conditions: Pneumococcal Vaccines, conditions: Immunosuppression, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: 15-valent pneumococcal conjugate vaccine, interventions name: 23-valent pneumococcal polysaccharide vaccine, outcomesModule primaryOutcomes measure: Change in opsonophagocytic assay (OPA) geometric mean titers (GMT), primaryOutcomes measure: Change in Immunoglobulin G (IgG) geometric mean concentrations (GMC), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06271668, orgStudyIdInfo id: 23-2356, secondaryIdInfos id: R61DA057610, type: NIH, link: https://reporter.nih.gov/quickSearch/R61DA057610, briefTitle: Clinical Decision Support to Improve System Naloxone Co-prescribing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months., conditionsModule conditions: Medication Abuse, conditions: Harm Reduction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200000, type: ESTIMATED, armsInterventionsModule interventions name: Naloxone Co-prescribing Clinical Decision Support (CDS), outcomesModule primaryOutcomes measure: Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone, secondaryOutcomes measure: Clinical decision support (CDS) acceptance rate, secondaryOutcomes measure: Subsequent opioid overdose/poisonings rates, secondaryOutcomes measure: Naloxone dispensed rate, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 89 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Hospital, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06271655, orgStudyIdInfo id: BFD-RST-23-004, briefTitle: Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE), acronym: RADIATE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Christopher Payette, class: OTHER, collaborators name: BioMérieux, descriptionModule briefSummary: The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests., conditionsModule conditions: Acute Respiratory Infection, conditions: Viral Infection, conditions: Upper Respiratory Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: SPOTFIRE R Panel, outcomesModule primaryOutcomes measure: Antibiotic Use, secondaryOutcomes measure: Emergency Department Length of Stay, secondaryOutcomes measure: Utilization of Alternative Tests, secondaryOutcomes measure: Patient Confidence in Diagnosis, secondaryOutcomes measure: Provider Confidence in Diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: George Washington University Hospital, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20037, country: United States, contacts name: Ryan Heidish, role: CONTACT, email: [email protected], contacts name: Christopher Payette, MD, role: CONTACT, email: [email protected], contacts name: Christopher Payette, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrew Meltzer, MD, MS, role: SUB_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False |
protocolSection identificationModule nctId: NCT06271642, orgStudyIdInfo id: 73822, briefTitle: Impact of Bluetooth Haptics Device Distraction on Mechanical Pain Thresholds Induced by PinPrick Stimulators, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This is a prospective, crossover study of healthy participants evaluating the mechanical pain threshold for weighted pinprick stimuli., conditionsModule conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Bluetooth Haptic Device (Experimental Frequency) + Needle Sham only, interventions name: Bluetooth Haptic Device (Control Frequency) + Needle Sham only, outcomesModule primaryOutcomes measure: Mechanical Pain Threshold, secondaryOutcomes measure: Mechanical pain sensitivity, secondaryOutcomes measure: Anxiety scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271629, orgStudyIdInfo id: 2204-042-1314, briefTitle: Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-02-26, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Ministry of Health, Republic of Korea, descriptionModule briefSummary: The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates.However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications.Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them., conditionsModule conditions: Rectal Cancer, conditions: Low Anterior Resection Syndrome, conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Insomnia severity index, outcomesModule primaryOutcomes measure: Impairment in the quality of sleep and quality of life in patients with Low Anterior Resection Syndrome (LARS)., secondaryOutcomes measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), secondaryOutcomes measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR29), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06271616, orgStudyIdInfo id: MC1873, secondaryIdInfos id: NCI-2024-01061, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 18-008754, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD., conditionsModule conditions: Chronic Graft Versus Host Disease, conditions: Hematopoietic and Lymphatic System Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Echocardiography, interventions name: Ibrutinib, outcomesModule primaryOutcomes measure: Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD), secondaryOutcomes measure: Cumulative incidence of non-relapse mortality (NRM), secondaryOutcomes measure: Cumulative incidence of relapse, secondaryOutcomes measure: Cumulative incidence of moderate/severe chronic GVHD, secondaryOutcomes measure: Cumulative incidence of moderate/severe chronic GVHD, secondaryOutcomes measure: Cumulative incidence of chronic GVHD of all grades, secondaryOutcomes measure: Cumulative incidence of late acute GVHD, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: NIH moderate/severe GVHD and relapse free survival (CRFS), secondaryOutcomes measure: Type and duration of immune suppressive therapy, secondaryOutcomes measure: Cumulative incidence of complete immune suppression (IS) discontinuation, secondaryOutcomes measure: Incidence of adverse events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Mohamed A. Kharfan Dabaja, M.D., M.B.A., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False |
protocolSection identificationModule nctId: NCT06271603, orgStudyIdInfo id: 23.02645.000357-MS01, secondaryIdInfos id: CPP Ile de France III, type: OTHER, domain: 23.02645.000357-MS01, briefTitle: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas, acronym: ECOBASO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Damae Medical, class: INDUSTRY, descriptionModule briefSummary: This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas., conditionsModule conditions: Basal Cell Carcinoma of the Skin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 704, type: ESTIMATED, armsInterventionsModule interventions name: diagnosis based on deepLive™ LC-OCT device, interventions name: diagnosis based on skin biopsy, outcomesModule primaryOutcomes measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management., primaryOutcomes measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management., primaryOutcomes measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management., secondaryOutcomes measure: Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm., secondaryOutcomes measure: Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm., secondaryOutcomes measure: Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm., secondaryOutcomes measure: Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm., secondaryOutcomes measure: Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm, secondaryOutcomes measure: Estimate the actual cost of conducting the diagnosis with LC-OCT technology., secondaryOutcomes measure: Compare healthcare consumption between the two groups at 1 year., secondaryOutcomes measure: Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Ambroise Paré, city: Boulogne-Billancourt, zip: 92100, country: France, contacts name: Professeur Philippe SAIAG, role: CONTACT, phone: 800-555-5555, email: [email protected], contacts name: Philippe SAIAG, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.83333, lon: 2.25, hasResults: False |
protocolSection identificationModule nctId: NCT06271590, orgStudyIdInfo id: CM-US-R03, briefTitle: MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels, acronym: MAGICAL-SV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Concept Medical Inc., class: INDUSTRY, collaborators name: Cardiovascular Research Foundation, New York, descriptionModule briefSummary: This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees., conditionsModule conditions: Coronary Artery Disease, conditions: Native Coronary Artery Stenosis, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2:1 randomized trial (MagicTouchTM Sirolimus-Coated Balloon VS Drug eluting stent (ZES or EES), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1605, type: ESTIMATED, armsInterventionsModule interventions name: Sirolimus Drug Coated Balloon, interventions name: Drug eluting stents (DES), outcomesModule primaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Procedural success, secondaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Ischemia driven target vessel revascularization (ID-TVR), secondaryOutcomes measure: Target vessel revascularization (TVR), secondaryOutcomes measure: Any revascularization, secondaryOutcomes measure: Target vessel failure (TVF), secondaryOutcomes measure: Q-wave myocardial infarction (MI), secondaryOutcomes measure: Non Q-wave myocardial infarction (MI), secondaryOutcomes measure: Any myocardial infarction (MI), secondaryOutcomes measure: Target vessel myocardial infarction (TV MI), secondaryOutcomes measure: Spontaneous myocardial infarction (MI), secondaryOutcomes measure: Procedural myocardial infarction (MI), secondaryOutcomes measure: Cardiovascular mortality, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Cardiovascular mortality or myocardial infarction (MI), secondaryOutcomes measure: All-cause mortality or MI, secondaryOutcomes measure: All-cause mortality, myocardial infarction (MI) or target vessel revascularization (TVR), secondaryOutcomes measure: Any probable or definite stent thrombosis, secondaryOutcomes measure: Probable stent thrombosis, secondaryOutcomes measure: Definite stent thrombosis, otherOutcomes measure: Angina as assessed by SAQ-7 (Seattle Angina Questionnaire), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271577, orgStudyIdInfo id: PRO-0013, briefTitle: Smartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II, acronym: STLEUISII, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: AliveCor, class: INDUSTRY, descriptionModule briefSummary: AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI).Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices., conditionsModule conditions: Myocardial Infarction, conditions: Ischemia, conditions: Myocardial Ischemia, conditions: Heart Diseases, conditions: Cardiovascular Diseases, conditions: Vascular Diseases, conditions: Heart Attack, conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: AliveCor 12-lead ECG, outcomesModule primaryOutcomes measure: Inter-rater variability for Standard 12-lead ECG readings, primaryOutcomes measure: Inter-rater variability for AC 12L ECG readings, primaryOutcomes measure: Number of standard 12-lead ECG readings requiring a consensus consultation, primaryOutcomes measure: Number of AC 12L ECG readings requiring a consensus consultation, primaryOutcomes measure: Sensitivity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: Specificity of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: Positive predictive value of AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: Negative predictive power of the AC 12L ECGs requiring consensus consultation, compared to standard 12-lead ECG requiring consensus consultation, for the diagnosis of STEMI, primaryOutcomes measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is STEMI, primaryOutcomes measure: Mean subjective correlation score for AC 12L ECGs in which the standard 12-lead ECG diagnosis is not STEMI, primaryOutcomes measure: Mean summative ST-segment elevation, summative ST-segment depression and summative ST-segment deviation for AC 12L ECGs compared to standard 12-lead ECGs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Julianne Rumer, role: CONTACT, phone: 507-255-1034, email: [email protected], contacts name: Anna Pick, role: CONTACT, phone: 507-775-0630, email: [email protected], contacts name: Gregory Barsness, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False |
protocolSection identificationModule nctId: NCT06271564, orgStudyIdInfo id: FDASU-Rec IM012415, briefTitle: Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: ZnO nanoparticles are now being widely researched for their anticancer properties. They show relatively high biocompatibility. They also show selective cytotoxicity against cancerous cells in in vitro condition compared with other nanoparticles. They can be further surface engineered to show increased selective cytotoxicity. The synthesis process of ZnO nanoparticles is relatively easy, with a wide variety of methods. Owing to these different methods of synthesis, their size and size distribution can be easily controlled. One of the novel methods of synthesis of ZnO is Magnetite ZnO-Fe3O4 Composite Nanoparticles.Magnetite ZnO-Fe3O4 conjugated NPs retained inherent selective property of ZnO and magnetic property of Fe3O4 NPs and showed preferential cytotoxicity towards breast cancer cell line MDA-MB-231, with no significant cytotoxicity towards noncancerous Mouse Fibroblast NIH 3T3 cell., conditionsModule conditions: Oral Potentially Malignant Lesions, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Magnetite ZnO Composite Nanoparticles, interventions name: Topical Placebo Gel, outcomesModule primaryOutcomes measure: Change in the clinical size in Low to Moderate Dysplastic OPLs using Magnetite ZnO-Fe3O4 Composite NPs using standardized photographs of the oral marker lesion for each patient, secondaryOutcomes measure: Effect of Magnetite ZnO-Fe3O4 Composite NPs on the change of the degree of Dysplasia during histopathological examination using a biopsy, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Ain shams University, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Nourhane Omara, Master's, role: CONTACT, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06271551, orgStudyIdInfo id: ESTRACISE, briefTitle: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy, acronym: ESTRACISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Central Finland Hospital District, class: OTHER, collaborators name: Tampere University, collaborators name: University of Jyvaskyla, collaborators name: Tampere University Hospital, descriptionModule briefSummary: The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 310, type: ESTIMATED, armsInterventionsModule interventions name: Transdermal estrogen, interventions name: Active Comparator: Androgen deprivation therapy, interventions name: Resistance training, outcomesModule primaryOutcomes measure: The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy., secondaryOutcomes measure: The occurrence of androgen deprivation therapy induced adverse effects., secondaryOutcomes measure: Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content, secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins), secondaryOutcomes measure: Number of participants with resistance training induced adverse events., secondaryOutcomes measure: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)., secondaryOutcomes measure: The Patient Health Questionnaire score (PHQ-9) overall and subdomain score., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271538, orgStudyIdInfo id: EP-USM-122023-001, briefTitle: Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: EP Plus Group Sdn Bhd, class: INDUSTRY, descriptionModule briefSummary: The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention., conditionsModule conditions: Irritable Bowel Syndrome, conditions: Gastrointestinal Diseases, conditions: Colonic Diseases, Functional, conditions: Intestinal Disease, conditions: Digestive System Disease, conditions: Pathologic Processes, conditions: Colonic Disease, conditions: Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Skal Pro, interventions name: Placebo, outcomesModule primaryOutcomes measure: Improving the severity of symptoms in individuals with IBS, assessed by IBS Symptom Severity Scale (IBSSSS), secondaryOutcomes measure: Change in stool consistency (Bristol Stool Scale), assessed by daily stool diary, secondaryOutcomes measure: Change in stool frequency and satisfaction after passing stool, assessed by daily stool diary, secondaryOutcomes measure: Change in abdominal bloating, assessed by Bloating Severity Questionnaire (BSQ), secondaryOutcomes measure: Improvement in Quality of Life, assessed by EQ-5D-5L Questionnaire, secondaryOutcomes measure: Change in Visceral Sensitivity Index, secondaryOutcomes measure: Assessment of psychological dysfunction suing Catastrophizing Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universiti Sains Malaysia, city: Kubang Kerian, state: Kelantan, zip: 16150, country: Malaysia, contacts name: Yeong Yeh Lee, MD, PhD, role: CONTACT, phone: +6097676846, phoneExt: 6845, email: [email protected], contacts name: Yeong Yeh Lee, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Thai Hau Koo, MD, role: SUB_INVESTIGATOR, geoPoint lat: 6.09123, lon: 102.27938, hasResults: False |
protocolSection identificationModule nctId: NCT06271525, orgStudyIdInfo id: P.T.REC/012/002532, briefTitle: Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis, acronym: CT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Shady Abdelsattar Refaat, class: OTHER, descriptionModule briefSummary: this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis, conditionsModule conditions: Cervical Spondylosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: cupping therapy, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: cupping therapy, outcomesModule primaryOutcomes measure: the nitric oxide level, secondaryOutcomes measure: cervical range of motion, secondaryOutcomes measure: pain intensity, eligibilityModule sex: ALL, minimumAge: 24 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06271512, orgStudyIdInfo id: REG-501, briefTitle: A Study of Participants With β-Thalassemia Treated With Betibeglogene Autotemcel, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2043-12, completionDateStruct date: 2043-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: bluebird bio, class: INDUSTRY, collaborators name: Center for International Blood and Marrow Transplant Research, descriptionModule briefSummary: The main aim of this study is to collect real-world longitudinal data on participants with β-thalassemia treated with betibeglogene autotemcel (beti-cel) in the post marketing setting. To assess the long-term safety, including the risk of newly diagnosed malignancies, after treatment with beti-cel and evaluate the long-term effectiveness of treatment with beti-cel., conditionsModule conditions: Beta-Thalassemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Number of Participants who Experience Each Individual Adverse Events of Interest (AEIs), secondaryOutcomes measure: Number of Participants with Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants with beti-cel related AEs, secondaryOutcomes measure: Event-Free Survival, secondaryOutcomes measure: Percentage of Participants Achieving Transfusion Independence, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCSF Benioff Children's Hospitals, status: RECRUITING, city: Oakland, state: California, zip: 94609, country: United States, geoPoint lat: 37.80437, lon: -122.2708, hasResults: False |
protocolSection identificationModule nctId: NCT06271499, orgStudyIdInfo id: AnkaraU-Smart-cannulation, briefTitle: The Effect of Using Smart Glasses Integrated Ultrasonography on Radial Artery Catheterization, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2022-12-28, completionDateStruct date: 2023-02-14, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Ankara University, class: OTHER, collaborators name: Ayşegül Güven, collaborators name: Bengi Safak, collaborators name: Ahmet Onat Bermede, descriptionModule briefSummary: The use of Ultrasonography (USG) in arterial catheterization, in which the comfort of the practitioner and hand-eye coordination become very important, is frequently needed by anesthesiologists in their daily practice. The aim of this study is to evaluate the success rate and anesthesiologist's satisfaction between two practitioners with different levels of experience in radial artery catheterization with smart glasses USG., conditionsModule conditions: Catheterization, conditions: Cannulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Radial artery catheterization with USG, interventions name: Radial artery catheterization with smart glasses integrated UGG, outcomesModule primaryOutcomes measure: The success rate, primaryOutcomes measure: The anesthesiologist's satisfaction, secondaryOutcomes measure: The cannulation time, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara University Medical Faculty, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06271486, orgStudyIdInfo id: RC. 40.5.2023, briefTitle: Pregabalin in Treatment of Postdural Puncture Headache, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, collaborators name: Benha University, descriptionModule briefSummary: Lumbar puncture (LP), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by Heinrich Quincke. It involves the retrieval and analysis of cerebrospinal fluid (CSF) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. Pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. It has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders, conditionsModule conditions: Postdural Puncture Headache, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Pregabalin 75mg, interventions name: An epidural blood patch (EBP), interventions name: conservative treatment., outcomesModule primaryOutcomes measure: the incidence of complete relief, secondaryOutcomes measure: The intensity of the headache, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neveen Kohaf, status: RECRUITING, city: Tanta, zip: 11865, country: Egypt, contacts name: Neveen Kohaf, role: CONTACT, phone: +201060383012, email: [email protected], contacts name: Nahed F. Abo-Elmatey, M.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Hany Bauiomy, M.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmed M. Abosakaya, M.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False |
protocolSection identificationModule nctId: NCT06271473, orgStudyIdInfo id: AinShamsU3, briefTitle: Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema., conditionsModule conditions: Efficacy, conditions: Safety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 20 eyes of 20 patients will be divided randomly into 2 groups:* Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only* Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution., outcomesModule primaryOutcomes measure: change in CMT by OCT at final visit, secondaryOutcomes measure: change in BCVA at final visit, otherOutcomes measure: any surgical complication or recurrence of DME, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain Shams university, status: ACTIVE_NOT_RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Ain Shams university, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Azza MA Said, MD, role: CONTACT, phone: +201006228992, email: [email protected], contacts name: David G Samuel, Msc, role: CONTACT, phone: +201064442469, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06271460, orgStudyIdInfo id: 2023-21-728, briefTitle: Disability in Patients With Non-specific Chronic Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Roland-Morris Disability Questionnaire, The Quebec Back Pain Disability Scale, and the Oswestry Disability Index in patients with chronic non-specific low back pain and to increase confidence in their use in clinical practice and research by determining the most appropriate minimal clinically significant difference values for this patient population., conditionsModule conditions: Chronic Nonspecific Low Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Traditional physiotherapy, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: The Roland-Morris Disability Questionnaire, primaryOutcomes measure: The Quebec Back Pain Disability Scale, primaryOutcomes measure: The Oswestry Disability Index, primaryOutcomes measure: The Perceived Global Impact, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Acıbadem Health Group, status: RECRUITING, city: Istanbul, state: None Selected, zip: 34752, country: Turkey, contacts name: Elif E Safran, asst. prof., role: CONTACT, phone: 500 4047, phoneExt: 216, email: [email protected], contacts name: Irmak Çavuşoğlu, asst. prof., role: CONTACT, phone: 500 4184, phoneExt: 216, email: [email protected], contacts name: Elif E Safran, asst. prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Irmak Çavuşoğlu, asst. prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Nuray Alaca, assoc. prof., role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06271447, orgStudyIdInfo id: 2023-21-705, briefTitle: Answerability and Minimal Clinical Significance of the Pain Questionnaires, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: To investigate the reliability and sensitivity of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and The Pain Catastrophizing Scale in patients with chronic non-specific low back pain undergoing multidisciplinary rehabilitation., conditionsModule conditions: Chronic Low-back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Traditional therapy, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: Fear-Avoidance Beliefs Questionnaire, primaryOutcomes measure: Tampa Scale for Kinesiophobia, primaryOutcomes measure: The Pain Catastrophizing Scale, primaryOutcomes measure: The Perceived Global Impact, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elif Esma Safran, status: RECRUITING, city: Istanbul, state: None Selected, zip: 34752, country: Turkey, contacts name: Elif E Safran, asst. prof., role: CONTACT, phone: 500 4047, phoneExt: 216, email: [email protected], contacts name: Nuray N Alaca, assoc. prof., role: CONTACT, phone: 500 4184, phoneExt: Safran, email: [email protected], contacts name: Elif E Safran, asst. prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Irmak I Çavuşoğlu, asst. prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Nuray N Alaca, assoc. prof., role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06271434, orgStudyIdInfo id: Olej z kryla/jelita, briefTitle: Effects of Krill Oil on Intestinal Integrity Markers in Elite Rowers., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-23, primaryCompletionDateStruct date: 2024-06-24, completionDateStruct date: 2024-06-24, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Poznan University of Physical Education, class: OTHER, descriptionModule briefSummary: The study aims to check the influence of krill oil on markers of intestinal injury and intoxication.Research group: the research will be conducted in a homogeneous group of professional rowers (N=30), all competitors qualified for the Polish Youth Rowing Team, aged 18 - 24. The sample size was confiremed in statistical analyses.Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.Hypotesis:The krill oil will infleunce the gut barier integrity., conditionsModule conditions: Endothelial Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: All competitors will be randomly divided into two groups (double-blind):A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.B. control (n = 15) receiving placebo. The supplementation period will be six weeks., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Triple, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: THYROX (Atlantic krill oil, interventions name: Placebo, outcomesModule primaryOutcomes measure: I-FABP (intestinal fatty acid binding protein), primaryOutcomes measure: CLDN-3, primaryOutcomes measure: LBP (lipopolysaccharide binding protein), primaryOutcomes measure: Catechyloamines, cortisol, primaryOutcomes measure: CD14, secondaryOutcomes measure: Food intake, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271421, orgStudyIdInfo id: 01/24, briefTitle: NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme, acronym: ANCHIALE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-09-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Poznan University of Medical Sciences, class: OTHER, collaborators name: MagForce USA, descriptionModule briefSummary: Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study.The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM.The main questions it aims to answer are:1. how NanoTherm therapy influences overall survival, and progression free survival;2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life.Participants will undergo:* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life;* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field;* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation;* after the first activation (10th day), the catheter will be removed;* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects., conditionsModule conditions: Glioblastoma Multiforme, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective longitudinal study will be performed recurrent glioblastoma multiforme patients who:1. are included for NanoTherm therapy (group A),2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: ANCHIALE is open-label study, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: NanoTherm therapy, interventions name: Glioma Resection, interventions name: radiotherapy according to Stupp protocol, interventions name: chemotherapy according to Stupp protocol, outcomesModule primaryOutcomes measure: Survival following the surgery [units months 1-24], primaryOutcomes measure: Progression free survival [units months 1-24], secondaryOutcomes measure: Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease], secondaryOutcomes measure: EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best], secondaryOutcomes measure: Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst], secondaryOutcomes measure: modified Rankin scale [0-best; 6-worst], secondaryOutcomes measure: Barthel index [range 0-100; 0-best, 100-worst], eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital, status: RECRUITING, city: Poznań, zip: 60-355, country: Poland, contacts name: Slawomir Michalak, Prof., role: CONTACT, phone: +4861 8691 535, email: [email protected], contacts name: Jakub Moskal, MD, PhD, role: CONTACT, phone: +4861 8691 422, email: [email protected], geoPoint lat: 52.40692, lon: 16.92993, hasResults: False |
protocolSection identificationModule nctId: NCT06271408, orgStudyIdInfo id: POL-Xe-005, briefTitle: Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Polarean, Inc., class: INDUSTRY, collaborators name: Aerogen, descriptionModule briefSummary: The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.Participants will:Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation)., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, interventions name: Vibrating Mesh Nebulizer, interventions name: Metered Dose Inhaler, interventions name: Jet Nebulizer, outcomesModule primaryOutcomes measure: Ventilation Defect Percent, secondaryOutcomes measure: Distribution of ventilated space, secondaryOutcomes measure: Membrane uptake of Xe 129, secondaryOutcomes measure: Red blood cell Xe 129 transfer, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Virginia Sheridan Snyder Translational Fontaine Research Unit, status: RECRUITING, city: Charlottesville, state: Virginia, zip: 22947, country: United States, contacts name: Roselove Roselove Nunoo-Asare, role: CONTACT, phone: 434-243-6074, email: [email protected], geoPoint lat: 38.02931, lon: -78.47668, hasResults: False |
protocolSection identificationModule nctId: NCT06271395, orgStudyIdInfo id: Chaoshengqiunang, briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations., conditionsModule conditions: Cricopharyngeal Achalasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Injectable Type A Botulinum Toxin, outcomesModule primaryOutcomes measure: functional oral intake scale, secondaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: The Fiberoptic Endoscopic Dysphagia Severity Scale, secondaryOutcomes measure: Murray secretion scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinzhu Rehabilitation Hospital, status: RECRUITING, city: Xinzhu, country: Taiwan, contacts name: Haim Liu, role: CONTACT, geoPoint lat: 22.46205, lon: 120.47335, hasResults: False |
protocolSection identificationModule nctId: NCT06271382, orgStudyIdInfo id: AIBU-SBF-SA-05, briefTitle: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Acupressure Group, interventions name: Sham Acupressure Group, interventions name: Foot Ankle Exercise Group, outcomesModule primaryOutcomes measure: Ankle Brachial Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271369, orgStudyIdInfo id: CCTL019CUS13, briefTitle: Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-11, primaryCompletionDateStruct date: 2023-02-15, completionDateStruct date: 2023-02-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier., conditionsModule conditions: Diffuse Large B-cell Lymphoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 613, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of patients with IP admission, primaryOutcomes measure: Number of IP admissions, primaryOutcomes measure: IP days, primaryOutcomes measure: Number of ICU stays, primaryOutcomes measure: ICU days, primaryOutcomes measure: Number of patients with OP visit, primaryOutcomes measure: Number of OP visits, primaryOutcomes measure: Number of patients with ER visit, primaryOutcomes measure: Number of ER visits, primaryOutcomes measure: Healthcare reimbursement costs, primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: Time to next treatment (TTNT) or death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis, city: East Hanover, state: New Jersey, zip: 07936, country: United States, geoPoint lat: 40.8201, lon: -74.36487, hasResults: False |
protocolSection identificationModule nctId: NCT06271356, orgStudyIdInfo id: STU00220278, briefTitle: Breast Cancer - Navigate - Prospective Cohort, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: The Chrysalis Initiative, descriptionModule briefSummary: The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach., conditionsModule conditions: Breast Cancer, conditions: Quality of Life, conditions: Chemotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: BC-Navigate, outcomesModule primaryOutcomes measure: Demand of BC-Navi: Recruitment Rate, primaryOutcomes measure: Demand of BC-Navi: Rentention Rate, primaryOutcomes measure: Acceptability of BC-Navi, primaryOutcomes measure: Preliminary Efficacy: Chemotherapy Initiation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Diana Buitrago, role: CONTACT, phone: 312-503-2866, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06271343, orgStudyIdInfo id: RC23_0394, briefTitle: Kidney Graft Tolerance KTOL, acronym: KTOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, descriptionModule briefSummary: Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens., conditionsModule conditions: Kidney Transplant Tolerance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection., secondaryOutcomes measure: Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones., secondaryOutcomes measure: Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nantes University Hospital, status: RECRUITING, city: Nantes, state: Loire-Atlantique, zip: 44093, country: France, contacts name: Christophe MASSET, PH, role: CONTACT, phone: 33 2 76 64 39 61, email: [email protected], geoPoint lat: 47.21725, lon: -1.55336, hasResults: False |
protocolSection identificationModule nctId: NCT06271330, orgStudyIdInfo id: AP_JBD_FarWest_004, briefTitle: Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD., acronym: FAR-WEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Rennes University Hospital, descriptionModule briefSummary: Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication., conditionsModule conditions: AMD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Faricimab, outcomesModule primaryOutcomes measure: Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment., secondaryOutcomes measure: Difference between time to recurrence before switch and after switch., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ducloyer, city: Nantes, zip: 44000, country: France, contacts name: Jean-Baptiste Ducloyer, MD, role: CONTACT, phone: 02 40 08 46 51, email: [email protected], contacts name: Yann Maucourant, MD, role: CONTACT, phone: 85 658, email: [email protected], geoPoint lat: 47.21725, lon: -1.55336, hasResults: False |
protocolSection identificationModule nctId: NCT06271317, orgStudyIdInfo id: AP_CL_001, briefTitle: Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique, conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Study postoperative morbidity after nissen sleeve gastrectomy in Nantes, primaryOutcomes measure: postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271304, orgStudyIdInfo id: BLUES, briefTitle: Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder, acronym: BLUES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Mental Health Services in the Capital Region, Denmark, class: OTHER, descriptionModule briefSummary: The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime)., conditionsModule conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Blue blocking eyewear, interventions name: Low filtration eyewear, outcomesModule primaryOutcomes measure: Manic symptoms, secondaryOutcomes measure: Mood instability, secondaryOutcomes measure: Objective sleep quality, secondaryOutcomes measure: Objective sleep quality, secondaryOutcomes measure: Subjective sleep quality, secondaryOutcomes measure: Subjective sleep quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271291, orgStudyIdInfo id: 23-000161, secondaryIdInfos id: NCI-2024-00504, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-000161, type: OTHER, domain: Mayo Clinic in Rochester, secondaryIdInfos id: P30CA015083, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA015083, secondaryIdInfos id: U01CA210138, type: NIH, link: https://reporter.nih.gov/quickSearch/U01CA210138, secondaryIdInfos id: U24CA274496, type: NIH, link: https://reporter.nih.gov/quickSearch/U24CA274496, briefTitle: Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2029-05-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured., conditionsModule conditions: Pancreatic Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15000, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer, primaryOutcomes measure: Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Ajay Goel, Ph.D., role: CONTACT, phone: 626-256-4673, phoneExt: 85200, contacts name: Ajay Goel, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Shounak Majumder, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Randall Brand, M.D., role: CONTACT, phone: 412-864-7516, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06271278, orgStudyIdInfo id: 2023-17, briefTitle: The Effect of Emotional Freedom Techniques Application on Nurses, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Gurkan KAPIKIRAN, class: OTHER, descriptionModule briefSummary: Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units., conditionsModule conditions: Occupational Stress, conditions: Alert Fatigue, Health Personnel, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was conducted as a randomised controlled study with experimental and control groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: Participants will be blinded to their group assignment. The subjects will be selected in a randomized order using software. Data collection will be conducted without involvement from research analysts., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: Emotional Freedom Technique, outcomesModule primaryOutcomes measure: Subjective Units of Disturbance Scale, primaryOutcomes measure: Alarm Fatigue Scale, primaryOutcomes measure: The General Work Stress Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inonu University Turgut OzaL Medical Center, status: RECRUITING, city: Malatya, zip: 44090, country: Turkey, contacts name: Turgut Ozal Medical Center, role: CONTACT, phone: +904223770100, email: [email protected], contacts role: CONTACT, email: [email protected], contacts name: Gurkan Kapikiran, Ph.D, role: PRINCIPAL_INVESTIGATOR, contacts name: Seher Çevik Aktura, Ph.D, role: SUB_INVESTIGATOR, contacts name: Şerafettin Okutan, Ph.D, role: SUB_INVESTIGATOR, contacts name: Remziye Cici, Ph.D, role: SUB_INVESTIGATOR, geoPoint lat: 38.35018, lon: 38.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06271265, orgStudyIdInfo id: 402-C-125, briefTitle: Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Pacira Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA)., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: EXPAREL, interventions name: bupivacaine, outcomesModule primaryOutcomes measure: The following model-predicted PK endpoint will be determined:, primaryOutcomes measure: The following model-predicted PK endpoint will be determined:, primaryOutcomes measure: The following model-predicted PK endpoint will be determined:, primaryOutcomes measure: The following model-predicted PK endpoint will be determined:, primaryOutcomes measure: The following model-predicted PK endpoint will be determined:, primaryOutcomes measure: The following model-predicted PK endpoint will be determined:, secondaryOutcomes measure: Vitals change from Baseline:, secondaryOutcomes measure: Vitals change from Baseline:, secondaryOutcomes measure: Vitals change from Baseline:, secondaryOutcomes measure: Vitals change from Baseline:, secondaryOutcomes measure: Vitals change from Baseline:, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Incidence of adverse events of special interest (AESIs), secondaryOutcomes measure: Incidence of serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271252, orgStudyIdInfo id: OriCAR-017 US-P1, briefTitle: A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: OriCell Therapeutics Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.RIGEL Study, conditionsModule conditions: Neoplasms, Plasma Cell, conditions: Neoplasms by Histologic Type, conditions: Neoplasms, conditions: Hemostatic Disorders, conditions: Vascular Diseases, conditions: Cardiovascular Diseases, conditions: Paraproteinemias, conditions: Blood Protein Disorders, conditions: Hematologic Diseases, conditions: Hemorrhagic Disorders, conditions: Lymphoproliferative Disorders, conditions: Immunoproliferative Disorders, conditions: Immune System Diseases, conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 81, type: ESTIMATED, armsInterventionsModule interventions name: OriCAR-017, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) of OriCAR-017 US-P1, primaryOutcomes measure: Dose-limiting toxicity (DLT), secondaryOutcomes measure: Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM, secondaryOutcomes measure: Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM, secondaryOutcomes measure: Assessment of Duration of Response (DOR) of treatment in patients with RR/MM, secondaryOutcomes measure: Progress-Free Survival (PFS) of treatment in patients with RR/MM, secondaryOutcomes measure: Assessment of Overall Survival (OS) of treatment in patients with RR/MM, secondaryOutcomes measure: Assessment of MRD negative Rate, secondaryOutcomes measure: Assessment of Overall Response Rate (ORR), secondaryOutcomes measure: Assessment of Disease Control Rate (DCR), secondaryOutcomes measure: Assessment of Clinical Benefit Rate (CBR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northside Hospital, city: Atlanta, state: Georgia, zip: 30342, country: United States, contacts name: Melhem Solh, role: CONTACT, email: [email protected], contacts name: Caitlin Guzowski, role: CONTACT, email: [email protected], geoPoint lat: 33.749, lon: -84.38798, hasResults: False |
protocolSection identificationModule nctId: NCT06271239, orgStudyIdInfo id: U1111-1299-9167, secondaryIdInfos id: 65318722.0.0000.5336, type: OTHER, domain: IRB-Pontifical Catholic University of Rio Grande do Sul, secondaryIdInfos id: RBR-2tq2jky, type: OTHER, domain: The Brazilian Registry of Clinical Trials (ReBEC), briefTitle: Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Pontificia Universidade Católica do Rio Grande do Sul, class: OTHER, collaborators name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., descriptionModule briefSummary: This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months., conditionsModule conditions: Frailty, conditions: Aging, conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.The Group Suggestions for a Healthy Life (CG) will receive exercise suggestions and guidance for maintaining a healthy routine for three months. After, they will undergo a three-month intervention using the VIVIFRAIL® protocol.Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The assessments will be conducted by trained researchers, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group (ViviFrail), interventions name: Group Suggestions for a Healthy Life (CG), outcomesModule primaryOutcomes measure: Short physical performance battery, secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: ICOPE questionnaire, secondaryOutcomes measure: Lawton Scale, secondaryOutcomes measure: 4-meter gait speed, secondaryOutcomes measure: Five Times Sit-to-Stand, secondaryOutcomes measure: Balance test in three positions, secondaryOutcomes measure: Self-perceived health, secondaryOutcomes measure: Adverse health outcomes - falls, secondaryOutcomes measure: Adverse health outcomes - hospitalization, secondaryOutcomes measure: Adverse health outcomes - institutionalization, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271226, orgStudyIdInfo id: OMUKAEK 2022/75, secondaryIdInfos id: OMUKAEK 2022/75, type: OTHER, domain: ONDOKUZ MAYIS UNIVERSTY, briefTitle: The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters, acronym: EFFECTOFACU, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-20, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).The main questions that the study aims to answer are:Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters.Acupressure applied to intensive care patients has an effect on physiological parameters.Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain., conditionsModule conditions: Intensive Care Patients, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Since there will be variability in patient admissions to intensive care units, block randomization will be used. Three different groups will be coded with different letters (A,B,C) and blocks will be created. Then randomization will be performed by assigning random numbers on the computer. The letters determined in the randomization will be written in closed envelopes and stored, and the randomization process will be carried out by an independent researcher. After the patient who meets the inclusion criteria is identified, the independent researcher will be contacted to find out which group the patient is in., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: participant and statistical analysis expert is blind., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: acupressure, interventions name: placebo acupressure, interventions name: control group, outcomesModule primaryOutcomes measure: neurological evaluation, primaryOutcomes measure: evaluation of pain, primaryOutcomes measure: evaluation of physiological parameters, secondaryOutcomes measure: evaluation of physiological parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Giresun Eğitim Araştırma Hastanesi, status: RECRUITING, city: Giresun, zip: 28000, country: Turkey, contacts name: emine yaman lezki, role: CONTACT, phone: +9005458026622, email: [email protected], geoPoint lat: 40.91698, lon: 38.38741, hasResults: False |
protocolSection identificationModule nctId: NCT06271213, orgStudyIdInfo id: 303841, briefTitle: The Gut-Lung Axis and Respiratory Illness in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2027-11-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: NHS Greater Glasgow and Clyde, class: OTHER, collaborators name: University of Glasgow, descriptionModule briefSummary: The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease.Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:* What does a healthy gut-lung axis look like?* Do children with respiratory issues show an altered gut microbiome?* Do children with GI issues show an altered lung microbiome?Part B is a longitudinal study design, that aims to assess the effects of biologics on the gut-lung axis by comparing the gut and lung microbiomes in children with asthma at two time-points who are indicated to start biologics therapy (Asthma treatment) or will not receive biologics therapy (asthma control).Participants will provide:* airway samples (to investigate the lung microbiome)* blood samples (to assess inflammatory and metabolic factors which may mediate communication between the two sites) whilst under general anaesthetic for a treatment related to their standard of care* stool samples (to assess gut microbiome)* dietary information (food diary and/or food frequency questionnaire) to assess relationships between diet and the gut-lung axis., conditionsModule conditions: Respiration Disorders, conditions: Respiratory Disease, conditions: Asthma in Children, conditions: Wheezing, conditions: Gastro-Intestinal Disorder, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: observational only - no interventions as part of study, outcomesModule primaryOutcomes measure: Assess differences in gut and lung microbiota diversity between groups, primaryOutcomes measure: Assess changes in gut and lung microbiota in children with asthma receiving biologics, primaryOutcomes measure: Determine mediators of gut-lung axis in health and disease, secondaryOutcomes measure: Nutritional influence in gut-lung axis, secondaryOutcomes measure: Multi-omics integration, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: NHS Greater Glasgow and Clyde: Royal Hospital for children, Glasgow, status: RECRUITING, city: Glasgow, country: United Kingdom, contacts name: Ross J Langley, MRCPCH, role: CONTACT, phone: 0141 451 6683, email: [email protected], geoPoint lat: 55.86515, lon: -4.25763, hasResults: False |
protocolSection identificationModule nctId: NCT06271200, orgStudyIdInfo id: MG-113-GP-03, briefTitle: Intervention on Metabolism and Related Chronic Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-01-19, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: National Health Research Institutes, Taiwan, class: OTHER, collaborators name: Tri-Service General Hospital, collaborators name: Chang Gung Memorial Hospital, collaborators name: National Taiwan University Hospital Hsin-Chu Branch, collaborators name: Taichung Armed Forces General Hospital, descriptionModule briefSummary: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1. The ILI group will be instructed to eat in 8 hours while fasting in 16 hours on daily basis over 24 weeks. Furthermore, enhanced daily physical activities with walking more than 10,000 steps will be implemented. The enrolled participants will be instructed to follow a diet with reduction of daily intake of 500 kcals per day. ILI group will be asked to use the Health2Sync mobile app to track self-measured outcomes and daily diet control. The investigators objectively measure step counts for participants of ILI group during 24-week intervention period using a wearable device (Fitbit Inspire 2). Participants are asked to attach the pedometer on their waist belt, except while bathing and sleeping. The ULI group will be instructed to follow habitual meal timing. In addition, all participants of both groups will receive the health education. Anthropometric, sociodemographic data, biochemical variables, and metabolic variables will be measured at baseline and during follow-up visit. DEXA and MRI of abdomen will be measured at baseline and during following up visits. The proposed trial is designed to provide 85% statistical power to detect a significant difference in changes in the metabolic syndrome severity score after reduction \> 5% body weight over 24 weeks., conditionsModule conditions: Metabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a randomized, parallel-group, observer-masked clinical trial. A total of 120 obese participants with MetS will be enrolled. Eligible subjects will be randomly assigned to the ILI group or ULI group with an allocation ratio of 2:1., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent fasting and 10,000 steps per day, outcomesModule primaryOutcomes measure: Change in the metabolic syndrome severity score (Z score) after reduction > 5% body weight from baseline to 24 weeks, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Molecular and Genomic Medicine, National Health Resesarch Institutes, city: Zhunan, state: Miaoli County, zip: 350, country: Taiwan, contacts name: Vivian Wang, Master, role: CONTACT, phone: +886-37-206166, phoneExt: 35374, email: [email protected], geoPoint lat: 22.57358, lon: 120.54147, hasResults: False |
protocolSection identificationModule nctId: NCT06271187, orgStudyIdInfo id: A-ER-110-507, briefTitle: Dynamic-orthosis Programs for Stroke Hand Function, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-22, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic-orthosis, interventions name: Traditional stroke occupational therapy training, outcomesModule primaryOutcomes measure: Fugl-Meyer Assessment- Upper Extremity, primaryOutcomes measure: Box and Block Test, primaryOutcomes measure: Motor Activity Log, secondaryOutcomes measure: Modified Ashworth scale, secondaryOutcomes measure: Upper limb joint range of motion, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cheng Kung University, status: RECRUITING, city: Tainan, zip: 701, country: Taiwan, contacts name: JER-HAO CHANG, PH.D., role: CONTACT, phone: 886-6-2353535, phoneExt: 5912, email: [email protected], geoPoint lat: 22.99083, lon: 120.21333, hasResults: False |
protocolSection identificationModule nctId: NCT06271174, orgStudyIdInfo id: RC23_0009, briefTitle: Avoid With Locoregional Analgesia Persistant Postoperative Pain In Children, acronym: AWA3PASIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Fondation Apicil, descriptionModule briefSummary: Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia"., conditionsModule conditions: Persistent Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: Carbocaine, interventions name: Profofol and/or Suxaméthonium and/or Sévoflurane, outcomesModule primaryOutcomes measure: Persistent Postoperative Pain, secondaryOutcomes measure: Screening of neuropathic pain if persistent postoperative pain - 3 months, secondaryOutcomes measure: Screening of neuropathic pain if persistent postoperative pain - 6 months, secondaryOutcomes measure: Screening of neuropathic pain if persistent postoperative pain - 12 months, secondaryOutcomes measure: 1st EN score in immediate post-operative ICU before morphine titration, secondaryOutcomes measure: Persistent postoperative pain at 6 months., secondaryOutcomes measure: Persistent postoperative pain at 12 months., secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Time in Post Interventional Care Unit, secondaryOutcomes measure: Opioïd dose received - Per-operative, secondaryOutcomes measure: Opioïd dose received - in Post Interventional Care Unit, secondaryOutcomes measure: Opioïd dose received, secondaryOutcomes measure: Intravenous Morphine dose received in Post Interventional Care Unit, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 183 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271161, orgStudyIdInfo id: F002, briefTitle: The Effect of Pharyngeal Cooling Applications on Postoperative Throat Pain and Nausea Vomiting, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to to evaluate the effects of a throat pack soaked with saline at +4 ºC on postoperative throat pain (POTP) and postoperative nausea and vomiting (PONV) in dental surgical procedures performed under general anesthesia. The main questions it aims to answer are: 1. How long can we keep the pharyngeal mucosa cold using tampons and cold wash solutions? 2. Does cooling the pharyngeal mucosa reduce the incidence of postoperative sore throat and nausea and vomiting?, conditionsModule conditions: Postoperative Pain, conditions: Postoperative Nausea and Vomiting, conditions: Throat, Sore, conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 84, type: ACTUAL, outcomesModule primaryOutcomes measure: The incidence of postoperative sore throat and noise vomiting was investigated in dental surgery involving the application of cooling to the pharyngeal area, particularly when a throat pack was used., secondaryOutcomes measure: Intraoperative change in nasopharyngeal temperature from baseline (ºC ), intraoperative opioid usage (mcg), postoperative analgesic usage (mg),antiemetic usage(mg) and any adverse events due to throat pack were recorded., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Funda Arun, city: Selçuklu, state: Konya, zip: 42000, country: Turkey, geoPoint lat: 37.8842, lon: 32.49222, hasResults: False |
protocolSection identificationModule nctId: NCT06271148, orgStudyIdInfo id: Mutah University, secondaryIdInfos id: Myah REC/133/2023, type: REGISTRY, domain: Mutah university school of medicine, briefTitle: Career and Lifestyle Among Female Surgeons in Jordan, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-03, primaryCompletionDateStruct date: 2023-12-17, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Mohammad Abu-Jeyyab, class: OTHER, descriptionModule briefSummary: A study conducted to evaluate the female surgeons in Jordan from different lifestyle, conditionsModule conditions: Surgery, conditions: Lifestyle, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 224, type: ACTUAL, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Career and Lifestyle Among Female Surgeons in Jordan, primaryOutcomes measure: Working Hours, primaryOutcomes measure: Sex Bias, primaryOutcomes measure: inadequate mentorship, primaryOutcomes measure: having 30 days of leave, primaryOutcomes measure: salary, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mutah University, city: Al-Karak, zip: 61710, country: Jordan, geoPoint lat: 31.16368, lon: 35.76204, hasResults: False |
protocolSection identificationModule nctId: NCT06271135, orgStudyIdInfo id: LU20170508, briefTitle: Assessing the Quality of Life of Patients With Rosacea, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-05-08, primaryCompletionDateStruct date: 2018-11-30, completionDateStruct date: 2018-11-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Medical University of Bialystok, class: OTHER, collaborators name: University of Lomza, descriptionModule briefSummary: The study population consisted of 160 patients (123 women and 37 men) with rosacea, who agreed to participate in this study. Patients were qualified for the study among people visiting the cosmetic studio in Choroszcz in the period from June 2017 to November 2018, based on the diagnosis of a dermatologist and cosmetologist. The cosmetic intervention was performed using CAPILLARY REPAIR SERUM (30ml). Study participants completed self-reported questionnaire and standardized questionnaires., conditionsModule conditions: Rosacea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: CAPILLARY REPAIR SERUM 30ml, outcomesModule primaryOutcomes measure: Elements influenced on quality of life of participants with rosacea, secondaryOutcomes measure: Self-reported questionnaire, secondaryOutcomes measure: Dietary Questionnaire, secondaryOutcomes measure: The Physical Activity Questionnaire, secondaryOutcomes measure: DLQI (Dermatology Life Quality Index), secondaryOutcomes measure: SWLS (Satisfaction With Life Scale), secondaryOutcomes measure: BDI (Beck Depression Inventory), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Bialystok, city: Białystok, zip: 15-089, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, hasResults: False |
protocolSection identificationModule nctId: NCT06271122, orgStudyIdInfo id: COMPET-1, briefTitle: Identification of Explanatory Factors for the Lack of Muscle Strength Gain Following a Pulmonary Rehabilitation Program in COPD Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2025-05-16, completionDateStruct date: 2025-05-16, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Korian, class: OTHER, descriptionModule briefSummary: Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease associated with various comorbidities, including muscle weakness (MW), which is very worrying due to its negative impact on patients' quality of life and survival. To address this issue, muscle strengthening is incorporated into pulmonary rehabilitation programs. However, its effectiveness is unclear, as although there is an average improvement in muscle strength, one in two patients does not show a clinically relevant improvement. To understand this non-response, it is crucial to examine the effect of muscle strengthening programs on the two main determinants of force production: the muscle and the central command. Muscle adaptations following a muscle strengthening program are well-documented, showing improvements in muscle function (cross-sectional area, lean mass, etc.). Conversely, only one study has investigated central adaptations after a muscle strengthening program, clearly demonstrating a lack of effect.The investigators hypothesize that patients showing no improvement in muscle strength after pulmonary rehabilitation (non-responders) have a significantly lower level of voluntary activation before starting the program compared to responding patients (responders)., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Voluntary activation assessed by magnetic stimulation, outcomesModule primaryOutcomes measure: Central voluntary activation assessed by transcranial magnetic stimulation (TMS), secondaryOutcomes measure: Muscle excitability assessed by femoral magnetic stimulation (FMS), secondaryOutcomes measure: Contractile properties assessed by femoral magnetic stimulation (FMS), secondaryOutcomes measure: Corticospinal excitability assessed by transcranial magnetic stimulation (TMS), secondaryOutcomes measure: Intra-cortical inhibitions transcranial magnetic stimulation (TMS), secondaryOutcomes measure: Voluntary activation assessed by femoral magnetic stimulation (FMS), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique du Souffle La Vallonie, status: RECRUITING, city: Lodève, zip: 34700, country: France, contacts name: Nelly Heraud, PhD, role: CONTACT, phone: +33467888491, email: [email protected], contacts name: Nicolas Oliver, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.71667, lon: 3.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06271109, orgStudyIdInfo id: Soh-Med-24-01-04MD, briefTitle: Short Term Surgical Outcomes of Anatomical Versus Non Anatomical Laparoscopic Liver Resection for Liver Tumors, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: aimed to discuss the short term surgical outcomes of Anatomical versus Non anatomical laparoscopic Liver resection for Liver tumors., conditionsModule conditions: Liver Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Anatomical laparoscopic liver resection for liver neoplasms, interventions name: Non-Anatomical laparoscopic liver resection for liver neoplasms, outcomesModule primaryOutcomes measure: complete resection of the neoplasm, secondaryOutcomes measure: residual liver tissue, secondaryOutcomes measure: recurrence rate, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06271096, orgStudyIdInfo id: 638/ADR/KMC, briefTitle: Intramuscular Midazolam Versus Intravenous Diazepam for Acute Seizure in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-01, primaryCompletionDateStruct date: 2022-11-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Arooj Khan, class: OTHER, descriptionModule briefSummary: IM-midazolam in acute seizures, whenever IV cannulation is not possible. It is easy to administer and can be used in prehospital settings as IV cannulation requires experience, especially in pediatric age group. Moreover, the transit time to the hospital can be prolonged in our areas which can delay the treatment if intravenous cannulation is considered. More studies are required to assess the feasibility of administering IM-midazolam in a prehospital setting to control acute seizures, conditionsModule conditions: Seizures, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was a randomized controlled trial carried out between November 2019 to November 2022 in the Pediatric department of Khyber Teaching Hospital. A total of 150 children who presented to the emergency department with seizures were enrolled in this study via consecutive sampling. This study was approved by the Ethical Review, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: Intra muscular Midazolam, interventions name: Intravascular Diazepam, outcomesModule primaryOutcomes measure: Fits Controlled, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Khyber Teaching Hospital, city: Peshawar, zip: 25000, country: Pakistan, geoPoint lat: 34.008, lon: 71.57849, hasResults: False |
protocolSection identificationModule nctId: NCT06271083, orgStudyIdInfo id: 2023-06541-01, briefTitle: Internet-based Behavior Therapy for Adults With Tourette Syndrome, acronym: TICNET, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, descriptionModule briefSummary: This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention., conditionsModule conditions: Tourette Syndrome, conditions: Chronic Tic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Exposure with response prevention, interventions name: Brief psychoeducation with general psychological support, outcomesModule primaryOutcomes measure: Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS), secondaryOutcomes measure: Yale Global Tic Severity Scale (YGTSS) - impairment scale, secondaryOutcomes measure: Clinical Global Impression (CGI), secondaryOutcomes measure: Gilles de la Tourette Syndrome Quality of Life Scale (QTS-QoL), secondaryOutcomes measure: Montgomery-Asberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Adult Tic Questionnaire (ATQ), secondaryOutcomes measure: Work and social adjustment scale (WSAS), secondaryOutcomes measure: Treatment Inventory of Costs in Psychiatric Patients (TIC-P), secondaryOutcomes measure: Assessing Quality of Life 6 Dimensions (AQoL-6D), otherOutcomes measure: Internet Intervention Patient Adherence Scale for Guided Internet-Delivered Behavioural Interventions (iiPAS), otherOutcomes measure: Credibility/Expectancy Questionnaire (CEQ), otherOutcomes measure: Working Alliance Inventory-Short Form Revised (WAI-SR), otherOutcomes measure: Checklist for negative events, otherOutcomes measure: Events during treatment and adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, status: RECRUITING, city: Stockholm, zip: 14157, country: Sweden, contacts name: Ekaterina Ivanova, PhD, role: CONTACT, phone: 0046765807416, email: [email protected], geoPoint lat: 59.33258, lon: 18.0649, hasResults: False |
protocolSection identificationModule nctId: NCT06271070, orgStudyIdInfo id: 2023-R23, briefTitle: Analysis of Correlation Between Skin Carotenoid Level and Basic Indicators of Health Status Related to Lifestyle in Vietnamese: An Observational Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: KAGOME CO., LTD., class: INDUSTRY, collaborators name: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited, descriptionModule briefSummary: To clarify the relationship between vegetable intake and lifestyle-related disease in Vietnam, we measure skin carotenoid levels and basic indicators of health status related to lifestyle and analyze the correlation between them. This is an important study that can lead to dietary suggestions for preventing lifestyle-related diseases in Vietnam., conditionsModule conditions: Lifestyle Risk Reduction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Non-intervention, outcomesModule primaryOutcomes measure: Skin carotenoid level, primaryOutcomes measure: Blood markers of lifestyle-related diseases, primaryOutcomes measure: BMI, primaryOutcomes measure: Body fat percentage, primaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dr. Binh_Teleclinic - Branch of E2E Solution Company Limited, status: RECRUITING, city: Hanoi, zip: 11612, country: Vietnam, contacts name: Nguyen Thuy Lan, Doctor, role: CONTACT, phone: +84 243 622 7799, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False |
protocolSection identificationModule nctId: NCT06271057, orgStudyIdInfo id: CARMOD, briefTitle: Golcadomide Post-CAR T-cell in R/R Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2026-01-15, completionDateStruct date: 2027-10-20, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: The Lymphoma Academic Research Organisation, class: OTHER, collaborators name: Lymphoma Study Association, descriptionModule briefSummary: This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator., conditionsModule conditions: Diffuse Large B-cell Lymphoma Refractory, conditions: Refractory Primary Mediastinal Large B-Cell Lymphoma, conditions: Refractory Transformed B-cell Non-Hodgkin Lymphoma, conditions: Refractory High Grade B-Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 65, type: ESTIMATED, armsInterventionsModule interventions name: golcadomide, outcomesModule primaryOutcomes measure: Complete metabolic response rate (CMR rate), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: Duration of response (DR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Time To Next anti-Lymphoma Treatment (TTNLT), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of Adverse Events and Serious Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Henri Mondor, city: Créteil, zip: 94010, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Chu Dijon Bourgogne, city: Dijon, zip: 21000, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Chu de Grenoble, city: La Tronche, zip: 38700, country: France, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Chru de Lille, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Institut Paoli Calmettes, city: Marseille, zip: 13273, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Chu de Montpellier, city: Montpellier, zip: 34090, country: France, geoPoint lat: 43.61092, lon: 3.87723, locations facility: Chu de Nantes, city: Nantes, zip: 44093, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hopital Saint-Louis, city: Paris, zip: 75475, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Chu de Bordeaux, city: Pessac, zip: 33604, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: Chu Pontchaillou, city: Rennes, zip: 35033, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Centre Henri Becquerel, city: Rouen, zip: 76038, country: France, geoPoint lat: 49.44313, lon: 1.09932, locations facility: Iuct Oncopole, city: Toulouse, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Chu Brabois, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False |
protocolSection identificationModule nctId: NCT06271044, orgStudyIdInfo id: RAILESS, briefTitle: a. Reducing Radioiodine Treatment in Papillary Thyroid Cancer. RAILESS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2014-10, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Helsinki University Central Hospital, class: OTHER, descriptionModule briefSummary: To study if its is safe to reduce the amount of postoperative treatments in those patients, who have been operated on because of a low-risk intrathyroidal papillary thyroid cancer with diameter of 11-20mm, and in whom postoperative thyroglobulin levels are of low level., conditionsModule conditions: to Omit Radioiodine Treatment Safely in Patients With Low -Risk Papillary Thyroid Cancer With Seize of 11-20mm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with low risk papillary thyroid cancer either received a radioiodine treatment according to the normal Finnish treatment schedule or were schedulded for only follow-up ., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: No masking., enrollmentInfo count: 61, type: ACTUAL, armsInterventionsModule interventions name: With radioiodine treatment, interventions name: With postoperative radioiodine treatment, outcomesModule primaryOutcomes measure: Event free situation during follow-up event free /disease free, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271031, orgStudyIdInfo id: LHS0211, briefTitle: Process Mapping and Data Collection to Inform a Computer Simulation Model of Hospitalised Patients With Bloodstream Infection, Sepsis and Systemic Infection, acronym: CSM-BSI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Liverpool University Hospitals NHS Foundation Trust, class: OTHER_GOV, descriptionModule briefSummary: The goal of this study is to create a computer simulation of patients with bloodstream infection to understand how changes in healthcare policies and resources affect patient treatment. This simulation will help doctors and health-care decision makers make better choices in treating these patients and avoid overusing antibiotics that can lead to antibiotic resistance. Antibiotic resistance is when bacteria can't be killed by antibiotics anymore. Participants will not receive treatments as this is an observational study, but the study will involve:* Interviews with healthcare staff to understand patient care pathways.* Analysis of historical data on bacteria causing infections and antibiotic treatments.* A 30-day observational study to observe patient treatment for bloodstream infections., conditionsModule conditions: Sepsis, conditions: Bloodstream Infection, conditions: Bacteraemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Generation of a software simulation model that is fine tuned to the observed data., secondaryOutcomes measure: Exploration of the performance of the model in different hypothesised scenarios., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-10-10, uploadDate: 2023-11-14T09:05, filename: Prot_ICF_000.pdf, size: 2058603, hasResults: False |
protocolSection identificationModule nctId: NCT06271018, orgStudyIdInfo id: GMIO-2024-0001, briefTitle: TocILizumab in aorTitis in GCA (TILT), acronym: TILT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: GMIOFrance, class: UNKNOWN, descriptionModule briefSummary: This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).Giant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.Multiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.The GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.Following the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.However, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.This observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA., conditionsModule conditions: Giant Cell Arteritis, conditions: Aortitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To evaluate the proportion of patients with remission of GCA, secondaryOutcomes measure: To assess the cumulative incidence of relapse, secondaryOutcomes measure: To assess the proportion of GCA in remission (according to EULAR consensus definitions) after treatment start, secondaryOutcomes measure: To assess the cumulative dose of prednisone, secondaryOutcomes measure: To assess the cumulative incidence of severe adverse events, secondaryOutcomes measure: To assess the proportion of radiological vascular progression, secondaryOutcomes measure: To assess the cumulative incidence of vascular revascularization procedures, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06271005, orgStudyIdInfo id: 000824, briefTitle: Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Genetic Disease Investigators, class: OTHER, descriptionModule briefSummary: This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves., conditionsModule conditions: Dry Eye Disease, conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: NeuroTears, interventions name: Placebo, outcomesModule primaryOutcomes measure: OSDI, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270992, orgStudyIdInfo id: 123R030, briefTitle: Oral Microbiome Diagnostics of Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2026-05-15, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, collaborators name: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE, descriptionModule briefSummary: The study aims to develop a deep learning-based diagnostic method for lung cancer using the oral microbiome. This innovative approach involves establishing an observational cohort of 576 individuals, including lung cancer patients, non-cancerous benign lung disease patients, and healthy controls, to collect tongue swab samples for 16S rRNA sequencing. Additionally, an international cohort of approximately 1700 individuals will be formed using in silico data. The project will utilize deep learning methods to analyze all data integratively and develop an AI diagnostic algorithm capable of distinguishing lung cancer patients from others. The diagnostic method's performance will be tested in a pilot clinical trial with 96 individuals using a PRoBE design. Led by experts in chest surgery, molecular microbiology, and bioinformatics, the project spans over 30 months and aims to create a non-invasive, easily accessible lung cancer screening method that could lead to significant diagnostic advancements and potential spin-off companies in the field of liquid biopsy/molecular diagnosis., conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 676, type: ESTIMATED, armsInterventionsModule interventions name: NCCN (National Comprehensive Cancer Network) diagnosis, outcomesModule primaryOutcomes measure: Diagnostics accuracy assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University Hospital, status: RECRUITING, city: Kayseri, zip: 38039, country: Turkey, contacts name: Aycan Gundogdu, PhD, role: CONTACT, phone: +90 352 207 6666, email: [email protected], geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06270979, orgStudyIdInfo id: ISHA, briefTitle: Intrinsic Capacity and Functional Ability Monitoring With an Integrated Data Eco-System for Healthy Ageing., acronym: ISHA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Prof. Ivan Bautmans, class: OTHER, collaborators name: Leiehome vzw, collaborators name: University Hospital, Antwerp, collaborators name: Universiteit Antwerpen, collaborators name: INNOVIRIS, collaborators name: AAL, descriptionModule briefSummary: In this study, 120 older adults (aged 65 years or older) either patients undergoing rehabilitation or older nursing home residents will be provided with an Eforto® device and the eco-System for Healthy Ageing (ISHA) mobile application to self-monitor intrinsic capacity for 4 months (if needed with assistance by an (in)formal caregiver). Preferably, the participants will use their own smartphone because mitigating smartphone-use-related issues.The aims of the study are:1. to evaluate the usability and feasibility of self-monitoring intrinsic capacity by using the ISHA system in rehabilitation and nursing home settings.2. to investigate if changes and variability in intrinsic capacity as measured with ISHA are related to changes in functional ability and quality of life.3. to explore individual trajectories of intrinsic capacity with the ISHA system., conditionsModule conditions: Frailty, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ISHA, outcomesModule primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Potential technical problems of the ISHA system, primaryOutcomes measure: Experiences with ISHA (usability, feasibility and acceptability outcome), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (gait speed; m/s) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (balance) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB, secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability (5-times sit-to stand (s)) measured with SPPB, secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with MoCa (0-30/30, the higher the better cognition), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Katz (6-24/24, the higher, more dependent), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in functional ability measured with Lawton (9-27/27, the higher, more independent), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in quality of life (Qol) measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol), secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with SarQol (short form, 14 items: 4-point Likert Scale: 0-100/100, the higher, the better Qol), secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)., secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)., secondaryOutcomes measure: The correlation between the changes in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)., secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)., secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)., secondaryOutcomes measure: The correlation between the variability in intrinsic capacity as measured with ISHA and the changes in Qol measured with Eq-5D-5L (0 no problem, 5 extreme problems + visual analogue scale(VAS) 0-100/100, the higher the better Qol)., eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270966, orgStudyIdInfo id: 28287 08/11/2023, briefTitle: Cognitive Remediation VR Tool for People With MCI: a Feasibility RCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Cagliari, class: OTHER, descriptionModule briefSummary: The need to promote research in active aging trough multidisciplinary and innovative approaches is strongly indicated by the European Union. Our study aims to assess the feasibility and provide a preliminary measure of effectiveness for an intervention using immersive virtual reality (VR) technology for cognitive remediation (CR) in individuals with Mild Cognitive Impairment (MCI), conditionsModule conditions: Mild Cognitive Impairment, conditions: Cognitive Remediation, conditions: Virtual Reality, conditions: Psychiatric Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Cognitive Remediation, outcomesModule primaryOutcomes measure: Side effects; Dropout rates; Proportion of recruited participants among those considered eligible, secondaryOutcomes measure: Short Form Health Survey, 12 items (SF-12), secondaryOutcomes measure: Brief Social Rhythms Scale (BSRS), secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Generalized Anxiety Disorder-7 item (GAD-7), secondaryOutcomes measure: Addenbrooke's Cognitive Examination (ACE-R), secondaryOutcomes measure: Matrix test, secondaryOutcomes measure: Rey's Word Test, secondaryOutcomes measure: Trail Making Test (TMT), secondaryOutcomes measure: Digit Span, secondaryOutcomes measure: Stroop Test, secondaryOutcomes measure: Frontal Assessment Battery (FAB), secondaryOutcomes measure: Cognitive Estimates Test (CET), secondaryOutcomes measure: Rey Figure Test, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Giovanni di Dio Hospital, city: Cagliari, state: CA, zip: 09100, country: Italy, geoPoint lat: 39.23054, lon: 9.11917, hasResults: False |
protocolSection identificationModule nctId: NCT06270953, orgStudyIdInfo id: DZ_NX_US, briefTitle: Non-invasive Monitoring: Impact on Patient Management and Outcomes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Turtle Shell Technologies Pvt. Ltd., class: INDUSTRY, descriptionModule briefSummary: Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery., conditionsModule conditions: No Specific Medical Conditions or Disease States, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Dozee Pro NX, outcomesModule primaryOutcomes measure: Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),, secondaryOutcomes measure: HCP experience response data, secondaryOutcomes measure: Care pathway mapping, eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 120 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oak Village Healthcare, status: RECRUITING, city: Lake Jackson, state: Texas, zip: 77566, country: United States, contacts name: Lindsay Darthard, LNFA, role: CONTACT, phone: 979-319-2306, email: [email protected], contacts name: Lindsay Darthard, LNFA, role: PRINCIPAL_INVESTIGATOR, contacts name: Marc A Wilson, MD, role: SUB_INVESTIGATOR, geoPoint lat: 29.03386, lon: -95.43439, hasResults: False |
protocolSection identificationModule nctId: NCT06270940, orgStudyIdInfo id: 2023.0922, briefTitle: Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy, acronym: PURPOSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes., conditionsModule conditions: Neuropathic Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Pulsed Radiofrequency (PRF) Treatment, outcomesModule primaryOutcomes measure: Duration PRF, primaryOutcomes measure: Type of PRF, primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Health Related Quality of life, primaryOutcomes measure: Patient Global Impression of Change: PGIC, primaryOutcomes measure: Use of opioids, primaryOutcomes measure: PROMIS-29, primaryOutcomes measure: PROMIS Global-10, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, zip: 1081 HV, country: Netherlands, contacts name: Katrin Stoecklein, Dr, role: CONTACT, phone: 0031 20 444 386, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06270927, orgStudyIdInfo id: 00003830, briefTitle: A Feasibility Study for Randomization of Code Stroke Imaging Strategies, acronym: CSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, collaborators name: Lone Star Stroke Research Consortium, descriptionModule briefSummary: The purpose of this study is to test feasibility of a comparative effectiveness framework for acute stroke imaging using prospective electronic health data. This is a prospective, cohort feasibility study of patients presenting to the Emergency Department with suspected acute ischemic stroke. The clinical stroke team will not be blinded to the imaging modality given the nature and purpose of the interventions/imaging. Knowledge of the imaging modality used and the knowledge gained from the resulting data will need to be considered for treatment decisions. Blinding will be maintained for data abstraction and analyses. Analysis will be on an "intent-to-scan" basis and all qualifying patients will be included in their assigned cohort., conditionsModule conditions: Brain Ischemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: MRI, interventions name: CT, outcomesModule primaryOutcomes measure: compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ascension Seton, status: RECRUITING, city: Austin, state: Texas, zip: 78712, country: United States, contacts name: Adrienne N Dula, PhD, role: CONTACT, phone: 512-495-5922, email: [email protected], contacts name: Karinne Berstis, MA, role: CONTACT, email: [email protected], geoPoint lat: 30.26715, lon: -97.74306, hasResults: False |
protocolSection identificationModule nctId: NCT06270914, orgStudyIdInfo id: IBIS, briefTitle: Inclusive Positive Behaviour Supports, acronym: IBIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-25, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: The Swedish Research Council, descriptionModule briefSummary: Background: While positive school climate is important for students' well-being and mental health, school personnel may experience challenges in creating a nurturing school climate. School-Wide Positive Behavioral Interventions and Supports (SW-PBIS) have shown positive effects on school climate, but fewer studies have been conducted in the European context. Aim: The present project aims to investigate the effectiveness of SW-PBIS programs for students' social-emotional skills and academic achievement as well as teachers' and students' perceptions of the learning environment. Furthermore, the study intends to evaluate how school-level factors mediate or moderate the effects of the intervention. In addition, the study includes a qualitative evaluation of the dynamic interaction processes that occur during program implementation in local school contexts. Methods: Data on school- and individual-level measures are collected in intervention and control schools. With regard to challenges in retaining control groups over extended time periods, two waves of recruitment are used. In the first wave, an active control group is used, and data are collected during three time points. In the second wave, a wait-list control group is used, and data are collected during two time points during one school year. Hierarchical regression analyses will be conducted to explore the effects of SW-PBIS on the outcomes of the study. An ethnomethodological approach will be applied to provide a detailed examination of the social interactional and meaning-making practices of different school implementation teams, and the negotiation of normative expectations and rules of conduct in peer-teacher-student interactions in different classrooms. Discussion: The study is expected to contribute knowledge on the effects of the SWPBIS program and how these effects may be mediated or moderated by school-level factors. Combining quantitative and qualitative methods to explore the significance of school contexts in the implementation of the SWPBIS program constitutes the strength of the study. The challenge in the study is the extended period of implementation of SWPBIS, which entails difficulties in retaining a control group over the required time period. Therefore, two waves of recruitment are used, encompassing different procedures of allocation to intervention or control groups., conditionsModule conditions: Behavior Problem, conditions: Social Skills, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study utilizes quasi-experimental non-randomized design, including two waves of participant recruitment. Two waves of recruitment are used. In the first wave of recruitment, intervention and active control group are used and outcomes will be measured at three time points. In addition to quantitative data, qualitative observations and interviews are conducted to get a deeper understanding of the process of implementation of SWPIS. In the second wave of data recruitment, intervention and wait-list control group are used and outcomes will be measured at two time points (pre- and post)., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: Inclusive Positive Behavior Interventions and Supports, outcomesModule primaryOutcomes measure: Social emotional skills, primaryOutcomes measure: Classroom environment, primaryOutcomes measure: Students' achievement, secondaryOutcomes measure: Collective self-efficacy, secondaryOutcomes measure: Problem behavior in classroom and school, otherOutcomes measure: Implementation fidelity, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Department of Education, status: RECRUITING, city: Uppsala, state: Uppland, zip: 752 37, country: Sweden, contacts name: Martin Karlberg, PhD, role: CONTACT, phone: 018-471 1669, email: [email protected], contacts name: Nina Klang, PhD, role: CONTACT, phone: 018-471 1674, email: [email protected], geoPoint lat: 59.85882, lon: 17.63889, hasResults: False |
protocolSection identificationModule nctId: NCT06270901, orgStudyIdInfo id: BMEL: 2822EPS008, briefTitle: Acute Effects of Legume-enriched Meals Compared to Western Diet Meals on Postprandial Metabolism in Participants With Increased Cardiometabolic Risk, acronym: LeguPlan_1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, collaborators name: Federal Ministry of Food and Agriculture (BMEL), collaborators name: Federal Office for Agriculture and Food (BLE), descriptionModule briefSummary: The aim of the study is to investigate the postprandial effects of legume-enriched meals compared to Western Diet meals on postprandial metabolism. In this context, older adults with increased risk for cardiometabolic diseases consume 4 mixed meals with 36 g or 62 g of protein either designed according to the Planetary Health Diet with legumes as primary protein source or the Western Diet with animal foods as primary protein source, in a randomized order. In a postprandial observation period of 6 hours, parameters of lipid metabolism, glucose and insulin metabolism, amino acid profile, as well as markers of inflammation and vascular function are analysed. Furthermore, neuropsychological parameters and satiety-associated hormones are investigated., conditionsModule conditions: Cardiovascular Diseases, conditions: Metabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: High Protein Planetary Health Diet, interventions name: Low Protein Planetary Health Diet, interventions name: High Protein Western Diet, interventions name: Low Protein Western Diet, outcomesModule primaryOutcomes measure: Parameters of lipid metabolism in blood, secondaryOutcomes measure: Parameters of lipid metabolism in blood, secondaryOutcomes measure: Parameters of lipid metabolism in blood, secondaryOutcomes measure: Parameters of lipid metabolism in blood, secondaryOutcomes measure: Parameters of lipid metabolism in blood, secondaryOutcomes measure: Parameters of glucose metabolism in blood, secondaryOutcomes measure: Parameters of glucose metabolism in blood, secondaryOutcomes measure: Parameters of glucose metabolism in blood, secondaryOutcomes measure: Parameters of glucose metabolism in blood, secondaryOutcomes measure: Parameters of glucose metabolism in blood, secondaryOutcomes measure: Blood amino acid profile, secondaryOutcomes measure: Blood urea, secondaryOutcomes measure: Uric acid in blood, secondaryOutcomes measure: Parameters of hunger and satiety in blood, secondaryOutcomes measure: Parameters of endothelial function in blood, secondaryOutcomes measure: Parameters of inflammation in blood, secondaryOutcomes measure: Endothelial function, secondaryOutcomes measure: Neuropsychological parameters, secondaryOutcomes measure: Neuropsychological parameters, secondaryOutcomes measure: Neuropsychological parameters, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bonn, Institute of Nutritional and Food Sciences, Nutrition Physiology, status: RECRUITING, city: Bonn, state: North-Rhine Westphalia, zip: 53115, country: Germany, contacts name: Sarah Egert, Prof. Dr., role: CONTACT, phone: + 49 (0) 228 / 73 59, email: [email protected], geoPoint lat: 50.73438, lon: 7.09549, hasResults: False |
protocolSection identificationModule nctId: NCT06270888, orgStudyIdInfo id: IRB23-1011, briefTitle: Hypofractionation (Radiation) Trial for Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: This study if for people who have been diagnosed with multiple myeloma and their doctors are recommending radiation to help treat it. Typically, radiation consists of 2-3 weeks of external beam radiation therapy. Doctors leading this study would like to see if a shorter radiation course (i.e., hypofractionation) for pelvic radiation is safe for multiple myeloma. Because participants in this study will receive a shortened radiation course, each daily treatment dose that is delivered would be slightly higher than normal. This higher daily dose would be delivered because the study team would like to see if higher doses of radiation are as safe given over a shorter number of days compared to 2-3 weeks. The purpose of this study is to make sure that hypofractionation is safe and effective for individuals with multiple myeloma., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Radiation, outcomesModule primaryOutcomes measure: Maximum Tolerated Dose of Radiation of Per Fraction, secondaryOutcomes measure: Rate of Grade 3 or Higher Adverse Events, secondaryOutcomes measure: Rate of Long-Term Adverse Events, secondaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Progression-free Survival, secondaryOutcomes measure: Local Control of the treated Lesion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Chicago Comprehensive Cancer Center, city: Chicago, state: Illinois, zip: 60637, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False |
protocolSection identificationModule nctId: NCT06270875, orgStudyIdInfo id: PROJECT ADAPT-HF, briefTitle: Addressing Pain Through Navigator-Led Palliative Care Optimized for Heart Failure (ADAPT-HF), acronym: ADAPT HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-03, completionDateStruct date: 2025-01-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: Using the MOST framework, factorial pilot design, and an iterative, community-based process, the purpose of this study is to pilot test to further develop and refine a palliative care (PC) intervention addressing pain of Black adults (age \> 18) with advanced HF. Thirty-six persons with advanced heart failure (HF) will be randomized to receive one of 16 conditions (different combinations of navigator coach-delivered PC pain intervention components)., conditionsModule conditions: Heart Failure NYHA Class III, conditions: Heart Failure NYHA Class IV, conditions: Chronic Illness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Data collectors and principal investigator will be blind to participant condition; participants will be instructed NOT to discuss their assignment with data collectors. Trials participants will know their intervention condition as will the palliative care coach involved in delivering the intervention., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ADAPT HF, outcomesModule primaryOutcomes measure: Feasibility of Intervention Delivery and Data Collection, primaryOutcomes measure: Acceptability of Intervention Measure (AIM), primaryOutcomes measure: PROMIS Pain Intensity Scale, primaryOutcomes measure: Pain Interference Scale Short Form 6b, primaryOutcomes measure: Feasibility of Intervention Measure, secondaryOutcomes measure: Edmonton Symptom Assessment Scale (ESES-r), secondaryOutcomes measure: Kansas City Cardiomyopathy Questionnaire- Short Form, secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: PROMIS General Self-efficacy, secondaryOutcomes measure: Self-care of Heart Failure Index, secondaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), secondaryOutcomes measure: Patient Activation Measure (PAM) Short Form, secondaryOutcomes measure: Brief Multidimensional Measure of Religiousness / Spirituality (BMMRS) - 6-item subscale for Religious/Spiritual Coping + 1 overall Q, secondaryOutcomes measure: Connor-Davidson Resilience Scale (CD-RISC-10), secondaryOutcomes measure: Discrimination in Medical Settings Scale Scale, secondaryOutcomes measure: Cost/Resource Utilization Form, secondaryOutcomes measure: SF Global Health Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270862, orgStudyIdInfo id: SSHRC-PEG2023-AAT, briefTitle: A Digital Active Aging Training Program for Older Adults, acronym: AAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Toronto Metropolitan University, class: OTHER, collaborators name: Social Sciences and Humanities Research Council of Canada, collaborators name: AGE-WELL and the Canadian Frailty Network, collaborators name: Cogniciti, collaborators name: Cognifit, collaborators name: Aging in Cloud, descriptionModule briefSummary: The proposed project aims to develop and validate a multi-dimensional digital active aging program integrated with resilience to promote the biopsychosocial functions of older adults aged 60, including Chinese older immigrants in Canada (Study 1) and English-speaking White Canadian older adults (Study 2).The proposed study takes a typical pretest-training-posttest design. Pretest and posttest: a battery of outcome measures on physical, psychological, and social functions will be administered to all participants. Data will also be used to identify sociodemographic risk predictors for outcome variables (i.e., biopsychosocial functions and resilience). Training: the participants will be randomly assigned to three arms to receive 4 weeks of 16 training/practice/control treatment sessions delivered via Zoom.In the "active aging with resilience (AR)" condition, participants will complete physical, cognitive, and social engagement training modules, starting with a 30-min resilience-building module. The traditional "active aging" (AA) training involves the same multi-domain active aging training without the initial resilience-building module. The "workshop training" (WT) control condition involves workshops following the same 4-week schedule on aging-related topics., conditionsModule conditions: Healthy Aging, conditions: Cognitive Change, conditions: Psychological Stress, conditions: Loneliness, conditions: Social Interaction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Resilience training, interventions name: cognitive training, interventions name: physical exercise, interventions name: social interaction, interventions name: workshop series, outcomesModule primaryOutcomes measure: Exercise Self-efficacy level (ESES), primaryOutcomes measure: the 5-item World Health Organization WellBeing Index (WHO-5), primaryOutcomes measure: Kessler Psychological Distress Scale (K10), primaryOutcomes measure: Multidimensional Scale of Perceived Social Support (MSPSS), primaryOutcomes measure: Conner-Davidson Resilience Scale 10-item (CD RISC-10), primaryOutcomes measure: Emotional regulation Questionnaire (ERQ), primaryOutcomes measure: Positive and Negative Affect Schedule (PANAS), primaryOutcomes measure: Visual working memory test, primaryOutcomes measure: Divided attention test, primaryOutcomes measure: Visual memory test, primaryOutcomes measure: Stroop test, primaryOutcomes measure: Sustained attention to response test, secondaryOutcomes measure: Satisfaction with life scale (SWLS), secondaryOutcomes measure: Instrumental Activities of Daily Living(IADL), secondaryOutcomes measure: The 6-item De Jong Gierveld Loneliness Scale, secondaryOutcomes measure: The Brief Approach/Avoidance Coping Questionnaire (BACQ), eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cognitive Aging Lab, status: RECRUITING, city: Toronto, state: Ontario, zip: M5B 2K3, country: Canada, contacts name: Lixia Yang, PhD, role: CONTACT, phone: 416-979-5000, phoneExt: 556522, email: [email protected], contacts name: Lixia Yang, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06270849, orgStudyIdInfo id: MTU-EC-SU-0-002/66, briefTitle: Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-24, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-20, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis., conditionsModule conditions: Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire, conditions: Reliability of Thai Version of the ICIQ-FLUTS LF, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Questionnaire, outcomesModule primaryOutcomes measure: How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity., primaryOutcomes measure: The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency., primaryOutcomes measure: The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability., secondaryOutcomes measure: The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Thammasat University Hospital, city: Khlong Luang, state: Pathumthani, zip: 12120, country: Thailand, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False |
protocolSection identificationModule nctId: NCT06270836, orgStudyIdInfo id: KS301P108, briefTitle: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR), acronym: GLOW2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Kodiak Sciences Inc, class: INDUSTRY, descriptionModule briefSummary: This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR., conditionsModule conditions: Non-proliferative Diabetic Retinopathy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized 1:1 into one of two arms: KSI-301 or sham., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Tarcocimab, interventions name: Sham injection, outcomesModule primaryOutcomes measure: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), secondaryOutcomes measure: Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy, secondaryOutcomes measure: Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Retina Consultants of Orange County, status: NOT_YET_RECRUITING, city: Fullerton, state: California, zip: 92835, country: United States, geoPoint lat: 33.87029, lon: -117.92534, locations facility: Global Research Management, Inc. - Lugene Eye Institute, status: NOT_YET_RECRUITING, city: Glendale, state: California, zip: 91204, country: United States, geoPoint lat: 34.14251, lon: -118.25508, locations facility: Northern California Retina Vitreous Associates, status: NOT_YET_RECRUITING, city: Mountain View, state: California, zip: 94040, country: United States, geoPoint lat: 37.38605, lon: -122.08385, locations facility: Retina Consultants of Southern California, status: NOT_YET_RECRUITING, city: Redlands, state: California, zip: 92374, country: United States, geoPoint lat: 34.05557, lon: -117.18254, locations facility: Blue Ocean Clinical Research, status: NOT_YET_RECRUITING, city: Clearwater, state: Florida, zip: 33761, country: United States, geoPoint lat: 27.96585, lon: -82.8001, locations facility: Florida Eye Associates, status: NOT_YET_RECRUITING, city: Melbourne, state: Florida, zip: 32901, country: United States, geoPoint lat: 28.08363, lon: -80.60811, locations facility: Center for Retina and Macular Disease, status: NOT_YET_RECRUITING, city: Winter Haven, state: Florida, zip: 33880, country: United States, geoPoint lat: 28.02224, lon: -81.73286, locations facility: Southeast Retina Center, status: NOT_YET_RECRUITING, city: Augusta, state: Georgia, zip: 30909, country: United States, geoPoint lat: 33.47097, lon: -81.97484, locations facility: Springfield Clinic LLP, status: NOT_YET_RECRUITING, city: Springfield, state: Illinois, zip: 62703, country: United States, geoPoint lat: 39.80172, lon: -89.64371, locations facility: Cumberland Valley Retina Consultants, status: NOT_YET_RECRUITING, city: Hagerstown, state: Maryland, zip: 21740, country: United States, geoPoint lat: 39.64176, lon: -77.71999, locations facility: Envision Ocular, LLC, status: NOT_YET_RECRUITING, city: Bloomfield, state: New Jersey, zip: 07003, country: United States, geoPoint lat: 40.80677, lon: -74.18542, locations facility: Cascade Medical Research Institute, status: NOT_YET_RECRUITING, city: Springfield, state: Oregon, zip: 97477, country: United States, geoPoint lat: 44.04624, lon: -123.02203, locations facility: Mid Atlantic Retina, status: NOT_YET_RECRUITING, city: Bethlehem, state: Pennsylvania, zip: 18017, country: United States, geoPoint lat: 40.62593, lon: -75.37046, locations facility: Southeastern Retina Associates PC, status: NOT_YET_RECRUITING, city: Knoxville, state: Tennessee, zip: 37922, country: United States, geoPoint lat: 35.96064, lon: -83.92074, locations facility: Retina Research Institute of Texas, status: RECRUITING, city: Abilene, state: Texas, zip: 79606, country: United States, geoPoint lat: 32.44874, lon: -99.73314, locations facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists, status: NOT_YET_RECRUITING, city: Amarillo, state: Texas, zip: 79106, country: United States, geoPoint lat: 35.222, lon: -101.8313, locations facility: Star Vision Research, status: NOT_YET_RECRUITING, city: Burleson, state: Texas, zip: 76028, country: United States, geoPoint lat: 32.54208, lon: -97.32085, locations facility: Texas Retina Associates, status: NOT_YET_RECRUITING, city: Plano, state: Texas, zip: 75075, country: United States, geoPoint lat: 33.01984, lon: -96.69889, locations facility: Strategic Clinical Research Group, LLC, status: NOT_YET_RECRUITING, city: Willow Park, state: Texas, zip: 76087, country: United States, geoPoint lat: 32.76263, lon: -97.65058, locations facility: Piedmont Eye Center, status: NOT_YET_RECRUITING, city: Lynchburg, state: Virginia, zip: 24502, country: United States, geoPoint lat: 37.41375, lon: -79.14225, locations facility: Emanuelli Research & Development Center, LLC, status: NOT_YET_RECRUITING, city: Arecibo, zip: 00612, country: Puerto Rico, geoPoint lat: 18.47245, lon: -66.71573, hasResults: False |
protocolSection identificationModule nctId: NCT06270823, orgStudyIdInfo id: NIMR/HQ/R.8a/Vol.IX/4331, briefTitle: Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-02-14, completionDateStruct date: 2025-02-14, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Kilimanjaro Clinical Research Institute, class: OTHER, collaborators name: Leiden University Medical Center, descriptionModule briefSummary: Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care, conditionsModule conditions: Transient Tachypnea of the Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 562, type: ESTIMATED, armsInterventionsModule interventions name: Knee-to-chest-flexion manoeuvre, outcomesModule primaryOutcomes measure: respiratory distress, secondaryOutcomes measure: adverse outcome of knee-to-chest flexion maneuver, eligibilityModule sex: ALL, maximumAge: 30 Minutes, stdAges: CHILD, contactsLocationsModule locations facility: Kilimanjaro Christian Medical Centre, status: RECRUITING, city: Moshi, state: Kilimanjaro, zip: P.O.Box 3010, country: Tanzania, contacts name: Febronia L Shirima, MD, role: CONTACT, phone: +255714143368, email: [email protected], contacts name: Bariki Mchome, PhD, role: CONTACT, phone: +255784280027, email: [email protected], contacts name: Febronia L Shirima, MD, role: SUB_INVESTIGATOR, contacts name: Bariki Mchome, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Blandina T Mmbaga, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -3.35, lon: 37.33333, hasResults: False |
protocolSection identificationModule nctId: NCT06270810, orgStudyIdInfo id: Aero-PA, briefTitle: Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-03-18, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kastamonu University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.The main question it aims to answer is:• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables., conditionsModule conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic Exercise, interventions name: Increasing non-Exercise Physical Activity, outcomesModule primaryOutcomes measure: Low Density Lipoprotein (LDL) Cholesterol, primaryOutcomes measure: High Density Lipoprotein (HDL) Cholesterol, primaryOutcomes measure: Total Cholesterol, primaryOutcomes measure: Glycated Hemoglobin (HbA1C), primaryOutcomes measure: Serum Triglycerides, primaryOutcomes measure: Maximal Oxygen Consumption, primaryOutcomes measure: Systolic Blood Pressure, primaryOutcomes measure: Diastolic Blood Pressure, secondaryOutcomes measure: Body Fat Percentage, secondaryOutcomes measure: Fat-free Mass, secondaryOutcomes measure: Waist Circumference, secondaryOutcomes measure: Hip Circumference, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kastamonu University, Çatalzeytin Vocational School, city: Çatalzeyti̇n, state: Kastamonu, zip: 37, country: Turkey, hasResults: False |
protocolSection identificationModule nctId: NCT06270797, orgStudyIdInfo id: KMUHIRB-E(I)-20230184, briefTitle: Pre-anesthesia Imaging-based Respiratory Assessment and Analysis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University Chung-Ho Memorial Hospital, class: OTHER, descriptionModule briefSummary: This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system., conditionsModule conditions: Clinical Decision Support System, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30000, type: ESTIMATED, armsInterventionsModule interventions name: intubation for general anesthesia, outcomesModule primaryOutcomes measure: A pre-anesthesia evaluation, primaryOutcomes measure: Perform non-invasive imaging capture., primaryOutcomes measure: difficult intubation prediction, secondaryOutcomes measure: time to successfully extubate the nasotracheal tube after anesthesia, secondaryOutcomes measure: safely discharged from post-anesthesia care unit (postoperative recovery room), secondaryOutcomes measure: side effects and adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, status: RECRUITING, city: Kaohsiung, state: Sanmin Dist, zip: 80756, country: Taiwan, contacts name: Tz Ping Gau, MD, role: CONTACT, phone: +886912060962, email: [email protected], geoPoint lat: 22.61626, lon: 120.31333, hasResults: False |
protocolSection identificationModule nctId: NCT06270784, orgStudyIdInfo id: 09.2024.122, briefTitle: Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-07-17, completionDateStruct date: 2024-09-17, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?Participants will:* undergo either traditional or orthodontic extraction* be monitored for postoperative paresthesia.Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage., conditionsModule conditions: Inferior Alveolar Nerve Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Traditional Extraction, interventions name: Orthodontic Extraction, outcomesModule primaryOutcomes measure: The effect of the extraction method on nerve injury, secondaryOutcomes measure: 2-point discrimination test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Marmara University, status: RECRUITING, city: Istanbul, state: Basibuyuk, zip: 34854, country: Turkey, contacts name: Senem Askin Ekinci, DDS, role: CONTACT, phone: +902167775000, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06270771, orgStudyIdInfo id: 5823, briefTitle: OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study, acronym: OURA MDS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Sunnybrook Health Sciences Centre, class: OTHER, descriptionModule briefSummary: A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months., conditionsModule conditions: MDS, conditions: Myelodysplastic Syndromes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: OURA Ring, outcomesModule primaryOutcomes measure: Feasibility of patients with MDS wearing the OURA ring, secondaryOutcomes measure: Exploratory correlations between physiologic changes captured by the wearable device and physical functioning, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sunnybrook Health Sciences Research Centre, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, contacts name: Rena Buckstein, role: CONTACT, phone: 416-480-5000, phoneExt: 689565, email: [email protected], contacts name: Geetha Yogendran, role: CONTACT, phone: 416-480-5000, phoneExt: 689565, email: [email protected], contacts name: Rena Buckstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06270758, orgStudyIdInfo id: 453/2023/Sper/IOR, briefTitle: Clinical Validation of BBCT-hip, acronym: ValidaBBCT-hip, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-07, primaryCompletionDateStruct date: 2030-11-06, completionDateStruct date: 2030-11-06, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study., conditionsModule conditions: Osteoporosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: CT scan at the femur, outcomesModule primaryOutcomes measure: Femoral fracture event, primaryOutcomes measure: BBCT-hip risk prediction, secondaryOutcomes measure: T-score, eligibilityModule sex: FEMALE, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rizzoli Orthopaedic Institute, status: RECRUITING, city: Bologna, zip: 40136, country: Italy, contacts name: Alessandra Aldieri, PhD, role: CONTACT, phone: +390516366565, email: [email protected], contacts name: Fabio Baruffaldi, role: CONTACT, phone: +390516366850, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, locations facility: Rizzoli Orthopaedic Institute, status: RECRUITING, city: Bologna, zip: 40136, country: Italy, contacts name: Alessandra Aldieri, PhD, role: CONTACT, phone: +39 051 636 6565, email: [email protected], contacts name: Fabio Baruffaldi, role: CONTACT, phone: + 39 051 6366850, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, hasResults: False |
protocolSection identificationModule nctId: NCT06270745, orgStudyIdInfo id: sdycllyy001, briefTitle: ICG Anastomotic Control in Digestive System Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Shandong Linglong Yingcheng Hospital, class: NETWORK, descriptionModule briefSummary: This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery., conditionsModule conditions: Surgical Anastomosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: indocyanine green, outcomesModule primaryOutcomes measure: Anastomotic leak at 30 days, secondaryOutcomes measure: Post-operative morbidity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shandong Linglong Yingcheng Hospital, status: RECRUITING, city: Yantai, state: Shandong, zip: 264000, country: China, contacts name: Xuan Qiu, MD, role: CONTACT, phone: 8618354280081, email: [email protected], contacts name: Ni Wang, MD, role: CONTACT, phone: 8618705353551, email: [email protected], geoPoint lat: 37.47649, lon: 121.44081, hasResults: False |
protocolSection identificationModule nctId: NCT06270732, orgStudyIdInfo id: PID2021-125444OB-100-II-iM, briefTitle: Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population., acronym: iMentalize, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-02-21, completionDateStruct date: 2025-03-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universitat Autonoma de Barcelona, class: OTHER, collaborators name: Ministerio de Economía y Competitividad, Spain, descriptionModule briefSummary: OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:* iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).* iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).* MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group)., conditionsModule conditions: Emotional Intelligence, conditions: Social Interaction, conditions: Mental Health Wellness 1, conditions: Well-Being, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, parallel group, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: iMentalize Program (iMentalize), interventions name: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA), interventions name: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU), outcomesModule primaryOutcomes measure: Parental Reflective Function Questionnaire (PRFQ), primaryOutcomes measure: Trait Meta-Mood Scale (24 items) (TMMS-24), primaryOutcomes measure: Basic Empathy Scale (BES), primaryOutcomes measure: Movie for the Assessment of Social Cognition (MASC), primaryOutcomes measure: Stirling Children's Wellbeing Scale (SCWBS), primaryOutcomes measure: Child Well-Being Level (CWBL), primaryOutcomes measure: Strengths and Difficulties Questionnaire (SDQ), primaryOutcomes measure: Achenbach System for Empirically Assessment (ASEBA), secondaryOutcomes measure: Observing Mediational Interaction (OMI), secondaryOutcomes measure: Parental Stress Questionnaire (PSI), secondaryOutcomes measure: Goldberg Health Questionnaire (28 items) (GHQ-28), secondaryOutcomes measure: Difficulties in Emotional Regulation Scale (DERS), secondaryOutcomes measure: Oxford Happiness Questionnaire (OHQ), secondaryOutcomes measure: Rosenberg's Self-Esteem Scale (RSES), secondaryOutcomes measure: Parental Sense of Competence Scale (PSOC), secondaryOutcomes measure: Self-Other Mentalization Scale (SOMS), secondaryOutcomes measure: Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5), secondaryOutcomes measure: Trait Meta-Mood Scale - Children version (TMMS-C), secondaryOutcomes measure: Big Five Questionnaire for Children and Adolescents (BFQ-NA), secondaryOutcomes measure: BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn), secondaryOutcomes measure: Rosenberg's Self-Esteem Scale - Child version (RSES-C), secondaryOutcomes measure: Battery of Socialization (BAS), otherOutcomes measure: Inventory of Learning Patterns, reduced version (60 items) (ILP-60), otherOutcomes measure: Relationship Questionnaire (RQ), otherOutcomes measure: Time with the Child (TC), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sergi Ballespí, status: RECRUITING, city: Barcelona, zip: 08193, country: Spain, contacts name: Anna Ciraso, Researcher, role: CONTACT, phone: +34661858272, email: [email protected], contacts name: Ana Carolina Pacheco, Researcher, role: CONTACT, phone: +573153561564, email: [email protected], geoPoint lat: 41.38879, lon: 2.15899, locations facility: Universitat Autònoma de Barcelona, status: RECRUITING, city: Barcelona, zip: 08193, country: Spain, contacts name: Anna Ciraso, Researcher, role: CONTACT, phone: +34661858272, email: [email protected], contacts name: Ana Carolina Pacheco, Researcher, role: CONTACT, phone: +573153561564, email: [email protected], geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06270719, orgStudyIdInfo id: SRP-9001-401, briefTitle: An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy, acronym: ENDURE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2038-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sarepta Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies., conditionsModule conditions: Duchenne Muscular Dystrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: delandistrogene moxeparvovec, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and Calculated Velocity) at Month 12, secondaryOutcomes measure: All Cohorts: Time to Rise From Floor (Supine to Stand), secondaryOutcomes measure: All Cohorts: Loss of Ambulation (LOA), secondaryOutcomes measure: All Cohorts: Performance of Upper Limb (PUL) Version 2.0 Entry Item Score, secondaryOutcomes measure: All Cohorts: Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity and Fatigue, secondaryOutcomes measure: All Cohorts: Pulmonary Function, as Measured Forced Vital Capacity (FVC) (% Predicted), secondaryOutcomes measure: All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO), secondaryOutcomes measure: All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Delandistrogene Moxeparvovec Cohorts: Time to Walk/Run 10 Meters (Calculated Velocity), secondaryOutcomes measure: Delandistrogene Moxeparvovec Post-trial Cohort: North Star Ambulatory Assessment (NSAA), eligibilityModule sex: MALE, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arkansas Children's Hospital, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72202, country: United States, contacts role: CONTACT, email: [email protected], contacts name: Aravindhan Veerapandiyan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Penn State Health Milton S. Hershey Medical Center, status: NOT_YET_RECRUITING, city: Hershey, state: Pennsylvania, zip: 17033, country: United States, contacts role: CONTACT, email: [email protected], contacts name: Ashutosh Kumar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.28592, lon: -76.65025, locations facility: Cook Children's Hospital, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76104, country: United States, contacts role: CONTACT, email: [email protected], geoPoint lat: 32.72541, lon: -97.32085, locations facility: Children's Hospital of the King's Daughters, status: RECRUITING, city: Norfolk, state: Virginia, zip: 23507, country: United States, contacts role: CONTACT, email: [email protected], contacts name: Crystal Proud, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.84681, lon: -76.28522, hasResults: False |
protocolSection identificationModule nctId: NCT06270706, orgStudyIdInfo id: PLN-101095-ONC-101, briefTitle: A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Pliant Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab.The study will consist of 2 main parts:* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design* Part 2: Dose-expansion cohorts using Simon's 2-stage design, conditionsModule conditions: Metastatic Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: PLN-101095, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0., primaryOutcomes measure: Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications., secondaryOutcomes measure: Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK)., secondaryOutcomes measure: Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK)., secondaryOutcomes measure: Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK)., secondaryOutcomes measure: Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1., secondaryOutcomes measure: Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Texas Accelerated Research Therapeutics (START), status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: NEXT Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78758, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: University of Texas MD Anderson Cancer Center, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: NEXT Virginia, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False |
protocolSection identificationModule nctId: NCT06270693, orgStudyIdInfo id: Dr Sushma, briefTitle: hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Postgraduate Institute of Dental Sciences Rohtak, class: OTHER, descriptionModule briefSummary: Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure., conditionsModule conditions: Apical Periodontitis, conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Endodontic treatment, outcomesModule primaryOutcomes measure: Serum hsCRP, primaryOutcomes measure: complete hemogram indices, secondaryOutcomes measure: Periapical index SCORE CHANGE, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PGIDS, city: Rohtak, state: Haryana, zip: 124001, country: India, geoPoint lat: 28.89447, lon: 76.58917, hasResults: False |
protocolSection identificationModule nctId: NCT06270680, orgStudyIdInfo id: STUDY00023019, briefTitle: Carotenoids for Collision Athletes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Penn State University, class: OTHER, collaborators name: MacuHealth, collaborators name: Orlando Regional Medical Center, descriptionModule briefSummary: This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo., conditionsModule conditions: Head Injury, conditions: Carotenoids, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Vision Edge Pro, interventions name: Placebo, outcomesModule primaryOutcomes measure: Blood and saliva biomarkers via venous blood draw and spitting into sterile cup., primaryOutcomes measure: Visual Performance: Speed of visual processing, primaryOutcomes measure: Visual Performance: Contrast Sensitivity, primaryOutcomes measure: Skin carotenoid concentration, primaryOutcomes measure: Retinal Nerve Fiber Layer Thickness, primaryOutcomes measure: Macular Pigment Optical Density, primaryOutcomes measure: Visual Quality of Life Scores, primaryOutcomes measure: Visual Quality of Life Scores, secondaryOutcomes measure: Demographic information, secondaryOutcomes measure: Demographic information, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Pennsylvania State University, city: University Park, state: Pennsylvania, zip: 16802, country: United States, contacts name: Semyon Slobounov, PhD, role: CONTACT, phone: 814-571-4298, email: [email protected], contacts name: Jonathan Kelly, MS, role: CONTACT, phone: 9495565035, email: [email protected], contacts name: Semyon Slobounov, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.80201, lon: -77.85639, hasResults: False |
protocolSection identificationModule nctId: NCT06270667, orgStudyIdInfo id: LYMfit, briefTitle: Effects of Exercise Training in Survivors of Lymphoma, acronym: LYMfit, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2028-09-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Norwegian School of Sport Sciences, class: OTHER, collaborators name: Uppsala University, descriptionModule briefSummary: This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases., conditionsModule conditions: Lymphoma, conditions: Physical Exercise, conditions: Cardiotoxicity, conditions: Cardiovascular Diseases, conditions: Chemotherapeutic Toxicity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic Exercise, interventions name: Combined Aerobic and Resistance Exercise, outcomesModule primaryOutcomes measure: VO2peak, secondaryOutcomes measure: Systolic- and diastolic heart chamber dimensions, secondaryOutcomes measure: Systolic- and diastolic longitudinal strain, secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Forced Vital Capacity, secondaryOutcomes measure: Forced Expiratory Volume 1 sec, secondaryOutcomes measure: Maximal voluntary ventilation, secondaryOutcomes measure: Diffusion capacity, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Global Health related Quality of life, secondaryOutcomes measure: Blood volume, secondaryOutcomes measure: Muscle fiber area, secondaryOutcomes measure: Muscle fiber type, secondaryOutcomes measure: Muscle mitochondria mass, otherOutcomes measure: Muscle genome-wide DNA methylation and gene expression, otherOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Norweigan School of Sport Sciences, status: NOT_YET_RECRUITING, city: Oslo, country: Norway, contacts name: Tormod S. Nilsen, PhD, role: CONTACT, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Helena Igelström, status: RECRUITING, city: Uppsala, country: Sweden, contacts name: Helena Igelström, PhD, role: CONTACT, contacts name: Anna Henriksson, PhD, role: CONTACT, phone: 709394175, phoneExt: 0046, email: [email protected], contacts name: Helena Igelström, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Anna Henriksson, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False |
protocolSection identificationModule nctId: NCT06270654, orgStudyIdInfo id: 2023322-12280, briefTitle: Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Malaya, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation, time to ambulation post surgery and quality of recovery., conditionsModule conditions: Lumbar Spine Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Erector spinae plane block, interventions name: Skin infiltration LA, outcomesModule primaryOutcomes measure: Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery, primaryOutcomes measure: Total opioid consumption intraoperative, primaryOutcomes measure: Total opioid consumption post-operative, primaryOutcomes measure: Timing of first rescue dose of iv morphine, secondaryOutcomes measure: The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation, secondaryOutcomes measure: Hemodynamic changes intraoperative, secondaryOutcomes measure: Hemodynamic changes intraoperative, secondaryOutcomes measure: Length of hospital stays, secondaryOutcomes measure: Time to ambulation after surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universiti Malaya Medical Centre, status: RECRUITING, city: Kuala Lumpur, state: Wilayah Persekutuan, zip: 51100, country: Malaysia, contacts name: Wei Keang Tan, M.D., role: CONTACT, phone: +60126655489, email: [email protected], contacts name: Wei Keang Tan, MD., role: PRINCIPAL_INVESTIGATOR, contacts name: Tzi Sen Lee, MBBS, role: SUB_INVESTIGATOR, contacts name: Dharmendra Ganesan, MBBS, FRCS, role: SUB_INVESTIGATOR, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False |
protocolSection identificationModule nctId: NCT06270641, orgStudyIdInfo id: STUDY00018628, briefTitle: Increasing Physical Activity for Adults With Multiple Sclerosis (MS), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, descriptionModule briefSummary: This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS)., conditionsModule conditions: Multiple Sclerosis (MS), conditions: Fatigue, conditions: Physical Inactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: ExerciseRx intervention, outcomesModule primaryOutcomes measure: Physical activity: daily average step count, secondaryOutcomes measure: Activity volume, secondaryOutcomes measure: Minutes/week of moderate intensity aerobic activity, secondaryOutcomes measure: Fatigue - PROMIS Fatigue-MS Short Form 8a, secondaryOutcomes measure: Pain intensity - PROMIS Pain Intensity Short Form 3a, secondaryOutcomes measure: Depressive symptom severity - PROMIS Depression Short Form 8a, secondaryOutcomes measure: Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a, secondaryOutcomes measure: Physical functioning - PROMIS Physical Function 10a, secondaryOutcomes measure: Pain interference - PROMIS Pain Interference Scale Short Form 6a, secondaryOutcomes measure: Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a, secondaryOutcomes measure: Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UW Medicine, status: RECRUITING, city: Seattle, state: Washington, zip: 98133, country: United States, contacts name: Laurie Kavanagh, MPH, role: CONTACT, phone: 206-668-4168, email: [email protected], geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06270628, orgStudyIdInfo id: NL85029.018.23, briefTitle: Personalized Live-remote Exercise Training for Cancer Survivors, acronym: LION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2027-10-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: German Cancer Research Center (DKFZ), Heidelberg, Germany, collaborators name: German Sport University Cologne (DSHS), Cologne, Germany, collaborators name: Cabrini Health (CAB), Malvern, Australia, collaborators name: Karolinska Institute (KI), Stockholm, Sweden, collaborators name: Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands, collaborators name: Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany, collaborators name: Fundacion Onkologikao (ONK), San Sebastian, Spain, collaborators name: Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal, descriptionModule briefSummary: BackgroundMany people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.Goal of the study:The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.Design of the studyIn the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.MeasurementsThe main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.Conclusion:This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively., conditionsModule conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT with two study arms: exercise group and wait list control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Exercise group, outcomesModule primaryOutcomes measure: Health-Related Quality of Life, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, primaryOutcomes measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Anxiety and Depression, secondaryOutcomes measure: CIPN_1, secondaryOutcomes measure: CIPN_2, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Pain, secondaryOutcomes measure: Cognitive problems, secondaryOutcomes measure: Work limitations, secondaryOutcomes measure: Body image, secondaryOutcomes measure: Fear of cancer recurrence, secondaryOutcomes measure: Habitual physical activity, secondaryOutcomes measure: Aerobic capacity on bike, secondaryOutcomes measure: Aerobic capacity on step, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Upper body muscle strength, secondaryOutcomes measure: Lower body muscle strength, secondaryOutcomes measure: Sit to stand test, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Balance, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Resting heart rate, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Height, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Inflammatory state, secondaryOutcomes measure: Growth factors, secondaryOutcomes measure: CRP, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Leucocyte counts, secondaryOutcomes measure: Quality-adjusted life years, secondaryOutcomes measure: Health-care, patient and family costs, secondaryOutcomes measure: Productivity losses, secondaryOutcomes measure: Exercise-related (serious) adverse events, otherOutcomes measure: Participants experience of sensor-based guidance, otherOutcomes measure: Trainer experience of sensor-based guidance, otherOutcomes measure: Compliance sensor-based guidance, otherOutcomes measure: Technical feasibility of sensor-based guidance, otherOutcomes measure: Aerobic capacity, otherOutcomes measure: Upper body muscle strength, otherOutcomes measure: Lower body muscle strength, otherOutcomes measure: Core muscle strength, otherOutcomes measure: Physical functioning, otherOutcomes measure: Balance, otherOutcomes measure: Socio-demographics, otherOutcomes measure: Self-efficacy, otherOutcomes measure: Social Support, otherOutcomes measure: Medical history, otherOutcomes measure: Concomitant diseases, otherOutcomes measure: Cancer + concomitant medication, otherOutcomes measure: Cancer characteristics, otherOutcomes measure: Cancer treatment history, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Utrecht, city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False |
protocolSection identificationModule nctId: NCT06270615, orgStudyIdInfo id: CRCBDD1712, briefTitle: Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model, acronym: SHOCKMATRIX, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: Traumabase Group, collaborators name: Capgemini Invent, collaborators name: Ecole polytechnique, collaborators name: EHESS (Ecole des hautes études en sciences sociales), collaborators name: CNRS (Centre national de la recherche scientifique), descriptionModule briefSummary: Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions., conditionsModule conditions: Wounds and Injuries, conditions: Traumatic Shock, conditions: Hemorrhagic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Ambispective validation of machine learning-based predictive model, outcomesModule primaryOutcomes measure: Fβ-score, with β = 4, secondaryOutcomes measure: Common binary classification metrics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Clichy, zip: 92110, country: France, contacts name: Mathilde Holleville, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.90018, lon: 2.30952, locations facility: Grenoble Alpes University Hospital, status: RECRUITING, city: La Tronche, zip: 38700, country: France, contacts name: Tobias Gauss, MD, role: CONTACT, phone: +33476769288, email: [email protected], contacts name: Samia Salah, role: CONTACT, phone: +33476769288, email: [email protected], geoPoint lat: 45.20429, lon: 5.73645, locations facility: Bicêtre Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Le Kremlin-Bicêtre, zip: 94270, country: France, contacts name: Marie Werner, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.81471, lon: 2.36073, locations facility: Lille University Hospital, Anaesthesia and Intensive Care Unit, status: RECRUITING, city: Lille, zip: 59037, country: France, contacts name: Benjamin Bijok, MD, role: CONTACT, email: [email protected], geoPoint lat: 50.63297, lon: 3.05858, locations facility: Pitié-Salpêtrière Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Paris, zip: 75013, country: France, contacts name: Arthur James, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: Georges-Pompidou European Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Paris, zip: 75015, country: France, contacts name: Nathalie Delhaye, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, locations facility: University Hospitals Strasbourg, Anaesthesia, Intensive Care and Peri-Operative Medicine Department, status: RECRUITING, city: Strasbourg, zip: 67200, country: France, contacts name: Alain Meyer, MD, role: CONTACT, email: [email protected], geoPoint lat: 48.58392, lon: 7.74553, locations facility: University Hospital of Toulouse, Polyvalent Intensive Care, status: RECRUITING, city: Toulouse, zip: 31059, country: France, contacts name: Véronique Ramonda, MD, role: CONTACT, email: [email protected], geoPoint lat: 43.60426, lon: 1.44367, hasResults: False |
protocolSection identificationModule nctId: NCT06270602, orgStudyIdInfo id: ONCOCAMP, secondaryIdInfos id: 6/23 oss, type: OTHER, domain: IRCCS I.N.T. "G. Pascale", briefTitle: The ONCOCAMP Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-14, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Naples, class: OTHER, descriptionModule briefSummary: The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study., conditionsModule conditions: Oncology, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 15000, type: ESTIMATED, armsInterventionsModule interventions name: Data collection (retrospective), interventions name: Data collection (prospective), outcomesModule primaryOutcomes measure: Incidence for each tumor of the patients included in the ROC platform, primaryOutcomes measure: Evaluation of the time interval between GOM activities, primaryOutcomes measure: Evaluation of the time interval between GOM activities, primaryOutcomes measure: Evaluation of the time interval between GOM activities, primaryOutcomes measure: Evaluation of the time interval between GOM activities, primaryOutcomes measure: Evaluation of the time interval between GOM activities, primaryOutcomes measure: Frequency of use of the services of the ROC platform, primaryOutcomes measure: Descriptive analysis of each subgroup of patients (subdivision by tumor type), primaryOutcomes measure: Spatial analysis for each patient, primaryOutcomes measure: Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA), primaryOutcomes measure: Percentage of patient included in clinical trial, primaryOutcomes measure: Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate, primaryOutcomes measure: Prevalence for each tumor of the patients included in the ROC platform, secondaryOutcomes measure: Description of pharmacological strategies, secondaryOutcomes measure: Description of diagnostic activities, secondaryOutcomes measure: Description of surgical strategies, secondaryOutcomes measure: Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA), secondaryOutcomes measure: Description of each surgical approach, secondaryOutcomes measure: Description of the different surgical techniques among the centers, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patients' reported outcome, secondaryOutcomes measure: Patients' satisfaction and evaluation of the diagnostic / therapeutic path, secondaryOutcomes measure: Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis, secondaryOutcomes measure: Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit, secondaryOutcomes measure: Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path, secondaryOutcomes measure: Survival analysis for each tumor, secondaryOutcomes measure: Life status assessment for each patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Asl Napoli 2 Nord, status: RECRUITING, city: Casavatore, state: Napoli, zip: 80020, country: Italy, contacts name: Filomena Sibilio, M.D., role: CONTACT, geoPoint lat: 40.89921, lon: 14.27663, locations facility: Asl Napoli 3 Sud, status: RECRUITING, city: Ercolano, state: Napoli, zip: 80056, country: Italy, contacts name: Mario Fusco, M.D., role: CONTACT, geoPoint lat: 40.80783, lon: 14.35012, locations facility: A.O. Moscati, status: RECRUITING, city: Avellino, zip: 83100, country: Italy, contacts name: Cesare Gridelli, M.D., role: CONTACT, geoPoint lat: 40.91494, lon: 14.79103, locations facility: Asl Avellino, status: RECRUITING, city: Avellino, zip: 83100, country: Italy, contacts name: Giuseppe Genua, M.D., role: CONTACT, geoPoint lat: 40.91494, lon: 14.79103, locations facility: A.O. Rummo, status: RECRUITING, city: Benevento, zip: 82100, country: Italy, contacts name: Antonio Grimaldi, M.D., role: CONTACT, geoPoint lat: 41.1307, lon: 14.77816, locations facility: Asl Benevento, status: RECRUITING, city: Benevento, zip: 82100, country: Italy, contacts name: Elena Fossi, M.D., role: CONTACT, geoPoint lat: 41.1307, lon: 14.77816, locations facility: Asl Caserta, status: RECRUITING, city: Caserta, zip: 81035, country: Italy, contacts name: Antonella Guida, M.D., role: CONTACT, geoPoint lat: 41.07262, lon: 14.33231, locations facility: A.O. S.Anna S. Sebastiano, status: RECRUITING, city: Caserta, zip: 81100, country: Italy, contacts name: Michele Orditura, M.D., role: CONTACT, geoPoint lat: 41.07262, lon: 14.33231, locations facility: A.O. Cardarelli, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Ferdinando Riccardi, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: A.O. Dei Colli, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Vincenzo Montesarchio, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Federico II, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Sabino De Placido, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: I.N.T. Pascale, status: RECRUITING, city: Napoli, zip: 80131, country: Italy, contacts name: Sandro Pignata, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: A.O.U. Luigi Vanvitelli, status: RECRUITING, city: Napoli, zip: 80138, country: Italy, contacts name: Fortunato Ciardiello, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Asl Napoli 1 Centro, status: RECRUITING, city: Napoli, zip: 80145, country: Italy, contacts name: Tiziana Spinosa, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale del Mare, status: RECRUITING, city: Napoli, zip: 80147, country: Italy, contacts name: Bruno Daniele, M.D., role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Asl Salerno, status: RECRUITING, city: Salerno, zip: 84124, country: Italy, contacts name: Giuseppe Di Lorenzo, M.D., role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, locations facility: A.O.U. Ruggi, status: RECRUITING, city: Salerno, zip: 84126, country: Italy, contacts name: Stefano Pepe, M.D., role: CONTACT, geoPoint lat: 40.67545, lon: 14.79328, hasResults: False |
protocolSection identificationModule nctId: NCT06270589, orgStudyIdInfo id: IRB-2023-1684, briefTitle: Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Purdue University, class: OTHER, collaborators name: University of Oregon, descriptionModule briefSummary: The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting restQuestion 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting restParticipants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities.Participants will complete the testing and/or receive treatments below:Day 1:* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)Days 2-5* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)* Participants' heart rate and self-reported affect and rating of physical exertion will be measured* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performanceResearcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: MF-HIIT, interventions name: MF-only, interventions name: HIIT-only, interventions name: Sitting rest, outcomesModule primaryOutcomes measure: Inhibition speed, primaryOutcomes measure: Inhibition accuracy, primaryOutcomes measure: Shifting speed, primaryOutcomes measure: Shifting accuracy, primaryOutcomes measure: N2-ERP, primaryOutcomes measure: P3-ERP, secondaryOutcomes measure: State Mindfulness Scale for Physical Activity (SMSPA), secondaryOutcomes measure: Rating of perceived exertion, secondaryOutcomes measure: Heart Rate, otherOutcomes measure: Dispositional mindfulness, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270576, orgStudyIdInfo id: HS3131, briefTitle: Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma, acronym: Nasal-LPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: National Jewish Health, class: OTHER, descriptionModule briefSummary: A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma., conditionsModule conditions: Asthma; Eosinophilic, conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Lipopolysaccharides, outcomesModule primaryOutcomes measure: Neutrophil heterogeneity using single cell RNA sequencing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Jewish Health, city: Denver, state: Colorado, zip: 80206, country: United States, contacts name: William J Janssen, MD, role: CONTACT, phone: 303-398-1366, contacts name: Olivia M VerBurg, BA, role: CONTACT, phone: 303-398-1201, contacts name: William J Janssen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, hasResults: False |
protocolSection identificationModule nctId: NCT06270563, orgStudyIdInfo id: P.T.REC/012/003967, briefTitle: High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to compare between the efficacy of high intensity LASER therapy and scapular stabilization exercises on ventilatory functions in forward head posture patients, conditionsModule conditions: Forward Head Posture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Postural advice, interventions name: Traditional exercise treatment, interventions name: Scapular stabilization exercises, interventions name: High intensity Laser therapy, outcomesModule primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: Forced expiratory volume at one second (FEV1), primaryOutcomes measure: FEV1/FVC, primaryOutcomes measure: Maximum voluntary ventilation (MVV), primaryOutcomes measure: Craniovertebral angle (CVA), primaryOutcomes measure: Neck Disability Index (NDI), secondaryOutcomes measure: Upper thoracic chest expansion, secondaryOutcomes measure: Middle thoracic chest expansion, secondaryOutcomes measure: Lower thoracic chest expansion, secondaryOutcomes measure: Visual analogue scale (VAS), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University, city: Giza, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False |
protocolSection identificationModule nctId: NCT06270550, orgStudyIdInfo id: DMI in Spastic Diplegia, briefTitle: Role of Dynamic Movement Intervention in Children With Spastic Diplegia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy., conditionsModule conditions: Spastic Diplegia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic Movement Intervention, outcomesModule primaryOutcomes measure: Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System., eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo University, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06270537, orgStudyIdInfo id: Dominus PMCF, briefTitle: Post-market Clinical Trial of the Dominus® Stent-Graft, acronym: DominusPMCF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-24, primaryCompletionDateStruct date: 2025-07-30, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Braile Biomedica Ind. Com. e Repr. Ltda., class: INDUSTRY, descriptionModule briefSummary: Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use, conditionsModule conditions: Thoracic Aortic Dissection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Stent-Graft Dominus® Endoprosthesis, outcomesModule primaryOutcomes measure: Early occurrence of adverse events (Safety Outcome), secondaryOutcomes measure: Device Success, secondaryOutcomes measure: Absence of endoprosthesis fracture, secondaryOutcomes measure: Endoleak, secondaryOutcomes measure: Reintervention-free, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Evangélico de Vila Velha, status: NOT_YET_RECRUITING, city: Vila Velha, state: Espirito Santo, zip: 29118-060, country: Brazil, contacts name: Rodrigo Argenta, role: CONTACT, geoPoint lat: -20.32972, lon: -40.2925, locations facility: Hospital Nossa Senhora da Conceição, status: NOT_YET_RECRUITING, city: Porto Alegre, state: Rio Grande Do Sul, zip: 91350-200, country: Brazil, contacts name: Eduardo A Silva, role: CONTACT, geoPoint lat: -30.03306, lon: -51.23, locations facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, status: RECRUITING, city: Ribeirão Preto, state: São Paulo, zip: 14048-900, country: Brazil, contacts name: Ewaldo Joviliano, role: CONTACT, geoPoint lat: -21.1775, lon: -47.81028, hasResults: False |
protocolSection identificationModule nctId: NCT06270524, orgStudyIdInfo id: RCAPHM21_0433, briefTitle: Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target, acronym: C5-MAG4, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assistance Publique Hopitaux De Marseille, class: OTHER, descriptionModule briefSummary: This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission., conditionsModule conditions: Immunoglobulin G4-Related Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Serum C5a concentration, secondaryOutcomes measure: frequency of C5aR1+ monocytes among total monocytes, secondaryOutcomes measure: frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06270511, orgStudyIdInfo id: 2222T1412, briefTitle: A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-19, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Shionogi, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to investigate different formulations of S-337395., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Part A will be open label; Part B will be double blind, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: S-337395, interventions name: Placebo, outcomesModule primaryOutcomes measure: Part A: Plasma Concentration of S-337395, primaryOutcomes measure: Part B: Number of Participants Experiencing Treatment-emergent Adverse Events, secondaryOutcomes measure: Part A: Number of Participants Experiencing Treatment-emergent Adverse Events, secondaryOutcomes measure: Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples), secondaryOutcomes measure: Part B: Plasma Concentration of S-337395, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON Lenexa, status: RECRUITING, city: Lenexa, state: Kansas, zip: 66219, country: United States, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False |
protocolSection identificationModule nctId: NCT06270498, orgStudyIdInfo id: 24811, briefTitle: Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure, acronym: RISE-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Raffaele De Caterina, class: OTHER, collaborators name: University of Pisa, Italy, descriptionModule briefSummary: The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo., conditionsModule conditions: Chronic Heart Failure, conditions: Iron-deficiency, conditions: Left Ventricular Systolic Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Sucrosomial iron, interventions name: Placebo, outcomesModule primaryOutcomes measure: Exercise capacity, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: 6MWT distance improvement, secondaryOutcomes measure: Quality of life improvement, secondaryOutcomes measure: Exercise capacity (peak oxygen consumption), secondaryOutcomes measure: F2-isoprostanes, secondaryOutcomes measure: Soluble NOX2-derived peptide (sNOX2-dp), secondaryOutcomes measure: H2O2, secondaryOutcomes measure: Phosphate, secondaryOutcomes measure: Fibroblast growth factor (FGF)-23, otherOutcomes measure: N-terminal pro-B-type natriuretic peptide (NTproBNP), otherOutcomes measure: Transferrin saturation (TSAT), otherOutcomes measure: Ferritin, otherOutcomes measure: Serum iron, otherOutcomes measure: Soluble transferrin receptor (sTfR), otherOutcomes measure: Hepcidin, otherOutcomes measure: Cardiac structure and function 1, otherOutcomes measure: Cardiac structure and function 2, otherOutcomes measure: Cardiac structure and function 3, otherOutcomes measure: Cardiac structure and function 4, otherOutcomes measure: Cardiac structure and function 5, otherOutcomes measure: Cardiac structure and function 6, otherOutcomes measure: Clinical outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270485, orgStudyIdInfo id: EA2/224/23, briefTitle: Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children, acronym: IPCOM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Charite University, Berlin, Germany, class: OTHER, collaborators name: University Medical Center Groningen, descriptionModule briefSummary: Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \< 5 years of age, conditionsModule conditions: Ventilation Therapy; Complications, conditions: Congenital Heart Disease, conditions: Children, Only, conditions: Hemodynamic Instability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: PEEP, outcomesModule primaryOutcomes measure: Cardiac Output, secondaryOutcomes measure: TAPSE (cm), secondaryOutcomes measure: respiratory mechanics, secondaryOutcomes measure: TAPSV (cm/s), secondaryOutcomes measure: Global Strain RV (%/sec), secondaryOutcomes measure: Lung Compliance (ml/Min/kg), secondaryOutcomes measure: Esophageal Pressure (mbar), secondaryOutcomes measure: EIT, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Deutsches Herzzentrum der Charité, status: RECRUITING, city: Berlin, zip: 13353, country: Germany, contacts name: Jan Clausen, MD, role: CONTACT, phone: 004917620808764, email: [email protected], contacts name: Michael Emeis, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, locations facility: UMCG, status: RECRUITING, city: Groningen, country: Netherlands, contacts name: Martin Kneyber, PhD, MD, role: CONTACT, email: [email protected], contacts name: Richard Hollander, MD, role: CONTACT, email: [email protected], geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06270472, orgStudyIdInfo id: tipp technique, briefTitle: Transinguinal Periperitoneal Technique in Inguinal Hernioplasty, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals, conditionsModule conditions: Hernia, Inguinal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: hernioplasty, outcomesModule primaryOutcomes measure: Recurrence rate of inguinal hernia 2 years follow up ., primaryOutcomes measure: Numerical rating score of pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270459, orgStudyIdInfo id: DSRB 2023/00954, briefTitle: Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke, acronym: TRUST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-08-14, completionDateStruct date: 2025-08-14, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Tan Tock Seng Hospital, class: OTHER, collaborators name: National University Hospital, Singapore, collaborators name: Singapore General Hospital, descriptionModule briefSummary: There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study is a multi-site prospective clinical trial, with single-arm study design with independent assessment of outcome measures (i.e., robotic metrics, standardized outcomes, quality of life, subjective measures)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: HMAN Robot, outcomesModule primaryOutcomes measure: Compliance Rates, secondaryOutcomes measure: Fugl Meyer Motor Assessment (FMA), secondaryOutcomes measure: Action Research Arm Test (ARAT), secondaryOutcomes measure: Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded), secondaryOutcomes measure: System Usability Scale (SUS), secondaryOutcomes measure: Intrinsic Motivation Inventory (IMI), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06270446, orgStudyIdInfo id: DSRB 2019/01135, briefTitle: Community Based Rehabilitation Model After Total Knee Replacement, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-07-01, completionDateStruct date: 2022-07-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Tan Tock Seng Hospital, class: OTHER, descriptionModule briefSummary: To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic, conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Data analysis blinded, enrollmentInfo count: 59, type: ACTUAL, armsInterventionsModule interventions name: Community based physiotherapy, interventions name: Outpatient physiotherapy, outcomesModule primaryOutcomes measure: TUG, primaryOutcomes measure: 30 sec chair stand test, primaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Knee flexion and extension, secondaryOutcomes measure: Passive range of motion, secondaryOutcomes measure: Presence of lag, otherOutcomes measure: OKS, eligibilityModule sex: ALL, minimumAge: 55 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tan Tock Seng Hospital, city: Singapore, country: Singapore, geoPoint lat: 1.28967, lon: 103.85007, hasResults: False |
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