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protocolSection identificationModule nctId: NCT06353659, orgStudyIdInfo id: M2024077, briefTitle: The Diagnostic Value of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to quantitatively assess the renal microcirculation changes by contrast-enhanced ultrasound (CEUS) and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore the diagnostic value of CEUS in critically ill acute kidney injury., conditionsModule conditions: Intensive Care Unit, conditions: Acute Kidney Injury, conditions: Ultrasound, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Contrast-enhanced Ultrasound, outcomesModule primaryOutcomes measure: Acute kidney injury (according to KDIGO 2012 criteria), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353646, orgStudyIdInfo id: XKY-C-004, briefTitle: XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Wu Wenming, class: OTHER, collaborators name: NeoCura, descriptionModule briefSummary: This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with ipilimumab and chemotherapy in pancreatic cancer patients following surgical resection., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: XH001, interventions name: Ipilimumab Injection, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: DFS, primaryOutcomes measure: 1-year DFS rate, primaryOutcomes measure: MFS, primaryOutcomes measure: OS, secondaryOutcomes measure: Elispot, secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: ctDNA, secondaryOutcomes measure: CA19-9, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06353633, orgStudyIdInfo id: AHekmatdoost, briefTitle: The Effect of Exclusion Diet for Crohn's Disease Plus Enteral Nutrition on Children and Adolescents With Crohn's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-10-20, completionDateStruct date: 2024-12-25, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Nutrition and Food Technology Institute, class: OTHER, descriptionModule briefSummary: In this study, children and adolescents with active Crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: formula, interventions name: exclusion diet, outcomesModule primaryOutcomes measure: PCDAI, primaryOutcomes measure: CRP, primaryOutcomes measure: ESR, primaryOutcomes measure: FC, primaryOutcomes measure: Alb, secondaryOutcomes measure: Arm Circumferance, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Height, secondaryOutcomes measure: weight, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353620, orgStudyIdInfo id: 1018, briefTitle: Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-03-18, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: Recent studies have shown that the aperiodic part of the signal (neuronal avalanches) of electroencephalography (EEG) contains important information about the dynamics of neuronal networks. Indeed, this has helped to identify functionally altered areas in patients with temporal epilepsy by simply using the resting EEG signal. Furthermore, it has been seen that the propagation of neuronal avalanches (VNs) correlates with the morphological organization of the cerebral cortex. Therefore, NAs represent a measure with direct utility for studying functional reorganization pre and post drug/surgical treatment. In addition, the aperiodic portion of the signal may represent a noninvasive measure of the excitation/inhibition relationship, which is known of being altered both in epilepsy and in some rare neurodevelopmental syndromes (example: Angelman and Dup15q), conditionsModule conditions: Epilepsy, conditions: Angelman Syndrome, conditions: Dup15q Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: High Density EEG recording, interventions name: Rey Complex Figure Test, outcomesModule primaryOutcomes measure: Differences in the network coherence values in theta and alpha band after treatment, primaryOutcomes measure: Stability of the alpha frequency band in the EEG activity, primaryOutcomes measure: Correlation of neural excitation and memory performance, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS E.Medea, status: RECRUITING, city: Conegliano, state: Treviso, zip: 31015, country: Italy, contacts name: Duma Gian Marco, PhD, role: CONTACT, phone: +39 0438414248, email: [email protected], geoPoint lat: 45.88805, lon: 12.30201, hasResults: False
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protocolSection identificationModule nctId: NCT06353607, orgStudyIdInfo id: 2023-02267; kt23Berdajs, briefTitle: Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or/and aortic dissection., conditionsModule conditions: Acute Aortic Dissection, conditions: Thoracic Aortic Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 730, type: ESTIMATED, outcomesModule primaryOutcomes measure: Assessment of the association between the prevalence of TAA and/or aAD in variants with genes associated with thoracic aortic disease., secondaryOutcomes measure: Investigate the genetic landscape of aortic specimens retrieved from surgical intervention tissues, and relate the genetic profile to cell molecular pathology., secondaryOutcomes measure: To assess the association between the aortic segment dimension (in CT scan and TEE images), tissue pathology and gene variants to determine the images predictive factors for TAA and/or aAD., secondaryOutcomes measure: To establish a risk prediction model for aAD and TAA based on genetic, clinical, and imaging endpoints., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, status: RECRUITING, city: Basel, zip: 4031, country: Switzerland, contacts name: Denis Berdajs, Prof. Dr., role: CONTACT, phone: 0041 61 328 71 80, email: [email protected], contacts name: Islam Salikhanov, Dr., role: CONTACT, phone: 0041 61 26 53225, email: [email protected], geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
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protocolSection identificationModule nctId: NCT06353594, orgStudyIdInfo id: COPERNICAN TRIAL, briefTitle: Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI, acronym: COPERNICAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2035-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Jorge Sanz Sanchez, class: OTHER, descriptionModule briefSummary: The objective is to compare a reduced stent strategy based on drug-coated balloon (DCB) percutaneous coronary intervention (PCI) with conventional drug-eluting stent (DES) coronary revascularization in patients presenting with ST-segment myocardial infarction (STEMI).Randomization will be performed after successful culprit-lesion guidewire crossing and flow restoration. Random allocation in a 1:1 fashion to one of the following strategies:* Study group: reduced stent PCI strategy (DCB-based)* Control group: conventional PCI strategy (DES-based)., conditionsModule conditions: ST Elevation Myocardial Infarction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1272, type: ESTIMATED, armsInterventionsModule interventions name: Primary PCI, outcomesModule primaryOutcomes measure: Target lesion failure (TLF), secondaryOutcomes measure: Incidence of all-cause death, secondaryOutcomes measure: Incidence of myocardial infarction, secondaryOutcomes measure: Incidence of cardiovascular death, secondaryOutcomes measure: Incidence of target lesion revascularization, secondaryOutcomes measure: Incidence of stent thrombosis, secondaryOutcomes measure: Incidence of acute vessel closure, secondaryOutcomes measure: Incidence of stroke, secondaryOutcomes measure: Incidence of acute kidney injury, secondaryOutcomes measure: Incidence of bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Y Politecnico La Fe, status: RECRUITING, city: Valencia, state: Comunidad Valenciana, country: Spain, contacts name: Jorge Sanz Sánchez, PI, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Consorcio Hospitalario Provincial de Castellon, status: NOT_YET_RECRUITING, city: Castelló, country: Spain, contacts name: David Tejada Ponce, PI, role: CONTACT, geoPoint lat: 41.01149, lon: 0.84856, locations facility: Hospital General Universitario de Elche, status: NOT_YET_RECRUITING, city: Elche, country: Spain, contacts name: Paula Tejedor Viñuela, PI, role: CONTACT, geoPoint lat: 38.26218, lon: -0.70107, locations facility: Hospital Universitari de Bellvitge, status: NOT_YET_RECRUITING, city: Hospitalet de Llobregat, country: Spain, contacts name: Neus Salvatella Giralt, PI, role: CONTACT, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Hospital Universitario 12 de Octubre, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Fernando Sarnago Cebada, PI, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario de La Princesa, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Fernando Rivero Crespo, PI, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Puerta de Hierro Majadahonda, status: NOT_YET_RECRUITING, city: Madrid, country: Spain, contacts name: Juan F Oteo Domínguez, PI, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Regional de Malaga, status: NOT_YET_RECRUITING, city: Málaga, country: Spain, contacts name: Cristobal Urbano Carrillo, PI, role: CONTACT, geoPoint lat: 36.72016, lon: -4.42034, locations facility: Hospital Universitario de Navarra, status: NOT_YET_RECRUITING, city: Pamplona, country: Spain, contacts name: Guillermo Sánchez Elvira, PI, role: CONTACT, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Hospital Universitario Virgen Del Rocio, status: NOT_YET_RECRUITING, city: Sevilla, country: Spain, contacts name: José Díaz Fernández, PI, role: CONTACT, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Hospital Universitari Joan Xxiii de Tarragona, status: NOT_YET_RECRUITING, city: Tarragona, country: Spain, contacts name: Mauricio Torres Sánchez, PI, role: CONTACT, geoPoint lat: 41.11667, lon: 1.25, locations facility: Consorcio Hospital General Universitario de Valencia, status: RECRUITING, city: Valencia, country: Spain, contacts name: Eva Rumiz González, PI, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Hospital Clinico Universitario de Valladolid, status: NOT_YET_RECRUITING, city: Valladolid, country: Spain, contacts name: Ignacio J Amat Santos, PI, role: CONTACT, geoPoint lat: 41.65518, lon: -4.72372, locations facility: Hospital Clinico Universitario Lozano Blesa, status: NOT_YET_RECRUITING, city: Zaragoza, country: Spain, contacts name: Antonela Lukic Otanovic, PI, role: CONTACT, geoPoint lat: 41.65606, lon: -0.87734, locations facility: Hospital Universitario Miguel Servet, status: NOT_YET_RECRUITING, city: Zaragoza, country: Spain, contacts name: Georgina A Fuertes Ferre, role: CONTACT, geoPoint lat: 41.65606, lon: -0.87734, hasResults: False
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protocolSection identificationModule nctId: NCT06353581, orgStudyIdInfo id: 4-2021-0924, briefTitle: Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-02-16, primaryCompletionDateStruct date: 2024-05-08, completionDateStruct date: 2024-05-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy., conditionsModule conditions: Locally Advanced Pancreatic Cancer, conditions: Metastatic Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: Neulapeg, interventions name: Control, outcomesModule primaryOutcomes measure: Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL), primaryOutcomes measure: development of neutropenic fever (febrile neutropenia), secondaryOutcomes measure: relative dose intensity, secondaryOutcomes measure: quality of life assessed according to EORTC QLQ-C30, secondaryOutcomes measure: Number of patients experiencing Adverse events (AEs), secondaryOutcomes measure: objective response rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Change in blood cytokine concentrations, secondaryOutcomes measure: G-CSF induced bone pain as assessed by questionnaires, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Severance Hospital, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06353568, orgStudyIdInfo id: 5.888.210, briefTitle: Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2027-10-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Nove de Julho, class: OTHER, descriptionModule briefSummary: This study seeks to evaluate the effect of photobiomodulation (PBM) in the prevention of Diabetic foot (DF), in patients at moderate and high risk for its development, through a controlled, randomized, double-blind clinical trial. Individuals between 18 and 75 years old of both sexes, with type 2 diabetes mellitus (DM), and moderate and high risk for DF will be randomized and allocated into 2 groups of 32 participants each. The PBM Group will use a boot with 1344 LEDs, 504 of which are 660 nm located on the sides of the boot (28.5 milliwatt, 10 J per LED); 504 850 nm also located on the sides of the boot (23 milliwatt, 8 J per LED); 168 of 660 nm located at the base of the boot (28.5 milliwatt, 10 J per LED); 168 of 850 nm also located at the base of the boot (23 milliwatt, 8 J per LED) once a day for 6 minutes, for 60 days and will receive therapeutic education. Participants will be evaluated at baseline, after 30 days (clinical examination) and after 60 days (clinical examination, Peripheral Neuropathy (PN) assessment, Peripheral Artery Disease (PAD) assessment, blood and urine tests, and quality of life)., conditionsModule conditions: Diabetic Foot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The PBM Group will use a boot with 1344 LEDs once daily for 6 minutes, over 60 days, and will receive therapeutic education.The Control Group will use a non-therapeutic LED boot (placebo) for 6 minutes once daily for 60 days and will also receive therapeutic education.Participants will be assessed at the beginning of the study (baseline) and after 30 days (clinical examination) and 60 days (clinical examination, assessment of Peripheral neuropathy, assessment of peripheral artery disease, blood and urine tests, and quality of life evaluation)., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: * 1 physician-researcher who will conduct all initial evaluations and follow-up examinations (excluding Doppler ultrasound, Ankle-Brachial Index - ABI, and Toe-Brachial Index - TBI), without knowledge of the subjects' allocation, and will administer the Informed Consent Form (ICF).* 1 Vascular surgeon researcher who will perform Doppler ultrasound, Ankle-Brachial Index (ABI), and Toe-Brachial Index (TBI) measurements during the initial assessment and follow-up examinations, without knowledge of the subjects' allocation.* 1 Nurse researcher who will retrieve the allocation envelope and provide the appropriate PBM equipment (active or placebo), as well as provide recommendations for its use at home.* 1 Researcher, who will not participate in any assessments, will prepare randomization and envelopes to ensure allocation confidentiality.* 2 physician residents who will provide daily contact for device usage control, guidance, addressing inquiries, etc., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Photobiomodulation, interventions name: Simulation of Photobiomodulation, interventions name: Therapeutic education, outcomesModule primaryOutcomes measure: Ulcer Incidence, primaryOutcomes measure: Ulcer Incidence, primaryOutcomes measure: Ulcer Incidence, secondaryOutcomes measure: Tactile sensitivity with Semmes-Weinstein monofilament, secondaryOutcomes measure: Tactile sensitivity with Semmes-Weinstein monofilament, secondaryOutcomes measure: Vibratory sensitivity, secondaryOutcomes measure: Vibratory sensitivity, secondaryOutcomes measure: Assessment of Achilles reflex, secondaryOutcomes measure: Assessment of Achilles reflex, secondaryOutcomes measure: Neuropathy Symptom Score (NSS), secondaryOutcomes measure: Neuropathy Symptom Score (NSS), secondaryOutcomes measure: Neuropathic Impairment Score (NIS), secondaryOutcomes measure: Neuropathic Impairment Score (NIS), secondaryOutcomes measure: Evaluation of the degree of ischemia, secondaryOutcomes measure: Evaluation of the degree of ischemia, secondaryOutcomes measure: Systolic peak velocity, secondaryOutcomes measure: Systolic peak velocity, secondaryOutcomes measure: Resistance Index, secondaryOutcomes measure: Resistance Index, secondaryOutcomes measure: Waveform pattern, secondaryOutcomes measure: Waveform pattern, secondaryOutcomes measure: Evaluation of claudication, secondaryOutcomes measure: Evaluation of claudication, secondaryOutcomes measure: Thermography, secondaryOutcomes measure: Thermography, secondaryOutcomes measure: Quality of Life Assessment, secondaryOutcomes measure: Quality of Life Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353555, orgStudyIdInfo id: PUMCH-20240311, briefTitle: Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-11, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism., conditionsModule conditions: Intracerebral Hemorrhage, conditions: Low T3 Syndrome, conditions: Neurocritical Care, conditions: Hormone Replacement Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Euthyrox, interventions name: Euthyrox, outcomesModule primaryOutcomes measure: blood pressure, primaryOutcomes measure: cerebral blood flow dynamics, primaryOutcomes measure: Whether to use vasoactive vasopressors, primaryOutcomes measure: neurological function, secondaryOutcomes measure: Days of the patients received intensive care, secondaryOutcomes measure: Mechanical ventilation time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking union medical college hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Junji Wei, role: CONTACT, phone: +8615801056698, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06353542, orgStudyIdInfo id: HCB/2023/1206, secondaryIdInfos id: PI23/01856, type: OTHER, domain: Institut d'Investigacions Biomèdiques August Pi i Sunyer, briefTitle: Barcelona Esquerra Glaucoma Artificial Intelligence-based Screening Program (BEGAS), acronym: BEGAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hospital Clinic of Barcelona, class: OTHER, descriptionModule briefSummary: Two primary care-based screening systems will be tested to identify subjects with referrable glaucoma to hospital care.Subjects between 45 to 64 years old living in the metropolitan area of Barcelona will be invited to participate in a one-time visit, with an optic disc examination and intraocular pressure (IOP).The criteria for referring a patient will be the detection of glaucoma but with two different approaches depending on which Integrated Practice Unit (IPU) the patients will be allocated to: one arm using an Artificial Intelligence (AI) reading software of the optic disc picture; and the other one will base their referral after an ophthalmic examination performed by an ophthalmologist.In both circuits, an optic nerve head photography will be obtained, and a masked reading center will be established to determine the ground truth for diagnosis.This screening trial will explore the level of agreement between both systems and the cost-effectiveness of each of them.Secondary analyses will include potential diagnostic composite scores (including other ancillary tests, such as optical coherence tomography images, that could maximize the screening process); the identification of population and disease characteristics (type of glaucoma, intraocular pressure) that could increase the effectivity and adherence to the screening process., conditionsModule conditions: Glaucoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Software analysis, interventions name: Ophthalmologist examination, outcomesModule primaryOutcomes measure: Diagnostic agreement between the AI software and the ophthalmic examination, primaryOutcomes measure: Health-Related Quality of Life (HRQoL), primaryOutcomes measure: Demographics, secondaryOutcomes measure: Intraocular pressure, secondaryOutcomes measure: Optical coherence tomography (OCT), secondaryOutcomes measure: Visual field, secondaryOutcomes measure: Cost-effective analysis of both screening methods, secondaryOutcomes measure: Risk score with parameters associated with positive screening of glaucoma, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic - ICOF, city: Barcelona, zip: 08028, country: Spain, contacts name: Nestor Ventura Abreu, MD, PhD, role: CONTACT, phone: +34932275400, phoneExt: 9336, email: [email protected], contacts name: Marta Pazos, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06353529, orgStudyIdInfo id: 17065, briefTitle: Sphenopalatine Ganglion Block for Postop Pain Management, acronym: SPGB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hamilton Health Sciences Corporation, class: OTHER, descriptionModule briefSummary: To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. The aim is to improve patient outcomes and reduce the need for pain medication after surgery., conditionsModule conditions: Pituitary, conditions: Pain, Postoperative, 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: 52, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution, interventions name: Placebo, outcomesModule primaryOutcomes measure: Post-operative pain score, secondaryOutcomes measure: Post-operative bleeding, secondaryOutcomes measure: Post-operative complications, secondaryOutcomes measure: Analgesic requirement, secondaryOutcomes measure: Length of stay, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hamilton General Hospital, city: Hamilton, state: Ontario, zip: L8L 2X2, country: Canada, contacts name: Dr. Kesava Reddy, MD, role: CONTACT, phone: 905-521-2100, email: [email protected], contacts name: Ms. Jessy Moore, MSc, role: CONTACT, phone: 289-686-8827, email: [email protected], geoPoint lat: 43.25011, lon: -79.84963, hasResults: False
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protocolSection identificationModule nctId: NCT06353516, orgStudyIdInfo id: 2310-117-126, briefTitle: The Effect of Intravenous Versus Volatile Anesthesia on Postoperative Cognitive Dysfunction in Elderly Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Chung-Ang University Gwangmyeong Hospital, class: OTHER, collaborators name: National Research Foundation of Korea, descriptionModule briefSummary: The goal of this clinical trial is to compare the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients undergoing surgery. The main questions it aims to answer are:* \[Is the permeability of blood-brain barrier between the intravenous anesthesia group and the inhalation gas anesthesia group in the elderly patients different?\]* \[Is the incidence of postoperative cognitive dysfunction between the intravenous anesthesia group and the inhalation gas anesthesia group different?\] Participants will be anesthetized with different categories of anesthetics. * Intravenous anesthetics * Inhalation gas anesthetics, conditionsModule conditions: Postoperative Cognitive Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants are randomly assigned to total intravenous anesthesia group or inhaled gas anesthesia group, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: This study is a double-blinded randomized controlled trial. The group assignment is conducted by the pre-generated random number table. The participant, investigator and the outcome assessor are blinded to the group assignment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: Propofol, interventions name: Sevoflurane, outcomesModule primaryOutcomes measure: Concentration of serum S100B levels, secondaryOutcomes measure: Incidence of Delirium, secondaryOutcomes measure: Incidence of Postoperative Cognitive Dysfunction, secondaryOutcomes measure: Concentration of serum albumin, secondaryOutcomes measure: Concentration of serum CRP, secondaryOutcomes measure: Concentration of serum IL6 levels, secondaryOutcomes measure: Concentration of serum TNFα levels, secondaryOutcomes measure: Concentration of cerebrospinal fluid (CSF) albumin, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chung-Ang University Gwangmyeong Hospital, status: RECRUITING, city: Gwangmyeong, state: Gyeonggi-do, zip: 14353, country: Korea, Republic of, contacts name: Wongook Wi, M.D., role: CONTACT, phone: 02-2222-1553, email: [email protected], hasResults: False
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protocolSection identificationModule nctId: NCT06353503, orgStudyIdInfo id: KAZ, briefTitle: Bone Marrow Aspirate Concentrate for Anterior Cruciate Ligament Tear Treatment., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2024-09-27, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: abdulmajeed hammadi, class: INDUSTRY, descriptionModule briefSummary: A single armed multicenter study enrolling 20 patients using autologous bone marrow aspirate concentrate (which is done under local or general anesthesia to aspirate around 1-2 cc/kg body weight then concentration which is done by using centrifugation and special disposable kit) local injection of 4 cc per joint under ultrasonic guidance ,completely sterile field with local anesthesia., conditionsModule conditions: Anterior Cruciate Ligament Tear, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single armed study open label, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: autologous bone marrow aspirate concentrate, outcomesModule primaryOutcomes measure: Functional recovery by clinical assessments of the ACL and overall knee joint stability., secondaryOutcomes measure: magnetic resonance imaging of the knee joint, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ministry of Health, status: RECRUITING, city: Baghdad, zip: 964, country: Iraq, contacts name: thamer A alrubaie, MD, role: CONTACT, phone: +9647700009294, email: [email protected], geoPoint lat: 33.34058, lon: 44.40088, hasResults: False
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protocolSection identificationModule nctId: NCT06353490, orgStudyIdInfo id: Geon-111001, briefTitle: The Clinical Performance Validation of Electronic Thermometer and Infrared Thermometers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-08-12, primaryCompletionDateStruct date: 2023-11-08, completionDateStruct date: 2024-08-11, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Geon Corporation, class: INDUSTRY, descriptionModule briefSummary: Geon Corporation develops ear thermometers and forehead thermometers that use infrared measurement technology to measure human body temperature. This study verify the accuracy and repeatability of investigational devices. Efficacy verification is carried out by comparing with the referent medical devices.The main objectives of this study are:1. To verify that the investigational devices and the reference medical devices have a reasonable deviation value.2. To verify the consistency of repeated measurements of investigational devices., conditionsModule conditions: Febrile, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: Infrared Forehead Thermometer (GE-TF03), interventions name: Infrared Ear Thermometer (GE-TE06), interventions name: Electronic Thermometer (MT-B321FB), interventions name: Electronic Thermometer (MT-B231), outcomesModule primaryOutcomes measure: Clinical Bias, primaryOutcomes measure: Limits of Agreement, primaryOutcomes measure: Clinical Repeatability, eligibilityModule sex: ALL, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hsinchu MacKay Memorial Hospital, city: Hsinchu, country: Taiwan, geoPoint lat: 24.80361, lon: 120.96861, locations facility: HsinChu Municipal MacKay Memorial Hospital, city: Hsinchu, country: Taiwan, geoPoint lat: 24.80361, lon: 120.96861, hasResults: False
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protocolSection identificationModule nctId: NCT06353477, orgStudyIdInfo id: EOU 2019-10, briefTitle: Hand, Foot, and Mouth Disease: Could EPs®7630 be a Treatment Option, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-01, primaryCompletionDateStruct date: 2022-06-01, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Eskisehir Osmangazi University, class: OTHER, collaborators name: Abdi Ibrahim Ilac San. ve Tic A.S., descriptionModule briefSummary: This randomized controlled study aims to evaluate the effectiveness and safety of the pharmaceutical extract EPs® 7630 from P.sidoides in treating hand, foot, and mouth disease in children. The study will investigate the impact of EPs® 7630 on the severity of the disease over a specific period and its effects on hospitalization rates and potential complications. This research aims to contribute to the treatment of hand, foot, and mouth disease in children., conditionsModule conditions: Hand, Foot, and Mouth Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: EPs® 7630 is an extract from the roots of Pelargonium sidoides, drug-extract ratio 1 : 8-10, extraction solvent ethanol 11% (w/w). The patients were divided into two groups: (i) group 1 received herbal drug EPs® 7630 by oral route \[Umca® solution; (3x10 drops; between 1-5 years of age, 3x20 drops; 6-12 years of age, 3x30 drops for children \>12 years of age)\] for 7 days and (ii) group 2 (control group) did not receive any herbal medication. The medication was administered orally, at least 30 minutes before or after meals. Patients in both groups were prescribed paracetamol (10 mg/kg/dose, 4 times a day, maximum 4,000 mg/day.) as an antipyretic agent. Temperature measurement was made at home and in the hospital via the axillary route., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ACTUAL, armsInterventionsModule interventions name: EPs® 7630, outcomesModule primaryOutcomes measure: the patient's fever status, restlessness, inappetence, and sleeplessness scores, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istinye University Medicine Faculty Hospital, city: Esenyurt, state: İstanbul, zip: 34517, country: Turkey, geoPoint lat: 41.02697, lon: 28.67732, hasResults: False
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protocolSection identificationModule nctId: NCT06353464, orgStudyIdInfo id: 2306009984, briefTitle: A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation, acronym: OPBIM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Drexel University, class: OTHER, descriptionModule briefSummary: This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: individuals consume two distinct preloads at separate sessions, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: Participants consume two preloads one at each visit, but are not informed which preload is being consumed on which test visit., enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Ensure and Water, outcomesModule primaryOutcomes measure: Grams of pizza consumed, primaryOutcomes measure: Baseline medial prefrontal cortex oxygenated hemoglobin, primaryOutcomes measure: Baseline lateral prefrontal cortex oxygenated hemoglobin, primaryOutcomes measure: medial prefrontal cortex Oxygenated hemoglobin concentration, primaryOutcomes measure: lateral prefrontal cortex Oxygenated hemoglobin concentration, secondaryOutcomes measure: medial prefrontal cortex Time to Peak Light Intensity, secondaryOutcomes measure: lateral prefrontal cortex Time to Peak Light Intensity, secondaryOutcomes measure: Preload Oxygenated Hemoglobin Difference, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Drexel University, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Principal Investigator, PhD RD, role: CONTACT, phone: 267-359-6287, email: [email protected], geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06353451, orgStudyIdInfo id: EK GZ 67/2021-2024, briefTitle: Digital Detox Study: A Randomized Controlled Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-01-21, completionDateStruct date: 2024-01-21, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Danube University Krems, class: OTHER, descriptionModule briefSummary: The aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy, 18-29 yo Austrian students.After inclusion and randomization to intervention- and control group, normal screen time behavior will be assessed for 10-days. After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks. Control group should use smartphones as usual. After that, mental health parameters will be assessed again in both groups (post-intervention, T1). After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2).Main outcome parameters are 1) Well-Being (WHO-5), depressive symptoms (PHQ-9), stress (PSQ-20), and sleep quality (ISI).The primary hypothesis (stated at Open Science Framework before Enrollment: https://osf.io/a9k76) is that mental health indicators, particularly stress, depressive symptoms, and sleep quality will improve throughout the intervention compared to the control group as well as to baseline., conditionsModule conditions: Health Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups, non blinded, randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 111, type: ACTUAL, armsInterventionsModule interventions name: Digital Detox, outcomesModule primaryOutcomes measure: Depressive Symptoms, primaryOutcomes measure: Stress, primaryOutcomes measure: Sleep Quality, primaryOutcomes measure: Well-being, secondaryOutcomes measure: Problematic smartphone use, secondaryOutcomes measure: Body Appreciation, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Eating Disorder, otherOutcomes measure: Physical Activity, otherOutcomes measure: Heart rate variability (HRV), otherOutcomes measure: Resting Heart Rate (RHR), otherOutcomes measure: Screen time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 29 Years, stdAges: ADULT, contactsLocationsModule locations facility: Danube University Krems, city: Krems, state: Lower Austria, zip: 3500, country: Austria, geoPoint lat: 48.40921, lon: 15.61415, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-08, uploadDate: 2024-03-26T06:01, filename: Prot_SAP_000.pdf, size: 251127, hasResults: False
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protocolSection identificationModule nctId: NCT06353438, orgStudyIdInfo id: 2024XXXX, briefTitle: Hydraulic Resistance and Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: College of Staten Island, the City University of New York, class: OTHER, collaborators name: Bay Ridge Center, descriptionModule briefSummary: The goal of this quasi-experimental study using a pre and post test design is to learn about the effect of participating in an exercise program with hydraulic exercise equipment on fall risk in the older adult population. The main questions it aims to answer are:* Does the use of hydraulic exercise equipment decrease fall risk in older adults?* Does the use of hydraulic exercise equipment improve function in older adults?Participants will be evaluated pre and post intervention for strength, fall risk using Berg Balance Scale, Tinetti Balance and Gait Assessment, Timed Up and Go, and functional ability using the Lower Extremity Functional Scale. Participants will engage in an exercise program using 5 different pieces of hydraulic exercise equipment (Frei FACTUM® novus II line) 2x/week for for 6 weeks for 30-45 minutes each session. The equipment uses concentric movements only and works agonist and antagonist muscles with each machine (IE: push and pull, both concentric)., conditionsModule conditions: Aging, conditions: Fall, conditions: Old Age; Debility, conditions: Muscle Weakness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Program, outcomesModule primaryOutcomes measure: Berg Balance Scale, primaryOutcomes measure: Timed Up and Go, primaryOutcomes measure: Tinetti Balance and Gait Assessment Tool, primaryOutcomes measure: Lower Extremity Functional Scale, secondaryOutcomes measure: Strength, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bay Ridge Center, city: Brooklyn, state: New York, zip: 11209, country: United States, contacts name: Mary Ann Coughlin, role: CONTACT, phone: 718-306-2924, email: [email protected], geoPoint lat: 40.6501, lon: -73.94958, hasResults: False
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protocolSection identificationModule nctId: NCT06353425, orgStudyIdInfo id: 0562/66, briefTitle: Multi-country Survey on Violence Against Women Among Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, collaborators name: Asia and Oceania Federation of Obstetrics and Gynaecology, descriptionModule briefSummary: The goal of this observational study is to explore and learn about violence against women (VAW) among reproductive-aged women in Asia and Oceania countries. The main questions it aims to answer are:* pattern and prevalence of VAW among reproductive-aged women* knowledge, attitude, and practice (KAP) towards VAW among reproductive-aged women* the need of support services for VAW among reproductive-aged womenParticipants will be ever-partnered women aged 15-49 years. The definition of "ever-partnered women" included women who have current and former husbands; current and former cohabiting; or non-cohabiting male intimate partners., conditionsModule conditions: Violence Against Women, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: prevalence of violence against women, primaryOutcomes measure: KAP towards violence against women, secondaryOutcomes measure: need of support services for violence against women, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353412, orgStudyIdInfo id: treatment methods of IIH, briefTitle: Current Treatment Methods of Idiopathic Intracranial Hypertension, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Aim of the study :1. to determine the response to each treatment plan.2. to determine when to choose specific treatment method.3. to determine complication of each type of treatment method, conditionsModule conditions: IIH - Idiopathic Intracranial Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Lumbar puncture, outcomesModule primaryOutcomes measure: Patient improvement regarding headache, visual symptoms, primaryOutcomes measure: Patients improvement regarding fundus examination during regular visual assessment, primaryOutcomes measure: Complication, secondaryOutcomes measure: Other, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353399, orgStudyIdInfo id: 23.0366, briefTitle: Guided Bone Regeneration With and Without the Use of Intra-marrow Penetrations, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Louisville, class: OTHER, descriptionModule briefSummary: The primary aims of this study are to compare, after 6 months, the clinical and histologic results of intra-marrow penetrations vs no intra-marrow penetrations when performing guided bone regeneration procedures., conditionsModule conditions: Ridge Augmentation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The study involves an investigator (surgeon) and an examiner. The examiner measures the clinical parameters before and after surgery and is blinded to the surgical procedure and if intra-marrow penetrations are utilized., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Intra-marrow penetrations, interventions name: No Intra-marrow penetrations, outcomesModule primaryOutcomes measure: Alveolar Ridge Width, primaryOutcomes measure: Alveolar Ridge Height, primaryOutcomes measure: Buccal Soft Tissue Thickness, secondaryOutcomes measure: Histomorphometric Measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Louisville, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Bindu Dukka, BDS, MSD, MPH, role: CONTACT, phone: 502- 852- 1817, email: [email protected], contacts name: Niti Patel, DMD, role: CONTACT, phone: 859-685-5423, email: [email protected], contacts name: Bindu Dukka, BDS, MSD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, locations facility: University of Louisville, status: RECRUITING, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: Himabindu Dukka, BDS, MSD, role: CONTACT, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False
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protocolSection identificationModule nctId: NCT06353386, orgStudyIdInfo id: 5684-01A, secondaryIdInfos id: MK-5684-01A, type: OTHER, domain: Merck, secondaryIdInfos id: 2023-506288-33, type: REGISTRY, domain: EU CT, secondaryIdInfos id: U1111-1292-6912, type: OTHER, domain: UTN, briefTitle: Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, collaborators name: Orion Corporation, Orion Pharma, descriptionModule briefSummary: Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01).The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC.This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study., conditionsModule conditions: Prostatic Neoplasms, Castration-Resistant, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Opevesostat, interventions name: Olaparib, interventions name: Docetaxel, interventions name: Cabazitaxel, outcomesModule primaryOutcomes measure: Number of participants who experience one or more dose-limiting toxicities (DLTs), primaryOutcomes measure: Number of participants who experience one or more adverse events (AEs), primaryOutcomes measure: Number of participants who discontinue study intervention due to an AE, primaryOutcomes measure: Prostate-specific antigen (PSA) response rate, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Radiographic progression-free survival (rPFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Time to first subsequent anticancer therapy (TFST), secondaryOutcomes measure: Time to pain progression (TTPP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353373, orgStudyIdInfo id: HZKY-PJ-2024-7, briefTitle: Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies, acronym: SmaVTE-BEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Navy General Hospital, Beijing, class: OTHER, descriptionModule briefSummary: Venous thromboembolism (VTE) is the third leading cause of cardiovascular disease deaths globally, and its incidence is increasing over the years. Hospital-acquired VTE accounts for approximately 75% of all deaths attributed to VTE. However, only half of patients with indications for VTE prophylaxis take preventive measures, and high rates of inappropriate VTE prophylaxis prescribing contribute to the gap between VTE prophylaxis and guidelines. To further minimize the gap between clinical practice and guidelines, a range of strategies have been employed across various fields of VTE prophylaxis. One of the most effective measures is the utilization of a Clinical Decision Support System (CDSS). Smart technology-based CDSS facilitates automated evaluation of VTE risk and detection, addressing issues at both the beginning and end of the in-hospital VTE prevention process. but there is still a lack of research on how to effectively implement evidence-based VTE prophylaxis in the middle of the process.In our hospital, routine use of DeVTEcare system (a CDSS for VTE risk assessment and integrated care) for in-hospital management of VTE has been launched since 2021. This study aims to investigate the effect of integrating bundled guideline-based VTE prevention strategies into the DeVTEcare system on in-hospital VTE prophylaxis., conditionsModule conditions: Venous Thromboembolism, conditions: Clinical Decision Support Systems, conditions: Digital Health, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 15626, type: ESTIMATED, armsInterventionsModule interventions name: Application of the modified DeVTEcare system, outcomesModule primaryOutcomes measure: In-hospital VTE, secondaryOutcomes measure: Guideline-compliant prescription of VTE prophylaxis, secondaryOutcomes measure: Preventable VTE, secondaryOutcomes measure: Hospital-related VTE death, secondaryOutcomes measure: Major bleeding, secondaryOutcomes measure: Non-major bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353360, orgStudyIdInfo id: HL-06, briefTitle: TTField in Combination With TMZ and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2025-07-15, completionDateStruct date: 2026-03-09, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM)., conditionsModule conditions: Glioblastoma Multiforme, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Tumor Treating Fields, interventions name: Tislelizumab, interventions name: Temozolomide (TMZ), outcomesModule primaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: PFS rate at 6 months, secondaryOutcomes measure: PFS rate at 1 year, secondaryOutcomes measure: OS rate at 1-year, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06353347, orgStudyIdInfo id: HTD1801.PCT106, briefTitle: Efficacy and Safety of Berberine Ursodeoxycholate (HTD1801) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-13, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: HighTide Biopharma Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (HTD1801) compared to placebo in patients with type 2 diabetes inadequately controlled with metformin., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 555, type: ESTIMATED, armsInterventionsModule interventions name: HTD1801, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary Endpoint: mean change in HbA1c, secondaryOutcomes measure: Double-blind (DB) Phase: mean change in fasting plasma glucose, secondaryOutcomes measure: DB Phase: mean change in 2-hour postprandial glucose, secondaryOutcomes measure: DB Phase: proportion of patients achieving HbA1c <7.0%, secondaryOutcomes measure: DB Phase: proportion of patients achieving HbA1c <6.5%, secondaryOutcomes measure: DB Phase: mean change in insulin sensitivity (HOMA-IR), secondaryOutcomes measure: DB Phase: mean change in low-density lipoprotein cholesterol (LDL-C), otherOutcomes measure: Open-Label Extension (OLE) Phase: mean change in HbA1c, otherOutcomes measure: OLE Phase: mean change in 2-Hour postprandial glucose, otherOutcomes measure: OLE Phase: proportion of patients achieving HbA1c <7.0%, otherOutcomes measure: OLE Phase: proportion of patients achieving HbA1c <6.5%, otherOutcomes measure: OLE Phase: mean change in insulin sensitivity (HOMA-IR), otherOutcomes measure: OLE Phase: mean change in LDL-C, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baogang Hospital of Inner Mongolia, status: RECRUITING, city: Baotou, country: China, geoPoint lat: 40.65222, lon: 109.82222, locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Luhe Hospital Capital Medical University, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Pinggu Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Norman Bethune Hospital of Jilin University, status: RECRUITING, city: Changchun, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: The First People's Hospital of Changde City, status: RECRUITING, city: Changde, country: China, geoPoint lat: 29.04638, lon: 111.6783, locations facility: Hunan Provincial People's Hospital, status: RECRUITING, city: Changsha, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Third Xiangya Hospital of Central South University, status: RECRUITING, city: Changsha, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Chongqing University Three Gorges Hospital, status: RECRUITING, city: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, locations facility: The Third People's Hospital of Datong, status: RECRUITING, city: Datong, country: China, geoPoint lat: 40.09361, lon: 113.29139, locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Handan First Hospital, status: RECRUITING, city: Handan, country: China, geoPoint lat: 36.60056, lon: 114.46778, locations facility: The Fourth Affiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Anhui Provincial Hospital, status: RECRUITING, city: Hefei, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Hospital of Anhui Medical University, status: RECRUITING, city: Hefei, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Hengshui People's Hospital (Harrison International Peace Hospital), status: RECRUITING, city: Hengshui, country: China, geoPoint lat: 37.73222, lon: 115.70111, locations facility: Heze Municipal Hospital, status: RECRUITING, city: Heze, country: China, geoPoint lat: 35.23929, lon: 115.47358, locations facility: Huai'an First People's Hospital, status: RECRUITING, city: Huai'an, country: China, geoPoint lat: 33.50389, lon: 119.14417, locations facility: Huangshi Central Hospital, status: RECRUITING, city: Huangshi, country: China, geoPoint lat: 30.24706, lon: 115.04814, locations facility: Huizhou Municipal Central Hospital, status: RECRUITING, city: Huizhou, country: China, geoPoint lat: 23.11147, lon: 114.41523, locations facility: Huzhou Central Hospital, status: RECRUITING, city: Huzhou, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: Jinan Central Hospital, status: RECRUITING, city: Jinan, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Jingzhou Central Hospital, status: RECRUITING, city: Jingzhou, country: China, geoPoint lat: 30.35028, lon: 112.19028, locations facility: Jinzhou Central Hospital, status: RECRUITING, city: Jinzhou, country: China, geoPoint lat: 41.10778, lon: 121.14167, locations facility: The First People's Hospital of Kashgar, status: RECRUITING, city: Kashgar, country: China, geoPoint lat: 39.47066, lon: 75.98951, locations facility: Hebei Petro China Center Hospital, status: RECRUITING, city: Langfang, country: China, geoPoint lat: 39.50972, lon: 116.69472, locations facility: Liaocheng People's Hospital, status: RECRUITING, city: Liaocheng, country: China, geoPoint lat: 36.45596, lon: 115.97766, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Jinghua), status: RECRUITING, city: Luoyang, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Henan University of Science and Technology (Kaiyuan), status: RECRUITING, city: Luoyang, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Nanjing Drum Tower Hospital - The Affiliated Hospital of Nanjing University Medical School, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Nanjing Jiangning Hospital, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Sir Run Run Hospital Nanjing Medical University, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First People's Hospital of Nanning, status: RECRUITING, city: Nanning, country: China, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The First Affiliated Hospital of Nanyang Medical College, status: RECRUITING, city: Nanyang, country: China, geoPoint lat: 32.99472, lon: 112.53278, locations facility: Panjin Liaohe Oilfield Gem Flower Hospital, status: RECRUITING, city: Panjin, country: China, geoPoint lat: 41.121, lon: 122.0739, locations facility: The First Hospital of Qiqihar, status: RECRUITING, city: Qiqihar, country: China, geoPoint lat: 47.34088, lon: 123.96045, locations facility: Shanghai East Hospital of Tongji University, status: RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Pudong New Area People's Hospital, status: RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shengjing Hospital of China Medical University, status: RECRUITING, city: Shenyang, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The Sixth People's Hospital of Shenyang, status: RECRUITING, city: Shenyang, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Shenzhen People's Hospital, status: RECRUITING, city: Shenzhen, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The University of Hong Kong - Shenzhen Hospital, status: RECRUITING, city: Shenzhen, country: China, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Taihe Hospital, status: RECRUITING, city: Shiyan, country: China, geoPoint lat: 32.6475, lon: 110.77806, locations facility: Siping City Central People's Hospital, status: RECRUITING, city: Siping, country: China, geoPoint lat: 43.16143, lon: 124.37785, locations facility: The First Affiliated Hospital of Suzhou University, status: RECRUITING, city: Suzhou, country: China, geoPoint lat: 31.30408, lon: 120.59538, locations facility: People's Hospital of Tianjin, status: RECRUITING, city: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Tonghua Central Hospital, status: RECRUITING, city: Tonghua, country: China, geoPoint lat: 41.71972, lon: 125.92639, locations facility: The Central Hospital of Wuhan, status: RECRUITING, city: Wuhan, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Yijishan Hospital of Wannan Medical College, status: RECRUITING, city: Wuhu, country: China, geoPoint lat: 31.33728, lon: 118.37351, locations facility: The First People's Hospital of Xiangtan City, status: RECRUITING, city: Xiangtan, country: China, geoPoint lat: 27.85, lon: 112.9, locations facility: The Affiliated Hospital of Xuzhou Medical University, status: RECRUITING, city: Xuzhou, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Yanan University Affiliated Hospital, status: RECRUITING, city: Yanan, country: China, locations facility: Yueyang People's Hospital, status: RECRUITING, city: Yueyang, country: China, geoPoint lat: 29.37455, lon: 113.09481, locations facility: Yuncheng Central Hospital, status: RECRUITING, city: Yuncheng, country: China, geoPoint lat: 35.02306, lon: 110.99278, locations facility: The Second Affiliated Hospital of Zhengzhou University, status: RECRUITING, city: Zhengzhou, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Affiliated Hospital of Jiangsu University, status: RECRUITING, city: Zhenjiang, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Zhumadian Central Hospital, status: RECRUITING, city: Zhumadian, country: China, geoPoint lat: 32.97944, lon: 114.02944, locations facility: Zhuzhou Central Hospital, status: RECRUITING, city: Zhuzhou, country: China, geoPoint lat: 27.83333, lon: 113.15, locations facility: Zibo Central Hospital, status: RECRUITING, city: Zibo, country: China, geoPoint lat: 36.79056, lon: 118.06333, locations facility: The First People's Hospital of Zunyi, status: RECRUITING, city: Zunyi, country: China, geoPoint lat: 27.68667, lon: 106.90722, hasResults: False
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protocolSection identificationModule nctId: NCT06353334, orgStudyIdInfo id: 2024-3-22-8, briefTitle: Butylphthalide's Safety and Efficacy for Improving Neurological Function Prognosis in Patients With Cardiac Arrest (BNCA Trial), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tang Ziren, class: OTHER, descriptionModule briefSummary: Butylphthalide (NBP) is a neuroprotective medication capable of ameliorating neurological dysfunction induced by ischemia, hypoxia, and reperfusion injury in the brain. However, evidence regarding the improvement of neurological function prognosis in patients with return of spontaneous circulation (ROSC) after cardiac arrest (CA) by NBP is limited. This study aims to evaluate the safety and efficacy of NBP treatment in improving the neurological function prognosis of patients with ROSC after CA.The study will be a single-center, randomized, double-blind, placebo-controlled trial. The sample size is estimated to be 100 patients. Eligible patients will be randomly allocated in a 1:1 ratio to receive either NBP or placebo treatment daily for a duration of 14 days. The initial administration of NBP or placebo treatment will commence within 6 hours after ROSC following CA. The primary outcome is the proportion of patients with Cerebral Performance Category (CPC) scores of 1-2 at 90 days after randomization in each group. The primary safety outcome is the percentage of severe adverse events occurring during the 14-day treatment period. This trial will determine the efficacy of NBP in providing neuroprotective effects for patients with ROSC after CA., conditionsModule conditions: Butylphthalide, conditions: Cardiac Arrest, conditions: Neuroprotective Drugs, 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: 100, type: ESTIMATED, armsInterventionsModule interventions name: Butylphthalide and Sodium Chloride Injection, interventions name: Saline Solution, outcomesModule primaryOutcomes measure: The proportion of patients with a CPC score of 1-2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Chao-Yang Hospital, city: Beijing, state: Beijing, zip: 100020, country: China, contacts name: Xingsheng Wang, M.D, role: CONTACT, phone: +86 15265386100, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06353321, orgStudyIdInfo id: STU-2024-0024, briefTitle: Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on RefleXion X1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: RefleXion Medical, descriptionModule briefSummary: To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) \[68Ga\]-PSMA-11 PET-CT using Illuccix on the same day., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: PET-CT imaging subsystem of the RefleXion X1 System Device, outcomesModule primaryOutcomes measure: Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353308, orgStudyIdInfo id: EA230308, briefTitle: Effectiveness of an Online Intervention Using a Feminist Approach on Gender Equality Promotion and Sexual Violence Prevention in China, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-12, primaryCompletionDateStruct date: 2024-02-10, completionDateStruct date: 2024-03-02, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: This paper presents the findings of a clustered randomized controlled trial (cRCT) that evaluated the effectiveness of an online feminist sexual health intervention among Chinese young adults, providing insights into the impacts of this innovative approach and contribute to the growing body of literature on feminist interventions for sexual health and equality promotion., conditionsModule conditions: Sexual Violence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 422, type: ACTUAL, armsInterventionsModule interventions name: Sexual Violence Prevention, interventions name: Sexual health intervention, outcomesModule primaryOutcomes measure: Rape myth acceptance, secondaryOutcomes measure: Sociocultural Attitudes toward Appearance, secondaryOutcomes measure: Sexual Attitudes Scale, secondaryOutcomes measure: Sexual Desire Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 29 Years, stdAges: ADULT, contactsLocationsModule locations facility: The university of Hong Kong, city: Hong Kong, zip: 000000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06353295, orgStudyIdInfo id: 22-38098, secondaryIdInfos id: CO-US-412-6436, type: OTHER_GRANT, domain: Gilead Sciences, briefTitle: Community-based, Peer-delivered PrEP for Female Sex Workers in Rural Uganda: The Peers for PrEP (P4P) Study, acronym: P4P, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Gilead Sciences, descriptionModule briefSummary: The overall goal of the P4P: Peers for PrEP (pre-exposure prophylaxis) study is to pilot test a peer-led and delivered intervention for biomedical HIV prevention that is tailored to women who engage in sex work in southwestern Uganda. This study will evaluate whether this intervention is feasible, acceptable, and increases uptake of biomedical prevention., conditionsModule conditions: HIV/AIDS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A single-arm pilot trial to evaluate a community-based, peer-led and delivered intervention to provide biomedical prevention products (e.g. pre-exposure prophylaxis \[PrEP\] and post-exposure prophylaxis \[PEP\]) for women who engage in sex work in southwestern Uganda. This study will test whether the intervention is feasible, acceptable, and increases biomedical prevention uptake., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: P4P intervention, outcomesModule primaryOutcomes measure: Uptake of biomedical prevention, secondaryOutcomes measure: Feasibility of delivery of the P4P intervention by peers, secondaryOutcomes measure: Acceptability of the P4P intervention, eligibilityModule sex: FEMALE, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Infectious Diseases Research Collaboration, city: Kampala, country: Uganda, contacts name: Jane Kabami, MPH, PhDc, role: CONTACT, phone: +256 312 281-479, email: [email protected], geoPoint lat: 0.31628, lon: 32.58219, hasResults: False
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protocolSection identificationModule nctId: NCT06353282, orgStudyIdInfo id: 24-000795, briefTitle: MDMA-Assisted Psychotherapy for Treatment Resistant PTSD in Adolescents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-07-01, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to determine the safety and feasibility of 3,4-methylenedioxymethamphetamine (MDMA) -assisted psychotherapy to treat resistant post-traumatic stress disorder (PTSD). The secondary objectives are the exploration of effectiveness for treatment-resistant PTSD, symptoms of depression, and anxiety symptoms., conditionsModule conditions: PTSD, Post Traumatic Stress Disorder, conditions: Adolescents, conditions: Psychotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: MDMA, interventions name: Psychotherapy, outcomesModule primaryOutcomes measure: Changes in heart rhythm via Carnation Ambulatory Heart Monitor, primaryOutcomes measure: Changes in blood pressure, primaryOutcomes measure: Change in pulse, primaryOutcomes measure: Change in body temperature, primaryOutcomes measure: Mean change in score of visual analog scale to assess potential for misuse of MDMA, secondaryOutcomes measure: Mean change in PTSD symptom severity via the Child PTSD Symptom Scale, secondaryOutcomes measure: Mean change in PTSD symptom severity via the Clinician-Administered PTSD Scale (CAPS-CA-5), secondaryOutcomes measure: Mean change in depression symptom severity via the Patient Health Questionnaire-9 (PHQ-9)., secondaryOutcomes measure: Mean change in anxiety symptom severity via the Generalized Anxiety Disorder 7-item (GAD-7), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: UCLA Semel Institute for Neuroscience and Human Behavior, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Jessica K Jeffrey, MD, MPH, MBA, role: CONTACT, phone: 310-825-5263, email: [email protected], contacts name: Marc J Weintraub, Ph.D., role: CONTACT, phone: 310-825-1300, email: [email protected], contacts name: Jessica K Jeffrey, MD, MPH, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06353269, orgStudyIdInfo id: 4255, briefTitle: Adherence to Vaginal Estrogen Therapy in Hypoestrogenic Women With Recurrent Urinary Tract Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: * The goal of this clinical trial is to learn about medication adherence to difference types of vaginal estrogen in women with low levels of estrogen (for example, post-menopausal women) who have recurrent urinary tract infections. Medication adherence means whether patients take their medicine as prescribed.* Another goal of the study is to learn about changes to the skin of the vagina before and after estrogen treatment, using a specialized imaging modality called optical coherence tomography, which is similar to receiving an ultrasound.* A third goal of the study is to learn about changes to the microbiome (all the bacteria that naturally live in our bodies) before and after treatment with vaginal estrogen. The researchers will be looking specifically at the microbiome in the urine and the vagina.Participants will be assigned by chance (like the flip of a coin) to receive one of three possible vaginal estrogen treatments - cream, tablets, or drug-eluting ring.* The main study tests and procedures include an initial visit in which the researchers will collect baseline information about participants and have participants complete a series of questionnaires.* There will then be 3 and 6 month follow-ups in which the researchers will have participants complete additional questionnaires and the researchers also assess whether participants are using the vaginal estrogen treatment that you were prescribed.If a participant is part of the microbiome cohort, they will also be asked to do the following:* a baseline visit in which urinary and vaginal specimens are collected to assess their baseline microbiome. The vaginal specimen collection will involve a q-tip swab inside the vagina; it is similar to a pap smear.* Finally, participants will have an imaging modality performed on their vagina called optical coherence tomography, which allows the researchers to assess the thickness of the vaginal walls and the blood vessel density. This imaging modality involves the insertion of a thin probe into the vagina to obtain the images of the vaginal wall.* These tests will then be repeated at 6 months to assess if vaginal estrogen treatment causes changes to the vagina., conditionsModule conditions: Recurrent Urinary Tract Infection, conditions: Hypoestrogenism, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: Estring Vaginal Product, interventions name: Vagifem, interventions name: Estrace 0.01% Vaginal Cream, outcomesModule primaryOutcomes measure: Adherence to vaginal estrogen treatment, secondaryOutcomes measure: UTI rates, secondaryOutcomes measure: validated patient questionnaire - Urinary Distress Inventory Short Form (UDI-6), secondaryOutcomes measure: validated patient questionnaires - UTI Symptoms Assessment Questionnaire (UTISA), secondaryOutcomes measure: validated patient questionnaires - Treatment Satisfaction with Medications Questionnaire (SATMED-Q), secondaryOutcomes measure: validated patient questionnaires - Patient Global Impression of Improvement Questionnaire (PGI-I), secondaryOutcomes measure: validated patient questionnaires - Medication Adherence Report Scale (MARS-5), secondaryOutcomes measure: optical coherence tomography measurements for nested OCT cohort - vaginal epithelial thickness, secondaryOutcomes measure: optical coherence tomography measurements for nested OCT cohort - blood vessel density, secondaryOutcomes measure: Vaginal health index for nested microbiome cohort, secondaryOutcomes measure: Vaginal maturation index for nested microbiome cohort, secondaryOutcomes measure: Urologic microbiome results for nested microbiome cohort, secondaryOutcomes measure: Vaginal microbiome results for nested microbiome cohort, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California Irvine Medical Center, status: RECRUITING, city: Orange, state: California, zip: 92868, country: United States, contacts name: CHARLOTTE TER HAAR, role: CONTACT, email: [email protected], geoPoint lat: 33.78779, lon: -117.85311, hasResults: False
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protocolSection identificationModule nctId: NCT06353256, orgStudyIdInfo id: 300012607, secondaryIdInfos id: UL1TR003096, type: NIH, link: https://reporter.nih.gov/quickSearch/UL1TR003096, secondaryIdInfos id: 24POST1198805, type: OTHER_GRANT, domain: American Heart Association, briefTitle: A Community Health Worker Intervention to Address Preeclampsia, acronym: AW2H, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: American Heart Association, collaborators name: National Center for Advancing Translational Sciences (NCATS), descriptionModule briefSummary: United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with PE to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants., conditionsModule conditions: Preeclampsia Postpartum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: usual postpartum care, outcomesModule primaryOutcomes measure: Acceptability, eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 56 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353243, orgStudyIdInfo id: STUDY00022901, briefTitle: Bilateral Infant Stimulation Study, acronym: BLISS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Oregon Health and Science University, class: OTHER, descriptionModule briefSummary: This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention., conditionsModule conditions: Parent-Child Relations, conditions: Preterm Birth, conditions: Stress Reaction, conditions: Hospitalism in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral alternating stimulation, outcomesModule primaryOutcomes measure: Parental anxiety, primaryOutcomes measure: Physiologic stress response, primaryOutcomes measure: Parental distress, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oregon Health and Science University Neonatal Intensive Care Unit, status: RECRUITING, city: Portland, state: Oregon, zip: 97219, country: United States, contacts name: Emily Garavatti, MD, role: CONTACT, phone: 503-494-2634, email: [email protected], geoPoint lat: 45.52345, lon: -122.67621, hasResults: False
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protocolSection identificationModule nctId: NCT06353230, orgStudyIdInfo id: 0001, briefTitle: Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children, acronym: Prolapse, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-15, primaryCompletionDateStruct date: 2020-10-14, completionDateStruct date: 2021-04-13, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children., conditionsModule conditions: Rectal Prolapse, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Randomly allocated groupA,B or C by computer generated lottery method.and participants ,care provider and outcome assessor were kept blind by removing the drug name from injection vial, enrollmentInfo count: 93, type: ACTUAL, armsInterventionsModule interventions name: injection 5% phenol in almond oil, interventions name: injection 15% hypertonic saline, interventions name: injection 50% dextrose water, outcomesModule primaryOutcomes measure: Recurrence, secondaryOutcomes measure: fecal incontinence, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: department of pediatric surgery King Edward Medical University, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06353217, orgStudyIdInfo id: IRB00419034, secondaryIdInfos id: K23DK128572, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DK128572, briefTitle: Study of a Primary Care Hypoglycemia Prevention Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2026-04-14, completionDateStruct date: 2026-04-14, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: This is a single site, pre-post pilot study. The objective is to evaluate the acceptability and feasibility of a primary care hypoglycemia prevention program for patients taking hypoglycemia-causing medications. The study will also evaluate relevant process outcomes and clinical outcomes for refining the intervention and planning for a larger efficacy trial., conditionsModule conditions: Diabetes Mellitus, conditions: Hypoglycemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre/post pilot study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Patient Group (Hypoglycemia Prevention Program), interventions name: Primary Care Physician Group, interventions name: Clinic Staff Group, outcomesModule primaryOutcomes measure: Overall acceptability to patients, primaryOutcomes measure: Overall acceptability to primary care providers, primaryOutcomes measure: Overall acceptability to clinic staff, otherOutcomes measure: Intervention coherence (patients), otherOutcomes measure: Opportunity costs (patients), otherOutcomes measure: Ethicality (patients), otherOutcomes measure: Affective attitude (patients), otherOutcomes measure: Burden (patients), otherOutcomes measure: Self-efficacy (patients), otherOutcomes measure: Perceived effectiveness (primary care providers), otherOutcomes measure: Intervention coherence (primary care providers), otherOutcomes measure: Opportunity costs (primary care providers), otherOutcomes measure: Affective attitude (primary care providers), otherOutcomes measure: Burden (primary care providers), otherOutcomes measure: Self-efficacy (primary care providers), otherOutcomes measure: Burden (clinic staff), otherOutcomes measure: Opportunity costs (clinic staff), otherOutcomes measure: Recruitment rate, otherOutcomes measure: Retention rate for second clinic visit, otherOutcomes measure: Continuous glucose monitoring (CGM) completion, otherOutcomes measure: Continuous glucose monitoring (CGM) wear time, otherOutcomes measure: Time needed to complete patient hypoglycemia profile, otherOutcomes measure: Duration of clinical visit, otherOutcomes measure: Patient completion of hypoglycemia assessment, otherOutcomes measure: Primary care provider use of provider hypoglycemia toolkit, otherOutcomes measure: Patient hypoglycemia burden on continuous glucose monitoring (CGM), otherOutcomes measure: Patient time below range on continuous glucose monitoring (CGM), otherOutcomes measure: Patient time above range on continuous glucose monitoring (CGM), otherOutcomes measure: Patient mean glucose on continuous glucose monitoring (CGM), otherOutcomes measure: Patient satisfaction with care, otherOutcomes measure: Patient activation, otherOutcomes measure: Patient self-reported hypoglycemic events, otherOutcomes measure: Changes to hypoglycemia-causing medications, otherOutcomes measure: Glucagon prescription, otherOutcomes measure: Continuous glucose monitoring (CGM) prescription, otherOutcomes measure: Change in Frequency of Referrals to Diabetes Self Management Training (DSMT), otherOutcomes measure: Frequency of hypoglycemia history discussions, otherOutcomes measure: Frequency of Hypoglycemia anticipatory guidance discussions, otherOutcomes measure: Frequency of Medication adherence discussions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins University School of Medicine, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Scott J Pilla, MD, MHS, role: CONTACT, phone: 908-768-0002, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06353204, orgStudyIdInfo id: 3325, briefTitle: Effectiveness of the Justice Diversion Halt-intervention, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Wetenschappelijk Onderzoek en Datacentrum, class: OTHER_GOV, collaborators name: Utrecht University, collaborators name: Leiden University, descriptionModule briefSummary: In the current study the effectiveness of the Dutch diversion measure Halt is investigated using a randomized controlled trial. Because of the thorough scientific substantiation of the intervention theory, it is hypothesized that receiving the Halt-intervention will lead to less recidivism in comparison to receiving no intervention., conditionsModule conditions: Criminal Recidivism, conditions: Delinquency, conditions: Antisocial Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A comparison between two groups will be made. One half of the participants will be randomly assigned to a group that receives the Halt-intervention, while the other group receives no Halt-intervention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1300, type: ESTIMATED, armsInterventionsModule interventions name: Halt-intervention, outcomesModule primaryOutcomes measure: Criminal Recidivism based on self-report, primaryOutcomes measure: Criminal Recidivism based on official police records, primaryOutcomes measure: Criminal Recidivism based on official judiciary records, primaryOutcomes measure: Truancy based on self-report, secondaryOutcomes measure: Conventional beliefs, secondaryOutcomes measure: Minimizing/mislabeling, secondaryOutcomes measure: Social skills, secondaryOutcomes measure: Taking responsibility for the consequences of behavior, secondaryOutcomes measure: Correct wrongdoing, secondaryOutcomes measure: Support from social network, secondaryOutcomes measure: Experienced legitimacy, secondaryOutcomes measure: Experienced treatment, secondaryOutcomes measure: Receiving adequate information, secondaryOutcomes measure: The right to be informed, secondaryOutcomes measure: Experienced voluntariness, secondaryOutcomes measure: Access to legal assistance, secondaryOutcomes measure: Knowledge of not obtaining a criminal record, secondaryOutcomes measure: Experienced stigmatisation, secondaryOutcomes measure: Experienced re-integration, otherOutcomes measure: Mental health problems during the last six months, otherOutcomes measure: Experienced problems, otherOutcomes measure: Delinquent friends, otherOutcomes measure: Parental involvement, otherOutcomes measure: Demographical characteristics, otherOutcomes measure: Halt-intervention program integrity, otherOutcomes measure: Characteristics Halt-employee, otherOutcomes measure: Perceived relationship with Halt-employee, otherOutcomes measure: Educational attainment, otherOutcomes measure: Type of criminal offense, otherOutcomes measure: Characteristics of referral to Halt-intervention, otherOutcomes measure: Types of modules used during the Halt-intervention, otherOutcomes measure: Parts of the Halt-intervention carries out as group or solo intervention, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: WODC, status: RECRUITING, city: The Hague, state: Zuid-Holland, zip: 2500EH, country: Netherlands, contacts name: Benthe J van Delft, MSc, role: CONTACT, email: [email protected], geoPoint lat: 52.07667, lon: 4.29861, hasResults: False
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protocolSection identificationModule nctId: NCT06353191, orgStudyIdInfo id: 19-002566, secondaryIdInfos id: NCI-2024-00943, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 19-002566, type: OTHER, domain: Mayo Clinic in Florida, secondaryIdInfos id: P30CA015083, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA015083, secondaryIdInfos id: R01HL169268, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL169268, secondaryIdInfos id: R56HL160643, type: NIH, link: https://reporter.nih.gov/quickSearch/R56HL160643, briefTitle: Biomarkers to Predict Cancer Therapy-related Cardiotoxicity, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-05-03, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy., conditionsModule conditions: Hematopoietic and Lymphatic System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Arizona, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: [email protected], contacts name: Myrah Manuel, role: CONTACT, phone: 480-574-3157, email: [email protected], contacts name: Lida A. Mina, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic in Florida, status: RECRUITING, 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: Pamela Williamson, role: CONTACT, phone: 904-953-4694, email: [email protected], contacts name: Nadine Norton, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Mayo Clinic in Rochester, status: SUSPENDED, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06353178, orgStudyIdInfo id: 20240314, briefTitle: Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers, acronym: BEACON, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Color Health, Inc., class: INDUSTRY, descriptionModule briefSummary: Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program., conditionsModule conditions: Cancer, conditions: Caregiving Stress, conditions: Caregiver Burnout, conditions: Survivorship, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Participants will be notified of a waitlist assignment upon enrolling. Those on the waitlist will receive the intervention after 3 months., enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cancer Connect Program, outcomesModule primaryOutcomes measure: Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Color Health, status: RECRUITING, city: Burlingame, state: California, zip: 94010, country: United States, geoPoint lat: 37.5841, lon: -122.36608, hasResults: False
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protocolSection identificationModule nctId: NCT06353165, orgStudyIdInfo id: CRO-2022-12-BAC-SNF-THA-YPZ, briefTitle: Anti-bacterial Clinical Study on Teeth, Tongue, Cheek, Gum, and Saliva, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-08, primaryCompletionDateStruct date: 2023-04-12, completionDateStruct date: 2023-04-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Colgate Palmolive, class: INDUSTRY, descriptionModule briefSummary: This 4-week clinical study was designed to examine the antibacterial efficacy of brushing with a 0.454% stannous fluoride toothpaste with potassium nitrate and pyrophosphate compared to a toothpaste containing 0.76% MFP (marketed as Colgate Cavity Protection Toothpaste) in different regions of the mouth (dental plaque, tongue, cheek, gum surface and in saliva) 12 hours post-brushing (overnight) after 2 and 4 weeks of product use., conditionsModule conditions: Plaque, Dental, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: blinded, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Stannous fluoride toothpaste, interventions name: Colgate Dental Cream, outcomesModule primaryOutcomes measure: Whole mouth scores of dental plaque, primaryOutcomes measure: Measurement of total bacterial counts on tongue, primaryOutcomes measure: Measurement of total bacterial counts on cheek, primaryOutcomes measure: Measurement of gingivitis, primaryOutcomes measure: Measurement of total bacterial counts in saliva, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: M U International Oral Science Research, Ltd., city: Bangkok, state: Krung Thep Maha Nakhon, zip: 10250, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06353152, orgStudyIdInfo id: GC506-507, briefTitle: Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells for Gastric/Gastroesophageal Junction Adenocarcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2025-11-16, completionDateStruct date: 2025-11-16, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, collaborators name: Gracell Biopharmaceuticals, Inc., descriptionModule briefSummary: A single-arm, open-label early-stage exploratory clinical study to evaluate the safety, tolerability and efficacy of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in subjects with gastric/gastroesophageal junction adenocarcinoma., conditionsModule conditions: Gastric Adenocarcinoma, conditions: Gastroesophageal Junction Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Claudin18.2-Targeted Chimeric Antigen Receptor T Cell Injection, outcomesModule primaryOutcomes measure: Occurrence of Dose limiting toxicity., primaryOutcomes measure: Incidence of treatment-emergent AEs, AESIs, and SAEs., secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of disease control (DDC), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Proliferation and persistence of Claudin18.2-Targeted Chimeric Antigen Receptor T Cell, secondaryOutcomes measure: Incidence of anti-CAR-T cell antibody in peripheral blood after infusion., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Shen Lin, Professor, role: CONTACT, phone: 010-88196561, email: [email protected], contacts name: Shen Lin, professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06353139, orgStudyIdInfo id: 90591, briefTitle: The Efficacy of Modified Olfactory Training for Patients With Olfactory Dysfunction, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:Is it possible that the device can treat olfactory disorders in adults? Compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction?, conditionsModule conditions: Olfactory Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Modified olfactory training device, outcomesModule primaryOutcomes measure: Clinically significant olfactory improvement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dawei Wu, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Dawei Wu, MD, PhD, role: CONTACT, phone: 13522503401, email: [email protected], contacts role: CONTACT, phoneExt: Wu, email: [email protected], contacts name: Dawei Wu, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06353126, orgStudyIdInfo id: DTACESALT, briefTitle: DEB-TACE Prior to Liver Transplantation in the Treatment of HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: The goal of the study is to explore whether the usage of DEB-TACE (Drug-Eluting Bead Transarterial Chemoembolization) prior to SALT (Sequential Adult Left Lateral Liver Transplantation) can prolong the recurrence-free survival in patients with hepatocellular carcinoma (HCC). It is a single-center, exploratory study. The patients scheduled for SALT receive DEB-TACE 2 weeks prior to the surgery.The primary outcome: Recurrence-free survival (RFS) The secondary outcome:1) Overall survival (OS)；2) Pathological response rate (Pathological Response); 3) Proportion of patients completing SALT; 4) Adverse events related to DEB-TACE., conditionsModule conditions: Liver Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: DEB-TACE, outcomesModule primaryOutcomes measure: Recurrence-free survival (RFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Pathological response rate (Pathological Response), secondaryOutcomes measure: Proportion of patients completing SALT, secondaryOutcomes measure: Adverse events related to DEB-TACE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353113, orgStudyIdInfo id: HS-2023-0254, briefTitle: Feasibility of a Prenatal Yoga Mobile App in African American Pregnant Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: San Diego State University, class: OTHER, descriptionModule briefSummary: The goal of this research is to test if a prenatal yoga app can improve well-being in African American/Black (AA) pregnant women. The main questions it aims to answer are:1. Is the Down Dog prenatal yoga app feasible for AA pregnant women?2. How does mental and physical health change after using the Down Dog app for 12-weeks?3. What cultural adaptations to the Down Dog app are needed?The study lasts for 12 weeks and participants are asked to:* do prenatal yoga with the app for at least 20 min/day, three days/week, from home* wear a Garmin Vivosmart 5 watch daily* complete four online surveys* complete an optional virtual interviewThis project aims to advance public health by contributing to a broader understanding of how prenatal yoga can support the health and well-being of AA pregnant women and promote optimal maternal and child health outcomes., conditionsModule conditions: Pregnancy Related, conditions: Mental Health Issue, conditions: Discrimination, Racial, conditions: Stress, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Down Dog Prenatal Yoga App, outcomesModule primaryOutcomes measure: Acceptability of the intervention, primaryOutcomes measure: Demand of the intervention, primaryOutcomes measure: Retention, primaryOutcomes measure: Ease of recruitment, secondaryOutcomes measure: Discrimination, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Perinatal Depression, secondaryOutcomes measure: Self-awareness, secondaryOutcomes measure: Mindfulness, secondaryOutcomes measure: Subjective physical activity, secondaryOutcomes measure: Objective physical activity (steps), secondaryOutcomes measure: Objective physical activity (intensity), secondaryOutcomes measure: Cardiac health (heart rate), secondaryOutcomes measure: Cardiac health (heart rate variability), secondaryOutcomes measure: Cultural adaptations, secondaryOutcomes measure: Birth outcomes (gestational age), secondaryOutcomes measure: Birth outcomes (type of delivery), secondaryOutcomes measure: Birth outcomes (intervention used for delivery), secondaryOutcomes measure: Birth outcomes (birth weight), secondaryOutcomes measure: Birth outcomes (maternal weight), secondaryOutcomes measure: Birth outcomes (pregnancy-related disorders), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 46 Years, stdAges: ADULT, contactsLocationsModule locations facility: San Diego State University, status: RECRUITING, city: San Diego, state: California, zip: 92182, country: United States, contacts name: Jeni Green, PhD, role: CONTACT, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
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protocolSection identificationModule nctId: NCT06353100, orgStudyIdInfo id: 230602006, briefTitle: Chronic Pain in the General Population of Chile, acronym: RDC, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Pontificia Universidad Catolica de Chile, class: OTHER, collaborators name: Chilean Safety Association (ACHS), descriptionModule briefSummary: The present study seeks to follow up the cohort of adults representative of Chile's urban population whose levels of chronic pain were evaluated in March 2023 (baseline) as part of the Mental Health Thermometer (MHT) study. The study consists of a 12 month follow-up telephone interview to assess parameters of chronic pain (CP) and subtypes, mental and physical health, lifestyle and adversity and work characteristics.The study objectives are as follows:1. Estimate the prevalence of CP and subtypes in the general population2. Explore the association between mental health indicators, perceived work stress and presence of CP in the population.3. Investigate the impact of CP (functional, occupational and social) among the subset of participants reporting CP4. Describe the use of management strategies in those who suffer from CP., conditionsModule conditions: Chronic Pain, conditions: Migraine Disability, conditions: Neuropathic Pain, conditions: Fibromyalgia, conditions: Depression, Anxiety, conditions: Self Harm, conditions: Insomnia, conditions: Loneliness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2365, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Chronic pain (past 3 months), primaryOutcomes measure: Depression (2 weeks), primaryOutcomes measure: Anxiety (2 weeks), secondaryOutcomes measure: Migraine Disability, secondaryOutcomes measure: Neuropathic Pain, secondaryOutcomes measure: Fibromyalgia, secondaryOutcomes measure: Self harm (2 weeks), secondaryOutcomes measure: Insomnia (2 weeks), secondaryOutcomes measure: Loneliness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pontificia Universidad Catolica de Chile, city: Santiago, state: RM, zip: 7550139, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False
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protocolSection identificationModule nctId: NCT06353087, orgStudyIdInfo id: B7451114, briefTitle: Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry), acronym: ATTRACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-11-15, completionDateStruct date: 2025-11-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics., conditionsModule conditions: Dermatitis, Atopic, conditions: Dermatitis, conditions: Eczema, conditions: Skin Diseases, conditions: Immune System Diseases, conditions: Janus Kinase Inhibitors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52, primaryOutcomes measure: Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52, primaryOutcomes measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52, secondaryOutcomes measure: Duration of Abrocitinib Treatment: All Participants, secondaryOutcomes measure: Demographic and baseline characteristics, secondaryOutcomes measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52, secondaryOutcomes measure: Change From Baseline in Investigator's Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52, secondaryOutcomes measure: Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52, secondaryOutcomes measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52, secondaryOutcomes measure: Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52, secondaryOutcomes measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52, secondaryOutcomes measure: Change From Baseline in Patient Global Assessment (PtGA), secondaryOutcomes measure: Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52, secondaryOutcomes measure: Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52, secondaryOutcomes measure: Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353074, orgStudyIdInfo id: 1335cemre., briefTitle: Uterine Preservation With Acar's Atony Suture for Postpartum Uterine Hemorrhage, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: This study is aimed to show effectiveness of a new suture technique to stop postpartum uterine bleeding due to uterine atony., conditionsModule conditions: Uterine Atony With Hemorrhage, conditions: Postpartum Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Postpartum hysterectomy and/or intensive care unit need ratio, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cemre Alan, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06353061, orgStudyIdInfo id: LACC-MET, briefTitle: Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients., conditionsModule conditions: Cervical Cancer, conditions: Radiotherapy, conditions: Metformin, conditions: Hypoxia, conditions: PET/CT, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, interventions name: Radiotherapy, interventions name: Chemotherapy, interventions name: PET/CT, outcomesModule primaryOutcomes measure: The degree to which metformin improves the hypoxic index measured by CAIX PET, secondaryOutcomes measure: Progression-free survival（PFS）, secondaryOutcomes measure: Changes in tumor volume during treatment, secondaryOutcomes measure: Hematologic and gastrointestinal toxicities assessed by CTCAE v5.0, secondaryOutcomes measure: Quality of life assessed by QLQ-C30, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06353048, orgStudyIdInfo id: Soh-Med-24-02-04MS, briefTitle: Short Term Radiological and Clinical Outcomes of Fixation of Schatzker II Tibial Plateau Fractures by Screws Only Versus Plate and Screws, Comparative Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, collaborators name: sohag university hospital, descriptionModule briefSummary: Tibial plateau fractures are complex injuries produced by high- or low-energy trauma. They principally affect young adults or the 'third age' population ,the tibial plateau is a major weight-bearing surface within the largest and most kinematically complex joint in the human body. Fractures occur as a result of a combination of an axial loading force and a coronal plane (varus/valgus) moment leading to articular shear and depression and mechanical axis malalignment,So Limb alignment and articular surface restoration, allowing early knee motion, are the main goals of surgical treatment.Soft-tissue damage in fractures around the knee is of critical importance. The oedema and inflammation associated with the trauma can easily lead to local venous compromise, dermal hypoxia, and additional soft-tissue injury. This commonly leads to blistering of the skin and in some cases dermal and even muscle necrosis. Blood-filled blisters should be expected to be associated with a worse outcome than clear fluid-filled ones. Management in the early stages of treatment should focus on preventing further soft-tissue injury while waiting to repair the fracture.Traditionally, initial radiograph diagnosis should include anteroposterior (AP), lateral and oblique views. But single radiographs do not allow an exact fragment identification and the initial fracture classification can change in 5% to 24% (mean 12%) of cases and treatment can change in up to 26% of cases after CT scan imaging . These findings and the wider availability of CT scanning have made the oblique views less important in the diagnosis. Intra- and peri-articular soft-tissue structures can be affected even in less complex fracture patterns and some X-ray or CT scan data can also suggest the existence of a lateral or medial meniscal tear. Articular depression \> 6 mm and/or articular widening \> 5 mm are associated with the existence of lateral meniscus, lateral collateral ligament (LCL) or posterior cruciate ligament injuries .Schatzer classification (published in 1974) will be used to complete understanding of the personality of these fracture which is the key element in decision making process when choosing the best possible treatment .In general ,tibial plateau fracture are to be operated on, but the decision whether to be operated or not on a specific fracture should be based on the fracture morphology ,soft tissues, the patient general condition and the expected limb axis and articular surface restoration.Usual indications for surgical treatment are :1. Intra-articular displacement of ⩾ 2 mm2. Metaphyseal -diaphyseal translation \> 1 cm3. Angular deformity more than 10 degree in the coronal or sagittal view4. Open fracture, compartment syndrome and associated ligament injury require repair.5. Associated fractures of the ipsilateral tibia or fibulaFrequently the depressed articular fragments have to elevated back toward the knee, followed by fixation and sometimes supplemented with bone graft to fill any cancellous bone voids left beneath the joint surface after fracture reduction .We will evaluate treatment outcomes of closed reduction and percutaneous cannulated screw fixation for tibial plateau fractures versus open reduction and fixation by plate, conditionsModule conditions: Tibial Plateau Fractures Schatzker Type II, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: fixation of tibial plateau fractures, outcomesModule primaryOutcomes measure: range of motion of knee joint using Rasmussen score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06353035, orgStudyIdInfo id: NaturalResourcesIFinland, secondaryIdInfos id: 346136, type: OTHER_GRANT, domain: Strategic Research Council Finland, secondaryIdInfos id: 346138, type: OTHER_GRANT, domain: Strategic Research Council Finland, briefTitle: Biodiversity Interventions for Well-Being, acronym: BIWE, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-30, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Natural Resources Institute Finland, class: OTHER_GOV, collaborators name: Tampere University, descriptionModule briefSummary: Biodiversity is essential for nature and human well-being. Land use has reduced biodiversity in cities, which weakens the functionality of the urban ecosystems and the well-being of citizens. This may also increase the risk of immune-mediated disorders among urban dwellers.In Biodiversity interventions for well-being (BIWE), microbial biodiversity interventions are performed to increase biodiversity in urban built areas. Results from the intervention trials are combined with publicly available land cover and ecological data. These are analyzed from the viewpoint of shifts in ecosystems and human well-being and immune regulation, ecological quality, and urban planning.The investigators set up an intervention study in which urban private yards are rewilded with diverse vegetation and decaying deadwood and plant residuals. The investigators aim to evaluate the effect of rewilding, and yard management practices on commensal microbiome, cortisol levels and well-being and salivary cytokine levels, and gene pathways., conditionsModule conditions: Microbial Colonization, conditions: Immune System Diseases, conditions: Well-Being, Psychological, conditions: Nature, Human, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention-control study in which intervention study subjects private yards are rewilded and control receives no treatment., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, maskingDescription: The research subjects were not randomized or masked to the intervention and control group, because the control group needs volunteers who have no intention of following the yard management instructions advised to the intervention group., enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Rewilding, outcomesModule primaryOutcomes measure: Skin Gammaproteobacteria, secondaryOutcomes measure: Salivary cytokines, secondaryOutcomes measure: Difference in diversity (Alpha and beta diversity) of skin, saliva and stool microbiota, secondaryOutcomes measure: Difference in observed species richness of skin, saliva and stool microbiota, secondaryOutcomes measure: Difference in taxonomies of skin, saliva and stool microbiota, secondaryOutcomes measure: Difference in microbial gene pathways of saliva and stool microbiota, secondaryOutcomes measure: Cortisol levels, secondaryOutcomes measure: Perceived Stress Scale, secondaryOutcomes measure: Warwick-Edinburgh Mental Wellbeing Scale, secondaryOutcomes measure: Depression Scale, secondaryOutcomes measure: Nature Relatedness Scale, secondaryOutcomes measure: Metabolites in urine, otherOutcomes measure: Associations between environmental factors and microbial measurements, salivary cytokine levels, hair cortisol levels, perceived well-being, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Natural Resources Institute Finland, city: Helsinki, state: Uusimaa, zip: 00970, country: Finland, geoPoint lat: 60.16952, lon: 24.93545, hasResults: False
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protocolSection identificationModule nctId: NCT06353022, orgStudyIdInfo id: RC23_0267, secondaryIdInfos id: 2023-508310-41, type: EUDRACT_NUMBER, briefTitle: Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma, acronym: IFm2022-01, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-04-20, completionDateStruct date: 2030-06-20, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Nantes University Hospital, class: OTHER, collaborators name: Janssen Pharmaceutica, descriptionModule briefSummary: This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD \[-\] \[standard-risk\] vs MRD \[+\] \[high-risk\] respectively).The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 103, type: ESTIMATED, armsInterventionsModule interventions name: Teclistamab, interventions name: Talquetamab, interventions name: Lenalidomide, interventions name: Bortezomib, interventions name: Daratumumab, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Rate of sustained MRD negativity (NGS, 10^-5), primaryOutcomes measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5), secondaryOutcomes measure: Number of adverse events, secondaryOutcomes measure: Rate of sustained MRD negativity (NGS, 10^-6), secondaryOutcomes measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-6)., secondaryOutcomes measure: Rate of conversion from positive MRD to negative MRD (NGS, 10^-5)., secondaryOutcomes measure: Number of the death, secondaryOutcomes measure: Number of responses, secondaryOutcomes measure: Number of progression-free survival, secondaryOutcomes measure: Percentage of duration of response, secondaryOutcomes measure: Percenatge of time to response, otherOutcomes measure: Percentage of value of biological prognostic factors influencing outcome and response., otherOutcomes measure: Percentage of score of quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CH de la Côte Basque, city: Bayonne, zip: 64109, country: France, geoPoint lat: 43.48333, lon: -1.48333, locations facility: CHU Caen, city: Caen, zip: 14033, country: France, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CHRU DIjon, city: Dijon, zip: 21000, country: France, geoPoint lat: 47.31667, lon: 5.01667, locations facility: Chd Vendee, city: La Roche-sur-Yon, zip: 85925, country: France, geoPoint lat: 46.66667, lon: -1.43333, locations facility: CHRU LILLE - Hôpital Claude Huriez, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU Limoges, city: Limoges, zip: 87000, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: CH Lyon Sud, city: Lyon, zip: 69495, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: IPC Marseille Institut Paoli Calmettes, city: Marseille, zip: 13009, country: France, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Montpellier, city: Montpellier, zip: 34295, 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: APHP Hôpital Saint Louis, city: Paris, zip: 75010, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Hôpital Saint-Antoine, city: Paris, zip: 75012, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: APHP Hôpital La Pitié Salpétrière, city: Paris, zip: 75013, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU BORDEAUX - Hôpital du Haut Lévêque, city: Pessac, zip: 33604, country: France, geoPoint lat: 44.81011, lon: -0.64129, locations facility: CHU Poitiers, city: Poitiers, zip: 86000, country: France, geoPoint lat: 46.58333, lon: 0.33333, locations facility: CHRU Rennes - Hôpital de Pontchaillou, city: Rennes, zip: 35033, country: France, geoPoint lat: 48.11198, lon: -1.67429, locations facility: ICANS Institut de Cancérologie Strasbourg Europe, city: Strasbourg, zip: 67200, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU Toulouse, city: Toulouse, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: CHU Tours Hôpital Bretonneau, city: Tours, zip: 37044, country: France, geoPoint lat: 47.38333, lon: 0.68333, locations facility: CHRU Nancy - Hôpitaux de Brabois, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, geoPoint lat: 48.65, lon: 6.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06353009, orgStudyIdInfo id: ICM 2021-2720, briefTitle: Effect of a Single Ultra-Processed Meal on Myocardial Endothelial Function Assessed With Positron Emission Tomography, acronym: SUPPER, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-20, primaryCompletionDateStruct date: 2023-04-28, completionDateStruct date: 2023-04-28, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Matthieu Pelletier-Galarneau, MD MSc, class: OTHER, descriptionModule briefSummary: The objective of this study is to evaluate the effect of an ultra-processed meal on myocardial endothelial function using positron emission tomography (PET).The proposed study is an open-label, randomized crossover clinical trial. Participants will be divided into 2 groups: half of the participants will consume a Mediterranean meal during the first experimental visit and an ultra-processed meal during the second, and vice versa for the other half. The order in which the meals will be consumed will be determined randomly.This project will contribute to clarify the role of diet in the development and progression of coronary artery disease. The results obtained from this study may potentially demonstrate the harmful effect of ultra-processed foods, even in the short term, on coronary arteries., conditionsModule conditions: Myocardial Endothelial Function, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: NOVA4 meal, interventions name: NOVA1-3 meal, outcomesModule primaryOutcomes measure: Myocardial blood flow values (ml/min/g) at maximum dose of adenosine., secondaryOutcomes measure: Myocardial blood flow values (ml/min/g) at rest and myocardial reserve., secondaryOutcomes measure: Myocardial blood flow values (ml/min/g) at intermediate dose of adenosine., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Matthieu Pelletier-Galarneau, city: Montreal, state: Quebec, zip: H1T 1C8, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06352996, orgStudyIdInfo id: Dentist Anas Kassas, briefTitle: Three-Dimensional Assessment of Maxillary Canine Retraction With and Without Power Arm, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-09, primaryCompletionDateStruct date: 2024-03-09, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Aim of the study: This trial will be conducted for three-dimensional assessment of canine retraction with and without power arm.Materials and methods:Twenty patients with age range between 14 to 25 years. Before bonding, a hook will be attached to the canine bracket in one side only. Leveling and alignment then The first premolars will be extracted and mini-implant will be inserted.Canine retraction using nickel titanium closed coil spring will start in the same day of upper first premolar extraction., conditionsModule conditions: Power Arm Canine Retraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Three-Dimensional Assessment of Maxillary Canine Retraction with Power Arm, interventions name: Three-Dimensional Assessment of Maxillary Canine Retraction without Power Arm, outcomesModule primaryOutcomes measure: Canine tipping, primaryOutcomes measure: Canine mobility, primaryOutcomes measure: Implant stability, primaryOutcomes measure: Pain assessment, primaryOutcomes measure: canine rotation, primaryOutcomes measure: canine retraction rate, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of dentistry Mansoura University, city: Mansoura, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06352983, orgStudyIdInfo id: 2014/11, briefTitle: Zirconium Dioxide Fixed Dental Prosthesis., statusModule overallStatus: COMPLETED, startDateStruct date: 2017-12-20, primaryCompletionDateStruct date: 2019-09-27, completionDateStruct date: 2023-01-20, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Malmö University, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to evaluate and compare bridges to replace one or two missing teeth in the mouth. The bridges will be made of two variants of ceramic material. We will evaluate the bridges for up to five years regarding technical and biological complications., conditionsModule conditions: Missing Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Both participant, care providers, dental technicians and the investigator are blinded in the process., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 31, type: ACTUAL, armsInterventionsModule interventions name: Fixed dental prosthesis, outcomesModule primaryOutcomes measure: Fractures, primaryOutcomes measure: De-bonding, secondaryOutcomes measure: Caries, secondaryOutcomes measure: Endodontic, secondaryOutcomes measure: Function, secondaryOutcomes measure: Esthetics, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Malmo university, city: Malmo, state: Skane, zip: 214 21, country: Sweden, geoPoint lat: 55.60587, lon: 13.00073, locations facility: Malmo university, city: Malmo, state: Skane, zip: 21421, country: Sweden, geoPoint lat: 55.60587, lon: 13.00073, hasResults: False
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protocolSection identificationModule nctId: NCT06352970, orgStudyIdInfo id: LundU-2024, briefTitle: Effects of Tuberculosis Infection on Development and Function of the Placenta, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Lund University, class: OTHER, collaborators name: Addis Ababa University, collaborators name: Armauer Hansen Research Institute, Ethiopia, descriptionModule briefSummary: The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.The main questions it aims to answer are:* Does TB infection affect the structure of the placenta?* Does TB infection affect the function of the placenta?Pregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:* Pathological lesions of the placenta* Gene and protein expression patterns linked to pregnancy-related disorders* Infant outcome at birth and at 6 weeks after birth, conditionsModule conditions: Pregnancy Related, conditions: Tuberculosis Infection, conditions: Placenta Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: TB infection, outcomesModule primaryOutcomes measure: Proportion of women with pathological placental findings according to the Amsterdam consensus criteria, secondaryOutcomes measure: Proportions of women with placental RNA and protein expression patterns linked to pregnancy- related disorders, secondaryOutcomes measure: Proportions of infants (born to participating women) with adverse outcome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352957, orgStudyIdInfo id: 23022022CERC, briefTitle: Use of ETElcalcetidefor pReserving vitamiN K-dependent proteIn activiTY ITAlian Study, acronym: ETERNITY-ITA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Istituto di Fisiologia Clinica CNR, class: OTHER, descriptionModule briefSummary: The goal of this Prospective Observational Study of comparative effectiveness is to provide real world evidence of the effect of Etelcalcetide in increasing actives form VKDPs levels such as BGP and MGP at 3, 9 and 18 months from baseline, with resulting correct bone mineralization and inhibition vascular calcification in hemodialysis patients.The study will enroll 160 hemodialysis patients: 80 patients treated with Etelcalcetide and 80 age and sex matched patients treated with Calcitriol or vitamin D analogs. The treating nephrologist will base the target dose of Etelcalcetide on individual-level in order to achieve the KDIGO PTH target. In the Etelcalcetide-treated group, the addition of calcitriol will be allowed when required by clinical practice (for correction of hypocalcemia). The main endpoint is the comparison of the levels of active forms of VKDP (MGP and BGP) between patients treated with Etelcalcetide and those treated with vitamin D or vitamin D analogues. The measurements of the biomarkers are scheduled at baseline and after 3, 9, and 18 months., conditionsModule conditions: Hemodialysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Levels of VKDP, secondaryOutcomes measure: Calcium, secondaryOutcomes measure: Phosphate, secondaryOutcomes measure: Magnesium, secondaryOutcomes measure: ALP, secondaryOutcomes measure: PTH, secondaryOutcomes measure: 25(OH)D, secondaryOutcomes measure: P1NP, secondaryOutcomes measure: CTX, secondaryOutcomes measure: TRAP 5b, secondaryOutcomes measure: BSAP, secondaryOutcomes measure: cFGF23, secondaryOutcomes measure: Klotho, secondaryOutcomes measure: Sclerostin, secondaryOutcomes measure: DKK1, secondaryOutcomes measure: Fetuin A, secondaryOutcomes measure: Zinc, secondaryOutcomes measure: Irisin, secondaryOutcomes measure: Serum Calcification Propensity T50 test, secondaryOutcomes measure: Hemoglobin (Hb), secondaryOutcomes measure: Hematocrit (Ht), secondaryOutcomes measure: Plates (PLTS), secondaryOutcomes measure: Reticulocytes, secondaryOutcomes measure: Iron, secondaryOutcomes measure: Ferritin, secondaryOutcomes measure: Transferrin, secondaryOutcomes measure: Transferrin Saturation, secondaryOutcomes measure: Albumin, secondaryOutcomes measure: KT/V, secondaryOutcomes measure: Aluminium, secondaryOutcomes measure: C-reactive Protein (CRP), secondaryOutcomes measure: Cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Cholesterol HDL, secondaryOutcomes measure: Cholesterol LDL, secondaryOutcomes measure: Vascular Calcification, secondaryOutcomes measure: Vertebral Fractures, secondaryOutcomes measure: BMD: Bone Mineral Density, secondaryOutcomes measure: Association between Verterbal Fractures and Vascular Calcificatiom, secondaryOutcomes measure: Novel quantitative computer-assisted scoring method for vascular calcifications., secondaryOutcomes measure: Effect of Etelcalcetide on cardiovascular events and all-cause mortality., secondaryOutcomes measure: Etelcalcetide Safety: Number of participants with treatment-related adverse events., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352944, orgStudyIdInfo id: AssiutMD, briefTitle: Procalcitonin as a Marker of Severity of Non-cystic Fibrosis Bronchiectasis in Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the role of procalcitonin in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children in correlation with other markers (functional and radiological severity ), conditionsModule conditions: Non-cystic Fibrosis Bronchiectasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: procalcitonin, outcomesModule primaryOutcomes measure: procalcitonin level in bronchoalveolar lavage as a biomarker for assessment of severity of non-CF bronchiectasis in children, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352931, orgStudyIdInfo id: TCD & TCUS in infants, briefTitle: Transcranial Ultrasound and Transcranial Doppler in Diagnosis and Detection of Outcome in Infants With Neurological Diseases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial Doppler in evaluation of intracerebral blood flow in comparison with other radiological modalities according to available imaging., conditionsModule conditions: Trancranial Doppler, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: transcranial and transcranial dopp;er, outcomesModule primaryOutcomes measure: To evaluate the accuracy of transcranial ultrasound in detection of brain pathology in infants with neurological diseases and value of transcranial doppler, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352918, orgStudyIdInfo id: B.30.2.ATA.0.01.00/395, briefTitle: Peripheral Central Catheter (PICC) Care, acronym: PICC, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies., conditionsModule conditions: NEWBORN, conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Palmar grasp reflex stimulation, outcomesModule primaryOutcomes measure: Pain level, secondaryOutcomes measure: Comfort, eligibilityModule sex: ALL, minimumAge: 28 Weeks, maximumAge: 36 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Ataturk University, city: Erzurum, zip: 25240, country: Turkey, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
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protocolSection identificationModule nctId: NCT06352905, orgStudyIdInfo id: 2157711, briefTitle: Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Baylor University, class: OTHER, collaborators name: University of St. Augustine for Health Sciences, descriptionModule briefSummary: This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Whole body vibration (WBV), interventions name: Control, outcomesModule primaryOutcomes measure: 3-meter backward walk test (3MBWT), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor University, status: RECRUITING, city: Waco, state: Texas, zip: 76798, country: United States, contacts name: Anne Boddy, role: CONTACT, phone: 904-806-2126, email: [email protected], geoPoint lat: 31.54933, lon: -97.14667, hasResults: False
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protocolSection identificationModule nctId: NCT06352892, orgStudyIdInfo id: 20210201, briefTitle: A Study to Evaluate AMG 133 in Chinese Participants With Obesity or Overweight, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-09-03, completionDateStruct date: 2024-09-03, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Amgen, class: INDUSTRY, descriptionModule briefSummary: The main objective of the study is to assess the pharmacokinetics (PK) of AMG 133 after a single subcutaneous (SC) administration in overweight or obese Chinese participants., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: AMG 133, outcomesModule primaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of AMG 133, primaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 133, primaryOutcomes measure: AUC from Time Zero Extrapolated to Infinity (AUCinf) of AMG 133, secondaryOutcomes measure: Number of Participants with Treatment-emergent Adverse Events, secondaryOutcomes measure: Number of Participants with Serious Adverse Events, secondaryOutcomes measure: Number of Participants with Anti-AMG 133 Antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352879, orgStudyIdInfo id: 18-Al-KindyCM, briefTitle: Prevalence, Types and Risk Factors of Urinary Incontinence Among Women in Baghdad, Iraq., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Al-Kindy College of Medicine, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to observe and describe the prevalence, types, and risk factors of urinary incontinence (UI) in adult women attending primary healthcare centers in Baghdad, Iraq. The main questions it aims to answer are:* What is the prevalence of incontinence among the targeted group?* What are the types of incontinence and what is the frequency of each type among the targeted group?* What is the effect of several risk factors on the occurrence and severity of urinary incontinence (including age, job, sexual activity, chronic constipation, chronic cough, parity, largest birth weight, and body mass index)? Participants will be asked to fill out a questionnaire consisting of the Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF) in addition to questions about the aforementioned risk factors., conditionsModule conditions: Urinary Incontinence, conditions: Urge Incontinence, conditions: Stress Incontinence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 384, type: ESTIMATED, outcomesModule primaryOutcomes measure: Arabic International Consultation On Incontinence Questionnaire-Urinary Incontinence Short Form (Arabic ICIQ-UI SF), secondaryOutcomes measure: Risk factors for urinary incontinence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baghdad Al- Karkh Health Directorate, status: RECRUITING, city: Baghdad, country: Iraq, contacts name: Harth Mohamed Kamber, FICMS (Uro.), role: CONTACT, phone: 009647706029071, email: [email protected], contacts name: Shahad Hameed Kadhom, MBChB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.34058, lon: 44.40088, locations facility: Baghdad Al-Russafa Health Directorate, status: RECRUITING, city: Baghdad, country: Iraq, contacts name: Harth Mohamed Kamber, FICMS (Uro.), role: CONTACT, phone: 009647706029071, email: [email protected], contacts name: Shahad Hameed Kadhom, MBChB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.34058, lon: 44.40088, hasResults: False
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protocolSection identificationModule nctId: NCT06352866, orgStudyIdInfo id: CASE3A23, briefTitle: Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Jack Khouri, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion. Siltuximab is an investigational (experimental) drug that works by binding directly to human interleukin-6 (IL-6). IL-6 is a cytokine; these are products that are secreted by certain cells of the immune system and effect other cells in participant's body. IL-6 regulates immune, inflammatory and metabolic processes. Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castleman's disease, which is a lymphoproliferative disorder. This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome (CRS) and Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) in participants prior to teclistamab administration. CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body. Siltuximab is experimental because it is not approved by the Food and Drug Administration (FDA) for prophylactic use prior to administration of teclistamab infusion., conditionsModule conditions: Multiple Myeloma, conditions: Cytokine Release Syndrome, conditions: Refractory Multiple Myeloma, conditions: Immune Effector Cell Associated Neurotoxicity Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study is an open label single cohort feasibility and efficacy study of siltuximab prophylaxis prior to infusion of teclistamab for treatment of RRMM. There is no planned dose escalation and no separate cohorts.Participants will receive a single dose of prophylactic siltuximab, 11 mg/kg, 2 hours prior to the administration of the first dose of teclistamab on day 1. There is no planned dose escalation of siltuximab, and teclistamab dosing will be done following the standard planned ramp-up. Participants will be hospitalized for 9 days according to teclistamab package insert and Cleveland Clinic institutional practice. Participants will be followed for the incidence of CRS and ICANS for the first two 22-day cycles of treatment., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Siltuximab, interventions name: Teclistamab(FDA-approved), outcomesModule primaryOutcomes measure: Change in CRS Rate, secondaryOutcomes measure: Safety assessment of a single dose of siltuximab as CRS prophylaxis, secondaryOutcomes measure: Incidence of grade ≥ 2 cytokine release syndrome after siltuximab prophylaxis, secondaryOutcomes measure: Incidence of all grade ICANS after siltuximab prophylaxis, secondaryOutcomes measure: Incidence of adverse events after siltuximab prophylaxis, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Hospitalization rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Jack Khouri, MD, role: CONTACT, phone: 866-223-8100, email: [email protected], contacts name: Jack Khouri, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06352853, orgStudyIdInfo id: Diathermy and skin incision cs, briefTitle: Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2022-10-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time, incisional blood loss, postoperative pain, wound healing and wound complications., conditionsModule conditions: Skin Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Skin incision in Cesarean Section by Diathermy, interventions name: Skin incision in Cesarean Section by Scalpel, outcomesModule primaryOutcomes measure: Skin incision time in scalpel versus diathermy group, primaryOutcomes measure: Estimation of incision blood loss in both groups, secondaryOutcomes measure: Postoperative pain in both groups, secondaryOutcomes measure: Postoperative wound healing in both groups, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shaimaa El Shemy, city: Giza, state: Cairo, zip: 11562, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06352840, orgStudyIdInfo id: HUM00231526, secondaryIdInfos id: 5K23HD099283-03, type: NIH, link: https://reporter.nih.gov/quickSearch/5K23HD099283-03, briefTitle: Novel Web-based, Self-directed Intervention for Chronic Pelvic Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: The study is being completed to evaluate the effectiveness of a web-based, self-management program for patients with Chronic Pelvic Pain (CPP).The overall hypothesis is that patients with chronic pelvic pain that have access to the My Pelvic Plan program will demonstrate improvements in pain, physical function, and quality of life with this integrative self-management approach., conditionsModule conditions: Chronic Pelvic Pain, conditions: Endometriosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Both participants and outcome assessors will be blinded to study group assignment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: My Pelvic Plan Website, interventions name: Control Group website, outcomesModule primaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups, primaryOutcomes measure: PROMIS pain intensity 1a between groups, primaryOutcomes measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups, secondaryOutcomes measure: Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference short form (SF) 4a between groups, secondaryOutcomes measure: PROMIS pain intensity 1a between groups, secondaryOutcomes measure: PROMIS Self Efficacy for Managing Symptoms SF 4a between groups, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Sara Till, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06352827, orgStudyIdInfo id: HUM00228948, secondaryIdInfos id: 1K23DK134752-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23DK134752-01, briefTitle: Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation., conditionsModule conditions: Constipation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 109, type: ESTIMATED, armsInterventionsModule interventions name: Surveys, outcomesModule primaryOutcomes measure: Percentage of encounters in which anorectal physiology testing is ordered or performed at the baseline routine-care gastroenterology office appointment, primaryOutcomes measure: Percentage of encounters in which pelvic floor physical therapy is ordered at the baseline routine-care gastroenterology office appointment, primaryOutcomes measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM), primaryOutcomes measure: Percentage of clinical symptom responders from the Patient Assessment of Constipation-Symptoms (PAC-SYM), secondaryOutcomes measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL), secondaryOutcomes measure: Percentage of constipation-specific quality-of-life responders from the Patient Assessment of Constipation-Quality of Life (PAC-QOL), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Brenda Ayala, role: CONTACT, phone: 734-936-4780, email: [email protected], contacts name: Eric Shah, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06352814, orgStudyIdInfo id: 1977152, briefTitle: Activities-based Locomotor Training Program Versus Traditional Physical Therapy in Children With Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2027-05-30, completionDateStruct date: 2027-05-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Baylor University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy on activity, participation, and central and peripheral neurophysiological adaptation in children with cerebral palsy., conditionsModule conditions: Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Activities-based locomotor training (physical therapy), outcomesModule primaryOutcomes measure: Gross Motor Function Measure-66 (GMFM), primaryOutcomes measure: Pediatric Neuromuscular Recovery Scale (PedsNRS), primaryOutcomes measure: Pediatric Evaluation of Disability Inventory (PEDI-CAT), primaryOutcomes measure: Pediatric Quality of Life Inventory CP Module (PedsQL-CP), primaryOutcomes measure: Functional near-infrared spectroscopy, primaryOutcomes measure: Electromyography, primaryOutcomes measure: ActiGraph sensors, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Baylor University, status: RECRUITING, city: Waco, state: Texas, zip: 76798, country: United States, contacts name: Megan Flores, role: CONTACT, phone: 512-529-4421, email: [email protected], geoPoint lat: 31.54933, lon: -97.14667, hasResults: False
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protocolSection identificationModule nctId: NCT06352801, orgStudyIdInfo id: EA230530, briefTitle: Effectiveness of Self-Compassion Intervention on Enhancing Self-Compassion and Psychological Well-Being of Children With Attention Deficit/Hyperactivity Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-28, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: The study aims to investigate the underlying mechanism between Attention Deficit/Hyperactivity Disorder traits (AD/HD traits) and psychological well-being through studying the role of perceived criticism, rejection sensitivity, self-compassion and growth mindset. It also aims to explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong Kong. The study will contribute to the current understanding of the supportive measures for children with AD/HD, and hopefully help to mobilize more resources to preserve children with AD/HD's mental health.The intervention program includes the following components:Participants will be randomly assigned to the self-compassion intervention group or the waitlist control group. The intervention group consists of two parts: children training session and parent group sessions. All children participants will complete a total of 6 training sessions, and each session will last around 90 minutes. Parents of the children participants will also complete a total of 3 group sessions, and each session will last around 90 minutes.To investigate the intervention effectiveness, children will be asked to complete a questionnaire assessing their levels of self-compassion, emotional regulation, as well as psychological well-being in terms of life satisfaction, positive and negative affect. Parents and teachers of participants will also be asked to complete a questionnaire covering children's emotional regulation, positive and negative affect. Questionnaire data collection will be conducted prior to the intervention (i.e., Time 1), immediately after the 6-session student and 3-session parent sessions (i.e., Time 2), and 2 months after the intervention (i.e., Time 3, a 2-month follow up). It takes approximately 20-30 minutes for children and parents to complete their questionnaires.Study Objectives:1. To investigate the underlying mechanism of the relationship between AD/HD traits and psychological well-being2. To explore the effectiveness of self-compassion intervention on enhancing self-compassion and psychological well-being of children with AD/HD in Hong KongHypotheses:1. AD/HD traits negatively predicts psychological well-being2. AD/HD traits positively predicts perceived criticism or rejection sensitivity3. Perceived criticism or rejective sensitivity negatively predicts psychological well-being4. Perceived criticism or rejective sensitivity mediates the relationship between AD/HD traits and psychological well-being5. Self-compassion moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being6. Growth mindset moderates the relationship between perceived criticism or rejection sensitivity and psychological well-being7. Children with AD/HD from self-compassion intervention group yield greater improvement in self-compassion, emotional regulation and psychological well-being, than waitlist-control group., conditionsModule conditions: ADHD, conditions: Self-Compassion, conditions: Psychological Well-Being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention Group: In Phase 1, children participants receive a 6-session self-compassion intervention training, plus parents of the participants receive a 3-session parent group. once to twice a week, 90 minutes per session.Wait-list Control: receives the same intervention in Phase 2, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Self-Compassion Intervention, outcomesModule primaryOutcomes measure: Self-Compassion Scale for Children (SCS-C), primaryOutcomes measure: Self-Compassion Scale for Children (SCS-C), primaryOutcomes measure: Self-Compassion Scale for Children (SCS-C), primaryOutcomes measure: Behavioural ratings on children's executive functions, primaryOutcomes measure: Behavioural ratings on children's executive functions, primaryOutcomes measure: Behavioural ratings on children's executive functions, primaryOutcomes measure: Student's Life Satisfaction Scale (SLSS), primaryOutcomes measure: Student's Life Satisfaction Scale (SLSS), primaryOutcomes measure: Student's Life Satisfaction Scale (SLSS), primaryOutcomes measure: Positive and Negative Affect Schedule for Children (PANAS-C/P), primaryOutcomes measure: Positive and Negative Affect Schedule for Children (PANAS-C/P), primaryOutcomes measure: Positive and Negative Affect Schedule for Children (PANAS-C/P), otherOutcomes measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN), otherOutcomes measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN), otherOutcomes measure: The Strengths and Weaknesses of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN), otherOutcomes measure: The Perceived Criticism Scale (PCS), otherOutcomes measure: The Perceived Criticism Scale (PCS), otherOutcomes measure: The Perceived Criticism Scale (PCS), otherOutcomes measure: Children's Rejection Sensitivity Questionnaire (CRSQ), otherOutcomes measure: Children's Rejection Sensitivity Questionnaire (CRSQ), otherOutcomes measure: Children's Rejection Sensitivity Questionnaire (CRSQ), otherOutcomes measure: Growth Mindset Scale, otherOutcomes measure: Growth Mindset Scale, otherOutcomes measure: Growth Mindset Scale, eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: The University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Kwan Lok TANG, role: CONTACT, phone: +852-66532947, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06352788, orgStudyIdInfo id: 202007224, briefTitle: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices, acronym: AFOSVA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Jason Wilken, class: OTHER, collaborators name: Mayo Clinic, collaborators name: Vanderbilt University Medical Center, collaborators name: Navy Medical Center San Diego, collaborators name: Minneapolis Veterans Affairs Medical Center, collaborators name: Johns Hopkins University, descriptionModule briefSummary: This study is designed to support evidence-based practice and optimal care by evaluating how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) influences outcomes following traumatic lower extremity injury., conditionsModule conditions: Foot Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants will be cast and fit with either a carbon fiber custom dynamic orthosis (CDO) with a modular or mono design. After being fit with the CDO they will complete testing with the CDO in three different configurations (A, B, C) in a randomized order and without the CDO., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Study participants, investigators, and outcome assessors will be blinded to the condition being tested and will only be introduced to each condition as A, B, or C. Only study coordinators, who will verify adherence with the study protocol (CDO configuration), will not be blinded., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Modular Carbon Fiber Custom Dynamic Orthosis (CDO), interventions name: Mono Carbon Fiber Custom Dynamic Orthosis (CDO), outcomesModule primaryOutcomes measure: PROMIS Physical Function, primaryOutcomes measure: PROMIS Pain Interference, primaryOutcomes measure: OPUS Satisfaction with Device and Services, primaryOutcomes measure: Modified Socket Comfort Score - Comfort, primaryOutcomes measure: Modified Socket Comfort Score - Smoothness, primaryOutcomes measure: Numerical Pain Rating Scale, primaryOutcomes measure: Preference - Ranked, primaryOutcomes measure: Preference - CDO Configuration, primaryOutcomes measure: Four Square Step Test (seconds), primaryOutcomes measure: Sit to Stand 5 Times (seconds), primaryOutcomes measure: Center of Pressure Velocity Magnitude (m/s), primaryOutcomes measure: Center of Pressure Velocity Timing (%stance), primaryOutcomes measure: Ankle Zero Moment Crossing (%stance), primaryOutcomes measure: Peak Ankle Dorsiflexion (degree), primaryOutcomes measure: Peak Ankle Plantarflexion Moment (Nm/kg), primaryOutcomes measure: Peak Ankle Push-Off Power (W/kg), secondaryOutcomes measure: PROMIS Satisfaction with Participation in Social Activities, secondaryOutcomes measure: PROMIS Satisfaction with Participation in Discretionary Social Activities, secondaryOutcomes measure: PROMIS Depression, otherOutcomes measure: 10 Meter Shuttle Run (seconds), otherOutcomes measure: Self Selected Walking Velocity (m/s), otherOutcomes measure: Ankle Range of Motion (degrees), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352775, orgStudyIdInfo id: IRB00107112, briefTitle: Calcium Carbonate on Labor Induction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Aurora Health Care, class: OTHER, descriptionModule briefSummary: The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes., conditionsModule conditions: Pregnancy, conditions: Uterine Contraction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Calcium Carbonate, outcomesModule primaryOutcomes measure: Duration of induction time, primaryOutcomes measure: Rate of labor dystocia, secondaryOutcomes measure: Rate of cesarean deliveries, secondaryOutcomes measure: Total amount of oxytocin after cervical ripening, secondaryOutcomes measure: Gastrointestinal side effects, secondaryOutcomes measure: Blood loss, secondaryOutcomes measure: Rate of postpartum hemorrhage (>/= 500mL), secondaryOutcomes measure: Neonatal composite adverse outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aurora Sinai Medical Center, city: Milwaukee, state: Wisconsin, zip: 53233, country: United States, contacts name: Marie Forgie, DO, role: CONTACT, phone: 414-219-5800, email: [email protected], contacts name: Emily Malloy, PhD, CNM, role: CONTACT, phone: 414-219-6649, email: [email protected], geoPoint lat: 43.0389, lon: -87.90647, hasResults: False
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protocolSection identificationModule nctId: NCT06352762, orgStudyIdInfo id: Izmir Dokuz Eylul University, briefTitle: The Effects of Upper Extremity Robotic Rehabilitation in Children With Spastic Hemiparetic Cerebral Palsy, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-02-15, primaryCompletionDateStruct date: 2017-08-15, completionDateStruct date: 2017-12-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Izmir Bakircay University, class: OTHER, descriptionModule briefSummary: Aims: To investigate the effects of upper extremity robotic rehabilitation on upper extremity skills and functional independence level in patients with hemiparetic Cerebral Palsy (hCP).Methods: 34 hCP patients attended the study. 17 children in the training group recived conventional physiotherapy and Robotic Rehabilitation. 17 children in the control group recived only conventional physiotherapy. Convantional physiotherapy program lasted 45 minutes, Robotic Rehabilitation program lasted 30 minutes. All participants were enrolled in sessions 3 times a week for 5 weeks. Measurements were made before and after the therapy. Outcome measures were Modified Ashworth Scale (MAS) for muscle tone, Abilhand-Kids Test for manual skills, The Quality of Upper Extremity Skills Test (QUEST) for upper extremity motor function and The WeeFIM for functional independence level., conditionsModule conditions: Spastic Hemiplegic Cerebral Palsy, conditions: Upper Extremity Paresis, conditions: Robotic Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was conducted as a randomized controlled study.The first of the cases that met the study criteria was included in the study group, and the second in the control group. Randomization continued in this way., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Conventional physiotherapy, interventions name: Robotic Rehabilitation, outcomesModule primaryOutcomes measure: Muscle Tone, primaryOutcomes measure: Upper Extremity Motor Function, primaryOutcomes measure: Manual Ability, primaryOutcomes measure: Functional Independence, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Nuriye Büyüktaş, city: Bursa, state: Nilüfer, zip: 16130, country: Turkey, geoPoint lat: 40.19559, lon: 29.06013, hasResults: False
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protocolSection identificationModule nctId: NCT06352749, orgStudyIdInfo id: BasqueCU2024, briefTitle: Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes (ExerMOT-NH), acronym: ExerMOT-NH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of the Basque Country (UPV/EHU), class: OTHER, collaborators name: Fundación Miranda, collaborators name: Residencia Albiz Santiago Llanos, collaborators name: Aspaldiko, collaborators name: Residencia Nuestra Señora de Begoña, Santurtzi, descriptionModule briefSummary: The benefits of multicomponent physical exercise (MPE) in the mental and physical health of older adults are widely accepted. However, during Covid19 pandemic, some face-to-face programs for physical exercise were canceled. The situation was particularly complex in nursing homes (NHs) because residents were often confined to their floors and many leisure activities were canceled. Online physical exercise sessions increased their popularity during the pandemic. However, there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs. The current project aims to assess a synchronous online MPE program's feasibility, acceptability, and effects. With this aim, first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed: face-to-face MPE, online MPE and control. Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior. Additionally, those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength, balance, and endurance. MPE will be performed through supervised sessions (2 per week). One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online. Study assessments will be conducted at baseline, at the end of the 24-week intervention, and after 24-week follow-up. The primary outcomes of the study will be changes in mental and physical health. Secondary outcomes will include other parameters of mental and physical health, together with physical activity, frailty, quality of life, and biological markers. The dropout rate, the adherence, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will be recorded. A mixed-model ANCOVA will be performed to compare the data between intervention and control groups, considering as co-variables baseline measurements. The statistical analysis will be performed on the whole sample and separated for sex/gender. The study received ethical approval (M10_2022_405_IRAZUSTA ASTIAZARAN). The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active., conditionsModule conditions: Physical Function, conditions: Cognitive Decline, conditions: Psychological Well-Being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Each group will be assigned to control, online intervention or face-to-face intervention, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The investigators in charge of doing the statistical analysis and assessing the outcome measures will be blinded to group allocation. Due to the characteristics of the study, blinding the participants and the care provider (i.e., the professional conducting the exercise sessions) to the group allocation is not possible., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Advice to increase physical activity and reduce sedentary behavior, interventions name: Online Physical Exercise, interventions name: Face-to-Face Exercise, outcomesModule primaryOutcomes measure: Trail Making Test (TMT), primaryOutcomes measure: Spanish Version of the Yesavage Depression Scale, primaryOutcomes measure: 30-seconds Chair Sit to Stand test, secondaryOutcomes measure: MoCA (Montreal Cognitive Assessment), secondaryOutcomes measure: Wechsler Adult Intelligence Scale III (WAIS-III), secondaryOutcomes measure: EuroQol-5 dimensions (EQ-5D-5L), secondaryOutcomes measure: The Spanish adaptation of the Basic Psychological Needs in Exercise Scale (BPNES) (Moreno et al., 2008), secondaryOutcomes measure: Zung's Anxiety Self-Assessment Scale (Hernández-Pozo, et al., 2008), secondaryOutcomes measure: Satisfaction with Life Scale, secondaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: The Biceps Curl Test, secondaryOutcomes measure: The 2-minute Walk Test (2-MWT), secondaryOutcomes measure: The 8 Feet Up-and-Go test, secondaryOutcomes measure: Handgrip strength test, secondaryOutcomes measure: Serum Brain Derived Neurotrophic Factor (BDNF), secondaryOutcomes measure: Serum Klotho, secondaryOutcomes measure: Serum Glucose, secondaryOutcomes measure: Serum Urea, secondaryOutcomes measure: Serum Creatinine, secondaryOutcomes measure: Serum Uric Acid, secondaryOutcomes measure: Serum Cholesterol, secondaryOutcomes measure: Serum Triglycerides, secondaryOutcomes measure: Serum HDL-Cholesterol, secondaryOutcomes measure: Serum LDL-Cholesterol, secondaryOutcomes measure: Serum Glutamate Pyruvate Transaminase, secondaryOutcomes measure: Serum Glutamate Oxaloacetate Transaminase, secondaryOutcomes measure: Serum gamma glutamyl transferase, secondaryOutcomes measure: Serum Alkaline Phosphatase, secondaryOutcomes measure: Serum Creatin Kinase, secondaryOutcomes measure: Serum Lactate Dehydrogenase, secondaryOutcomes measure: Serum Bilirubin, secondaryOutcomes measure: Serum Sodium, secondaryOutcomes measure: Serum Potassium, secondaryOutcomes measure: Serum Chloride, secondaryOutcomes measure: Serum C Reactive Protein, secondaryOutcomes measure: Serum Albumin, secondaryOutcomes measure: Serum Total Protein, secondaryOutcomes measure: Serum Calcium, secondaryOutcomes measure: Serum Phosphorus, secondaryOutcomes measure: Serum D Vitamin, secondaryOutcomes measure: Erythrocyte count, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Hematocrit, secondaryOutcomes measure: Mean Corpuscular Volume (MCV), secondaryOutcomes measure: Mean Corpuscular Hemoglobin (MCH), secondaryOutcomes measure: Mean Corpuscular Hemoglobin Concentration (MCHC), secondaryOutcomes measure: Red Cell Distribution Width (RDW), secondaryOutcomes measure: Leucocyte Count, secondaryOutcomes measure: Neutrophil Count and Percentage, secondaryOutcomes measure: Lymphocyte Count and Percentage, secondaryOutcomes measure: Monocyte Count and Percentage, secondaryOutcomes measure: Eosinophil Count and Percentage, secondaryOutcomes measure: Basophil Count and Percentage, secondaryOutcomes measure: Platelet Count, secondaryOutcomes measure: Platelet Mean Volumen, secondaryOutcomes measure: Physical activity, sedentary lifestyle and sleep will be evaluate using accelerometry, secondaryOutcomes measure: Fried's frailty phenotype score, secondaryOutcomes measure: Frail-NH frailty scale, secondaryOutcomes measure: The Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Attendance rate, secondaryOutcomes measure: Dose modification, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Residencia Aspaldiko, status: RECRUITING, city: Portugalete, state: Bizkaia, zip: 48920, country: Spain, contacts name: Alvaro Mosquera, role: CONTACT, phone: 34-946250000, email: [email protected], geoPoint lat: 43.32099, lon: -3.02064, locations facility: Residencia Nuestra Señora de Begoña, status: NOT_YET_RECRUITING, city: Santurtzi, state: Bizkaia, zip: 48980, country: Spain, contacts name: Janire R Ochoa, role: CONTACT, phone: 944836875, email: [email protected], geoPoint lat: 43.32842, lon: -3.03248, locations facility: Residencia Albiz Santiago LLanos, status: NOT_YET_RECRUITING, city: Sestao, state: Bizkaia, zip: 48910, country: Spain, contacts name: Olatz Larrinaga, role: CONTACT, phone: 946572220, email: [email protected], geoPoint lat: 43.30975, lon: -3.00716, locations facility: Fundación Miranda, status: NOT_YET_RECRUITING, city: Barakaldo, state: Vizcaya, zip: 48902, country: Spain, contacts name: Celia Gómez, role: CONTACT, phone: 944382675, email: innovación@fundaciónmiranda.org, geoPoint lat: 43.29639, lon: -2.98813, hasResults: False
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protocolSection identificationModule nctId: NCT06352736, orgStudyIdInfo id: LUTS2023, briefTitle: Status of Disease Burden of Lower Urinary Tract Symptoms in Chinese Male Community, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: This study, set up as a cross-sectional survey, seeks to delve into the disease burden and the demographic specifics of lower urinary tract symptoms (LUTS) among the male community in China. The investigators's main aim is to map out the overall and age-specific prevalence rates of LUTS within the Chinese male population. These insights are critical for understanding the public health dimensions of this condition. Moreover, the investigators plan to investigate several secondary aspects: the correlation of LUTS prevalence with factors like urbanization levels (rural vs. urban), geographical distribution, and lifestyle choices. Another significant focus will involve examining the treatment landscape for LUTS, looking at the portion of sufferers receiving treatment, the diversity in treatment durations, and the types of treatments employed (medication vs. surgery). This comprehensive analysis is intended to shed light on the prevailing management strategies for LUTS in China. The study is scheduled to unfold over 36 months and will comprise three pivotal phases: initial preparations, recruitment of subjects and collection of data, followed by the analysis of data and compilation of reports. The investigators will employ a range of methods such as questionnaires, physical exams, laboratory tests, imaging, and other medical evaluations to amass extensive data. This will allow the investigators to evaluate the prevalence of LUTS across various age groups among men and address the current gaps in epidemiological understanding., conditionsModule conditions: Lower Urinary Tract Symptoms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 12567, type: ESTIMATED, outcomesModule primaryOutcomes measure: International Prostate Symptom Score(IPSS), primaryOutcomes measure: Overactive Bladder Syndrome Score(OABSS), primaryOutcomes measure: International Consultation on Incontinence Questionnaire - Short Form(ICIQ-SF), primaryOutcomes measure: Quality of Life Score（QOL）, secondaryOutcomes measure: Prostatic volume, secondaryOutcomes measure: Maximum urinary flow rate, secondaryOutcomes measure: Residual urine, secondaryOutcomes measure: free prostatic specific antigen(fPSA), secondaryOutcomes measure: total prostatic specific antigen(tPSA), secondaryOutcomes measure: fPSA/ tPSA, eligibilityModule sex: MALE, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA General Hospital, status: RECRUITING, city: Beijing, zip: 100853, country: China, contacts name: Qing Yuan, Doctor's degree, role: CONTACT, phone: 18910980422, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06352723, orgStudyIdInfo id: 2024P000856, briefTitle: Cenobamate in the Intensive Care Unit, acronym: CENOBITE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome., conditionsModule conditions: Epilepsy, conditions: Neurologic Disorder, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm pilot study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Cenobamate, outcomesModule primaryOutcomes measure: Target level, primaryOutcomes measure: Maintenance level, secondaryOutcomes measure: Seizure cessation, secondaryOutcomes measure: Seizure burden change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06352710, orgStudyIdInfo id: 2022-01510, briefTitle: Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-12, primaryCompletionDateStruct date: 2025-06-12, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Cantonal Hospital of St. Gallen, class: OTHER, descriptionModule briefSummary: Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.The increasing use of smartphones offers unprecedented opportunities for data collection. We developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity).By acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, we aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. We will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. We hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making., conditionsModule conditions: Disc Disease, conditions: Instabilities Lumbar, conditions: Brain Tumor, conditions: Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: OP-Tracker App, outcomesModule primaryOutcomes measure: Subjective Well-Being (SWI), secondaryOutcomes measure: EQ-5D-5L, secondaryOutcomes measure: Rate of adverse events, secondaryOutcomes measure: Severity of adverse events, secondaryOutcomes measure: Correlation between TDN/CDG and SWI/QoL, secondaryOutcomes measure: Correlation between baseline factors and TDN grade, secondaryOutcomes measure: Difference between rate of adverse events and TDN distribution between different surgery groups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kantonsspital St.Gallen, status: RECRUITING, city: St.Gallen, zip: 9007, country: Switzerland, contacts name: Linda Bättig, MD, role: CONTACT, phone: +41 71 494 11 99, email: [email protected], geoPoint lat: 47.42391, lon: 9.37477, hasResults: False
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protocolSection identificationModule nctId: NCT06352697, orgStudyIdInfo id: DELI_MASLD, briefTitle: Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study), statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Bogomolets National Medical University, class: OTHER, collaborators name: Taras Shevchenko National University of Kyiv, collaborators name: Danylo Halytsky Lviv National Medical University, collaborators name: Kyiv City Clinical Endocrinology Center, collaborators name: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, collaborators name: MirImmunoFarm, collaborators name: Stellar Biotics, descriptionModule briefSummary: The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD patients.The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month., conditionsModule conditions: Metabolic Dysfunction Associated Steatotic Liver Disease, conditions: Steatotic Liver Disease, conditions: Hepatic Steatosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Probiotic lysate (postbiotic and metabiotc), interventions name: Placebo, outcomesModule primaryOutcomes measure: changes in fatty liver index (FLI), primaryOutcomes measure: hepatic steatosis index (HSI), primaryOutcomes measure: TyG index, secondaryOutcomes measure: Concentration of AST, secondaryOutcomes measure: Concentration of ALT, secondaryOutcomes measure: Concentration of Gamma-glutamyl Transferase (GGT), secondaryOutcomes measure: Concentration of Total Cholesterol (TC), secondaryOutcomes measure: Concentration of Tryglicerides (TG), secondaryOutcomes measure: Concentration of LDL-Cholesterol (LDL-C), secondaryOutcomes measure: Concentration of VLDL-Cholesterol (VLDL-C), secondaryOutcomes measure: Concentration of HDL-Cholesterol (HDL-C), secondaryOutcomes measure: Concentration of high sensitivity CRP (hs-CRP), secondaryOutcomes measure: Concentration of IL-6, secondaryOutcomes measure: waist circumferences (WC), secondaryOutcomes measure: body mass index (BMI), secondaryOutcomes measure: visceral fat content, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bogomolets National Medical University, city: Kyiv, zip: 01601, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Kyiv City Clinical Endocrinology Center, city: Kyiv, zip: 01601, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Taras Shevchenko National University of Kyiv, city: Kyiv, zip: 01601, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, city: Kyiv, zip: 02000, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Danylo Halytsky Lviv National Medical University, city: Lviv, zip: 79010, country: Ukraine, geoPoint lat: 49.83826, lon: 24.02324, hasResults: False
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protocolSection identificationModule nctId: NCT06352684, orgStudyIdInfo id: DP0001-SEV-CAB-II, secondaryIdInfos id: RS-2023-00227526, type: OTHER_GRANT, domain: Korea Ministry of Science and ICT, briefTitle: Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-24, primaryCompletionDateStruct date: 2025-01-14, completionDateStruct date: 2025-01-14, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: BeamWorks Inc., class: INDUSTRY, collaborators name: Severance Hospital, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination, conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ACTUAL, armsInterventionsModule interventions name: CadAI-B for Breast, outcomesModule primaryOutcomes measure: Area Under the LROC Curve, secondaryOutcomes measure: Lesion detection sensitivity and specificity, eligibilityModule sex: FEMALE, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Severance Hospital, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06352671, orgStudyIdInfo id: 023-286, briefTitle: Prospective Long-Term Outcomes of a Standardized Ross Procedure, acronym: ROSS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Baylor Research Institute, class: OTHER, descriptionModule briefSummary: This standardized prospective long-term outcome analysis will help reaffirm these findings via a multicenter patient cohort and describe the best practices/techniques for stabilization of the autograft and right ventricular outflow tract reconstruction., conditionsModule conditions: Ross Procedure (Pulmonary Autograft Replacement), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, outcomesModule primaryOutcomes measure: Survival of the patient at 1-, 5- and 10-year intervals, secondaryOutcomes measure: Rate of re-hospitalization, secondaryOutcomes measure: Rate of peri operative morbidity, secondaryOutcomes measure: Rate of re-operation, secondaryOutcomes measure: Rate of re-intervention, secondaryOutcomes measure: NYHA status, secondaryOutcomes measure: Anticoagulant usage, secondaryOutcomes measure: Bleeding events, secondaryOutcomes measure: Post operative infection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Baylor Scott and White Heart Hospital, status: RECRUITING, city: Plano, state: Texas, zip: 75093, country: United States, contacts name: Rincy Rajan, role: CONTACT, phone: 469-814-4981, email: [email protected], contacts name: Sarah Hale, role: CONTACT, phone: 4698144845, email: [email protected], contacts name: William Brinkman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.01984, lon: -96.69889, hasResults: False
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protocolSection identificationModule nctId: NCT06352658, orgStudyIdInfo id: #1/2024, briefTitle: Efficacy of Mandibular Advancement Device for Mild-Moderate Apnea, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-10, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Nourhan M.Aly, class: OTHER, descriptionModule briefSummary: This was a prospective randomized controlled clinical trial that aimed to compare the efficacy of conventional and CAD CAM mandibular advancement device., conditionsModule conditions: Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: Conventional mandibular advancement device, interventions name: CAD CAM mandibular advancement device, outcomesModule primaryOutcomes measure: Apnea hypopnea index, primaryOutcomes measure: Epwoth sleeplness scale (ESS), primaryOutcomes measure: Oxygen saturation, primaryOutcomes measure: Snoring index, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Alexandria University, Egypt, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06352645, orgStudyIdInfo id: STUDY00004879, briefTitle: Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: Guangdong Bixdo Health Technology Co., Ltd., descriptionModule briefSummary: The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal., conditionsModule conditions: Plaque Induced Gingivitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: Bixdo Ultra Compact Water Flosser, interventions name: Manual toothbrush, outcomesModule primaryOutcomes measure: Inflammation Reduction, primaryOutcomes measure: Bacterial plaque removal, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tufts University School of Dental Medicine, city: Boston, state: Massachusetts, zip: 02111, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06352632, orgStudyIdInfo id: ACT-GLOBAL_Master, briefTitle: A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke, acronym: ACT-GLOBAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The George Institute, class: OTHER, collaborators name: University of Calgary, collaborators name: Berry Consultants, descriptionModule briefSummary: Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment/s associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Adaptive Platform Trial evaluating multiple interventions in multiple domains, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Standard-dose intravenous tenecteplase, interventions name: Low-dose intravenous tenecteplase, interventions name: No intravenous tenecteplase, interventions name: Conservative Blood Pressure Control, interventions name: Moderate Blood Pressure Control, interventions name: Intensive Blood Pressure Control, interventions name: Placebo, interventions name: NoNO-42, outcomesModule primaryOutcomes measure: modified Rankin scale (mRS) scores, secondaryOutcomes measure: Excellent functional neurological outcome, secondaryOutcomes measure: Independent functional neurological outcome, secondaryOutcomes measure: Health Related Quality of Life, otherOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352619, orgStudyIdInfo id: ACT-GLOBAL_AIS_03, briefTitle: Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial, acronym: ENCHANTED3/MT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: The George Institute, class: OTHER, collaborators name: University of Calgary, collaborators name: Changhai Hospital, descriptionModule briefSummary: Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure (BP) lowering in post-EVT acute ischaemic stroke (AIS) patients. Although two trials indicate harm from very intensive target-based treatment (SBP \<130 mmHg), the others neutral effects in the SBP range 140-160 mmHg. The ENCHANTED3/MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy. ENCHANTED3/MT will randomize (1:1:1) up to 2,000 patients with SBP ≥150 mmHg post-EVT to conservative (no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP \[≥180mmHg\]), moderate (SBP reduction by 10-20mmHg or a target of 160 ± 5, whichever is higher; no control if low-high baseline SBP \[150-160mmHg\]), or intensive (SBP reduction by 30-50mmHg or a target of 140±5 mmHg, whichever is higher) BP management., conditionsModule conditions: Ischemic Stroke, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Conservative SBP Control, interventions name: Moderate SBP Control, interventions name: Intensive SBP Control, outcomesModule primaryOutcomes measure: modified Rankin scale, secondaryOutcomes measure: Excellent functional neurological outcome, secondaryOutcomes measure: Independent functional neurological outcome, secondaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Ordinal shift of 7 levels of modified Rankin scale, secondaryOutcomes measure: National Institute of Health Stroke Scale (NIHSS) score, secondaryOutcomes measure: Any intracranial haemorrhage (ICH), secondaryOutcomes measure: Symptomatic intracerebral haemorrhage (sICH), secondaryOutcomes measure: Serious Adverse Event (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352606, orgStudyIdInfo id: 36264PR558/2/24, briefTitle: Spinal and General Anesthesia in Neonates Undergoing Herniorrhaphy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare spinal and general anesthesia in neonates undergoing herniorrhaphy., conditionsModule conditions: Spinal Anesthesia, conditions: General Anesthesia, conditions: Neonates, conditions: Inguinal Herniorrhaphy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Spinal anesthesia, interventions name: General anesthesia, outcomesModule primaryOutcomes measure: Heart rate, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial blood pressure, secondaryOutcomes measure: Incidence of bradycardia, secondaryOutcomes measure: Incidence of hypotension, secondaryOutcomes measure: Incidence of postoperative apnea, secondaryOutcomes measure: The duration of surgery, secondaryOutcomes measure: Need for postoperative O2 supplementation, secondaryOutcomes measure: Hospital stays, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule locations facility: Tanta University Hospitals, status: RECRUITING, city: Tanta, state: ElGharbia, zip: 31527, country: Egypt, contacts name: Mohammed S Elsharkawy, MD, role: CONTACT, phone: 00201148207870, email: [email protected], contacts name: Ahmed E Abo ElKheir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06352593, orgStudyIdInfo id: 36264PR557/2/24, briefTitle: Intraoperative Dexmedetomidine Infusion in Endovascular Intervention for Aneurysmal Subarachnoid Hemorrhage, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-06, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the role of intraoperative dexmedetomidine infusion in endovascular intervention for aneurysmal subarachnoid hemorrhage., conditionsModule conditions: Dexmedetomidine, conditions: Infusion, conditions: Endovascular, conditions: Aneurysmal Subarachnoid Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative Dexmedetomidine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of vasospasm, secondaryOutcomes measure: Incidence of morbidity and mortality (M/M), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University Hospitals, status: RECRUITING, city: Tanta, state: ElGharbia, zip: 31527, country: Egypt, contacts name: Mohammed S Elsharkawy, MD, role: CONTACT, phone: 00201148207870, email: [email protected], contacts name: Ahmed E Abo ElKheir, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06352580, orgStudyIdInfo id: COVID-19 Pediatric, briefTitle: Covid-19 Pandemic and Pediatric Dentistry, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Abant Izzet Baysal University, class: OTHER, descriptionModule briefSummary: Coronavirus (SARS-CoV-2), which emerged in Wuhan, China in 2019 and causes severe respiratory infection, poses a potential risk for dentists and patients during dental treatments. It is a common situation during the pandemic period for parents of children needing dental treatment to want to postpone their children's treatment due to Covid-19. This study aimed to evaluate parents' concerns about their children's dentist appointments and ongoing dental treatments in the presence of the quarantine imposed due to Covid-19 and the Covid-19 vaccines that have started to be administered worldwide. In the study, an informative survey consisting of 26 questions was applied to determine how parents feel about the COVID-19 pandemic, how concerned they are about their children's oral health and dental treatment plan, and the changes caused by COVID-19 vaccination practices. The questions were created by 3 different experienced dentists and analysed by 2 different experienced dentists. Questions 7 and 26 were repeated at the beginning and end of the survey to give the same question and answer meaning. Thus, the reliability of the survey was tested., conditionsModule conditions: COVID-19 Pandemic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 438, type: ACTUAL, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Approach to dental treatments, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deniz Sıla Özdemir Çelik, city: Merkez, state: Bolu, zip: 14030, country: Turkey, hasResults: False
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protocolSection identificationModule nctId: NCT06352567, orgStudyIdInfo id: BakircayU1394/1414, briefTitle: Symptoms Associated With Chemotherapy-Induced Peripheral Neuropathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2024-06-22, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Izmir Bakircay University, class: OTHER, descriptionModule briefSummary: Breast cancer remains the most frequent type of cancer globally. Nevertheless, the increased rate of disease-free survival of breast cancer brought the specific need of managing of short and long-term side effects of multimodal treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating conditions which is characterized by a wide variety of experienceable symptoms by patients that need to be addressed in detail. Therefore, in this cross-sectional study, it was aimed to assess the potential symptoms associated with CIPN of patients with breast cancer who underwent systemic chemotherapy. In addition, it was aimed to assess the potential associations between experienced symptoms of CIPN and sociodemographic (age, body mass index etc.) and clinical features (mean exposed dose, type of surgery (if any) etc.)., conditionsModule conditions: Chemotherapy-induced Peripheral Neuropathy, conditions: Breast Cancer, conditions: Breast Cancer Female, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 112, type: ESTIMATED, armsInterventionsModule interventions name: European Organization for Research and Treatment of Cancer-Chemotherapy Induced Peripheral Neuropathy (EORTC-CIPN20) questionnaire, outcomesModule primaryOutcomes measure: Assessment of perceived Chemotherapy Induced Peripheral Neuropathy symptoms, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bakircay University Çiğli State and Training Hospital, Department of Medical Oncology, status: RECRUITING, city: İzmir, state: Çiğli, zip: 35620, country: Turkey, contacts name: Murat Akyol, MD, role: CONTACT, phone: +902324930000, email: [email protected], contacts name: Alper Tuğral, PT, MSc, role: CONTACT, phone: +905074421420, email: [email protected], geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06352554, orgStudyIdInfo id: 2023/ETH02474:STING, secondaryIdInfos id: 224842/Z/21/Z, type: OTHER_GRANT, domain: Wellcome Trust, secondaryIdInfos id: 75A50122C00028, type: OTHER_GRANT, domain: HHS/BARDA OTA, briefTitle: Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections, acronym: STING, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: SpeeDx Pty Ltd, class: INDUSTRY, collaborators name: Biomedical Advanced Research and Development Authority, collaborators name: Wellcome Trust, collaborators name: German Federal Ministry of Education and Research, collaborators name: Australian Research Council Research Hub to Combat Antimicrobial Resistance, descriptionModule briefSummary: This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens., conditionsModule conditions: Diagnosis, conditions: Gonorrhea, conditions: Resistance Bacterial, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics., secondaryOutcomes measure: To study the performance of the InSignia assay in determining antibiotic susceptibility of NG against commonly used & clinically relevant agents in clinical samples with comparison to gold standard methods., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352541, orgStudyIdInfo id: SOPH232-1122/I, briefTitle: Study Evaluating PRO-232 an Ophthalmic Solution Compared to Placebo., acronym: PRO-232, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase I study evaluating safety and tolerability through the incidence of unexpected adverse events and IOP measurement, as well as through the incidence of stinging after its administration, compared to placebo., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase I, controlled, comparative, parallel groups, double blind, one center., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double blind., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: PRO-232, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence Unexpected Related Adverse Reactions, primaryOutcomes measure: Changes in intraocular pressure (IOP), primaryOutcomes measure: Incidence of Stinging, secondaryOutcomes measure: Incidence of Expected Related Adverse Events, secondaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA), secondaryOutcomes measure: Changes in the integrity of the ocular surface (fluorescein staining), secondaryOutcomes measure: Incidence of ocular symptoms (foreign body sensation and tearing), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352528, orgStudyIdInfo id: CA127-1070, briefTitle: A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-07-24, completionDateStruct date: 2025-07-24, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function., conditionsModule conditions: Hepatic Impairment, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Repotrectinib, outcomesModule primaryOutcomes measure: Maximum observed plasma concentration (Cmax), primaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), primaryOutcomes measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)), primaryOutcomes measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)), secondaryOutcomes measure: Number of participants with Adverse Events (AEs), secondaryOutcomes measure: Number of participants with Severe Adverse Events (SAEs), secondaryOutcomes measure: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Number of participants with clinical safety laboratory test abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Local Institution - 0003, city: Miami Lakes, state: Florida, zip: 33014, country: United States, contacts name: Site 0003, role: CONTACT, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Local Institution - 0001, city: Orlando, state: Florida, zip: 32809, country: United States, contacts name: Site 0001, role: CONTACT, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Local Institution - 0002, city: San Antonio, state: Texas, zip: 78215, country: United States, contacts name: Site 0002, role: CONTACT, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06352515, orgStudyIdInfo id: T cells in Ulcerative colitis, briefTitle: T Lymphocyte Subsets in Ulcerative Colitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. Study the distribution of peripheral blood T lymphocyte subsets among ulcerative colitis patients.2. Correlation of T-cell subsets to therapeutic response/ disease activity.3. Assess the value of circulating IgG anti-Integrin αvβ6 in UC., conditionsModule conditions: Ulcerative Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Flow cytometry, outcomesModule primaryOutcomes measure: Study the distribution of T-cell subsets among ulcerative colitis patients., primaryOutcomes measure: Correlation of T-cell subtypes to therapeutic response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352502, orgStudyIdInfo id: 202112-28, briefTitle: An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-28, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Tang-Du Hospital, class: OTHER, descriptionModule briefSummary: EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis., conditionsModule conditions: EGF-R Positive Non-Small Cell Lung Cancer, conditions: CNS Metastases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Furmonertinib, outcomesModule primaryOutcomes measure: Intracranial Objective response rate, primaryOutcomes measure: Intracranial Disease Control Rate, primaryOutcomes measure: Intracranial progression-free survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Safety/Adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tangdu Hopspital, status: RECRUITING, city: Xi'an, state: Shanxi, zip: 710038, country: China, contacts name: Haichuan Su, PhD, role: CONTACT, phone: 18629190366, email: [email protected], contacts name: Jie Min, PhD, role: CONTACT, phone: 13709202616, email: [email protected], contacts name: Haichuan Su, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jie Min, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
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protocolSection identificationModule nctId: NCT06352489, orgStudyIdInfo id: Posterior component separation, briefTitle: Evaluation of Posterior Component Separation Technique in the Management of Complex Ventral Hernia., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: * Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall.* Detect most common post operative complications related to AWR techniques in a 6 months duration after operation., conditionsModule conditions: Ventral Hernia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Posterior component separation technique., outcomesModule primaryOutcomes measure: Hernia recurrence, secondaryOutcomes measure: post operative short term complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352476, orgStudyIdInfo id: 10881-669, briefTitle: The Effect of Sleep Hygiene Given to Epilepsy Patients on Seizure Frequency and Sleep Quality, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Epilepsy is a disease that can be seen in everyone, including neurological, chronic, elderly and children. An estimated 50 million people in the world have epilepsy, patients have a history of two or more seizures, the exact cause is unknown, it negatively affects home, work and school life, and it directs individuals from their independent roles to semi-dependent and fully dependent roles (Smith \& Wagner \& Jonathan, 2015). "Neuronal networks hypersynchronization" develops epileptic seizures, can cause insomnia, and sleep quality may decrease with drug treatment (Sünter and Ağan, 2019). NREM sleep causes seizures through the "ictal and interactive effect" of sleep (Alp and Altındağ, 2014). Insomnia increases seizure discharges, neurological and systemic complications may develop, and serious morbidity and mortality may occur (Özer, 2005). Epilepsy patients frequently experience daytime sleepiness and nighttime insomnia (Gümüşyayla and Vural, 2017). Complementary medical approaches are also recommended along with drug treatment. Sleep hygiene training is recommended for sleep health in epilepsy as in chronic diseases. With good sleep health, symptoms can be eliminated and sequelae can be prevented by reducing epileptic discharges (Gammino at all., 2016). Quality sleep is essential for physiological and psychological health, and sleep disorders can be corrected with sleep hygiene training (Günaş, 2018). Randomized studies including sleep hygiene training are needed to prevent seizure recurrences, prevent or treat comorbid psychological diseases, and improve life activities of epilepsy patients (Lee at all., 2015). One-third of people's lives are spent in sleep, regular and adequate sleep protects physiological and psychological health, sleep hygiene training contributes to the recovery of sleep disorders and accompanying psychological comorbid diseases, sleep hygiene training is cost-free and easy to implement, where daily activities and behaviors are regulated, appropriate environmental conditions are provided. By regulating the circadian rhythm, melatonin is released during sleep at night and sleep disorders are prevented by preventing excessive cortisol release (http://www.psikiyatri.net/uyku-hijyeni / Access date: 28 May 2022; Alp and Altındağ, 2014; Güneş, 2018). . No research has been found on sleep hygiene training to relieve sleep deprivation, which is common in epilepsy patients. With good sleep hygiene, sleep and quality of life can be improved and epileptic seizures can be prevented or reduced.Purpose of the research; To determine the effect of sleep hygiene training given to epilepsy patients on seizure frequency and sleep quality. Non-drug clinical research is an experimentally planned research with a pre-test post-test control group trial model., conditionsModule conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research is an experimental study with a pre-test and post-test control group trial model., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The participant will not know whether he or she is in the experimental or control group., whoMasked: PARTICIPANT, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Sleep Hygiene Training, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, otherOutcomes measure: epileptic seizure diary, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06352463, orgStudyIdInfo id: 406.XS.03.068, briefTitle: Intervention Social Anxiety: Combining Parent-child Treatment, acronym: ISA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Leiden University, class: OTHER, collaborators name: Leids Universitair Behandel en Expertise Centrum (LUBEC), collaborators name: GGZ Delfland, collaborators name: Netherlands Organisation for Scientific Research, descriptionModule briefSummary: The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously., conditionsModule conditions: Social Anxiety Disorder of Childhood, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Denken + Doen = Durven, interventions name: Supportive Parenting for Anxious Childhood Emotions, outcomesModule primaryOutcomes measure: Change in severity of social anxiety in children, secondaryOutcomes measure: Change in anxiety-related symptoms and family accommodation, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: GGZ Delfland, status: NOT_YET_RECRUITING, city: Delft, state: South-Holland, zip: 2600GA, country: Netherlands, contacts name: Anika Bexkens, role: CONTACT, email: [email protected], geoPoint lat: 52.00667, lon: 4.35556, locations facility: Leiden University, status: RECRUITING, city: Leiden, state: South-Holland, zip: 2333AK, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, locations facility: LUBEC, status: RECRUITING, city: Leiden, state: South-Holland, zip: 2333ZB, country: Netherlands, contacts name: Anika Bexkens, role: CONTACT, email: [email protected], geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
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protocolSection identificationModule nctId: NCT06352450, orgStudyIdInfo id: DPT/Batch-Fall19/558, briefTitle: Comparison of Active Isolated Stretching Versus Myofascial Release of Knee Joint in Office Workers, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Superior University, class: OTHER, descriptionModule briefSummary: "Office workers often spend long hours sitting, which can lead to stiffness and reduced mobility. By studying these two techniques AIS and MFR, we can determine which one is more effective in helping office workers to improve their flexibility and range of motion in the knee joint because their sedentary work environment often leads to musculoskeletal issues, including limited knee joint mobility.AIS involves stretching specific muscles while actively engaging opposing muscles to enhance the effectiveness of the stretch. It aims to increase the extensibility of muscles and improve joint mobility. On the other hand, MFR focuses on releasing tension and adhesions in the fascia, the connective tissue surrounding muscles and joints, to restore mobility and reduce pain.Understanding the benefits and effectiveness of these techniques will contribute to evidence-based practices in occupational health and help office workers maintain optimal joint health", conditionsModule conditions: Stiffness; Spine, conditions: Mobility Limitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Active isolated stretching (AIS), interventions name: Myofascial release (MFR), outcomesModule primaryOutcomes measure: Numaric Pain Scale, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Zahra Medical complex Johar town, Laser spine center Model town, Laser spine center Johar town., city: Lahore, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06352437, orgStudyIdInfo id: 1507-0001, secondaryIdInfos id: 2023-508767-79-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1302-5933, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), briefTitle: A Study to Test How Well Different Doses of BI 3034701 Are Tolerated by Healthy Men and People With Overweight or Obesity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-07-14, completionDateStruct date: 2025-07-14, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to healthy people and people with overweight or obesity. It has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy.The purpose of this study is to find out how well different doses of BI 3034701 are tolerated by healthy men (Part A) and people with overweight or obesity (Part B). Another goal of this study is to find out how different doses of BI 3034701 are taken up in the blood.Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo. In this study, BI 3034701 is given to humans for the first time.Participants in Part A are in the study up to 10 weeks. During this time, they visit the study site 8 times. Participants in Part B are in the study for about 6 months. They visit the study regularly. At some of the visits, participants in both parts stay at the study site for up to 5 nights. During the study, the doctors collect information on any health problems of the participants., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: BI 3034701, interventions name: Placebo matching BI 3034701, outcomesModule primaryOutcomes measure: Part A and Part B: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator, secondaryOutcomes measure: Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) following a single dose of BI 3034701, secondaryOutcomes measure: Part A: Maximum measured concentration of the analyte in plasma (Cmax) following a single dose of BI 3034701, secondaryOutcomes measure: Part B: Area under the concentration-time curve in plasma over the time interval from 0 to 168 hours (AUC0-168) following multiple doses of BI 3034701, secondaryOutcomes measure: Part B: Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352424, orgStudyIdInfo id: 1458-0006, secondaryIdInfos id: 2023-506233-30-01, type: REGISTRY, domain: CTIS (EU), secondaryIdInfos id: U1111-1293-4672, type: REGISTRY, domain: WHO Registry, briefTitle: A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-09, completionDateStruct date: 2024-12-09, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The main objective of this trial is to investigate the effect of BI 1820237 alone, BI 456906 alone, combination of BI 1820237 and BI 456906 versus placebo on brain activity., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: BI 456906, interventions name: BI 1820237, interventions name: Placebo for BI 1820237, interventions name: Placebo for BI 456906, outcomesModule primaryOutcomes measure: Blood Oxygen Level Dependent (BOLD) signal changes following treatment with single dose of BI 1820237 alone, BI 456906 alone, and combination of BI 1820237 + BI 456906 versus placebo, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352411, orgStudyIdInfo id: 1404-0009, secondaryIdInfos id: 2023-508557-13-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1298-3135, type: REGISTRY, domain: WHO registry, briefTitle: A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-08, primaryCompletionDateStruct date: 2024-11-26, completionDateStruct date: 2024-11-26, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood.Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons.Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects., conditionsModule conditions: Healthy, conditions: Renal Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: BI 456906, outcomesModule primaryOutcomes measure: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), primaryOutcomes measure: Maximum measured concentration of BI 456906 in plasma (Cmax), secondaryOutcomes measure: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), secondaryOutcomes measure: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352398, orgStudyIdInfo id: BBTuysuz, briefTitle: Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Burcu Bozdogan Tuysuz, class: OTHER, descriptionModule briefSummary: The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded., conditionsModule conditions: Video-Assisted Thoracoscopic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: erector spina plan block, interventions name: Serratus posterior superior intercostal plan block (SPSIPB), interventions name: 0.25% bupivacaine, outcomesModule primaryOutcomes measure: morphine consumption first 24 hours, secondaryOutcomes measure: NRS pain score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medenıyet Unıversıty, city: Istanbul, state: Kadıkoy, zip: 34734, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06352385, orgStudyIdInfo id: SH9H-2024-TK16-1.0, briefTitle: Epidemiological Investigation of Malocclusion in China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection., conditionsModule conditions: Epidemiological Investigation, conditions: Malocclusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 19847, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The Prevalence rate of malocclusion, secondaryOutcomes measure: Dental Aesthetic Index of each age group, secondaryOutcomes measure: Index of Orthodontic Treatment Need of each age group, otherOutcomes measure: dietary habit, otherOutcomes measure: oral hygiene habits, otherOutcomes measure: Bad oral habit, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06352372, orgStudyIdInfo id: tPBM Study, briefTitle: Safety and Efficacy of tPBM for Epileptiform Activity in Autism, acronym: tPBM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Richard Frye, class: OTHER, descriptionModule briefSummary: For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions., conditionsModule conditions: Autism Spectrum Disorder, conditions: EEG With Periodic Abnormalities, conditions: Epilepsy, conditions: Neurodevelopmental Disorders, conditions: Neurological Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a prospective, open label study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after treatment with, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM), outcomesModule primaryOutcomes measure: Childhood Autism Rating Scores (CARS), secondaryOutcomes measure: EEG Delta Power, otherOutcomes measure: Seizure frequency and severity, otherOutcomes measure: Social Responsiveness Scale (SRS), otherOutcomes measure: Clinical Global Impression Scale (CGI), otherOutcomes measure: NIH Toolbox, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Rossignol Medical Center, city: Phoenix, state: Arizona, zip: 85050, country: United States, contacts name: Richard E Frye, M.D., PhD, role: CONTACT, phone: 321-259-7111, email: [email protected], contacts name: Richard E Frye, M.D., PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False
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