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protocolSection identificationModule nctId: NCT06310746, orgStudyIdInfo id: HLX6018-FIH101, briefTitle: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Shanghai Henlius Biotech, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product., conditionsModule conditions: IPF, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: GARP/TGF-β1 monoclonal antibody, interventions name: Placebo, outcomesModule primaryOutcomes measure: The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: CL, secondaryOutcomes measure: λz, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06310733, orgStudyIdInfo id: REC 66-517-1-1, briefTitle: The Effects of Probiotics, Lactobacillus GG, in the Treatment of Abdominal Pain in Children With Functional Abdominal Pain Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-02-20, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Prince of Songkla University, class: OTHER, descriptionModule briefSummary: Recurrent or chronic abdominal pain is one of the common gastrointestinal problems in children. While most children do not have organic origins (so called functional abdominal pain disorders; FAPDs), the symptoms can nevertheless be severe enough to impair the patient's quality of life, growth, and development. To help rule out organic disorders and diagnose this condition, some individuals underwent multiple invasive and costly studies.Generally, the diagnosis of FAPDs is based on clinical symptoms and criteria, it can be divided into irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP) and functional dyspepsia (FD). Approximately 14% of children globally, between the ages of 4 and 18, experience functional abdominal pain issues8. In Thailand, the prevalence of FAPDs among adolescents (mean age of 16 years) was 5.3%, functional dyspepsia and irritable bowel syndrome were found to be the most prevalent subtypes.The pathogenesis of FAPDs is believed to result from disruptions in the microbiota-gut-brain axis, which may happen early in life or throughout. Hence, several studies, specifically in western countries, reported the role of probiotics, specifically Lactobacillus rhamnosus GG (LGG), in modulating abdominal symptoms in children with FAPDs.It is widely known that the diversity of gut microbiota depends on multiple factors including ethnicity, mode of delivery, dietary and environmental factors. However, the studies on the use of probiotics in pediatric patients with FAPDs have been mainly conducted in western countries. Since there are limited studies on the effectiveness of probiotics in Asian children with FAPDs, the investigators aim to evaluate the effects of probiotics, LGG, in the treatment of children who suffered from FAPDs.The secondary objectives are to measure daily pain score in children with and without FAPDs, to evaluate and compare the diversity of fecal microbiota in children with FAPDs and those without FAPDs, and to compare the diversity of fecal microbiota between children with FAPDs who took probiotics and those who did not., conditionsModule conditions: Functional Abdominal Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: LGG, interventions name: Placebo, outcomesModule primaryOutcomes measure: The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs, primaryOutcomes measure: The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs, primaryOutcomes measure: The response rate of 4 week-probiotics (LGG) on the severity of abdominal pain (number of episodes or the intensity of pain), compared to the conventional treatment, in children who suffered from FAPDs, secondaryOutcomes measure: To measure daily pain score in children with and without FAPDs, secondaryOutcomes measure: To measure daily pain score in children with and without FAPDs, secondaryOutcomes measure: To measure daily pain score in children with and without FAPDs, secondaryOutcomes measure: To compare the diversity of fecal microbiota in children with FAPDs who took probiotics and those who did not, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Atchariya Chanpong, status: RECRUITING, city: Songkhla, country: Thailand, contacts name: Atchariya Chanpong, M.D, Ph.D., role: CONTACT, phone: +6674451250, email: atchariya.c@psu.ac.th, geoPoint lat: 7.19882, lon: 100.5951, hasResults: False
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protocolSection identificationModule nctId: NCT06310720, orgStudyIdInfo id: 23-10026618, briefTitle: Postpartum Video Education in High Risk Populations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs., conditionsModule conditions: Postpartum Hemorrhage, conditions: Postpartum Depression, conditions: Postpartum Sepsis, conditions: Postpartum Preeclampsia, conditions: Patient Empowerment, conditions: Patient Education, conditions: Postpartum Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Video Education, outcomesModule primaryOutcomes measure: Change in baseline and post-education questionnaire score, secondaryOutcomes measure: Change in post-education and post-discharge questionnaire score, secondaryOutcomes measure: Number of participants who attended 6 week postpartum visit, secondaryOutcomes measure: Healthcare utilization: Number of clinic visits, secondaryOutcomes measure: Healthcare utilization: Number of phone calls, secondaryOutcomes measure: Healthcare utilization: Number of urgent care/emergency room visits, secondaryOutcomes measure: Mean difference in patient satisfaction rating, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alexandra Cohen Hospital for Women and Newborns, city: New York, state: New York, zip: 10065, country: United States, contacts name: Heather Lipkind, MD, MSce, role: CONTACT, phone: 212-746-3045, email: hlipkind@weill.cornell.edu, contacts name: Heather Lipkind, MD, MSce, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06310707, orgStudyIdInfo id: EU RCT: ePatch vs 24h Holter, secondaryIdInfos id: 2022-A02338-35, type: OTHER, domain: ANSM, French competent authority, secondaryIdInfos id: EA4/071/23, type: OTHER, domain: German Ethics Committee_Charité Universitätsmedizin Berlin, briefTitle: Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-09, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Philips Clinical & Medical Affairs Global, class: INDUSTRY, descriptionModule briefSummary: This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring., conditionsModule conditions: Arrythmia, conditions: Syncope, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center, prospective, randomized, unblinded, two-arm study, to include approximately 128 subjects treated with the ePatch Extended Wear Holter (worn for 7 days) and approximately 128 subjects treated with a Standard Wear Holter (worn for 24 hours). Randomization will be balanced for gender., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: ePatch ® Extended Wear Holter (EWH), outcomesModule primaryOutcomes measure: Diagnostic yield (frequency) of clinically actionable arrythmia, secondaryOutcomes measure: Number of Atrial Fibrillation (AF) diagnoses > 30 seconds, secondaryOutcomes measure: Occurrence of symptomatic events, secondaryOutcomes measure: Number of Clinically actionable arrhythmia, secondaryOutcomes measure: Patient Quality of Life as measured by EQ-5D-5L, secondaryOutcomes measure: Patient Quality of Life as measured by Patient Experience Survey, secondaryOutcomes measure: Cost related to cardiac monitoring, secondaryOutcomes measure: Time Holter is worn/ removed, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel, status: RECRUITING, city: Bron, zip: 69677 Cedex, country: France, contacts name: Philippe Chevalier, MD PhD, role: CONTACT, phone: +33.472.357.027, email: philippe.chevalier@chu-lyon.fr, contacts name: Philippe Chevalier, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin, status: NOT_YET_RECRUITING, city: Berlin, zip: D-12203, country: Germany, contacts name: Tharusan Thevathasan, MD, role: CONTACT, phone: +49 1577 4407864, email: tharusan.thevathasan@dhzc-charite.de, contacts name: Tharusan Thevathasan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.52437, lon: 13.41053, hasResults: False
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protocolSection identificationModule nctId: NCT06310694, orgStudyIdInfo id: EGE-HEM-SL-01, briefTitle: Additional Circular Dressing Material, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-27, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site., conditionsModule conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 91, type: ACTUAL, armsInterventionsModule interventions name: intervention group (Elastane circular dressing on sterile transparent dressing), outcomesModule primaryOutcomes measure: Skin Penetration Difficulty Rating Scale, primaryOutcomes measure: Visual Infusion Phlebitis Diagnostic Scale, primaryOutcomes measure: Infiltration Rating Scale, primaryOutcomes measure: Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Şeyma Turan, city: Turgutlu, state: Manisa, zip: 45400, country: Turkey, geoPoint lat: 38.49533, lon: 27.6997, hasResults: False
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protocolSection identificationModule nctId: NCT06310681, orgStudyIdInfo id: ETH2223-2528, briefTitle: Pilot Testing of a Co-adapted Group Programme for Parents/Carers of Children With Complex Neurodisability, acronym: ENCOMPASS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: City, University of London, class: OTHER, descriptionModule briefSummary: The goal of this pilot feasibility study is to test a co-adapted community-based group programme ("Encompass") with parents/carers of children with complex neurodisability under 5 years of age in East London in the UK.The main questions it aims to answer are:* Is it feasible and acceptable to carry out this newly co-adapted programme with two groups of parents/carers of children with complex neurodisability under the age of 5?* Is it feasible to carry out an evaluation of the above programme, which could then inform a protocol for larger scale evaluation?The main activities for the parent/carer participants will include:* Attending ten "Encompass" parent/carer groups* Filling in questionnaires at the start and end of the groups* Attending an interview with the researcher to discuss their experiencesThe groups will be facilitated by a healthcare professional and a parent with lived experience. They will also be interviewed about their experiences after the groups have been completed., conditionsModule conditions: Complex Neurodevelopmental Disorder, conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: "Encompass" group programme, outcomesModule primaryOutcomes measure: Group Attendance, primaryOutcomes measure: Recruitment - percentage of eligible participants who consent to take part, primaryOutcomes measure: Follow-up response rate-self-complete outcomes questionnaire(s), primaryOutcomes measure: Fidelity - delivery on items described in the Fidelity Checklist, secondaryOutcomes measure: Family Empowerment Scale (FES), secondaryOutcomes measure: Power Ladder Question (PLQ), secondaryOutcomes measure: Parent Patient Activation Measure (P-PAM), secondaryOutcomes measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), secondaryOutcomes measure: Parent/carer Quality of Life - EuroQoL-5D-5-level (EQ-5D-5L), secondaryOutcomes measure: Parent/carer Needs and Goals, secondaryOutcomes measure: Childhood Cost Calculator (C3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barts Health NHS Trust, Children's Occupational Therapy, Mile End Hospital, city: London, zip: E1 4EH, country: United Kingdom, contacts name: Frances Badenhorst, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: East London NHS Foundation Trust, Specialist Children's and Young People's Services, city: London, zip: E15 4PT, country: United Kingdom, contacts name: Melissa Homer, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06310668, orgStudyIdInfo id: CBT IN substance use disorder, briefTitle: Has CBT an Effect on Emotional Intelligence in Patients With Substance Use Disorder?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Egyptian Medical Syndicate, class: OTHER, descriptionModule briefSummary: Aim of the study: In this study, the change in emotional intelligence will be assessed before and after group CBT sessions in male patients with substance use disorder in the inpatient department of the addiction unit at Mansoura University Hospital., conditionsModule conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: group cognitive behavioral therapy sessions, outcomesModule primaryOutcomes measure: emotional intelligence, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310655, orgStudyIdInfo id: 202403078, briefTitle: Online Proton Adaptive Radiotherapy, acronym: PARTy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: This is a pilot study evaluating the feasibility of daily online adaptive planning for patients undergoing proton radiation therapy.Patients undergoing proton radiation therapy normally undergo extensive pre-planning for their treatment. However, accounting for uncertainties in treatment delivery remains a challenge for a variety of reasons, such as differences in patient anatomy from pre-planning to the day of treatment. Online adaptive planning is a process consisting of generating the original pre-plan on the patient on a treatment day, assessing the pre-plan's coverage and safety, and if changes are needed, the plan is changed in order to optimize the treatment while the patient is still on the treatment table. This study is assessing the feasibility and safety of this approach in order to gather data for a larger trial., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All patients will receive 5 fractions of proton radiotherapy for their cancer. At the time of each fraction, the initial pre-plan will be compared to the newly generated adapted plan, and the optimal treatment will be administered., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Proton SBRT, outcomesModule primaryOutcomes measure: Feasibility of online proton adaptive radiotherapy, secondaryOutcomes measure: Safety of online proton adaptive radiotherapy as measured by the amount of grade 2 and higher radiation-related toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Allen Mo, M.D., Ph.D., role: CONTACT, phone: 314-717-2320, email: amo@wustl.edu, contacts name: Allen Mo, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Hyun Kim, M.D., role: SUB_INVESTIGATOR, contacts name: Stephanie Perkins, M.D., role: SUB_INVESTIGATOR, contacts name: Joshua Schiff, M.D., role: SUB_INVESTIGATOR, contacts name: Weiren Liu, M.D., role: SUB_INVESTIGATOR, contacts name: Hailei Zhang, Ph.D., role: SUB_INVESTIGATOR, contacts name: Yi Huang, M.S., role: SUB_INVESTIGATOR, contacts name: Robbie Beckert, role: SUB_INVESTIGATOR, contacts name: Eric Laugeman, M.S., role: SUB_INVESTIGATOR, contacts name: Farideh Pak, Ph.D., role: SUB_INVESTIGATOR, contacts name: Mike Watts, M.S., role: SUB_INVESTIGATOR, contacts name: Xiandong Zhao, Ph.D., role: SUB_INVESTIGATOR, contacts name: Tianyu Zhao, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False
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protocolSection identificationModule nctId: NCT06310642, orgStudyIdInfo id: 2020-217, briefTitle: Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness, acronym: PAMS, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-20, primaryCompletionDateStruct date: 2023-03-13, completionDateStruct date: 2023-03-13, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: CHRISTUS Health, class: OTHER, descriptionModule briefSummary: A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score., conditionsModule conditions: AMS, conditions: Acute Mountain Sickness, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Enrolled a cohort of consenting, healthy subjects aged \>17 years. Thirty subjects enrolled in the study. 15 subjects received prochlorperazine. 15 subjects received placebo., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients were blinded in this study., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Immediate descent from altitude., interventions name: Diphenhydramine, interventions name: Prochlorperazine 10 mg, outcomesModule primaryOutcomes measure: Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups, secondaryOutcomes measure: Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency, city: Corpus Christi, state: Texas, zip: 78405, country: United States, geoPoint lat: 27.80058, lon: -97.39638, hasResults: False
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protocolSection identificationModule nctId: NCT06310629, orgStudyIdInfo id: CMUH112-REC3-163, briefTitle: Oxygenation Efficacy of "Intrinseque Health" Non-Rebreathing Mask ("IHNRM"), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2025-02-21, completionDateStruct date: 2025-05-21, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: China Medical University Hospital, class: OTHER, descriptionModule briefSummary: Based on early bench-testing data and subsequent clinical case studies in the U.S., "Intrinseque Health" non-rebreathing mask (IHNRM) has delivered virtual elimination of air entrainment and preferential delivery of all available oxygen first into the alveolar spaces by sequential opening of valves in its controller manifold, even at oxygen flow as low as 10 LPM, patient can attain high alveolar oxygen concentration of 75% or more-far higher than attainable with face mask or nasal cannula.Numerous intubated patients emerging from the operating room require intensive critical care specialist supervision in order to transition to the regular care. This would enable higher patient turnover and more efficient utilization of hospital resources, if patient can be transited to the regular care earlier by using a device that supports high oxygenation. This will enable a faster, safe and smooth extubation in critical care, and earlier discharge from intensive care ward.This study is anticipated to take only around 2.5 hour per patient to complete. Patients meeting the inclusion and exclusion criteria of this study are placed on IHNRM and monitored until steady state of SpO2 of 95% or higher on 7-10 LPM has been maintained for at least 2 hours, when they can be discharged from the post-anesthesia care unit (PACU) to the regular care ward.The study is the parallel design study. 60 patients will be randomly selected to use the IHNRM, and 30 subjects will be placed on HFNC. Blood oxygen concentration (SpO2), respiratory rate, end tidal CO2 concentration (EtCO2), and vital sign will be recorded in the study. The endpoint of the study is to compare the effect after using between "IHNRM" and HFNC., conditionsModule conditions: Respiratory Disease, conditions: Respiratory Distress Syndrome, conditions: Respiratory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: High Flow Nasal Cannula, interventions name: "Intrinseque Health" Non-Rebreathing Mask ("IHNRM"), outcomesModule primaryOutcomes measure: Time to reach SpO2 Criteria in Run-in, primaryOutcomes measure: The percentage of subjects to reach SpO2 Criteria in maintenance, eligibilityModule sex: ALL, minimumAge: 3 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Internal Medicine, China Medical Univdersity Hospital, status: RECRUITING, city: Taichung, country: Taiwan, contacts name: Chih-Chihng Yen, MD, PhD, role: CONTACT, phone: 886-4-22052121, phoneExt: 3483, email: d5210@mail.cmuh.org.tw, contacts name: Chih-Ching Yen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
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protocolSection identificationModule nctId: NCT06310616, orgStudyIdInfo id: 219888, briefTitle: A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-05-28, completionDateStruct date: 2024-05-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: ViiV Healthcare, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: VH4524184, interventions name: Loestrin, outcomesModule primaryOutcomes measure: Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184, primaryOutcomes measure: AUC0-Tau, ss of EE and NEA with coadministration with VH4524184, primaryOutcomes measure: Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184, primaryOutcomes measure: Cmax for EE and NEA with coadministration with VH4524184, secondaryOutcomes measure: Number of participants with adverse events (AEs) and severity of AEs, secondaryOutcomes measure: Number of participants with AEs leading to discontinuation of study intervention, secondaryOutcomes measure: Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter), secondaryOutcomes measure: Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]), secondaryOutcomes measure: Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio), secondaryOutcomes measure: Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR, secondaryOutcomes measure: Maximum plasma concentration at steady state (Cmax,ss) for VH4524184, secondaryOutcomes measure: Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184, secondaryOutcomes measure: Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184, secondaryOutcomes measure: Trough concentration prior to the next dose (Ctrough) for VH4524184, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: GSK Investigational Site, status: RECRUITING, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Chinonye Chika Ogbonnaya-Odor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06310603, orgStudyIdInfo id: IRB-23-42, briefTitle: Determinants and Outcomes of High vs. Low Ultra-processed Feeding, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2025-08-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Oklahoma State University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are:• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health., conditionsModule conditions: Healthy Nutrition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Low-Processed Food Diet, outcomesModule primaryOutcomes measure: Body Weight, primaryOutcomes measure: Body Composition, primaryOutcomes measure: Fat Mass Percentage, primaryOutcomes measure: Fat-Free Mass Percentage, secondaryOutcomes measure: Triglyceride Levels, secondaryOutcomes measure: Glucose Levels, secondaryOutcomes measure: Cholesterol Levels, secondaryOutcomes measure: HDL, secondaryOutcomes measure: LDL, secondaryOutcomes measure: Alanine transaminase (ALT), secondaryOutcomes measure: Aspartate transaminase (AST), otherOutcomes measure: Energy Intake, otherOutcomes measure: Energy Expenditure, otherOutcomes measure: Gut Microbiome Collection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Laboratory for Applied Nutrition and Exercise Science (LANES), status: RECRUITING, city: Stillwater, state: Oklahoma, zip: 74075, country: United States, contacts name: Sam Emerson, PhD, role: CONTACT, email: sam.emerson@okstate.edu, contacts name: Tyler Godsey, B.S., role: CONTACT, phone: 405-744-7708, email: tylgods@okstate.edu, contacts name: Sam Emerson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.11561, lon: -97.05837, hasResults: False
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protocolSection identificationModule nctId: NCT06310590, orgStudyIdInfo id: NRT6003-HCC-2022, secondaryIdInfos id: CTR20230515, type: OTHER, domain: Center for Drug Evaluation, NMPA, briefTitle: Safety and Efficacy of NRT6003 in Patients With Unresectable Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-08, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Chengdu New Radiomedicine Technology Co. LTD., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC., conditionsModule conditions: Unresectable Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: NRT6003 Injection, outcomesModule primaryOutcomes measure: Adverse events/ Severe adverse events, primaryOutcomes measure: Localized Objective response rates (ORR), secondaryOutcomes measure: Hepatic time to progression (hTTP), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to progression (TTP), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Concentration of Alpha fetoprotein (AFP), secondaryOutcomes measure: Quality of life (QoL), secondaryOutcomes measure: Yttrium-90 distribution, secondaryOutcomes measure: Resection rate of liver target lesions, secondaryOutcomes measure: Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, status: RECRUITING, city: Hefei, state: Anhui, country: China, contacts name: Lianxin Liu, role: CONTACT, contacts name: Lianxin Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Fujian Provincial Cancer Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, contacts name: Hailan Lin, role: CONTACT, contacts name: Hailan Lin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.06139, lon: 119.30611, locations facility: The First Affiliated Hospital of Xiamen University, status: RECRUITING, city: Xiamen, state: Fujian, country: China, contacts name: Jinxiong Huang, role: CONTACT, contacts name: Jinxiong Huang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.47979, lon: 118.08187, locations facility: The First Affiliated Hospital of Jinan University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Hao Xu, role: CONTACT, contacts name: Hao Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Henan Cancer Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, country: China, contacts name: Hailiang Li, role: CONTACT, contacts name: Hui Yang, role: CONTACT, contacts name: Hailiang Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Hui Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Hunan Provincial People's Hospital, status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Hua Xiang, role: CONTACT, contacts name: Hua Xiang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Zhongda Hospital, Southeast University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Gaojun Teng, MD, role: CONTACT, phone: +8602583272084, email: zdyyjgb@163.com, contacts name: Gaojun Teng, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First Hospital of China Medical University, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Haibo Shao, role: CONTACT, contacts name: Haibo Shao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: West China Hospital, Sichuan University, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Hong Wu, role: CONTACT, contacts name: Hong Wu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: The Affiliated Hospital of Southwest Medical University, status: RECRUITING, city: Luzhou, state: Sichuan, country: China, contacts name: Yue Chen, role: CONTACT, contacts name: Yue Chen, role: PRINCIPAL_INVESTIGATOR, locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Guoliang Shao, role: CONTACT, contacts name: Guoliang Shao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The First Affiliated Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Tingbo Liang, role: CONTACT, contacts name: Tingbo Liang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The First Affiliated Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, state: Zhejiang, country: China, contacts name: Chang Yu, role: CONTACT, contacts name: Chang Yu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.99942, lon: 120.66682, locations facility: The Southwest Hospital of Army Medical University, status: RECRUITING, city: Chongqing, country: China, contacts name: Leida Zhang, role: CONTACT, contacts name: Leida Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, country: China, contacts name: Wentao Li, role: CONTACT, contacts name: Wentao Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The First Affiliated Hospital of Naval Medical University, status: RECRUITING, city: Shanghai, country: China, contacts name: Changjing Zuo, role: CONTACT, contacts name: Changjing Zuo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Third Affiliated Hospital of Naval Medical University, status: RECRUITING, city: Shanghai, country: China, contacts name: Hui Liu, role: CONTACT, contacts name: Hui Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Zhongshan Hospital, Fudan University, status: RECRUITING, city: Shanghai, country: China, contacts name: Zhiping Yan, role: CONTACT, contacts name: Hongcheng Shi, role: CONTACT, contacts name: Zhiping Yan, role: PRINCIPAL_INVESTIGATOR, contacts name: Hongcheng Shi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Tianjin Medical University Cancer Insititute & Hospital, status: RECRUITING, city: Tianjin, country: China, contacts name: Wei Lu, role: CONTACT, contacts name: Wei Lu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06310577, orgStudyIdInfo id: EH23-343, briefTitle: Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NorthShore University HealthSystem, class: OTHER, descriptionModule briefSummary: The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy., conditionsModule conditions: Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Self-controlled, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Leak-free bronchoscope adapter, outcomesModule primaryOutcomes measure: Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter", primaryOutcomes measure: Heart rate (bpm), primaryOutcomes measure: Blood pressure (mmHg), primaryOutcomes measure: Oxygenation as measured by SpO2, primaryOutcomes measure: Assessment of adverse events, secondaryOutcomes measure: Evaluation of bronchoscope adapter tidal volume loss efficacy, secondaryOutcomes measure: Evaluation of bronchoscope adapter aerosolization efficacy, secondaryOutcomes measure: Peak airway pressure (cmH2O), secondaryOutcomes measure: Dynamic compliance (mL/CmH2O), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310564, orgStudyIdInfo id: 2023-18, briefTitle: Low and Intermediate Risk oliGometastatic coloREctal cancEr patieNts Treated With Stereotactic ABlative Radiotherapy, acronym: GREENLaIT-SABR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2031-04, completionDateStruct date: 2031-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an experimental study without drug or device, randomized, open-label, non-profit, sponsored by the IRCCS Sacro Cuore Don Calabria Hospital in Negrar, which will take place at the Department of Advanced Oncological Radiotherapy and 18 other Italian centers.The reason for this research study is to evaluate whether stereotactic radiotherapy treatment (SABR), in addition to the systemic chemotherapy treatment foreseen by clinical practice for low-intermediate risk oligometastatic colorectal cancer, is able to:* delay possible local recurrence and/or distant polymetastatic progression* improve disease-free survival* reduce side effects in the short and long termthus inducing an improvement in the quality of life of patients suffering from this type of pathology.Therefore, as part of this randomized study, before starting first or second line systemic therapy for his tumor, the patient will be randomized to one of the following treatment arms:* Experimental arm: ablative stereotactic radiotherapy on all sites of oligometastatic disease (from 1 to 3 sites, performed at most within the second cycle of systemic therapy)* Control arm: no ablative stereotactic radiotherapy to sites of oligometastatic diseaseThe procedure that is intended to be tested in the experimental arm is a stereotactic radiotherapy treatment on oligometastases (up to a maximum of 3 sites), with ablative dosage (effective biological dose \>100 Gy), performed before the start of systemic therapy of I or II line (at most within the second cycle of the same).It is hoped that the addition of this type of radiotherapy will increase the potential clinical benefit of the treatment in the context of colorectal cancer., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule interventions name: SABR, outcomesModule primaryOutcomes measure: Progression-free survival (PFS)., secondaryOutcomes measure: Time to the polymetastatic conversion (tPMC), secondaryOutcomes measure: Local control (LC): the time between randomization to the date of radiological development of local progression after SABR., secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Time to start of the next systemic treatment line (NEST), secondaryOutcomes measure: Number of adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Number of acute side-effects, secondaryOutcomes measure: Number of Late side-effects, secondaryOutcomes measure: questionnaire QLQ-C30, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria di Negrar, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Luca Nicosia, Doctor, role: CONTACT, phone: +39(0)456014800, email: luca.nicosia@sacrocuore.it, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06310551, orgStudyIdInfo id: 218804, briefTitle: First Time in Human Study of Long Acting VH4524184 Formulations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2025-02-13, completionDateStruct date: 2026-11-27, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: ViiV Healthcare, class: INDUSTRY, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Oral VH4524184, interventions name: VH4524184 Formulation A SC, interventions name: Placebo Formulation A SC, interventions name: rHuPH20, interventions name: VH4524184 Formulation B SC, interventions name: Placebo Formulation B SC, interventions name: VH4524184 Formulation C SC, interventions name: Placebo Formulation C SC, interventions name: VH4524184 Formulation A IM, interventions name: Placebo Formulation A IM, outcomesModule primaryOutcomes measure: Percentage of participants reporting AEs and related AEs, primaryOutcomes measure: Percentage of participants with AEs by severity, primaryOutcomes measure: Percentage of participants discontinuing the treatment due to AEs, primaryOutcomes measure: Liver panel laboratory parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST] and alkaline phosphatase) change from baseline after the administration of LAI VH4524184, primaryOutcomes measure: Liver panel laboratory parameters (total bilirubin) change from baseline after the administration of LAI VH4524184, primaryOutcomes measure: Liver panel laboratory parameters (International normalized ratio) change from baseline after the administration of LAI VH4524184, primaryOutcomes measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (ALT, AST and alkaline phosphatase), primaryOutcomes measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (total bilirubin), primaryOutcomes measure: Maximum toxicity grade increase from baseline in liver panel laboratory parameters (International normalized ratio), primaryOutcomes measure: Percentage of participants reporting injection site reaction (ISR) AEs, primaryOutcomes measure: Duration of injection site reaction AEs, primaryOutcomes measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of Long-Acting Injectable (LAI) VH4524184 following single dose administration, primaryOutcomes measure: Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration, primaryOutcomes measure: Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration, primaryOutcomes measure: Cmax of LAI VH4524184 following multiple dose administration, primaryOutcomes measure: Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration, primaryOutcomes measure: Tmax of LAI VH4524184 following multiple dose administration, primaryOutcomes measure: Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration, primaryOutcomes measure: t1/2 of LAI VH4524184 following multiple dose administration, secondaryOutcomes measure: Percentage of participants with treatment emergent Grade 3 or Grade 4 laboratory abnormalities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Patrick Yao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95362, lon: -94.73357, locations facility: GSK Investigational Site, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Chinonye Chika Ogbonnaya-Odor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
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protocolSection identificationModule nctId: NCT06310538, orgStudyIdInfo id: 2024BZYLL0110, briefTitle: Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hongguo Rong, class: OTHER, descriptionModule briefSummary: In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024., conditionsModule conditions: Breast Hyperplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: kou sha, interventions name: Hongjin Xiaojie Capsules, outcomesModule primaryOutcomes measure: Breast pain score, primaryOutcomes measure: Short Form McGill Pain Inquiry Scale (SF-MPQ), secondaryOutcomes measure: Breast color ultrasound score, secondaryOutcomes measure: Palpation lump score, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: The quality of life rating scale (QOL), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310525, orgStudyIdInfo id: DROWN_DDF2, briefTitle: Using Machine Learning to Optimise the Danish Drowning Formula, acronym: DROWN_DDF2, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation., conditionsModule conditions: Drowning, conditions: Drowning and Submersion While in Bath-Tub, conditions: Drowning and Submersion While in Natural Water, conditions: Drowning and Submersion While in Swimming-Pool, conditions: Drowning and Submersion Due to Fall Off Ship, conditions: Drowning and Nonfatal Submersion, conditions: Drowning, Near, conditions: Drowning; Asphyxia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Drowning incident, outcomesModule primaryOutcomes measure: Sensitivity of the machine learning algorithm as a drowning identification tool, primaryOutcomes measure: Specificity of the machine learning algorithm as a drowning identification tool, primaryOutcomes measure: PPV of the machine learning algorithm, primaryOutcomes measure: NPV of the machine learning algorithm, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06310512, orgStudyIdInfo id: ANZHEN HOSPITOL-LY-04, briefTitle: Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients", acronym: PharmMTMH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Beijing Anzhen Hospital, class: OTHER, descriptionModule briefSummary: The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention., conditionsModule conditions: Hypertension, conditions: Medication Therapy Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Structured drug therapy management, outcomesModule primaryOutcomes measure: systolic blood pressure, secondaryOutcomes measure: diastolic blood pressure, secondaryOutcomes measure: Change from baseline in mean sitting systolic blood pressure at 3 months, secondaryOutcomes measure: Change from baseline in number of medication-related problems (MRP) at 6 months, secondaryOutcomes measure: Average number of medication-related problems (MRP) resolved after 6 months, secondaryOutcomes measure: The compliance rate of blood pressure after 6 months, secondaryOutcomes measure: Effective rate of blood pressure lowering after 6 months, secondaryOutcomes measure: Time to BP Attainment in Intervention and Non-Intervention Groups, secondaryOutcomes measure: Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used., secondaryOutcomes measure: Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06310499, orgStudyIdInfo id: DROWN_COD, briefTitle: Primary or Secondary Drowning, acronym: DROWN_COD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: According to WHO's rules, any death certificate must state the underlying cause of death and contributory causes of death may also be stated.Differentiating between primary and secondary drowning is difficult, as information preceding the drowning incident is rarely available. Yet, knowing the most frequent causes of secondary drowning may provide useful information to healthcare professionals working in prehospital Emergency Medical Services, as this may affect prehospital treatment., conditionsModule conditions: Drowning, conditions: Drowning; Anoxia, conditions: Drowning, Near, conditions: Drowning in Swimming Pool, conditions: Drowning; Asphyxia, conditions: Drowning/Diving/SCUBA Accident, conditions: Drowning or Immersion of Unknown Intent, conditions: Drowning and Submersion, Undetermined Intent, conditions: Drowning and Submersion While in Bath-Tub, conditions: Drowning and Submersion While in Natural Water, conditions: Drowning and Submersion Due to Sailboat Sinking, conditions: Drowning and Submersion Due to Fall Off Ship, conditions: Drowning and Submersion While in Swimming-Pool, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Drowning, outcomesModule primaryOutcomes measure: Autopsy rate, primaryOutcomes measure: Primary fatal drowning rate, primaryOutcomes measure: Secondary fatal drowning rate, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06310486, orgStudyIdInfo id: DROWN_CALL, briefTitle: The Emergency Call on Drowning, acronym: DROWN_CALL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: This study aims to 1) describe patient-, setting-, and dispatcher-related characteristics in drowning-related emergency calls to the Emergency Medical Dispatch Centre (1-1-2 emergency phone) and 2) factors associated with 30-day survival. The investigators will separately analyse drowning-related out-of-hospital cardiac arrest (OHCA) and drowning-related non-OHCA. If feasible, the investigators will qualitatively analyse the calls to identify and describe potential barriers for an optimal handling strategy., conditionsModule conditions: Drowning, conditions: Drowning; Anoxia, conditions: Drowning, Near, conditions: Drowning; Asphyxia, conditions: Drowning and Nonfatal Submersion, conditions: Drowning or Immersion of Unknown Intent, conditions: Drowning and Submersion, Undetermined Intent, conditions: Drowning and Submersion While in Bath-Tub, conditions: Drowning and Submersion While in Natural Water, conditions: Drowning and Submersion Due to Sailboat Sinking, conditions: Drowning and Submersion Due to Fall Off Ship, conditions: Drowning and Submersion While in Swimming-Pool, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Drowning-related OHCA, interventions name: Drowning-related non-OHCA, outcomesModule primaryOutcomes measure: Patient-related characteristics influencing the 30-day survival, primaryOutcomes measure: Setting-related characteristics influencing the 30-day survival, primaryOutcomes measure: Caller-related characteristics influencing the 30-day survival, primaryOutcomes measure: Dispatcher-related characteristics influencing the 30-day survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
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protocolSection identificationModule nctId: NCT06310473, orgStudyIdInfo id: NFEC-2023-582, briefTitle: Neoadjuvant Cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: For locally advanced esophagogastric junction and gastric cancer, neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate and reduce recurrence rate.Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of cadonilimab Plus Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer., conditionsModule conditions: Gastric Cancer, conditions: Esophagogastric Junction Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Oxaliplatin, interventions name: Capecitabine, outcomesModule primaryOutcomes measure: Pathologic complete remission rate (pCR), secondaryOutcomes measure: Major pathologic response，MPR, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: 3-year disease-free survival rate of 3year (DFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510-515, country: China, contacts name: Guoxin Li, M.D., Ph.D., role: CONTACT, phone: +86-138-0277-1450, email: gzliguoxin@163.com, contacts name: Guoxin Li, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Liying Zhao, M.D., Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06310460, orgStudyIdInfo id: PCP, briefTitle: Evaluation of "PreCut-Papillectomy" in Difficult Biliary Cannulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Kliniken Ludwigsburg-Bietigheim gGmbH, class: OTHER, descriptionModule briefSummary: To evaluate the effectiveness and sefety of papillectomy to enable bile duct access during endoscopic retrograde cholangiography in patients with difficult biliary cannulation., conditionsModule conditions: Cholangiopancreatography, Endoscopic Retrograde, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Papillectomy, outcomesModule primaryOutcomes measure: Rate of treatment success, primaryOutcomes measure: Adverse event rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310447, orgStudyIdInfo id: IstanbulBUFC2, briefTitle: Determination of Ecological Awareness and Attitudes Levels of Undergraduate Physiotherapy Students in Istanbul, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-03, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule briefSummary: The natural environment, which is the living environment of all living things; Technological advances and industrialization activities are being affected more and more negatively every day. Increasing energy demand and resource consumption due to population growth lead to negative consequences on ecological balance, such as environmental pollution, climate change and loss of natural environments. Health services have also increased resource use with the advancement of technology and caused negative effects on the environment. Health services have been slow to understand their impact on the environment. The aim of the study is to determine the environmental awareness and environmental attitude levels of physiotherapy and rehabilitation department students, to popularize the field of "Environmental Physiotherapy" and to enable the training of physiotherapist candidates with high environmental awareness., conditionsModule conditions: Ecological and Environmental Concepts, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 151, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Ecological Footprint Awareness Scale, primaryOutcomes measure: Environmental Awareness Scale, primaryOutcomes measure: Environmental Attitude Scale, secondaryOutcomes measure: Participant Information Form, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Bilgi University, city: Istanbul, zip: 34440, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06310434, orgStudyIdInfo id: PI23/00409, briefTitle: Analysis of COMPASsion and Humanisation of Adolescents Facing the End-of-life Processes., acronym: COMPAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Instituto de Salud Carlos III, class: OTHER_GOV, descriptionModule briefSummary: The investigators want to work on compassion, understood as the recognition of the suffering of others that motivates us to try to alleviate it. The goal of this Multicenter project, with a mixed sequential transformative methodology, is to analyze the impact of a participatory process of awareness and reflection on compassion, in the face of end-of-life processes, in adolescents aged 12-23 years in 6 Spanish provinces, and to understand how the participatory process can transform and improve their compassion.As the adolescents must be the protagonists of change, the study will be conducted with students enrolled in one public secondary school and in one degree in a public University, that belongs to the same "health area" in each province. The investigators also include families' and teachers' knowledge of the context because it can support the interventions of change proposals.Compassion will be assessed using the Compassion for the Lives of Others Scale (COOLS), comprising 26 items. Similarly, adolescents' attitudes toward death are another important concept and will be explored through the Death Anxiety Scale (DAS), which has 15 questions. Both scales will be distributed to the adolescents, requesting their permission anonymously.After the survey, a second phase will start with a Participatory Action Research (PAR) with different activities. The objective is to generate awareness of the need to improve it, allowing the participants to design the interventions, based on evidence-based proposals (cinema forum, colloquiums with testimonies of volunteers accompanying palliative patients, organization of Death Cafe, artistic and literary activities, generation of grief groups, etc.).At the end of the project, the investigators will evaluate the adolescent compassion level and create discussion groups again to understand the impact of the interventions.With this project, the investigators will empower new generations of people to encourage, facilitate, support, and celebrate mutual care and family and community development in end-of-life processes. The translation and implications of the results for clinical practice will contribute to reducing inequalities in health research in a vulnerable group of special interest, especially when treatments can do nothing for their survival but with interventions such as those in this study, the investigators can ensure quality and dignity of life as long as there is life., conditionsModule conditions: Compassion, conditions: Death Anxiety, conditions: Adolescent Behavior, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1852, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire, interventions name: Discussion group, interventions name: Reflective diary, outcomesModule primaryOutcomes measure: Describe and improve the level of compassion of high school and university students., primaryOutcomes measure: Describe and improve the attitude towards death of high school and university students., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 23 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Instituto Murciano de Investigación Biosanitaria, city: Murcia, state: MU, zip: 30120, country: Spain, contacts name: Eva Abad-Corpa, PhD, role: CONTACT, email: eva.abad@um.es, contacts name: Miriam Espinosa-Sánchez, MhD, role: CONTACT, email: miriam.espinosa1@um.es, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False
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protocolSection identificationModule nctId: NCT06310421, orgStudyIdInfo id: Screening_SMA, briefTitle: Spinal Muscular Atrophy Neonatal Screening Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-16, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Burlo Garofolo, class: OTHER, descriptionModule briefSummary: Spinal muscular atrophy (SMA) is a group of disorders caused by the degeneration of the motor neuron cells of the anterior horn of the spinal cord and, in some subtypes, of the bulbar motor neurons. Almost all cases are genetically determined. Most SMAs are autosomal recessive diseases, caused by homozygous deletions of the survival motor neuron (SMN) gene located on the long arm of chromosome 5. The estimated incidence of recessive childhood and juvenile SMA linked to deletion of the SMN gene is 1 in 6000 to 10000 live births, with a carrier frequency of 1 in 35 in the general population, making it a major genetic cause of infant mortality. Up to 95-97% of all childhood cases are due to homozygous deletions of the survival motor neuron 1 (SMN1) gene, or telomeric SMN, located on chromosome 5q11.2-13.3. The remaining 3-5% of cases are due to small mutations in SMN1 (rather than complete deletions).Until a few years ago, the prognosis of type 1 SMA was poor. In the absence of therapies, the only measures were supportive (ventilation, nutrition) and the prospect, especially in the early forms, was to accompany them towards an early end of life. There are currently three treatment options available: nusinersen, risdiplam, and gene therapy with onasemnogene abeparvovec. The three options were found to be equally effective in reducing the symptoms of the disease, making it possible to reach or safeguard fundamental stages in a child's neuromotor development, starting from the ability to remain seated. At this moment, gene therapy is probably the preferred choice. To date, in Italy, there are approximately 100 patients undergoing gene therapy.To ensure maximum benefit for affected patients, it is essential that the therapy is administered as soon as possible. Literature shows how the administration of gene therapy in pre-symptomatic subjects made it possible to achieve a better neurological outcome compared to symptomatic patients. From this perspective, the inclusion of spinal muscular atrophy in neonatal screening is of fundamental relevance., conditionsModule conditions: Spinal Muscular Atrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: PROSPECTIVE, enrollmentInfo count: 11500, type: ESTIMATED, armsInterventionsModule interventions name: Screening SMA test, outcomesModule primaryOutcomes measure: Rate of newborn screened, eligibilityModule sex: ALL, minimumAge: 48 Hours, maximumAge: 72 Hours, stdAges: CHILD, contactsLocationsModule locations facility: SC Pediatria Gorizia - Monfalcone, status: RECRUITING, city: Monfalcone, state: Gorizia, country: Italy, contacts name: Danica Dragovic, MD, role: CONTACT, phone: +39 0481 487252, email: danica.dragovic@asugi.sanita.fvg.it, geoPoint lat: 45.80463, lon: 13.53292, locations facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo", status: RECRUITING, city: Trieste, zip: 34137, country: Italy, contacts name: Sheila Ulivi, MSc, role: CONTACT, phone: +36.040 3785 226, email: sheila.ulivi@burlo.trieste.it, contacts name: Luca Ronfani, PhD MD, role: CONTACT, phone: +39.040.3785.297, email: luca.ronfani@burlo.trieste.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06310408, orgStudyIdInfo id: 0214022024, briefTitle: Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: to determine the comparison of nasal masks and nasal prongs on the pain response of neonate, conditionsModule conditions: Nasal Mask, conditions: Nasal Prong, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 1 group give nasal mask1 group give nasal prong, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: nasal mask, interventions name: nasal prong, outcomesModule primaryOutcomes measure: pain response, eligibilityModule sex: ALL, minimumAge: 26 Weeks, maximumAge: 44 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310395, orgStudyIdInfo id: AMI_H.MAR, briefTitle: Analysis of the Acute Mesenteric Ischemia in a Single Institution Over 10 Years, acronym: AMI_HMAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hospital del Mar, class: OTHER, descriptionModule briefSummary: Acute mesenteric ischemia (AMI) is a notorious disease with a high mortality, the diagnostic and management is truly multidisciplinary, and the aim of this study is to analyse the results of the patients admited with an AMI in Hospital de Mar., conditionsModule conditions: Acute Mesenteric Ischemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06310382, orgStudyIdInfo id: GH55-CRS001, briefTitle: A Phase I/II Clinical Study to Evaluate The Safety, PK, PD of GH55 in Patients With MAPK Mutant Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-07, primaryCompletionDateStruct date: 2025-05-26, completionDateStruct date: 2025-08-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Suzhou Genhouse Bio Co., Ltd., class: OTHER, collaborators name: Shanghai East Hospital, collaborators name: Shandong Tumor Hospital, descriptionModule briefSummary: This is a multi-center, open-label, dose escalation phase I and dose expansion phase II study aimed to evaluate the safety, tolerability, PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors.This study is divided into two parts, namely the dose escalation phase I study and the dose expansion phase II study., conditionsModule conditions: Advanced Solid Tumors With MAPK Signal Pathway Mutant, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: GH55, outcomesModule primaryOutcomes measure: Number of participants with dose limiting toxicities, primaryOutcomes measure: Number of participants with adverse events, primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Plasma concentration (Cmax), secondaryOutcomes measure: Time to achieve Cmax (Tmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai East Hospital, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200120, country: China, contacts name: JIN LI, DOCTORATE, role: CONTACT, phone: 021-38804518, email: lijin@csco.org.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06310369, orgStudyIdInfo id: EORTC 2335-GUCG, briefTitle: Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2030-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: European Organisation for Research and Treatment of Cancer - EORTC, class: NETWORK, descriptionModule briefSummary: We aim to investigate a possible role for radiotherapy in good prognosis bladder cancer patients has been identified as a possible alternative to cystectomy, especially for patients non-eligible for surgery but has yet to be fully explored., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: radiation therapy, outcomesModule primaryOutcomes measure: Proportion of patients with a CR at 6 months post-radiotherapy, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: overall survival, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310356, orgStudyIdInfo id: CORDELIA, briefTitle: Continuous Glucose Monitoring for Women With Gestational Diabetes, acronym: CORDELIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: University Hospital, Antwerp, collaborators name: General Hospital Groeninge, collaborators name: Onze Lieve Vrouw Hospital, collaborators name: AZ Delta, collaborators name: Ziekenhuis Netwerk Antwerpen (ZNA), collaborators name: Vitaz, collaborators name: Centre Hospitalier Universitaire de Liege, collaborators name: Erasme University Hospital, collaborators name: Université Catholique de Louvain, collaborators name: Centre Hospitalier Mouscron, collaborators name: University Hospital, Ghent, collaborators name: AZ Turnhout, collaborators name: AZ Sint-Lucas Gent, collaborators name: AZ St- Jan Brugge, collaborators name: AZ St Maarten Mechelen, collaborators name: Imelda Hospital, Bonheiden, descriptionModule briefSummary: There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 17 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance., conditionsModule conditions: Gestational Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 386, type: ESTIMATED, armsInterventionsModule interventions name: Freestyle Libre 3, interventions name: Glucometer, outcomesModule primaryOutcomes measure: a composite of pregnancy outcomes, secondaryOutcomes measure: time in glucose range overnight between 70-95mg/dl, secondaryOutcomes measure: time in glucose range during the day between 70-95mg/dl, secondaryOutcomes measure: time in glucose range overnight between 63-140mg/dl, secondaryOutcomes measure: time in glucoserange during the day between 63-140mg/dl, secondaryOutcomes measure: time in glucose range during the day between 54-95mg/dl, secondaryOutcomes measure: time in glucose range overnight between 54-95mg/dl, secondaryOutcomes measure: time in glucose range overnight between 63-120mg/dl, secondaryOutcomes measure: time in glucose range during the day between 63-120mg/dl, secondaryOutcomes measure: hypoglycemia <54mg/dl, secondaryOutcomes measure: hypoglycemia <50mg/dl, secondaryOutcomes measure: hypoglycemia <63mg/dl, secondaryOutcomes measure: hypoglycemia <70mg/dl, secondaryOutcomes measure: standard deviation, secondaryOutcomes measure: Coefficient of Variance, secondaryOutcomes measure: mean amplitude of glycemic excursions, secondaryOutcomes measure: glucose time overnight >100mg/dl, secondaryOutcomes measure: glucose postprandial time >120mg/dl, secondaryOutcomes measure: glucose postprandial time >140mg/dl, secondaryOutcomes measure: glucose time >180mg/dl, secondaryOutcomes measure: mean HbA1c, secondaryOutcomes measure: Glucose management indicator, secondaryOutcomes measure: timing of start insulin treatment, secondaryOutcomes measure: mean insulin dose, secondaryOutcomes measure: mean gestational weight gain, secondaryOutcomes measure: rate of postpartum hemorrhage, secondaryOutcomes measure: rate of macrosomia, secondaryOutcomes measure: rate of baby >4.5Kg, secondaryOutcomes measure: rate of Small-for-gestational age infant, secondaryOutcomes measure: rate of cesarean section, secondaryOutcomes measure: rate of instrumental delivery, secondaryOutcomes measure: rate of perineal inury, secondaryOutcomes measure: rate of labor inductions, secondaryOutcomes measure: rate of preeclamspia, secondaryOutcomes measure: rate of gestational hypertension, secondaryOutcomes measure: rate of fetal malformation, secondaryOutcomes measure: rate of miscarriage, secondaryOutcomes measure: rate of polycythemia, secondaryOutcomes measure: rate of neonatal hypoglycemia, secondaryOutcomes measure: Treatment satisfaction, secondaryOutcomes measure: Quality of life based on Short Form (SF-36) score, secondaryOutcomes measure: dietary intake, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: fear for hypoglycaemia, secondaryOutcomes measure: fear for hyperglycaemia, secondaryOutcomes measure: symptoms of depression, secondaryOutcomes measure: symptoms of anxiety, secondaryOutcomes measure: user-friendliness of CGM, secondaryOutcomes measure: user-friendliness of CGM compared to oral glucose tolerance test (OGTT), secondaryOutcomes measure: duration of breastfeeding, secondaryOutcomes measure: rate of hypercholesterolemia, secondaryOutcomes measure: night glucose time in range between 70-180mg/dl, secondaryOutcomes measure: day glucose time in range between 70-180mg/dl, secondaryOutcomes measure: day glucose time in range <70mg/dl, secondaryOutcomes measure: night glucose time in range <70mg/dl, secondaryOutcomes measure: night glucose time in range >180mg/dl, secondaryOutcomes measure: day glucose time in range >180mg/dl, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: OLV Aalst-Asse, city: Aalst, state: Oost-Vlaanderen, zip: 9300, country: Belgium, contacts name: Inge Van Pottelbergh, MD PhD, role: CONTACT, geoPoint lat: 50.93604, lon: 4.0355, locations facility: UZA, city: Antwerp, country: Belgium, contacts name: Niels Bochanen, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, locations facility: ZNA Antwerpen, city: Antwerp, country: Belgium, contacts name: Astrid Morrens, MD, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, locations facility: Imelda Bonheiden, city: Bonheiden, zip: 2820, country: Belgium, contacts name: Da Hae Lee, MD, role: CONTACT, geoPoint lat: 51.02261, lon: 4.54714, locations facility: AZ St Jan Brugge, city: Brugge, zip: 8000, country: Belgium, contacts name: Sara Vandewalle, role: CONTACT, geoPoint lat: 51.20892, lon: 3.22424, locations facility: Erasme, city: Brussel, country: Belgium, contacts name: Tiphaine Carton, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: UCL, city: Brussel, country: Belgium, contacts name: Fabian Lurquin, role: CONTACT, geoPoint lat: 50.85045, lon: 4.34878, locations facility: UZ Gent, city: Gent, zip: 9000, country: Belgium, contacts name: Joke Marlier, MD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: AZ St Lucas Gent, city: Gent, country: Belgium, contacts name: Inge Van Boxelaer, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: AZ Groeninge Kortrijk, city: Kortrijk, zip: 8510, country: Belgium, contacts name: Ellen Heyns, MD, role: CONTACT, geoPoint lat: 50.82803, lon: 3.26487, locations facility: UZ Leuven, city: Leuven, country: Belgium, contacts name: Katrien Benhalima, MD PhD, role: CONTACT, email: katrien.benhalima@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, locations facility: CHU de Liège, city: Liège, country: Belgium, contacts name: JC Philips, role: CONTACT, geoPoint lat: 50.63373, lon: 5.56749, locations facility: AZ St Maarten Mechelen, city: Mechelen, country: Belgium, contacts name: Kathleen Bollaerts, role: CONTACT, geoPoint lat: 51.02574, lon: 4.47762, locations facility: Centre Hospitalier Mouscron, city: Mouscron, country: Belgium, contacts name: Philippe Oriot, role: CONTACT, geoPoint lat: 50.74497, lon: 3.20639, locations facility: AZ Delta Roeselare, city: Roeselare, country: Belgium, contacts name: Xavier-Philippe Aers, role: CONTACT, geoPoint lat: 50.94653, lon: 3.12269, locations facility: Vitaz, city: Sint-Niklaas, country: Belgium, contacts name: Peter Coremans, role: CONTACT, geoPoint lat: 51.16509, lon: 4.1437, locations facility: AZ Turnhout, city: Turnhout, country: Belgium, contacts name: Joke Cuypers, MD, role: CONTACT, geoPoint lat: 51.32254, lon: 4.94471, hasResults: False
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protocolSection identificationModule nctId: NCT06310343, orgStudyIdInfo id: 304993, briefTitle: ADAs to Alemtuzumab, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-04-25, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: The main aim is to quantify the changes in alemtuzumab antibody-anti-alemtuzumab over a 24 months period, conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Alemtuzumab, outcomesModule primaryOutcomes measure: To quantify the longitudinal changes in alemtuzumab ADAs, secondaryOutcomes measure: 1. Relative occurrence of infusion-related reactions based on high alemtuzumab ADA levels prior to course 2., secondaryOutcomes measure: 2. Relative change in lymphocyte counts after the second infusion of alemtuzumab in ADA positive patients to assess the health economic impact of infusion-related reactions., secondaryOutcomes measure: 3. Relative change in relapses or EDSS score based on alemtuzumab ADA levels to assess the health economic impact of disease activity., secondaryOutcomes measure: 4. Relative change in relapses or EDSS score based on alemtuzumab ADA levels, secondaryOutcomes measure: 5. Relative change in T2 lesion number or Gd-enhancing lesions, and serum NfL based on alemtuzumab ADA levels to assess the health economic impact of disease activity., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Barts Health NHS Trust, city: London, state: Second Floor Neurophys Dept, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06310330, orgStudyIdInfo id: 2019/1059, briefTitle: TRUST-ACE - Anticancer-treatment Cardiotoxicity Identification by Echocardiography, acronym: TRUST-ACE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Norwegian University of Science and Technology, class: OTHER, collaborators name: St. Olavs Hospital, descriptionModule briefSummary: TRUST-ACE will compare a simplified echocardiographic protocol focusing on ventricular function with the guideline recommended comprehensive echocardiographic examination using a randomised design in follow-up of breast-cancer patients with respect to identification of cancer treatment related cardiac dysfunction (CTRCD).Secondly, the study will evaluate whether novel tools used to improve standardization of recordings as well as automated measurements of central measurements, e.g. ejection fraction (EF) and global longitudinal strain (GLS) can improve the precision of echocardiography in daily clinical practice., conditionsModule conditions: Breast Neoplasm Malignant Primary, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization 1:1 to two different modes of follow-up, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: No masking, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive echocardiographic follow-up, interventions name: Simplified echocardiographic follow-up, outcomesModule primaryOutcomes measure: Proportion of patients correctly classified with cancer therapy related cardiac dysfunction (CTRCD), otherOutcomes measure: Proportion of patients misclassified as having/not having cancer therapy related cardiac dysfunction (CTRCD), otherOutcomes measure: Risk classification, otherOutcomes measure: Risk classification, otherOutcomes measure: Test-retest variability, systolic left ventricular size and function, otherOutcomes measure: Test-retest variability, systolic left ventricular size and function, otherOutcomes measure: Test-retest variability, diastolic left ventricular size and function, otherOutcomes measure: Test-retest variability, diastolic left ventricular size and function, otherOutcomes measure: Test-retest variability, right ventricular size and function, otherOutcomes measure: Test-retest variability, right ventricular size and function, otherOutcomes measure: Time consumption, otherOutcomes measure: Time consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Olavs hospital, status: RECRUITING, city: Trondheim, zip: 7491, country: Norway, contacts name: Rune Wiseth, MD, PhD, role: CONTACT, phone: 92247845, phoneExt: 47, email: rune.wiseth@stolav.no, geoPoint lat: 63.43049, lon: 10.39506, hasResults: False
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protocolSection identificationModule nctId: NCT06310317, orgStudyIdInfo id: CNR-IRIB-PRO-2024-003, briefTitle: Applied Behavior Analysis With Technologies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istituto per la Ricerca e l'Innovazione Biomedica, class: OTHER, descriptionModule briefSummary: Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors., conditionsModule conditions: Autism, conditions: Autism Spectrum Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Applied Behavior Analysis protocol, interventions name: Traditional intervention, outcomesModule primaryOutcomes measure: Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR), status: RECRUITING, city: Messina, zip: 98164, country: Italy, contacts name: Flavia Marino, role: CONTACT, phone: +393395798263, email: flavia.marino@irib.cnr.it, contacts name: Maria Valeria Maiorana, role: CONTACT, phone: +393285856656, email: mariavaleria.maiorana@irib.cnr.it, contacts name: Flavia Marino, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Pioggia, role: SUB_INVESTIGATOR, contacts name: Paola Chilà, role: SUB_INVESTIGATOR, contacts name: Roberta Minutoli, role: SUB_INVESTIGATOR, contacts name: Noemi Vetrano, role: SUB_INVESTIGATOR, contacts name: Chiara Failla, role: SUB_INVESTIGATOR, contacts name: Germana Doria, role: SUB_INVESTIGATOR, contacts name: Ileana Scarcella, role: SUB_INVESTIGATOR, contacts name: Cinzia Grasso, role: SUB_INVESTIGATOR, contacts name: Mariaelena Franchina, role: SUB_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, hasResults: False
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protocolSection identificationModule nctId: NCT06310304, orgStudyIdInfo id: INCB18424-153, briefTitle: A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-04-16, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is conducted to determine the Relative Bioavailability of Ruxolitinib XR Tablets Compared With Ruxolitinib IR Tablets Administered Orally in Healthy Participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Ruxolitinib IR, interventions name: Ruxolitinib XR, outcomesModule primaryOutcomes measure: INCB018424 pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Number of participants with Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Additional INCB018424 pharmacokinetic (PK) in Plasma, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, Inc, city: Lincoln, state: Nebraska, zip: 68502, country: United States, geoPoint lat: 40.8, lon: -96.66696, hasResults: False
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protocolSection identificationModule nctId: NCT06310291, orgStudyIdInfo id: GLU001, briefTitle: VTP-1000 in Adults With Celiac Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Barinthus Biotherapeutics, class: INDUSTRY, descriptionModule briefSummary: GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000., conditionsModule conditions: Celiac Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The Single Ascending Dose part of the trial contains a placebo controlled randomized 4+2 design, where four participants will receive active IMP and two placebo. The Multiple Ascending Dose is a standard sequential design, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: VTP-1000, interventions name: Matched Placebo, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest (AESIs), primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard Clinical Chemistry laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard Coagulation laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard hematology laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in standard urinalysis laboratory safety parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities 12-lead electrocardiogram (ECG) parameters, primaryOutcomes measure: Changes from baseline and clinically significant abnormalities in vital signs, primaryOutcomes measure: Number of participants with changes from baseline in anti-tissue transglutaminase (anti-tTG) immunoglobulin A (IgA) antibodies, primaryOutcomes measure: Changes in physical examination findings, secondaryOutcomes measure: PART A SAD:Maximum concentration in plasma (Cmax) rapamycin component, secondaryOutcomes measure: PART A SAD: Time corresponding to Cmax (Tmax) of rapamycin component, secondaryOutcomes measure: AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component, secondaryOutcomes measure: AUC extrapolated to infinity (AUC0-∞)of rapamycin component, secondaryOutcomes measure: Half-life of rapamycin component, secondaryOutcomes measure: Clearance of rapamycin component, secondaryOutcomes measure: Volume of distribution of rapamycin component, secondaryOutcomes measure: Part B MAD:Maximum concentration in plasma (Cmax) rapamycin component, secondaryOutcomes measure: Part B MAD:Time corresponding to Cmax (Tmax) of rapamycin component, secondaryOutcomes measure: Part B MAD:AUC from time 0 to last quantifiable concentration (AUC0-t) of rapamycin component, secondaryOutcomes measure: Part B MAD:AUC extrapolated to infinity (AUC0-∞)of rapamycin component, secondaryOutcomes measure: Part B MAD: Half-life of rapamycin component, secondaryOutcomes measure: Part B MAD: Clearance of rapamycin component, otherOutcomes measure: Gluten Antigen-specific T Cell Responses - Enzyme linked immunospot (ELISpot), otherOutcomes measure: Gluten Antigen-specific T Cell Responses - Intracellular cytokine staining (ICS), otherOutcomes measure: T cell receptor (TCR) sequencing, otherOutcomes measure: Serum Cytokine Concentrations, otherOutcomes measure: Cytokine Whole Blood Stimulation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06310278, orgStudyIdInfo id: 1030312, briefTitle: Ossiview Normative Mobility Data Collection Protocol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Audioptics Medical Incorporated, class: INDUSTRY, descriptionModule briefSummary: The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss.The main questions the study aims to answer are:* What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus?* Are there any significant differences in these vibrational responses associated with sex or age?Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants., conditionsModule conditions: Conductive Hearing Loss, Middle Ear, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Ossicular mobility measurement, outcomesModule primaryOutcomes measure: Umbo mobility, primaryOutcomes measure: Incus mobility, secondaryOutcomes measure: Dependence on age and sex, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310265, orgStudyIdInfo id: TABED 1-24-21, briefTitle: Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-04-05, completionDateStruct date: 2024-04-22, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: The study aimed to investigate anesthesia management of pediatric patients in the Ankara Bilkent City Hospital during the earthquake disaster of February 6., conditionsModule conditions: Earthquake, conditions: Crush Injury, conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Retrospective observational study, outcomesModule primaryOutcomes measure: The anesthesia management under pediatric earthquake victims, eligibilityModule sex: ALL, minimumAge: 30 Days, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, status: RECRUITING, city: Ankara, zip: 06800, country: Turkey, contacts name: Sengul Ozmert, role: CONTACT, phone: +905323861201, email: sengulozmert@yahoo.com.tr, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Ankara Bilkent City Hospital,Department Of Anesthesiology and Reanimation, status: RECRUITING, city: Ankara, state: Çankaya, zip: 06800, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06310252, orgStudyIdInfo id: PRO_010-2023, briefTitle: Safety and Efficacy of an Intrastromal Transform Corneal Allograft (TCA) for Presbyopia Correction - Long Term Follow-up, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Allotex, Inc., class: INDUSTRY, descriptionModule briefSummary: The objective of this clinical study is to evaluate the long term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.A maximum of 101 eyes of qualified and consented subjects will undergo long term follow-up after instrastromal implantation of the TCA for presbyopia., conditionsModule conditions: Presbyopia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 101, type: ESTIMATED, armsInterventionsModule interventions name: Opthalmic assessments, outcomesModule primaryOutcomes measure: An exploratory data collection project with no primary safety or effectiveness endpoints., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gemini - Oční klinika Zlín, status: RECRUITING, city: Zlín, zip: 760 01, country: Czechia, contacts name: Stodůlka, role: CONTACT, phone: +420 577 202 202, email: info@gemini.cz, geoPoint lat: 49.22645, lon: 17.67065, locations facility: Wellington Eye Clinic, status: NOT_YET_RECRUITING, city: Dublin, zip: D18 T8P3, country: Ireland, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Medipol University, status: RECRUITING, city: Istanbul, zip: 34214, country: Turkey, contacts name: Tanriverdi, role: CONTACT, phone: +904447044, email: international@medipol.com.tr, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Centre For Sight, status: NOT_YET_RECRUITING, city: East Grinstead, zip: RH149 4RH, country: United Kingdom, geoPoint lat: 51.12382, lon: -0.0061, hasResults: False
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protocolSection identificationModule nctId: NCT06310239, orgStudyIdInfo id: WRNMMC-2023-0434, secondaryIdInfos id: 67407, type: OTHER_GRANT, domain: PRORP, briefTitle: Microbiome Population Adaptation Study, acronym: OLIMPAS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-11-30, completionDateStruct date: 2029-11-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Walter Reed National Military Medical Center, class: FED, descriptionModule briefSummary: The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively. The investigators will also collect control samples to correct for turnovers in species compositions that may naturally occur and to compare the residual limb microbiome to the sound contralateral limb. The investigators will sequence the bacterial community using universal bacterial primers. Using these sequences, The investigators will borrow from ecological theory and calculate the alpha and beta diversity. The alpha diversity will determine the species and abundance of each species that are present, while the beata diversity will allow us to compare how species assemblages and frequencies change between time points. Then, the investigators will take a phylogenetic modeling approach to determine if particular species assemblages correlate with rates of wound healing. The investigators will construct phylogenies from the sequences at the different time points and "paint" the rate of wound healing along the phylogeny (e.g., improved, stagnated, worsened). Using Akaike and Bayesian information criterion, the investigators can determine which phylogenetic model best explains the patterns the investigators see across patients. Lastly, the investigators will quantify soft tissue stability and health and correlate this with the homeostasis of the microbial community. Specifically, the investigators will determine if redundant soft tissue leads to altered microbial communities that can impact the rate of wound healing. Finally, the investigators will further stratify these data to compare microbial communities between the sexes, upper versus lower limbs, and proximal versus distal amputations. This work will allow us to better treat infections after OI surgery and can shed light on wound healing process so that the investigators can better treat limb loss patients and the military community as a whole., conditionsModule conditions: Amputation With Osseointegration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Collection of biologic samples and data, outcomesModule primaryOutcomes measure: Determine if OI surgery causes changes in the microbiome community using phylogenies, primaryOutcomes measure: Determine if changes in the microbiome community predicts wound healing using phylogenetic comparative methods, primaryOutcomes measure: Quantify soft tissue health using a modified Holger Score (0 = healthy soft issue and 6 = unhealthy soft tissue) to phylogenetically correlate this with microbiome homeostasis., secondaryOutcomes measure: Floral profiles, secondaryOutcomes measure: Floral colonization, secondaryOutcomes measure: Clinical guidelines, secondaryOutcomes measure: Surgical site questionnaire, secondaryOutcomes measure: Post-OI hygiene guidelines, secondaryOutcomes measure: Soft tissue stability guidelines, secondaryOutcomes measure: Holger score validation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Orhopaedic Surgery Service, Walter Reed National Military Medical Center,, status: RECRUITING, city: Bethesda, state: Maryland, zip: 20889, country: United States, contacts name: Angelica M Melendez-Munoz, role: CONTACT, phone: 202-549-3229, email: angelica.m.melendez-munoz.ctr@health.mil, contacts name: Toby L Perkins, role: CONTACT, phone: 240-308-0548, email: toby.l.perkins.ctr@health.mil, contacts name: Ean R Saberski, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False
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protocolSection identificationModule nctId: NCT06310226, orgStudyIdInfo id: 23-000347, briefTitle: Phenotyping Response to Spinal Cord Stimulation in Chronic Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: Chronic low back pain (CLBP) is a debilitating condition and costly to treat. Long-term drug treatment often fails due to habituation, breakthrough of pain, or adverse effects of drug treatment. Opioid use to manage this pain has contributed to the opioid epidemic. Spinal cord stimulators have emerged as a promising treatment and reduces reliance on drugs. However, response to spinal cord stimulation (SCS) is unpredictable. It is difficult to predict which patients will respond positively to SCS because the physiological mechanism for treatment responsiveness is unclear. Therefore, the aim of this study is to investigate how spinal cord stimulators affect functional measures in patients with CLBP, including functional MRI, neurophysiology, gait analysis, and questionnaires. The results of this study can lead to the widespread adoption of spinal cord stimulators as a safe and effective therapy for CLBP, reducing the reliance on opioids and mitigating the opioid epidemic's impact., conditionsModule conditions: Chronic Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Epidural electrical spinal cord stimulator, outcomesModule primaryOutcomes measure: Detection of brain connectivity using functional MRI, secondaryOutcomes measure: Detection of brain waves using electroencephalography (EEG), otherOutcomes measure: Neurological gait kinematics assessment, otherOutcomes measure: Neurophysiological functional assessment using somatosensory evoked potential (SSEP), otherOutcomes measure: Neurophysiological functional assessment using pain-related evoked potential (PREP), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Los Angeles, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Chau, role: CONTACT, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06310213, orgStudyIdInfo id: 17368, briefTitle: Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-06-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without* Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable., conditionsModule conditions: Hydrocephalus in Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Aim 1: Comparison of neonates and infants with hydrocephalus and without Aim 2: Using smart soft contact lens (SSCL) for pre- and post-operative measurements on neonates and/or infants managed operatively (shunt placement) Aim 3: Direct validation by comparing SSCL to external ventricular drain (EVD) intracranial pressure (ICP) monitoring Aim 4: Using SSCL for pre- and post- reservoir tap measurements on neonates and/or infants managed operatively (reservoir placement) Aim 1: 10 patients per arm, two arms Aim 2: 5-10 patients, one arm Aim 3: 5-10 patients, one arm Aim 4: 5-10 patients, one arm, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Non-Invasive Pressure Monitor, outcomesModule primaryOutcomes measure: Efficacy of modified smart soft contact lens evaluation of external intracranial pressure, eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Riley Hospital for Children, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Jignesh Talior, MD, role: CONTACT, phone: 317-944-6201, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
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protocolSection identificationModule nctId: NCT06310200, orgStudyIdInfo id: IRB-2023-398, briefTitle: Sphenopalatine Ganglion Block and Cold Induced Headaches, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Wright State University, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block, conditionsModule conditions: Cold Induced Headache, conditions: Brain Freeze, conditions: Cold Induced Cephalgia, conditions: Headache, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: All besides PI, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Lidocaine Topical 4% Topical Solution, interventions name: Bitrex, interventions name: normal saline, outcomesModule primaryOutcomes measure: Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia, secondaryOutcomes measure: Degree of pain, secondaryOutcomes measure: Duration of brain freeze, secondaryOutcomes measure: Time to onset of headache, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310187, orgStudyIdInfo id: STUDY00023967, secondaryIdInfos id: U54DA058271-01, type: NIH, link: https://reporter.nih.gov/quickSearch/U54DA058271-01, briefTitle: Little Cigar Oxidants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2029-08, completionDateStruct date: 2029-08, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 6 exposure groups. These include a high oxidant unflavored little cigar exposure condition, a low oxidant unflavored little cigar exposure condition, a high oxidant flavored exposure condition, a low oxidant flavored exposure little cigar exposure condition, their usual cigarette, and a control condition (unlit little cigar). Following the smoking of each product, exhaled breath condensate samples will be collected at baseline, 30, 60, 90, 120 and 150 minutes. Samples will be analyzed for levels of oxidant markers including hydrogen peroxide, 8-isoprostanes, and C-reactive protein, as well as nicotine, 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) and N'-nitrosonornicotine (NNN)., conditionsModule conditions: Tobacco Use, conditions: Oxidative Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Williams Design for Cross over-trials with a 6-period 6-treatment cross-over design in 36 healthy daily cigarette smokers., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: High Oxidant Unflavored Little Cigar - Group A, interventions name: Low Oxidant Unflavored Little Cigar - Group B, interventions name: High Oxidant Flavored Little Cigar - Group C, interventions name: Low Oxidant Flavored Little Cigar - Group D, interventions name: Usual Cigarette - Group E, interventions name: Unlit Little Cigar - Group F, outcomesModule primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Hydrogen Peroxide Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 8-isoprostanes Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: C-reactive Protein Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: Nicotine Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone [NNK] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, primaryOutcomes measure: N'-nitrosonornicotine [NNN] Concentration in Exhaled Breath Condensate, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310174, orgStudyIdInfo id: IRB00362883, briefTitle: Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications, acronym: SCAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-22, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife., conditionsModule conditions: Central Venous Catheter Exit Site Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 144, type: ESTIMATED, outcomesModule primaryOutcomes measure: User satisfaction with the new cannulation knife for CVC insertion., secondaryOutcomes measure: Frequency of skin incision revisions., secondaryOutcomes measure: Frequency of procedures being aborted and restarted., secondaryOutcomes measure: Frequency of reverting to use of the scalpel normally used to make the incision., secondaryOutcomes measure: Presence of a clean, dry dressing., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Lisa Fornaresio, PhD, role: CONTACT, phone: 443-927-3984, email: lisa.fornaresio@jhmi.edu, contacts name: Zyriah Robinson, role: CONTACT, phone: 443.927.3983, email: zyriah.robinson@jhmi.edu, contacts name: James Gammie, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06310161, orgStudyIdInfo id: 855161, briefTitle: Light Therapy in End Stage Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test light therapy in patients with end stage kidney disease who are receiving hemodialysis. The main aim is to determine if light therapy decreases fatigue severity. Participants will receive light therapy using special glasses for one hour during the dialysis sessions for four weeks of treatment., conditionsModule conditions: End Stage Renal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bright light, interventions name: Dim Light, outcomesModule primaryOutcomes measure: Fatigue Severity Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310148, orgStudyIdInfo id: UW 24-019, briefTitle: Evaluation of the Chronic Disease Co-Care Pilot Scheme, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Health and Medical Research Fund, collaborators name: Primary Healthcare Office, Hong Kong, descriptionModule briefSummary: The Chronic Disease Co-Care (CDCC) Pilot Scheme is initiated for early screening and management of people with hypertension (HT), pre-diabetes mellitus (pre-DM) and diabetes mellitus (DM) in Hong Kong. This study will evaluate the quality of care, feasibility, acceptability, effectiveness and cost-effectiveness of the Scheme.This is a 12-month cohort study among the District Health Centre (DHC) or DHC Express, healthcare providers, CDCC participants and a comparison group of 1,886 non-participants. All the person-in charge, 2 family doctors and 1 of each allied health provider from each DHC/DHC Express will be administered with the questionnaires on quality of care and costing. All CDCC participants will be included in subject characteristics, among which a convenience sample of 548 will complete a telephone survey on experience, enablement and satisfaction of the CDCC Pilot Scheme. The health outcomes of 1,886 CDCC participants and 1,886 non-participants will be compared for evaluation of effectiveness and cost-effectiveness.Participant characteristics, enablement, compliance to the standards of care, and costing of CDCC Pilot Scheme will be summarized using descriptive statistics. Differences in the proportion of patients meeting treatment targeted for HT, pre-DM and DM after 12 months will be compared by chi-squared test and logistic regressions. The incremental cost-effectiveness ratio will be evaluated by comparing with the World Health Organization (WHO) threshold. This study will inform future healthcare planning and policy for manpower and resource allocation., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Hypertension, conditions: Chronic Disease, conditions: Disease Management, conditions: Primary Healthcare, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 3772, type: ESTIMATED, armsInterventionsModule interventions name: The Chronic Disease Co-Care (CDCC) Pilot Scheme, outcomesModule primaryOutcomes measure: Characteristics of the Chronic Disease Co-Care (CDCC) participants, primaryOutcomes measure: Healthcare providers' adherence to care standards on the evaluation framework by the quality of care questionnaire, primaryOutcomes measure: Enablement of CDCC participants by the Chinese Patient Enablement Instrument, primaryOutcomes measure: Effectiveness of the CDCC Pilot Scheme on disease control for pre-diabetes mellitus (pre-DM) and DM in percent of Glycated Hemoglobin (HbA1c) and hypertension (HT) in millimeter of mercury of systolic blood pressure (SBP)/diastolic blood pressure (DBP), primaryOutcomes measure: The additional costs for delivering the CDCC Pilot Scheme by the costing questionnaire, primaryOutcomes measure: The cost-effectiveness for delivering the CDCC Pilot Scheme on the incremental cost-effectiveness ratio, secondaryOutcomes measure: Experience and satisfaction of CDCC participants by the experience and enablement questionnaire, secondaryOutcomes measure: Number of attendance to doctor consultation on times in comparison groups, secondaryOutcomes measure: Rate of diagnosis of HT and/or DM on dichotomous yes/no response in comparison groups, secondaryOutcomes measure: Changes in mean HbA1c/FPG in percent between two groups, secondaryOutcomes measure: Changes in mean SBP and DBP in millimeter of mercury between two groups, secondaryOutcomes measure: Changes in mean of HbA1c in percent between two groups, secondaryOutcomes measure: Changes in BMI in kilogram per square metre between two groups, secondaryOutcomes measure: Changes in the rate of smoking cessation and rate of alcohol abstinence between two groups by the Health Risk Factor Assessment, secondaryOutcomes measure: The predicted 10-year cardiovascular disease (CVD) risk between two groups, secondaryOutcomes measure: Amount of direct medical costs between two groups, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jockey Club Building for Interdisciplinary Research 5 Sassoon Road, Pok Fu Lam, HONG KONG, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Eric Yuk Fai Wan, role: CONTACT, phone: 852 28315057, phoneExt: 852 28147475, email: yfwan@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06310135, orgStudyIdInfo id: STUDY-23-00816, briefTitle: Filtered Eyewear to Prevent Light-induced Melatonin Suppression - Aim 1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine the relative effectiveness of monocular and binocular light exposures, with and without selective blue-blocking filtering, on nocturnal melatonin suppression, subjective sleepiness, and visual performance of night shift workers., conditionsModule conditions: Sleep Quality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Filtered Eyewear, interventions name: Unfiltered Eyewear, interventions name: No Filters, outcomesModule primaryOutcomes measure: Melatonin Levels, secondaryOutcomes measure: Karolinska Sleepiness scale to measure Subjective Sleepiness, secondaryOutcomes measure: Numerical Verification Task (NVT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Light and Health Research Center, city: Menands, state: New York, zip: 12204, country: United States, contacts name: Barbara Plitnick, RN, role: CONTACT, phone: 518-242-4603, email: barbara.plitnick@mountsinai.org, contacts name: Mariana Figueiro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.69202, lon: -73.72456, hasResults: False
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protocolSection identificationModule nctId: NCT06310122, orgStudyIdInfo id: ESWT on planter fascitis, briefTitle: Effect of Extracorporeal Shockwave Therapy on Gait Parameters in Patients With Planter Fascitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of this study is :* to determine the effect of extracorporeal shockwave on pain intensity in patients with plantar fasciitis.* to determine the effect of extracorporeal shockwave on foot function in patients with plantar fasciitis.* to determine the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis, conditionsModule conditions: Plantar Fascitis, conditions: Extracorporeal Shockwave Therapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups : group (A), group (B) One of them will receive traditional treatment ( ultra sound, exercises) Other one will recieve extracorporeal shockwave therapy and traditional treatment also, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Extracorporeal shockwave therapy, interventions name: ultrasound, outcomesModule primaryOutcomes measure: Stride length mean distance measured by (meter), primaryOutcomes measure: stride time mean time measured by (second), primaryOutcomes measure: speed mean distance/ time measured by (meter/second), primaryOutcomes measure: cadence mean number of steps /times., secondaryOutcomes measure: pain intensity level., otherOutcomes measure: Foot function, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310109, orgStudyIdInfo id: 2358_OPBG 2020, briefTitle: Effect of Pediatric Intensive Care Unit Diaries on PICS-p, acronym: PICS-p, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-14, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bambino Gesù Children's Hospital IRCCS, class: OTHER, collaborators name: Ministry of Health, Italy, descriptionModule briefSummary: When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge.To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge.The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too.The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference.The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved., conditionsModule conditions: Post Intensive Care Syndrome, conditions: Narrative Medicine, conditions: Post Traumatic Stress Disorder, conditions: Anxiety, conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: PICU diary, outcomesModule primaryOutcomes measure: Parent's Post Traumatic Stress Disease (PTSD), primaryOutcomes measure: Parent's Anxiety, primaryOutcomes measure: Child's Strengths and difficulties, primaryOutcomes measure: Child's Post Traumatic Stress Disease (PTSD), primaryOutcomes measure: Child's Anxiety, primaryOutcomes measure: Child's Depression, secondaryOutcomes measure: Satisfaction with PICU care, secondaryOutcomes measure: Patient's Quality of Life, eligibilityModule sex: ALL, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Bambino Gesù Children's Hospital IRCCS, status: RECRUITING, city: Rome, zip: 00165, country: Italy, contacts name: Orsola Gawronski, PhD, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06310096, orgStudyIdInfo id: E-59394181-604.01-79277, briefTitle: Role of Thoracolumbar Fascia Stretching on Pain Parameters With Non-Specific Chronic Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-11, completionDateStruct date: 2024-03-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Atılım University, class: OTHER, collaborators name: Kirsehir Ahi Evran Universitesi, descriptionModule briefSummary: Role of Thoracolumbar Fascia Stretching on Pain Parameters with Non-Specific Chronic Low Back Pain, conditionsModule conditions: Pain, conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: TLF fascial stretching exercise, interventions name: conventional physiotherapy program., outcomesModule primaryOutcomes measure: Pain threshold, primaryOutcomes measure: Temporal summation, primaryOutcomes measure: NRS(Numerical rating scales), secondaryOutcomes measure: Pain Sensitivity Scale (PSS), secondaryOutcomes measure: Brief Pain Inventory (BPI), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Atılım University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Naime Uluğ, PhD., role: CONTACT, phone: +905365434409, email: naime.ulug@atilim.edu.tr, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06310083, orgStudyIdInfo id: SMR for Turbinate Hypertrophy, briefTitle: Endoscopic Submucosal Resection Turbinoplasty VS Turbinectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ahmed Nabil Selim, class: OTHER, descriptionModule briefSummary: The aim of our study is to compare endoscopic submucosal resection Turbinoplasty and partial inferior turbinectomy regarding clinical and radiological evaluation and its possible complications in the treatment of Chronic inferior turbinate hypertrophy., conditionsModule conditions: Turbinate; Hypertrophy Mucous Membrane, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of 40 patients were enrolled in the study. The patients were randomly classified into two groups, with 20 in each group.Group A (study group): who applied for Endoscopic submucosal resection Turbinoplasty.Group B (control group): Who applied for partial inferior turbinectomy., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The surgeons performed the nasal surgery and evaluating postoperative measurable outcomes was blinded about cases who were subjected to Endoscopic submucosal resection Turbinoplasty, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Submucosal Resection Turbinoplasty Versus Partial Inferior Turbinectomy, outcomesModule primaryOutcomes measure: Nasal Obstruction, primaryOutcomes measure: Nasal Discharge, primaryOutcomes measure: Crustations, secondaryOutcomes measure: intra operative blood loss, secondaryOutcomes measure: Duration of operation (Minutes ), secondaryOutcomes measure: Hyposmia, otherOutcomes measure: Size Of Anterior part of Turbinate, otherOutcomes measure: Size Of Posterior part of Turbinate, otherOutcomes measure: Space of Anterior nasal Cavity, otherOutcomes measure: Space of posterior nasal Cavity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Azhar University Hospital of Assiut, city: Assiut, zip: 17511, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06310070, orgStudyIdInfo id: IRB-23-1965, briefTitle: 3D Printed Personalized Ostomy Appliance, acronym: 3DPPOA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03-05, primaryCompletionDateStruct date: 2025-03-05, completionDateStruct date: 2025-06-05, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Carilion Clinic, class: OTHER, collaborators name: Virginia Polytechnic Institute and State University, descriptionModule briefSummary: The goal of this clinical trial is to learn about the effectiveness of using a 3D scan for a personal ostomy appliance. The main question it aims to answer is:• Whether or not a 3D scan of a stoma reduces leakages and improves patient quality of life in regard to using a personalized ostomy appliance.Participants will* Spend 2 weeks with their standard of care ostomy appliance* Spend 2 weeks with their personalized ostomy appliance made from a 3D scan* Participate in daily surveys and weekly quality of life surveys conducted over the phone, conditionsModule conditions: 3D Printing, conditions: Ostomy, conditions: Leakage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 3D Printed Personalized Ostomy Appliance, outcomesModule primaryOutcomes measure: Incidence of Leaks, secondaryOutcomes measure: Number of appliances, secondaryOutcomes measure: Overall patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310057, orgStudyIdInfo id: 4139, briefTitle: Tofacitinib in the Treatment of Refractory Axial Spondyloarthritis Patients: A Dose Escalation Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, class: OTHER, collaborators name: Incepta Pharmaceuticals Ltd, descriptionModule briefSummary: The goal of this clinical trial is to assess the efficacy of tofacitinib in refractory axial spodyloarthritis (ax-SpA) with dose escalation from 10mg to 15mg. Patients will start on 10mg and then divided into 2 groups (10 and 15) at 3rd month according to major improvement criteria.The main question\[s\] it aims to answer are:* Efficacy and safety of tofacitinib in different doses* If escalation of tofacitinib is justified if clinical criteria is not fulfilled at 10mg, conditionsModule conditions: Axial Spondyloarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Dose escalation study, all the patients will recieve 10mg tofacitinib at the beginning. Then at 3rd month, one group will continue at 10mg, if they fulfill the ASDAS major improvement criteria and other group will escalate to 15mg., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ACTUAL, armsInterventionsModule interventions name: Tofacitinib, outcomesModule primaryOutcomes measure: To assess the ASDAS CRP major improvement criteria in refractory ax-SpA patients with dose escalation from 10mg to 15mg, secondaryOutcomes measure: Clinicodemographic characteristics of Ax-SpA, ASDAS CRP outcome rates, quality of life, adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bangabandhu Sheikh Mujib Medical University, city: Dhaka, zip: 1000, country: Bangladesh, geoPoint lat: 23.7104, lon: 90.40744, hasResults: False
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protocolSection identificationModule nctId: NCT06310044, orgStudyIdInfo id: Commiphora Myrrh, briefTitle: Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Clinically compare the post-operative pain, incidences post-operative swelling, post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation, versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit., conditionsModule conditions: Necrotic Pulp, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Root canal irrigant Commiphora Myrrh 50%, outcomesModule primaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: incidence of Post-operative swelling, otherOutcomes measure: Amount of intracanal Bacterial CFUs/ml, otherOutcomes measure: Number of analgesic Counting Tablets taken by the patient after endodontic treatment, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310031, orgStudyIdInfo id: CL-00545, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06310018, orgStudyIdInfo id: 2023A070902, briefTitle: Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE, acronym: SONIC-PE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Boston Scientific Corporation, descriptionModule briefSummary: SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding., conditionsModule conditions: Pulmonary Embolism, conditions: Right Ventricular Dysfunction, conditions: Right Ventricular Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: multicenter, prospective, single-arm study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis, outcomesModule primaryOutcomes measure: Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours, primaryOutcomes measure: Frequency of ISTH major bleeding at 72 hours, secondaryOutcomes measure: Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours, secondaryOutcomes measure: Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06310005, orgStudyIdInfo id: 1466-0003, briefTitle: A Study in Healthy Japanese Men to Test How Well Different Doses of BI 3006337 Are Tolerated, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-18, completionDateStruct date: 2024-10-18, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Trial consists of a single-rising dose (SRD) and multiple dose (MD) part. In SRD part, the groups will be dosed consecutively in ascending order. The decision proceeding to MD part will be based upon safety and tolerability of all the preceding dose groups in SRD part. Within each dose group, patients will be randomized to either BI 3006337 or placebo., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The trial is designed single-blind. The treatments administered (BI 3006337 or placebo) will be blinded to subjects but will be known to the investigators (outcome assessors)., whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: BI 3006337, interventions name: Placebo, outcomesModule primaryOutcomes measure: SRD + MD part: Percentage of patients with any treatment-emergent adverse event assessed as drug-related by the investigator, secondaryOutcomes measure: SRD part: Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf), secondaryOutcomes measure: SRD part: Maximum measured concentration of BI 3006337 in serum (Cmax), secondaryOutcomes measure: MD part: Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCtau, ss) after the last dose in Week 6, secondaryOutcomes measure: MD part: Maximum measured concentration of BI 3006337 in serum at steady state (Cmax, ss) after the last dose in Week 6, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Research Hospital Tokyo, status: RECRUITING, city: Tokyo, Shinjuku-ku, zip: 160-0004, country: Japan, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 0120201230, email: nippon@bitrialsupport.com, hasResults: False
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protocolSection identificationModule nctId: NCT06309992, orgStudyIdInfo id: 1404-0056, secondaryIdInfos id: 2023-505303-23-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1299-9925, type: REGISTRY, domain: WHO registry, briefTitle: A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2026-02-16, completionDateStruct date: 2026-03-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: This study is open to adults who are at least 18 years old and have* presumed or confirmed NASH together with overweight or obesity and* a body mass index (BMI) of 30 kg/m² or more, or* a BMI of 27 kg/m² and at least one weight-related health problem.People with a history of other chronic liver diseases cannot take part in this study.The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 13 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works., conditionsModule conditions: Obesity, conditions: Non-Alcoholic SteatoHepatitis (NASH), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Survodutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Relative reduction in liver fat content of at least 30% from baseline to Week 48 (yes/no) assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF), primaryOutcomes measure: Relative change (%) in body weight from baseline to Week 48, secondaryOutcomes measure: Absolute change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF, secondaryOutcomes measure: Relative change (%) from baseline to Week 48 in liver fat content assessed by MRI-PDFF, secondaryOutcomes measure: Reduction from baseline to Week 48 in Iron corrected T1 (cT1) levels of ≥80 ms (yes/no), secondaryOutcomes measure: Absolute change from baseline to Week 48 in alanine amino transferase (ALT) levels, secondaryOutcomes measure: Relative change from baseline to Week 48 in alanine amino transferase (ALT) levels, secondaryOutcomes measure: Absolute change from baseline to Week 48 in waist circumference [cm], secondaryOutcomes measure: Relative change from baseline to Week 48 in waist circumference [cm], secondaryOutcomes measure: Absolute change from baseline to Week 48 in Homeostasis Model Assessment -Insulin Resistance (HOMA-IR) (Fasting Plasma Insulin (FPI) [mlU/L] · Fasting Plasma Glucose (FPG) [mmol/L]/22.5), secondaryOutcomes measure: Absolute change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE), secondaryOutcomes measure: Relative change from baseline to Week 48 in liver stiffness assessed by magnetic resonance elastography (MRE), secondaryOutcomes measure: Absolute change in liver volume [mL] from baseline to Week 48 measured using MRI, secondaryOutcomes measure: Relative change in liver volume [mL] from baseline to Week 48 measured using MRI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Panax Clinical Research, status: RECRUITING, city: Miami Lakes, state: Florida, zip: 33014, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Verus Clinical Research Corporation, status: RECRUITING, city: Miami, state: Florida, zip: 33135, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Louisiana Research Center, LLC, status: RECRUITING, city: Shreveport, state: Louisiana, zip: 71105, country: United States, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 833-602-2368, email: unitedstates@bitrialsupport.com, geoPoint lat: 32.52515, lon: -93.75018, hasResults: False
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protocolSection identificationModule nctId: NCT06309979, orgStudyIdInfo id: 111-903, briefTitle: A Study to Assess Growth in Children With Idiopathic Short Stature, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2040-12-31, completionDateStruct date: 2040-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: BioMarin Pharmaceutical, class: INDUSTRY, descriptionModule briefSummary: Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest., conditionsModule conditions: Idiopathic Short Stature, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Change in annualized growth velocity (AGV), primaryOutcomes measure: Change in Height Z-score, primaryOutcomes measure: Change in Standing Height, primaryOutcomes measure: Change in BMI, primaryOutcomes measure: Change in BMI Z-score, secondaryOutcomes measure: Frequency of event rates of medical events of interest, secondaryOutcomes measure: Frequency of Serious Medical Events, secondaryOutcomes measure: Association between specific variants and growth velocity, secondaryOutcomes measure: Association between other health outcomes directly related to short stature, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's National Health System, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20010, country: United States, geoPoint lat: 38.89511, lon: -77.03637, hasResults: False
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protocolSection identificationModule nctId: NCT06309966, orgStudyIdInfo id: BHV7000-303, secondaryIdInfos id: 2023-808811-21-00, type: REGISTRY, domain: EU CTR, briefTitle: Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy, acronym: RISE 3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Biohaven Therapeutics Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy., conditionsModule conditions: Focal Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 390, type: ESTIMATED, armsInterventionsModule interventions name: BHV-7000, interventions name: BHV-7000, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline in 28-day average seizure frequency during Weeks 8 to 16 of Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dm Healthworks, status: NOT_YET_RECRUITING, city: Kissimmee, state: Florida, zip: 34741, country: United States, contacts name: Deeba Ahmad, role: CONTACT, phone: 407-716-1563, email: drdm22@gmail.com, geoPoint lat: 28.30468, lon: -81.41667, locations facility: Y&L Advance Health Care, Inc d/b/a Elite Clinical Research, status: NOT_YET_RECRUITING, city: Miami, state: Florida, zip: 33144, country: United States, contacts name: Yalexis Lorenzo, role: CONTACT, phone: 305-262-3396, email: ylorenzo@eliteclinicalresearch.com, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Research Institute of Orlando, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32806, country: United States, contacts name: Michelle Clevenger, role: CONTACT, phone: 407-652-6011, email: Michelle@researchinstituteoforlando.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Comprehensive Neurology Clinic, status: NOT_YET_RECRUITING, city: Orlando, state: Florida, zip: 32825, country: United States, contacts name: Elliuz Leal, role: CONTACT, phone: 407-208-0708, email: elealcrc@gmail.com, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Knight Neurology, status: RECRUITING, city: Rockledge, state: Florida, zip: 32955, country: United States, contacts name: Joseph Hilde, role: CONTACT, phone: 855-564-4484, email: jhilde01@knightneurology.com, geoPoint lat: 28.35084, lon: -80.72533, locations facility: PENS, status: RECRUITING, city: Tampa, state: Florida, zip: 33609, country: United States, contacts name: Susan Ngo, role: CONTACT, phone: 813-873-7367, email: sngo@pensresearch.org, geoPoint lat: 27.94752, lon: -82.45843, locations facility: University Medical Center New Orleans, status: NOT_YET_RECRUITING, city: New Orleans, state: Louisiana, zip: 70112, country: United States, contacts name: Heather Scuderi, role: CONTACT, phone: 504-702-4624, email: heather.scuderi@lcmchealth.org, geoPoint lat: 29.95465, lon: -90.07507, locations facility: DelRicht Research, status: NOT_YET_RECRUITING, city: New Orleans, state: Louisiana, zip: 70119, country: United States, contacts name: Reggie Mister, role: CONTACT, phone: 504-336-2667, email: rmister@delricht.com, geoPoint lat: 29.95465, lon: -90.07507, locations facility: UNC-Chapel Hill, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27514, country: United States, contacts name: Monica Coudurier, role: CONTACT, phone: 919-966-6727, email: m_coudurier@unc.edu, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Cincinatti Children's Hospital, status: NOT_YET_RECRUITING, city: Cincinnati, state: Ohio, zip: 45229, country: United States, contacts name: Nikki Kamos, role: CONTACT, phone: 513-803-4552, email: nichole.kamos@cchmc.org, geoPoint lat: 39.12713, lon: -84.51435, locations facility: MUSC, status: NOT_YET_RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: Robin Bulgarino, role: CONTACT, phone: 843-792-1115, email: bulgarino@musc.edu, geoPoint lat: 32.77657, lon: -79.93092, locations facility: WR-ClinSearch, status: NOT_YET_RECRUITING, city: Chattanooga, state: Tennessee, zip: 37421, country: United States, contacts name: Jessica Benvenuto, role: CONTACT, phone: 423-698-4584, email: jbenvenuto@wakeresearch.com, geoPoint lat: 35.04563, lon: -85.30968, locations facility: ANESC Research, status: NOT_YET_RECRUITING, city: El Paso, state: Texas, zip: 79912, country: United States, contacts name: Shruti Konda, role: CONTACT, phone: 915-974-2200, phoneExt: 3, email: shrutik@anesc.net, geoPoint lat: 31.75872, lon: -106.48693, locations facility: UTHealth Houston, status: NOT_YET_RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Maria Poblete, role: CONTACT, phone: 713-500-7201, email: Maria.Poblete@uth.tmc.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06309953, orgStudyIdInfo id: 937, briefTitle: A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Bausch & Lomb Incorporated, class: INDUSTRY, descriptionModule briefSummary: An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease, conditionsModule conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Miebo, outcomesModule primaryOutcomes measure: Mean change from baseline (CFB) in dry eye symptom severity at Visit 3, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 205, status: NOT_YET_RECRUITING, city: Petaluma, state: California, zip: 94954, country: United States, geoPoint lat: 38.23242, lon: -122.63665, locations facility: Site 203, status: RECRUITING, city: Pittsburg, state: Kansas, zip: 66762, country: United States, geoPoint lat: 37.41088, lon: -94.70496, locations facility: Site 204, status: NOT_YET_RECRUITING, city: Stillwater, state: Minnesota, zip: 55082, country: United States, geoPoint lat: 45.05636, lon: -92.80604, locations facility: Site 202, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64154, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Site 201, status: NOT_YET_RECRUITING, city: Brecksville, state: Ohio, zip: 44141, country: United States, geoPoint lat: 41.31978, lon: -81.62679, hasResults: False
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protocolSection identificationModule nctId: NCT06309940, orgStudyIdInfo id: Basal ganglionic haemorrhage, briefTitle: Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate, conditionsModule conditions: Basal Ganglionic Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Prognostic factors of surgical evacuation of basal ganglionic haemorrhage, outcomesModule primaryOutcomes measure: Prognostic factors of surgical evacuation of basal ganglionic haemorrhage, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309927, orgStudyIdInfo id: 0025-24-ASF, briefTitle: Operative Hysteroscopy Versus Suction Curettage for Surgical Termination of Early Pregnancy Loss (Miscarriage), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Assaf-Harofeh Medical Center, class: OTHER_GOV, descriptionModule briefSummary: Non-blinded prospective randomized study. 100 women diagnosed with early pregnancy loss up to 10 gestational weeks who opted for surgical management (after being offered the options of conservative management and medical treatment) will be recruited.Qualifying patients will sign an informed consent form and will be randomly assigned to the two arms of the study:1. Surgical uterine evacuation by the traditional ultrasound-guided suction curettage (control group)2. Surgical uterine evacuation by operative hysteroscopy using a tissue removal device (study group).The surgical procedure will be determined randomly by computer generated allocation.All surgical procedures will be performed under general anesthesia in an outpatient surgical suite. The operative time, operative blood loss and intraoperative complications will be recorded by the research team.Following the surgical procedure, the patients will be monitored and discharged home as per our department's day-surgery protocol. Immediate post-operative complications will be recorded until discharge.One week after the procedure, a telephone interview will be conducted to assess any procedure-related complications.A diagnostic hysteroscopy without anesthesia will be scheduled 6 weeks postoperatively to assess for retained products of conception and for intrauterine adhesions. The diagnostic hysteroscopy will be performed by a practitioner who will be blinded to the type of surgery performed.6 months after the procedure, a telephone questionnaire will be conducted to assess for subsequent pregnancies., conditionsModule conditions: Early Pregnancy Loss, conditions: Intrauterine Adhesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Operative hysteroscopy (by tissue removal device), interventions name: Suction curettage, outcomesModule primaryOutcomes measure: Operative complications, primaryOutcomes measure: Intrauterine adhesions, primaryOutcomes measure: Subsequent fertility, secondaryOutcomes measure: Conversion from operative hysteroscopy to suction curettage, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shamir Medical Center, city: Be'er Ya'aqov, zip: 70200, country: Israel, contacts name: Noam Smorgick, MD, role: CONTACT, email: nsmorgik@shamir.gov.il, geoPoint lat: 31.93864, lon: 34.83749, hasResults: False
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protocolSection identificationModule nctId: NCT06309914, orgStudyIdInfo id: Pro00074459, briefTitle: The Effects of Mirtoselect®, Virtiva®, and Enovita® on Cognitive Performance and Mood States, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-05-06, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Applied Science & Performance Institute, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, double-blind, placebo-controlled, 4-week intervention clinical study assessing the efficacy of Mirtoselect®, Virtiva® Plus, and Enovita® on cognitive performance and mood states, and the occurrence of adverse events in response to daily supplementation. The desired sample size for this study is 64 subjects. To account for potential dropouts, we aim to enroll up to 20% over the desired sample size. Therefore, this study will enroll up to 76 healthy men and women (25-55 years of age). Subjects will be randomly divided into four study groups: Placebo, Virtiva® ginkgo biloba extract, Mirtoselect® bilberry extract, or Enovita® grape seed extract. Blocked randomization will be deployed in which subjects are divided into blocks of 4 subjects and each subject within a block is randomly assigned to one of the four study groups., conditionsModule conditions: Mental Processes, conditions: Cognitive Change, conditions: Mood Change, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Enovita Grape Seed Extract, interventions name: Mirtoselect Bilberry Extract, interventions name: Virtiva Plus Ginko Biloba Extract, outcomesModule primaryOutcomes measure: Change in Visual Memory, primaryOutcomes measure: Change in Verbal Memory, primaryOutcomes measure: Change in Finger Tapping Test (FTT) Results, primaryOutcomes measure: Change in Symbol Digit Coding (SDC) Test Results, primaryOutcomes measure: Change in Stroop Test Results, primaryOutcomes measure: Change in Shifting Attention Test Results, primaryOutcomes measure: Change in Continuous Performance Test Results, secondaryOutcomes measure: Change in Abbreviated Profile of Mood States (POMS) Score, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Applied Science and Performance Institute, status: RECRUITING, city: Tampa, state: Florida, zip: 33607, country: United States, contacts name: Jacob Wilson, PhD, role: CONTACT, phone: 813-673-8888, email: jwilson@theaspi.com, contacts name: Justine Davis, MS, role: CONTACT, phone: 813-673-8888, email: jdavis@theaspi.com, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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protocolSection identificationModule nctId: NCT06309901, orgStudyIdInfo id: ankaraYBU2019-199, briefTitle: Facial Distortion Model and Instrument Assisted Soft Tissue Mobilization Techniques, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-30, primaryCompletionDateStruct date: 2021-12-01, completionDateStruct date: 2022-05-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: To compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair., conditionsModule conditions: Meniscus Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 33, type: ACTUAL, armsInterventionsModule interventions name: Exercise, interventions name: Fascial Distortion Model, interventions name: Instrument Assisted Soft Tissue Mobilisation, outcomesModule primaryOutcomes measure: Visual Analog Scale, primaryOutcomes measure: environmental measurement, primaryOutcomes measure: Power Track Manuel Muscle Tester, primaryOutcomes measure: sit and reach test, primaryOutcomes measure: Goniometric measurement, primaryOutcomes measure: The Western Ontario Meniscal Evaluation Tool (WOMET ), primaryOutcomes measure: Lysholm Knee Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yıldırım Beyazıt University Yenimahalle Training and Research Hospital, city: Ankara, zip: 06010, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06309888, orgStudyIdInfo id: 2023-18, briefTitle: Magnetic Resonance Imaging of Cognitive Deficits in the Brain of Individuals With Spinal Cord Injury, acronym: SCI_Cog, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Swiss Paraplegic Research, Nottwil, class: NETWORK, descriptionModule briefSummary: In the case of spinal cord injury, rehabilitation is particularly focused on motor skills. Non-motor impairments such as thinking difficulties did not receive a lot of attention to date.In this research project, the investigators want to find out how thinking difficulties become noticeable in the brain with spinal cord injury.Participation procedure: Participants who take part will be asked to come to an examination once. The duration of the examination is between 2 and 2.5 hours (including around 55 minutes in the magnetic resonance imaging scanner, including preparation and follow-up)., conditionsModule conditions: Spinal Cord Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Brain activity, secondaryOutcomes measure: Behavioral performance, secondaryOutcomes measure: Behavioral performance, secondaryOutcomes measure: Behavioral performance, secondaryOutcomes measure: Behavioral performance, secondaryOutcomes measure: Behavioral performance, secondaryOutcomes measure: Brain morphometry, secondaryOutcomes measure: Level of life satisfaction, secondaryOutcomes measure: Level of anxiety, secondaryOutcomes measure: Level of pain, secondaryOutcomes measure: Quality of sleep, secondaryOutcomes measure: Level of attention and awareness, secondaryOutcomes measure: Motor symptom severity, secondaryOutcomes measure: Demographics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Swiss Paraplegic Research, status: RECRUITING, city: Nottwil, state: Lucerne, zip: 6207, country: Switzerland, contacts name: Jothini Sritharan, MSc, role: CONTACT, phone: +41419396557, email: jothini.sritharan@paraplegie.ch, contacts name: Jothini Sritharan, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 47.13472, lon: 8.13772, hasResults: False
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protocolSection identificationModule nctId: NCT06309875, orgStudyIdInfo id: ENF- 25-2018, briefTitle: Effect of the PLAN CUIDARTE on the Caregiving Competence of People With Heart Failure, acronym: PLANCUIDARTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-06-25, completionDateStruct date: 2024-11-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Universidad de la Sabana, class: OTHER, collaborators name: Universidad de Caldas, descriptionModule briefSummary: According to the World Health Organization (WHO), by 2021 cardiovascular diseases (CVD) will be a public health problem, among them heart failure (HF), since this is a chronic disease, patients should be competent in their care. Despite the above, according to research conducted in Colombia, 59.7% of people with chronic noncommunicable diseases (NCDs) have a level of care competence considered not optimal; patients report not having sufficient knowledge of the disease or experience feelings of lack of tools for the management of symptoms and the challenges of post-hospitalization.The objective of the research is to determine the effect of the PLAN CUIDARTE on the caregiving competence of people with HFMethodology: Pre-posttest randomized clinical trial, with blinding of the participants, where the intervention "PLAN CUIDARTE" is applied and the initial and subsequent caregiving competence is evaluated in the comparison group and in the intervention group for pretest - posttest and between-group comparisons., conditionsModule conditions: Heart Failure, conditions: Caregiver Burden, conditions: Discharge Plan, conditions: Care Transitions, conditions: Nursing, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A pre-post test Randomized Clinical Trial (RCT) is proposed with a comparison group, with blinding of the participants with blinding of the participants, with application of a pilot test beforehand. pilot test.The intervention group is established as the group that receives the PLAN CUIDARTE (intervention described later) and as a comparison group the one receiving the conventional discharge plan (described later), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: PLAN CUIDARTE, interventions name: Conventional care, outcomesModule primaryOutcomes measure: Care Competence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad de Caldas, city: Manizales, state: Caldas, zip: 170004., country: Colombia, contacts name: Claudia Marcela Vallejo, Mag, role: CONTACT, phone: +573163614224, email: marcela.vallejo@ucaldas.edu.co, geoPoint lat: 5.06889, lon: -75.51738, hasResults: False
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protocolSection identificationModule nctId: NCT06309862, orgStudyIdInfo id: 5993, briefTitle: Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Sunnybrook Health Sciences Centre, class: OTHER, descriptionModule briefSummary: Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes., conditionsModule conditions: Cardio-Oncology, conditions: Cardiomyopathy Due to Drug, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Define changes in CMR tissue and blood biomarkers during ICI treatment., primaryOutcomes measure: Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction., primaryOutcomes measure: Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309849, orgStudyIdInfo id: Jerash University, briefTitle: Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail"., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: South Valley University, class: OTHER, descriptionModule briefSummary: Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear., conditionsModule conditions: Cervical Radiculopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trail (RCT) will be used in the study. Participants will be dived into experimental group and control group. Each group will includes 30 participants., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: includes 30 participants., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Manual physiotherapy intervention( cervical traction, suboccipital release, muscle energy technique), outcomesModule primaryOutcomes measure: 1-Hart Rate (HR) (bpm) using Electro Cardiac Graphic (ECG). 2- Blood pressure (mm Hg) using Sphygmomanometer., secondaryOutcomes measure: 3- Range of Motion (ROM) (in degrees) of the cervical spine using Electro-Goniometer. 4- the pain using Visual Analogue Scale (VAS) from (0-10), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06309836, orgStudyIdInfo id: SID03, briefTitle: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma, acronym: REGISTRO-BCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-23, primaryCompletionDateStruct date: 2024-06-23, completionDateStruct date: 2024-06-23, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse, class: OTHER, descriptionModule briefSummary: Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma., conditionsModule conditions: Basal Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: clinical evolution, treatment and prognosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs Fondazione Policlinico Gemelli, status: RECRUITING, city: Roma, state: ITA, zip: 00168, country: Italy, contacts name: peris MD Peris, role: CONTACT, phone: 0630154211, email: ketty.peris@unicatt.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06309823, orgStudyIdInfo id: 1000080330, briefTitle: A Single-patient Clinical Trial of MAS825 in a Patient With XIAP Deficiency, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-08, primaryCompletionDateStruct date: 2024-01-17, completionDateStruct date: 2024-01-17, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: The Hospital for Sick Children, class: OTHER, descriptionModule briefSummary: MAS825 is a bi-specific IgG1 monoclonal antibody that simultaneously targets IL-1 beta and IL-18, thereby neutralizing both cytokines that are thought to be integral to the pathogenesis of XLP-2. Clinical trials are currently examining its efficacy in other diseases associated with elevations of these cytokines, including NLRC4-associated disease and hidradenitis suppurativa. This study proposes to assess the effectiveness of MAS825 in a single patient with XLP-2, who has previously demonstrated response to blockade of IL-1 beta and IL-18. Given the lack of alternative pharmaceutical options for XLP-2, this represents the only known medication option that avoids the toxicity associated with high-dose corticosteroids and the morbidity associated with hematopoietic stem cell transplantation., conditionsModule conditions: X-linked Lymphoproliferative Syndrome Type 2 (XLP-2), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ACTUAL, armsInterventionsModule interventions name: MAS825, outcomesModule primaryOutcomes measure: Impact of MAS825 on Physician Global Assessment Score, primaryOutcomes measure: Impact of MAS825 on Physician Severity Assessment of Disease Signs and Symptoms, primaryOutcomes measure: Patient/Parent Global Assessment of Disease Activity, eligibilityModule sex: MALE, minimumAge: 13 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: The Hospital for Sick Children, city: Toronto, state: Ontario, zip: M5G1X8, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06309810, orgStudyIdInfo id: 2022-35, briefTitle: Stereotactic Radiosurgery (SRS) in Malignant Spasticity and Hypertonia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is a pilot, experimental, monocentric study. The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view, and therefore induce an improvement in posture and quality of life in patients with malignant spasticity.The study foresees the enrollment of about 10 patients, in a period of 24 months. The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique, and a prescription dose between 45 and 60 Gy; subsequently the patients will be followed up for one year., conditionsModule conditions: Spasticity/Paresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, outcomesModule primaryOutcomes measure: MAS, secondaryOutcomes measure: Acute and late toxicity (CTCAE), secondaryOutcomes measure: Quality of life (SF-12), secondaryOutcomes measure: Quality of nursing (VAS), secondaryOutcomes measure: Radiological characteristics and treatment-related changes of the spinal roots, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria di Negrar, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Luca Nicosia, Doctor, role: CONTACT, phone: +39(0)456014800, email: luca.nicosia@sacrocuore.it, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
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protocolSection identificationModule nctId: NCT06309797, orgStudyIdInfo id: OSATAGUN2, briefTitle: Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-02, primaryCompletionDateStruct date: 2024-01-26, completionDateStruct date: 2024-02-05, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Özlem SARAÇ ATAGÜN, class: OTHER, descriptionModule briefSummary: This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: single-center, single-blinded, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The investigator carrying out the measurements was not aware of which patients were assigned to the test group., whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Interdental brush+HA, interventions name: Interdental brush, outcomesModule primaryOutcomes measure: Gingival index (GI), primaryOutcomes measure: Plaque index (PI), primaryOutcomes measure: Papillary bleeding index (PBI), primaryOutcomes measure: Pocket depth (PD), primaryOutcomes measure: Clinical attachment loss (CAL), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi, city: Ankara, zip: 06010, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06309784, orgStudyIdInfo id: RD 2595, secondaryIdInfos id: NIHR II-LA-1116-20004, type: OTHER_GRANT, domain: NIHR, briefTitle: Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Royal United Hospitals Bath NHS Foundation Trust, class: OTHER, collaborators name: University of Bath, collaborators name: Great Western Hospitals NHS Foundation Trust, descriptionModule briefSummary: The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess:Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff, conditionsModule conditions: Orthopaedic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants undergoing orthopaedic Surgery, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Drill Guidance System (DGS), outcomesModule primaryOutcomes measure: Accuracy of placement of a screw or K wire in scaphoid bones, primaryOutcomes measure: Accuracy of placement of a screw or K wire in other bones, secondaryOutcomes measure: Length of material part of the procedure, secondaryOutcomes measure: Number of fluoroscopy (perioperative X-ray) images performed, secondaryOutcomes measure: Number of patients with treatment related adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Immediate acceptability to surgeons and theatre staff, secondaryOutcomes measure: Initial acceptability to surgeons and theatre staff, secondaryOutcomes measure: Overall acceptability to surgeons and theatre staff, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal United hospitals NHS Foundation Trust, status: RECRUITING, city: Bath, country: United Kingdom, contacts name: Jane Carter, BSc, role: CONTACT, phone: 01225821095, email: jane.carter14@nhs.net, geoPoint lat: 51.3751, lon: -2.36172, locations facility: Great Western Hospital MHS foundation Trust, status: RECRUITING, city: Swindon, country: United Kingdom, contacts name: Adam Smith, FRCS, role: CONTACT, phone: 07533793889, email: adam.smith@doctors.org.uk, geoPoint lat: 51.55797, lon: -1.78116, hasResults: False
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protocolSection identificationModule nctId: NCT06309771, orgStudyIdInfo id: PROMESS - QOL, briefTitle: Preventive Remediation for Optimal MEdical StudentS (PROMESS), acronym: PROMESS, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Research on Healthcare Performance Lab U1290, class: OTHER, descriptionModule briefSummary: Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance.The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective.Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future.The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life and academic performance of 2nd cycle medical students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers., conditionsModule conditions: Health Behavior, conditions: Health-Related Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled clinical trial. Randomization into two groups: INTERVENTION group and CONTROL group. The INTERVENTION group will have the opportunity to follow a preventive remediation program based on 3 modules: stress management, sleep improvement and fatigue reduction, and sedentary behaviors reduction and physical activity promotion. The order of following the 3 modules will be randomized. The CONTROL group will not receive any intervention., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Assessors of pre and posttest measures will be blinded to the group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Stress management, sleep improvement and fatigue reduction, sedentary behaviors reduction and physical activity promotion., outcomesModule primaryOutcomes measure: Quality of life. Change from pre-intervention in a composite score obtained at the Brief Quality Of Life questionnaire at the post-interventional measure at Week 27., secondaryOutcomes measure: Academic self-efficacy. Change from the pre-intervention in score obtained at the Academic self-efficacy questionnaire at the post-interventional measure at Week 27., secondaryOutcomes measure: Wu self efficacy questionnaire. Change from pre-intervention in score obtained at the adapted Wu self efficacy questionnaire at the post-interventional measure at Week 27., secondaryOutcomes measure: Academic performances. Scores and ranks obtained at all the official exams during the 2023-2024 academic year., secondaryOutcomes measure: VAS - quality of life. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of Quality Of Life, secondaryOutcomes measure: VAS - self-confidence. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-confidence., secondaryOutcomes measure: VAS - self-efficacy. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of self-efficacy., secondaryOutcomes measure: VAS - resources. Evolution of the score obtained at the 100-mm Visual Analogue Scale assessing the perceived level of resources., secondaryOutcomes measure: VAS - work-life balances. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the work-life balances., secondaryOutcomes measure: VAS - stressors quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived quantity of stressors., secondaryOutcomes measure: VAS - stress quality: Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the emotional valence associated with the stress level., secondaryOutcomes measure: VAS - stress coping. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the management of stressful situations., secondaryOutcomes measure: VAS - stress quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of stress., secondaryOutcomes measure: VAS - sleep quality. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) characterizing the sleep quality., secondaryOutcomes measure: VAS - sleep quantity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the quantity of sleep., secondaryOutcomes measure: VAS - sleep fatigue. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of fatigue., secondaryOutcomes measure: VAS - physical fitness. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of physical fitness., secondaryOutcomes measure: VAS - physical activity. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the level of physical activity., secondaryOutcomes measure: VAS - sedentary behaviors. Evolution of the score obtained at the 100-mm Visual Analogue Scale (VAS) assessing the perceived level of sedentary behaviors., secondaryOutcomes measure: Perceived level of stress. Change from pre-intervention in score obtained at the Perceived Stress Scale (PSS) at the post-interventional measure at Week 27., secondaryOutcomes measure: Coping strategies.Change from pre-intervention in scores obtained at the Brief Cope Inventory (BCI) at the post-interventional measure at Week 27., secondaryOutcomes measure: Quantity of stressors. Score obtained at the Holmes and Rahe Questionnaire Inventory during the pre-intervention., secondaryOutcomes measure: Big-5. Scores obtained at the Big-5 questionnaire., secondaryOutcomes measure: Perceived level of sleep troubles. Change from pre-intervention in score obtained at the Pittsburgh Sleep Questionnaire Inventory (PSQI) at the post-interventional measure at Week 27., secondaryOutcomes measure: Epworth Sleepiness scale. Change from the pre-intervention in score obtained at the Epworth Sleepiness scale at the post-interventional measure at Week 27., secondaryOutcomes measure: Multidimensional Fatigue. Change from the pre-intervention in score obtained at the Multidimensional Fatigue Inventory (MFI) at the post-interventional measure at Week 27., secondaryOutcomes measure: Reduced composite scale of morningness. Score obtained at the reduced composite scale of morningness (RCSMS)., secondaryOutcomes measure: Perceived level of physical activity. Change from the pre-intervention in score obtained at the Global Physical Activity Questionnaire (GPAQ) at the post-interventional measure at Week 27., secondaryOutcomes measure: Perceived level of sedentary. Change from the pre-intervention in score obtained at the Rapid Physical Activity Questionnaire (RPAQ) at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in cardiac coherence at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in the SDNN score in at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in the RMSSD score in at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) marker. Change from pre-intervention in the pnn50% score in at the post-interventional measure at Week 27., secondaryOutcomes measure: Heart rate variability (HRV) markers.Change from pre-intervention in the Low frequency / High frequency ratio (LF/HF) ratio in at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Time in Bed at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Total Sleep duration at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep efficiency at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep Onset Latency at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Wake after Sleep Onset at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Number of Awakenings at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Mid-sleep point at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Bedtime at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep Onset time at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep Inertia at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Wake-up time at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sleep regularity index at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Total activity at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Moderate-to-vigorous Physical Activity (MVPA) at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in light physical activity at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Steps count at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in energy expenditure at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in sedentary breaks at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in Sedentary time at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in prolonged sedentary bouts at the post-interventional measure at Week 27., secondaryOutcomes measure: Actimetry records. Change from pre-intervention in vector of the dynamic body acceleration (VeDBA) at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Strength. Change from pre-intervention in the force developed during a maximal isometric contraction of the quadriceps at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Power. Change from pre-intervention in height of jump at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Power. Change from pre-intervention in time of flight at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Power. Change from pre-intervention in relative power at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Endurance. Change from pre-intervention in speed through the endurance test at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Endurance. Change from pre-intervention in VO2max through the endurance test at the post-interventional measure at Week 27., secondaryOutcomes measure: Physical fitness markers - Endurance. Change from pre-intervention in heart rate during the endurance test at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers. Change from the pre-intervention in Body Mass Index (BMI) at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers. Change from the pre-intervention in fat mass at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers. Change from the pre-intervention in Skeletal muscle mass at the post-interventional measure at Week 27., secondaryOutcomes measure: Body composition markers.Change from the pre-intervention in total body hydration at the post-interventional measure at Week 27., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the stress module., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sedentary behaviors and physical activity module., secondaryOutcomes measure: Composite score - Student's satisfaction. Score ranging from 0 to 100 accessing the student's level of satisfaction of the sleep module., secondaryOutcomes measure: Question recommendation. Answer to the question "Would you recommend a friend to participate at the PROMESS project?" asked during the post-intervention., secondaryOutcomes measure: Question Habits change. Answer to the question "Do you think that your participation at the PROMESS project has modified your health behaviors/actions?" asked during the post-intervention., secondaryOutcomes measure: Question Habits change. Answer to the question ""For which behaviors do you think you have modified your habits/actions?" asked during the post-intervention., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RESHAPE, city: Lyon, zip: 69008, country: France, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
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protocolSection identificationModule nctId: NCT06309758, orgStudyIdInfo id: 115022, briefTitle: BreinZorg: Feasibility Study Into an Online Lifestyle Platform for MCI and SCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Radboud University Medical Center, class: OTHER, descriptionModule briefSummary: Dementia is the most common disease in older individuals and this century's biggest healthcare challenge. Many patients who visit the memory clinic with memory complaints do not have dementia but instead are diagnosed with mild cognitive impairment (MCI) or subjective cognitive decline (SCD). MCI or SCD may be a pre-dementia stage. Many patients with MCI or SCD often leave their consultation with unanswered questions, and unsure what they, themselves can do to reduce dementia risk. Patients with MCI and SCD have a heightened risk of developing dementia. Therefore, this group would possibly benefit most from preventive strategies. Around 40% of dementia cases is attributable to modifiable factors. Thus, managing a healthy lifestyle may reduce dementia risk.To answer the information request many patients have when leaving the memory clinic and to fill the knowledge gap an online tool has been developed.The goal of this mixed-method feasibility study is to investigate the usability, feasibility, patient experience, and effectiveness of the personalized, multi-domain online website in older adults with MCI or SCD.The main questions it aims to answer are:* Is the new website being used by the target population?* How does the target population experience the use of the website?* What is the effect of using the website?Participants will have access to the website and are free to use the website in any way they want., conditionsModule conditions: Mild Cognitive Impairment, conditions: Cognitive Decline, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: mixed-method study with a single-arm pre-post design with a duration of 3 months and extended follow-up after 6 months., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Breinzorg, outcomesModule primaryOutcomes measure: Acceptability of the new online website following the theoretical framework of acceptability, primaryOutcomes measure: Adoption / Uptake of the new online website. Website usage data., primaryOutcomes measure: Demand of the new online website. Website usage data., primaryOutcomes measure: Practicality of the new online website., primaryOutcomes measure: Feeling of trust in yourself and your own abilities., primaryOutcomes measure: Feeling of control about own life and future., primaryOutcomes measure: Motivation to change lifestyle for reduction of dementia risk., primaryOutcomes measure: Awareness about dementia risk reduction, secondaryOutcomes measure: Change in alcohol consumption, secondaryOutcomes measure: Change in smoking behaviour, secondaryOutcomes measure: Change in physical exercise., secondaryOutcomes measure: Change in Diet., secondaryOutcomes measure: Change in Sleep behaviour, secondaryOutcomes measure: Change in cognitive activities., secondaryOutcomes measure: Change in Stress levels, secondaryOutcomes measure: Change in Mental health Quality of Life, eligibilityModule sex: ALL, minimumAge: 61 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309745, orgStudyIdInfo id: THERATEST, briefTitle: THERApy De-escalation for TESTicular Cancer, acronym: THERATEST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: THERATEST is looking to collect data from 30 patients actively receiving de-escalation treatments or other standard of care treatments in two UK hospitals. THERATEST is a feasibility study to determine whether patients are willing to be recruited, the impact of de-escalation treatments on patients' cancers and quality of life, whether we should proceed with these treatments in a larger study, and if so how the study should be conducted. A feasibility study prepares the ground for a larger study and improves the chances of the subsequent study producing valuable evidence, and helps to avoid wasting precious resources on larger trials that are unlikely to be informative. We hope that information from THERATEST will bridge the current knowledge gap and allow clinicians to design bigger trials to actively compare the different treatment strategies., conditionsModule conditions: Seminoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: retroperitoneal lymph node dissection, interventions name: Carboplatin AUC10, outcomesModule primaryOutcomes measure: FEASIBILITY of recruitment and retention, secondaryOutcomes measure: QUALITY OF LIFE assessed by difference in HRQOL scores, secondaryOutcomes measure: QUALITY OF LIFE assessed by difference in differences in sexual drive, function, and overall satisfaction, secondaryOutcomes measure: Progression free SURVIVAL, secondaryOutcomes measure: OVERALL SURVIVAL, secondaryOutcomes measure: SAFETY and complication of all treatments, eligibilityModule sex: MALE, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barts and London Hospital NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: THERATEST Study coordinator, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06309732, orgStudyIdInfo id: 4491, secondaryIdInfos id: 2006-001963-52, type: EUDRACT_NUMBER, secondaryIdInfos id: TE 2006-09, type: OTHER, domain: Barts and the London NHS Trust, briefTitle: GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT), acronym: GAMEC-II, statusModule overallStatus: COMPLETED, startDateStruct date: 2006-07, primaryCompletionDateStruct date: 2013-06, completionDateStruct date: 2014-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, descriptionModule briefSummary: St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects., conditionsModule conditions: Testicular Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Pegfilgrastim, interventions name: Dactinomycin, interventions name: Methotrexate, interventions name: Etoposide, interventions name: Cisplatin, interventions name: Epirubicin, outcomesModule primaryOutcomes measure: Response rate to GAMEC-S or GAMEC-A, secondaryOutcomes measure: Relapse-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: MALE, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Barts and the London NHS Trust, city: London, zip: EC1A 7BE, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06309719, orgStudyIdInfo id: 339479, briefTitle: Hyaluronic Acid and Polynucleotides for Supra-bony Defects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, collaborators name: Geistlich Pharma AG, descriptionModule briefSummary: The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel., conditionsModule conditions: Periodontal Diseases, conditions: Wound Heal, conditions: Periodontal Inflammation, conditions: Periodontal Pocket, conditions: Periodontal Attachment Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Periodontal Access Flap (AF) + Combined Formulation of Hyaluronic acid and Polydeoxyribonucleotides (PNHA), interventions name: Periodontal Access Flap (AF), outcomesModule primaryOutcomes measure: Early wound healing molecular events through GCF, primaryOutcomes measure: Early gingival tissue vascularization pattern when supra-bony defects are treated with AF, in association or not with PNHA, secondaryOutcomes measure: Periodontal parameters and periodontal inflamed surface area (PISA) on the teeth involved in the surgery, secondaryOutcomes measure: Probing pocket depth (PPD), secondaryOutcomes measure: Gingival recession (REC), secondaryOutcomes measure: Clinical attachment level (CAL), secondaryOutcomes measure: Suppuration, secondaryOutcomes measure: Gingival phenotype, secondaryOutcomes measure: Keratinized tissue (KT), secondaryOutcomes measure: Full mouth plaque score (FMPS), secondaryOutcomes measure: Full mouth bleeding score (FMBS), secondaryOutcomes measure: Early Healing Index (EHI), secondaryOutcomes measure: Gingival morphometric changes, secondaryOutcomes measure: Oral impact on daily performance (OIDP), secondaryOutcomes measure: Dentine/root sensitivity, secondaryOutcomes measure: Food impaction, secondaryOutcomes measure: Patient perception about therapy, secondaryOutcomes measure: Global ratings of Periodontal Health and Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barts Health NHS Trust Dental Hospital, city: London, zip: E1 1BB, country: United Kingdom, contacts name: Vandana Luthra, role: CONTACT, phone: +44(0)207 882 6348, email: BHNT.Clinicaloralresearchcentre@nhs.net, contacts name: Elena Calciolari, DDS, MS, PhD, role: CONTACT, email: e.calciolari@qmul.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Centre for Oral Clinical Research (COCR), city: London, zip: E1 2AD, country: United Kingdom, contacts name: Vandana Luthra, role: CONTACT, phone: +44(0)207 882 6348, email: BHNT.Clinicaloralresearchcentre@nhs.net, contacts name: Elena Calciolari, DDS, MS, PhD, role: CONTACT, email: e.calciolari@qmul.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06309706, orgStudyIdInfo id: JXHU, briefTitle: A Retrospective Cone Beam Computed Tomography Study of The Lateral Wall Bony Window, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-01, primaryCompletionDateStruct date: 2020-01-01, completionDateStruct date: 2020-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: The Dental Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: Three experienced observers were asked to screen all the CBCT images from the Stomatology Hospital,Zhejiang University School of Medicine, between September 1, 2019 and December 31, 2019, and counted 1000 maxillary sinus CBCT images that met the criteria. Later, 1000 CBCT images were further measured and analyzed, and indicators such as maxillary sinus buccal wall thickness, morphology, whether there is blood vessel or not, whether there is bone septa or not were counted. The variation rules and related factors were summarized by SPSS analysis., conditionsModule conditions: Lateral Wall Thickness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Lateral wall thickness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06309693, orgStudyIdInfo id: IRB-300011310, briefTitle: Postoperative Pain Management Following Robotic Assisted Sacrocolpopexy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: In the effort to reduce postoperative opioid use, there has been increasing interest in developing multimodal pain regimens to better manage postoperative pain while minimizing opioid use and their subsequent side effects that can be detrimental to the healing process. Standard of care approaches to better manage postoperative pain include the Enhanced Recovery After Surgery (ERAS) protocol and the use of peripheral and truncal nerve blocks. Truncal nerve blocks are widely used as an additional modality to provide longer lasting postoperative analgesia and have been adopted as part of the standard of care. The goal of this clinical trial is to compare the effects of ERAS alone versus the quadratus lumborum (QL) nerve block on the postoperative pain experience for women with pelvic organ prolapse undergoing robotic assisted sacrocolpopexy. Subjects will be randomized to the ERAS protocol or the QL block. The main questions the study aims to answer are: 1) does the QL block decrease patient reported pain scores postoperatively; and 2) does the QL block decrease the amount of opioid pain medications in the immediate postoperative period? The primary outcome measure will be median patient reported pain score in the post-anesthesia care unit (PACU) following surgery., conditionsModule conditions: Pelvic Organ Prolapse, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will be a randomized control trial in which patients undergoing robotic-assisted sacrocolpopexy with concurrent robotic assisted hysterectomy or robotic assisted sacrocolpopexy after previous hysterectomy will be randomized to one of two standard of care approaches for postoperative pain management: the enhanced recovery after surgery (ERAS) protocol and the quadratus lumborum truncal nerve block. Subjects will undergo one of two standard of care approaches to postoperative pain management and be asked about their pain postoperatively., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Quadratus Lumborum (QL) Block, interventions name: Enhanced Recovery After Surgical (ERAS) Protocol, outcomesModule primaryOutcomes measure: Median postoperative patient reported pain score in post-anesthesia recovery unit (PACU), secondaryOutcomes measure: Maximum postoperative patient reported pain score in PACU, secondaryOutcomes measure: Total oral morphine equivalents (OME) required in PACU Total oral morphine equivalents (OME) required in post-anesthesia recovery unit, secondaryOutcomes measure: Rates of postoperative nausea and vomiting (PONV) in PACU, secondaryOutcomes measure: Rates of overnight admission, secondaryOutcomes measure: Total time spent in PACU, secondaryOutcomes measure: Rates of initial active voiding trial failures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06309680, orgStudyIdInfo id: 280992, briefTitle: Accuracy of Metagenomic Blood Sampling to Identify Pathogen in Infective Endocarditis Patients, acronym: AMetIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-24, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Queen Mary University of London, class: OTHER, collaborators name: Barts & The London NHS Trust, collaborators name: Quadram Institute Bioscience, descriptionModule briefSummary: Infective Endocarditis is an infection, usually a bacterium, which attacks the heart and can cause valves to leak and produces a bacterial mass which can break off from the valves and block the blood supply to important organs.We are very keen to improve the treatment of this disease and we are measuring the impact of the treatments that we give to patients so that we have a very clear idea of which treatments work best and also which treatments are less successful.A key part of the treatment is the accurate determination of the causative organism which allows appropriate targeted antibiotic and antifungal medication to be administered.Accurate antibiotic regimes require detection of the causative organism and its sensitivities to each antibiotic. Antibiotic choice is then based on effectiveness, toxicity, ease of use and national guidelines. The current best technique for identifying bacteria is blood culture where organisms are identified by growing them from blood samples. However, this takes up to 5 days from sampling, resulting in delays to the correct diagnosis. Until this time, treatment requires the use of generic, more toxic antibiotic regimes.New techniques are emerging to identify causative organisms from blood. Metagenomics allows the sequencing of bacterial DNA allowing precise identification of the infecting organism., conditionsModule conditions: Infective Endocarditis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: diagnostic accuracy of CMg in blood, secondaryOutcomes measure: to evaluate the results of Nanopore CMg in identifying the causative organism in patients with BCNIE, secondaryOutcomes measure: 1. Optimal timing of blood sampling, secondaryOutcomes measure: 3. Metagenomic Techniques, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Bartholomew's Hospital. West Smithfield, status: RECRUITING, city: London, zip: EC1A 7BE, country: United Kingdom, contacts name: Innocent M Bvekerwa, role: CONTACT, phone: 07852209005, email: i.bvekerwa@nhs.net, contacts name: Simon Woldman, role: CONTACT, email: simon.woldman@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06309667, orgStudyIdInfo id: SL-MG12-P1, briefTitle: A Study to Assess Safety, Pharmacokinetics and Pharmacodynamics of PG-102(MG12) in Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-06-26, completionDateStruct date: 2024-06-26, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: ProGen. Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5)., conditionsModule conditions: Healthy, conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: PG-102(MG12), interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part A, primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part B, primaryOutcomes measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A, primaryOutcomes measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B, primaryOutcomes measure: Number of participants with clinically significant abnormalities in vital signs for Part A, primaryOutcomes measure: Number of participants with clinically significant abnormalities in vital signs for Part B, primaryOutcomes measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A, primaryOutcomes measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B, secondaryOutcomes measure: Maximum plasma concentration (Cmax) for Part A, secondaryOutcomes measure: Maximum plasma concentration (Cmax) for Part B, secondaryOutcomes measure: Time to maximum plasma concentration (tmax) for Part A, secondaryOutcomes measure: Time to maximum plasma concentration (tmax) for Part B, secondaryOutcomes measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A, secondaryOutcomes measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B, secondaryOutcomes measure: Terminal half-life (t1/2) for Part A, secondaryOutcomes measure: Terminal half-life (t1/2) for Part B, secondaryOutcomes measure: Apparent total clearance (CL/F) for Part A, secondaryOutcomes measure: Apparent total clearance (CL/F) for Part B, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Catholic University Seoul St.Mary Hospital,, status: RECRUITING, city: Seocho, state: Seoul, zip: 06591, country: Korea, Republic of, contacts name: Kyunghwa Son, Ph.D, role: CONTACT, phone: 02-6098-2818, email: bd@progen.co.kr, geoPoint lat: 37.49056, lon: 127.02, hasResults: False
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protocolSection identificationModule nctId: NCT06309654, orgStudyIdInfo id: PNU, briefTitle: Home-Based Circuit Training in Overweight/Obese Older Adult Patients With Knee Osteoarthritis and Type 2 Diabetes, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-13, primaryCompletionDateStruct date: 2023-09-13, completionDateStruct date: 2023-12-29, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Princess Nourah Bint Abdulrahman University, class: OTHER, descriptionModule briefSummary: Background: Obesity and type 2 diabetes mellitus (T2DM) are considered two of the most prevalent metabolic diseases linked to the onset of knee pain caused by osteoarthritis. Regular exercise has been documented as a principal component of a prevention, management, and treatment strategy for knee osteoarthritis (KOA) patients. However, evidence-based exercise protocols for individuals with comorbidities such as obesity, T2DM, and KOA are scarce. Thus, the present pragmatic randomized controlled trial aimed to investigate the effectiveness of a 12-week home-based circuit training (HBCT) protocol on various indicators related to KOA and cardiometabolic health among overweight/obese older adult patients with KOA and T2DM during the COVID-19 lockdown. Methods: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention. Results: HBCT significantly improved HBCT improved the vast majority of outcomes related to cardiometabolic health and knee osteoarthritis symptoms compared to CON (p\<0.05). No significant differences were detected in total bilirubin, sodium, urea, resting heart rate, or KOOS-sport between HBCT and CON. Conclusion: These findings suggest that an injury-free HBCT program may improve several cardiometabolic health- and KOA-related indices in overweight/obese patients with T2DM and KOA. Such results may encourage clinicians and practitioners to adopt real-world exercise training approaches when prescribing physical exercise to patients characterized by impaired metabolic and musculoskeletal health., conditionsModule conditions: Aerobic Exercise, conditions: Strength Training, conditions: Glycemic Control, conditions: Blood Pressure, conditions: Oxidative Stress, conditions: Metabolic Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Seventy overweight or obese patients with KOA and T2DM (62.2 ± 6.1 years; 56% female) were randomly assigned to the intervention group (n = 35, HBCT) or the no-exercise control group (n = 35, CON). HBCT performed a progressive protocol (seven exercises; 15-30 repetitions per exercise, 1 min passive rest between exercises; 2-4 rounds per session; 20-60 min total session duration). The knee injury and osteoarthritis symptoms, cardiovascular and metabolic risk factors, cardiorespiratory fitness, and renal function were assessed at baseline and following the 12-week intervention., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: 12-week home-based circuit training (HBCT), interventions name: Standard of care (CONT), outcomesModule primaryOutcomes measure: Blood pressure, primaryOutcomes measure: The A1C test, primaryOutcomes measure: blood oxygen levels, primaryOutcomes measure: cardiorespiratory fitness, primaryOutcomes measure: interleukin 6 (IL-6), primaryOutcomes measure: Superoxide dismutases (SOD), eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Princess Nourah bint Abdulrahman University, city: Riyadh, zip: 11671, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, hasResults: False
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protocolSection identificationModule nctId: NCT06309641, orgStudyIdInfo id: MetHb 001, briefTitle: Methemoglobinemia Following Intravenous Iron Treatment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Claudia Seiler, class: OTHER, descriptionModule briefSummary: Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose., conditionsModule conditions: Methemoglobinemia, conditions: Anemia, conditions: Iron Deficiencies, conditions: Side Effect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample after treatment, interventions name: Case reports, outcomesModule primaryOutcomes measure: Difference in methemoglobin after ferric derisomaltose, primaryOutcomes measure: Difference in methemoglobin after ferric carboxymaltose, secondaryOutcomes measure: Difference in methemoglobin depending on drug dosage, secondaryOutcomes measure: Difference in methemoglobin depending on age, secondaryOutcomes measure: Difference in methemoglobin depending on sex, secondaryOutcomes measure: Difference in methemoglobin depending on hemoglobin level before treatment, secondaryOutcomes measure: Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron., secondaryOutcomes measure: Association between difference in methemoglobin and venous lactate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of Clinical Research Dalarna, city: Falun, zip: 79182, country: Sweden, contacts name: Claudia Seiler, MD, role: CONTACT, phone: +46 70 2896416, email: claudia.seiler@regiondalarna.se, geoPoint lat: 60.60357, lon: 15.62597, hasResults: False
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protocolSection identificationModule nctId: NCT06309628, orgStudyIdInfo id: PGX-006, briefTitle: Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-21, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Paragonix Technologies, class: INDUSTRY, collaborators name: Picomole Inc, descriptionModule briefSummary: This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy., conditionsModule conditions: Lung Transplant Rejection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Breathe sample, outcomesModule primaryOutcomes measure: Volatile Organic Compound profile, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
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protocolSection identificationModule nctId: NCT06309615, orgStudyIdInfo id: PDX-001_2, briefTitle: Decision Impact Study of PreciseDx Breast, acronym: PDxBRUTILITY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2029-05-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Precise Dx, Inc., class: INDUSTRY, collaborators name: The Cleveland Clinic, descriptionModule briefSummary: The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Decision Impact Study of PreciseDx Breast on treating Oncologist, primaryOutcomes measure: Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist, secondaryOutcomes measure: Decision Impact on long term outcomes, eligibilityModule sex: FEMALE, minimumAge: 23 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309602, orgStudyIdInfo id: 22-0465, briefTitle: Investigation of a Free Water Protocol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-01-01, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Poudre Valley Health System, class: OTHER, descriptionModule briefSummary: Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol., conditionsModule conditions: Oropharyngeal Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Free Water Protocol, interventions name: Control / Standard Care, outcomesModule primaryOutcomes measure: Dysphagia Handicap Index, primaryOutcomes measure: Oral Assessment Guide, primaryOutcomes measure: Qualitative data, secondaryOutcomes measure: Adverse events: Aspiration pneumonia/pneumonitis, secondaryOutcomes measure: Liquid intake, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center of the Rockies, city: Loveland, state: Colorado, zip: 80538, country: United States, contacts name: Emily Main, MS, CCC-SLP, role: CONTACT, phone: 970-624-4369, email: emily.main@uchealth.org, contacts name: Brian Daily, MD, role: SUB_INVESTIGATOR, contacts name: Cordelie Witt, MD, role: SUB_INVESTIGATOR, contacts name: Lucie Uncapher, MD, role: SUB_INVESTIGATOR, contacts name: Brandon Petrun, MD, role: SUB_INVESTIGATOR, geoPoint lat: 40.39776, lon: -105.07498, hasResults: False
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protocolSection identificationModule nctId: NCT06309589, orgStudyIdInfo id: YIHM, briefTitle: The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Yilihamu·Abilitifu, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis., conditionsModule conditions: Primary Biliary Cholangitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Vitamin D, outcomesModule primaryOutcomes measure: UDCA response: Paris I criteria, primaryOutcomes measure: UDCA response: Barcelona criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: People's Hospital of Xinjiang Uygur Autonomous Region, city: Urumqi, state: Xinjiang, zip: 830001, country: China, geoPoint lat: 43.80096, lon: 87.60046, hasResults: False
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protocolSection identificationModule nctId: NCT06309576, orgStudyIdInfo id: PBRC 2023-069, briefTitle: Experimental Approach to Test Predictions of Body Weight Regulation Models, acronym: DIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Pennington Biomedical Research Center, class: OTHER, collaborators name: Tulane University, descriptionModule briefSummary: The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either underweight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation., conditionsModule conditions: Obesity, conditions: Underweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Fasting-refeeding cycle, outcomesModule primaryOutcomes measure: Compensatory response, secondaryOutcomes measure: Timing of the compensatory response, secondaryOutcomes measure: Protein balance, secondaryOutcomes measure: Carbohydrate balance, secondaryOutcomes measure: Lipid balance, secondaryOutcomes measure: Overall appetite, secondaryOutcomes measure: Food preference, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Sleeping metabolic rate, secondaryOutcomes measure: Leptin, secondaryOutcomes measure: Appetite-regulating hormones, secondaryOutcomes measure: Metabolites, secondaryOutcomes measure: Gonadotrophic axis, secondaryOutcomes measure: Thyroid axis, secondaryOutcomes measure: Hypothalamic-pituitary-adrenal axis, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309563, orgStudyIdInfo id: 31J301, briefTitle: Metabolic Effects of a Diet Replaced With Essential Amino Acids, acronym: AMINOB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing., conditionsModule conditions: Obesity Morbid, conditions: Weight Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Aminoacid supplementation, interventions name: Placebo, outcomesModule primaryOutcomes measure: Muscle mass, secondaryOutcomes measure: 6 minute walking test (6MWT), eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, Site Piancavallo, status: RECRUITING, city: Oggebbio, state: Verbania, zip: 28921, country: Italy, contacts name: Amelia Brunani, MD, role: CONTACT, phone: 390323514232, email: brunani@auxologico.it, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
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protocolSection identificationModule nctId: NCT06309550, orgStudyIdInfo id: 09W002, briefTitle: Provocative Tests for HFpEF, acronym: TEST-PEF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: exercise test, outcomesModule primaryOutcomes measure: Mortality, primaryOutcomes measure: Hospitalization for heart failure, primaryOutcomes measure: Atrial fibrillation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20149, country: Italy, contacts name: Sergio Caravita, MD, PhD, role: CONTACT, phone: +39 02 61911 2930, email: s.caravita@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06309537, orgStudyIdInfo id: 09C830, briefTitle: Chemoreflex Sensitivity in HFpEF, acronym: CHEMO-HFpEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: chemoreflex evaluation, outcomesModule primaryOutcomes measure: difference in chemoreflex sensitivity between HFpEF and healthy controls, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano, city: Milan, zip: 20149, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06309524, orgStudyIdInfo id: 09C332, briefTitle: Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair, acronym: HERITAGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome., conditionsModule conditions: Tricuspid Regurgitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: Tricuspid transcatheter edge-to-edge repair, outcomesModule primaryOutcomes measure: Inverse remodeling of right heart chambers, primaryOutcomes measure: Heart failure hospitalization, primaryOutcomes measure: Death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, state: Lombardia, zip: 20149, country: Italy, contacts name: Michele Tomaselli, role: CONTACT, phone: +3902619112992, email: michetomaselli@gmail.com, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06309511, orgStudyIdInfo id: 09C218, briefTitle: Subendocardial Viability Ratio in Hypertension, acronym: SEVR-HT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database., conditionsModule conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Arterial tonometry, outcomesModule primaryOutcomes measure: Buckberg index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi", status: RECRUITING, city: Mascalucia, state: Catania, country: Italy, contacts name: Antonino Di Guardo, MD, role: CONTACT, email: ninodiguardo58@gmail.com, contacts name: Massimo Catanuso, MD, role: CONTACT, email: catanusomassimo@hotmail.it, geoPoint lat: 37.57465, lon: 15.04964, locations facility: Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa "Anna Maria Pirrelli", Università degli Studi di Bari "Aldo Moro". Policlinico Consorziale di Bari, status: RECRUITING, city: Bari, country: Italy, contacts name: Pietro Nazzaro, MD, role: CONTACT, email: pietro.nazzaro@uniba.it, contacts name: Sebastiano Cicco, MD, role: CONTACT, email: sebastiano.cicco@uniba.it, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Istituto Auxologico Italiano IRCCS, status: RECRUITING, city: Milano, zip: 20145, country: Italy, contacts name: Paolo Salvi, MD, role: CONTACT, phone: +390261911, phoneExt: 2968, email: p.salvi@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia, status: RECRUITING, city: Reggio Emilia, country: Italy, contacts name: Angelo Ghirarduzzi, MD, role: CONTACT, email: ghirarduzzi.angelo@ausl.re.it, contacts name: Chiara Grasselli, MD, role: CONTACT, email: chiara.grasselli@ausl.re.it, geoPoint lat: 44.69825, lon: 10.63125, locations facility: Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste, status: RECRUITING, city: Trieste, country: Italy, contacts name: Andrea Grillo, MD, role: CONTACT, email: andr.grillo@gmail.com, contacts name: Bruno Fabris, MD, role: CONTACT, email: b.fabris@fmc.units.it, geoPoint lat: 45.64953, lon: 13.77679, hasResults: False
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protocolSection identificationModule nctId: NCT06309498, orgStudyIdInfo id: 05C307, briefTitle: Residual Adrenal Function in Addison's Disease, acronym: ADD-RES, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.11-deoxycortisol levels will be assessed in all recruited patients, conditionsModule conditions: Adrenal Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: blood test, outcomesModule primaryOutcomes measure: prevalence of RAF, secondaryOutcomes measure: prevalence of adrenal crisis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20135, country: Italy, contacts name: Valentina Morelli, role: CONTACT, phone: 02619112547, email: v.morelli@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06309485, orgStudyIdInfo id: WGI0301-P2G-01, briefTitle: Phase 2 Study of WGI-0301 in Combination With Sorafenib for Advanced HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhejiang Haichang Biotech Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors., conditionsModule conditions: Advanced Hepatocellular Carcinoma (HCC), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: WGI-0301 at MTD/RP2D dose IV infusion, QW, interventions name: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW, interventions name: Sorafenib 400 mg PO, BID continuously, interventions name: Sorafenib 400 mg PO, BID, outcomesModule primaryOutcomes measure: Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1., secondaryOutcomes measure: Safety of each dose group., secondaryOutcomes measure: Tolerability of each dose group., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309472, orgStudyIdInfo id: NIHR302528, briefTitle: Trial of Mirtazapine for Depression in IBD, acronym: MDIBD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: King's College Hospital NHS Trust, collaborators name: Imperial College London, collaborators name: London North West Healthcare NHS Trust, collaborators name: Imperial College Healthcare NHS Trust, collaborators name: Guy's and St Thomas' NHS Foundation Trust, descriptionModule briefSummary: This study will test whether it is feasible to conduct a clinical trial of mirtazapine (an antidepressant tablet) in patients who have both depression and inflammatory bowel disease (IBD). The study design is a randomised controlled trial (a study in which people are allocated by chance to receive different interventions). The trial will compare mirtazapine against a placebo (dummy) tablet in 76 patients with both depression and IBD.The investigators will recruit outpatients aged 18 or over with a diagnosis of any IBD attending gastroenterology clinics. Either in person or remotely, patients will complete a brief screening questionnaire for depression. Those scoring positive for depression will be invited for a 15-minute interview for clinical depression. Those with clinical depression will be invited to take part. Participants will be randomly allocated by a computer to take either 1) mirtazapine tablet once at night for 12 weeks; or 2) placebo (dummy) tablet once at night for 12 weeks. The study is 'blinded', meaning neither patients nor the study team will know which medication they are taking. Throughout, participants will be able to access other treatments for depression, such as talking therapies.The investigators will measure how many people join the study; how many remain in the trial; how many complete treatment; how many tablets people take; and assess overall acceptability of the trial. Participants will complete brief questionnaires to measure their mental health and IBD symptoms after 4 weeks, 8 weeks, 12 weeks and 16 weeks. Participants will also provide blood samples and faecal samples to measure inflammation.If successful, this trial will support an application for a larger version of the study., conditionsModule conditions: Major Depressive Disorder, conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Mirtazapine and placebo manufactured to appear identical through over-encapsulation, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Mirtazapine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Recruitment feasibility, primaryOutcomes measure: Trial adherence, primaryOutcomes measure: Treatment adherence, primaryOutcomes measure: Study procedures acceptability and compliance, primaryOutcomes measure: Overall acceptability, secondaryOutcomes measure: Quick Inventory for Depressive Symptomatology-16 Questionnaire, secondaryOutcomes measure: Patient Health Questionnaire-9 questionnaire, secondaryOutcomes measure: Generalised Anxiety Disorder-7 questionnaire, secondaryOutcomes measure: Inflammatory Bowel Disease Control questionnaire, secondaryOutcomes measure: Inflammatory Bowel Disease Fatigue Assessment Scale, secondaryOutcomes measure: Chalder Fatigue Scale, secondaryOutcomes measure: Maudsley 3-item Visual Analogue Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: 9-item Avoidant Restrictive Food Intake Disorder Screen, secondaryOutcomes measure: Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) Questionnaire, secondaryOutcomes measure: Inflammatory Bowel Disease Resource Use Questionnaire (IBD-RUQ) items on employment and healthcare contacts, secondaryOutcomes measure: Birmingham Irritable Bowel Syndrome Symptoms Questionnaire, secondaryOutcomes measure: Harvey Bradshaw Index (Crohn's disease patients only), secondaryOutcomes measure: Simple Clinical Colitis Activity Index (ulcerative colitis patients only), secondaryOutcomes measure: Dietary Screener Questionnaire, secondaryOutcomes measure: Concentration of faecal calprotectin, secondaryOutcomes measure: Concentration of serum high-sensitivity C-reactive protein, secondaryOutcomes measure: Concentration of serum interleukin-23, secondaryOutcomes measure: Concentration of serum interleukin-22, secondaryOutcomes measure: Concentration of serum granulocyte-macrophage colony-stimulating factor, secondaryOutcomes measure: Concentration of serum interleukin-5, secondaryOutcomes measure: Concentration of serum interleukin-13, secondaryOutcomes measure: Concentration of serum interleukin-17A, secondaryOutcomes measure: Concentration of serum tumor necrosis factor alpha, secondaryOutcomes measure: Concentration of serum interferon-gamma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 125 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06309459, orgStudyIdInfo id: IRB 2023/04-34, briefTitle: Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect., conditionsModule conditions: Triple Negative Breast Cancer, conditions: Carbonic Anhydrase IX, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Carbonic anhydrase staining levels, outcomesModule primaryOutcomes measure: Poor prognostic factors in patients with TNBC, primaryOutcomes measure: The treatment success with inhibiting the CA IX enzyme levels' effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kahramanmaraş Sütçü İmam University, city: Kahramanmaraş, zip: 46000, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False
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