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protocolSection identificationModule nctId: NCT06364059, orgStudyIdInfo id: aSDH-TT, briefTitle: A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Charles University, Czech Republic, class: OTHER, collaborators name: Military University Hospital, Prague, descriptionModule briefSummary: Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes., conditionsModule conditions: Acute Subdural Hematoma, conditions: Acquired Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Decompressive craniectomy with evacuation of subdural hematoma, outcomesModule primaryOutcomes measure: Level of consciousness at time of injury, primaryOutcomes measure: Initial size of subdural hematoma, primaryOutcomes measure: Initial midline shift, primaryOutcomes measure: Chronic use of anti-clotting medication, primaryOutcomes measure: Trauma severity analyzed using Injury Severity Score (ISS)., primaryOutcomes measure: Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II), primaryOutcomes measure: The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC)., primaryOutcomes measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months., primaryOutcomes measure: The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months., secondaryOutcomes measure: Number of revisions., secondaryOutcomes measure: Time from injury to surgery., secondaryOutcomes measure: Time of operation., secondaryOutcomes measure: The need for reversal of the effects of anticoagulants., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Military University Hospital Prague, city: Praha, zip: 16209, country: Czechia, contacts name: Michal Soták, M.D., Ph.D., role: CONTACT, phone: +420973202999, email: [email protected], contacts name: Tomáš Tyll, M.D., Ph.D., role: CONTACT, phone: +420973202999, email: [email protected], contacts name: Tomáš Tyll, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
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protocolSection identificationModule nctId: NCT06364046, orgStudyIdInfo id: ZJLS-KLDMIR-22006, briefTitle: Efficacy and Safety of DEB-BACE Combined With Serplulimab in First-line Treatment of SCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Central Hospital of Lishui City, class: OTHER, descriptionModule briefSummary: This project aims to conduct a prospective, single-center, randomized, open-label, two-arm study to compare the clinical efficacy and safety of bronchial arterial chemoembolization with drug-eluting beads (DEB-BACE) combined with serplulimab versus conventional intravenous chemotherapy combined with Serplulimab as first-line treatment for SCLC patients. The objective is to provide evidence-based support for clinical practice., conditionsModule conditions: Carcinoma, conditions: Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Drug-eluting beads bronchial arterial chemoembolization, interventions name: Serplulimab, interventions name: Intravenous chemotherapy, outcomesModule primaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Time to tumor untreatable progression, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Overall Response, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Tumor biomarkers, secondaryOutcomes measure: Eastern Cooperative Oncology Group Score, secondaryOutcomes measure: Recurrence rate of hemoptysis, secondaryOutcomes measure: Quality of life Questionare-Core score, secondaryOutcomes measure: The incidence of adverse events and serious adverse events, secondaryOutcomes measure: Pain assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lishui central hospital, city: Lishui, state: Zhejiang, zip: 323000, country: China, geoPoint lat: 28.46042, lon: 119.91029, hasResults: False
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protocolSection identificationModule nctId: NCT06364033, orgStudyIdInfo id: CLL2624, briefTitle: Biological and Clinical Efficacy of Shingrix in Patients With CLL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2028-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Gruppo Italiano Malattie EMatologiche dell'Adulto, class: OTHER, descriptionModule briefSummary: This is a biological study. Patients who are eligible to receive Shingrix through the Italian National Health System will be invited to participate in the study. According to AIFA indication, the two doses of vaccine will be administered 4-8 weeks apart. Blood samples will be collected prior to the first vaccine dose (i.e. within the time frame of 3 months prior to the first dose) and 1, 6, 12, 24 and 36 months after the second vaccine dose to evaluate the serological response of Shingrix., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, conditions: CLL-like MBL, conditions: Varicella-zoster Virus Reactivation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 312, type: ESTIMATED, armsInterventionsModule interventions name: serologic response evaluation, outcomesModule primaryOutcomes measure: Serologic response evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UOC Ematologia ASST dei Sette Laghi, city: Varese, country: Italy, contacts name: Marta Coscia, role: CONTACT, geoPoint lat: 45.82058, lon: 8.82511, hasResults: False
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protocolSection identificationModule nctId: NCT06364020, orgStudyIdInfo id: APHP230067, briefTitle: Assessment of Risk Factors in Patients With Non-carious Cervical Lesions, acronym: LACIS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies., conditionsModule conditions: Anxiety, conditions: Stress, conditions: Non-carious Cervical Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To investigate the association between anxiety/stress and the presence of NCCL., secondaryOutcomes measure: To investigate the association between bruxism and the presence of NCCL., secondaryOutcomes measure: To investigate the association between eating disorders and the presence of NCCL., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Rothschild - Service Odontologie, city: Paris, zip: 75012, country: France, contacts name: Caroline Mocquot, MCU-PH, role: CONTACT, phone: +33622971627, email: [email protected], contacts name: Maria Clotilde Carra, Professor, role: CONTACT, phone: +33630746555, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06364007, orgStudyIdInfo id: SLiu0401, briefTitle: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sulai Liu, class: OTHER, descriptionModule briefSummary: The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: HAIC+STRIDE+Len, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: DCR, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University), status: RECRUITING, city: Changsha, state: Hunan, country: China, contacts name: Chuang Peng, PhD, role: CONTACT, phone: 15200850489, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06363994, orgStudyIdInfo id: ICP-CL-00128, briefTitle: A Global Phase 3 Study of Orelabrutinib+BR vs.BR in Pts With TN MCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-25, primaryCompletionDateStruct date: 2034-12-25, completionDateStruct date: 2035-12-25, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: InnoCare Pharma Inc., class: INDUSTRY, descriptionModule briefSummary: Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL), conditionsModule conditions: Mantle Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 490, type: ESTIMATED, armsInterventionsModule interventions name: Orelabrutinib, interventions name: Bendamustine Injection, interventions name: Rituximab, interventions name: Orelabrutinib Placebo, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Progression-free Survival (PFS) for Arm A vs. Arm C, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363981, orgStudyIdInfo id: JagiellonianU72, briefTitle: Multisite rTMS for Mood, Cognitive Impairment and Other Symptoms of Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Jakub Antczak, class: OTHER, collaborators name: Andrzej Frycz Modrzewski Krakow University, descriptionModule briefSummary: Depressed mood is the main symptom of depression, but other symptoms like cognitive impairment, anhedonia or sleep disorders may also contribute to patients suffering and are difficult to treat. rTMS is a relatively novel treatment option, whose therapeutic potential is still investigated and optimized. The aim of this study is to assess the effect of rTMS applied over two stimulation sites on cognitive impairment, anhedonia and sleep disorders in depression., conditionsModule conditions: Unipolar Depression, conditions: Bipolar Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Prospective, randomized, sham-controlled clinical trial in parallel design, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Placebo intervention will be delivered with a programmable coil for magnetic stimulation, which can be switched by a third person between modes of active (therapeutic) and sham stimulation. In the sham-mode coil elicits similar sounds as in the active stimulation, but induces only negligible magnetic field., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Active rTMS over the left DLPFC and over the left DMPFC, interventions name: Active rTMS over the left DLPFC, interventions name: Sham rTMS, outcomesModule primaryOutcomes measure: Beck Depression Inventory 2, primaryOutcomes measure: Froward digit span, primaryOutcomes measure: Language part of Addenbrooke's Cognitive Examination, secondaryOutcomes measure: Dimensional Anhedonia Rating Scale, secondaryOutcomes measure: Athens Insomnia Scale, secondaryOutcomes measure: Pittsburgh Sleep Quality Index, secondaryOutcomes measure: Epworth Sleepiness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Education of Research and Development Center, Babinski Clinical Hospital, city: Cracovia, zip: 30393, country: Poland, contacts name: Wojciech Korzeniowski, MD, role: CONTACT, phone: +48 12 652 42 00, email: [email protected], contacts name: Jakub Antczak, MD, role: CONTACT, phone: +48 12 25 50, email: [email protected], geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
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protocolSection identificationModule nctId: NCT06363968, orgStudyIdInfo id: 1743326, briefTitle: Biomarkers in the Retina for Prognosticating Mental Health Treatments, acronym: BRIGHT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2030-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: VA Puget Sound Health Care System, class: FED, descriptionModule briefSummary: Title: ERG as a potential biomarker of SSRI-responsive PTSD: A pilot studyPosttraumatic stress disorder (PTSD) affects many individuals who experience a traumatic event. Previous studies suggest that there is a connection between the brain and the retina, and that the electroretinogram (ERG) may be a valuable biomarker to tell us more about signals in the brain that are related to mental health disorders like PTSD. The goal of this observational study is to examine the ERG waveform in veterans with PTSD before and after a single dose of the selective serotonin reuptake inhibitor (SSRI), sertraline. Sertraline is one of two FDA-approved medications for the treatment of PTSD. The main questions this pilot study aims to answer are:1. How does sertraline, an SSRI, influence the ERG waveform in veterans with PTSD?2. Is there a significant correlation between baseline ERG signals and the change in ERG following SSRI treatment?Participants will be asked to:* Undergo ERG recordings before and after a single dose of sertraline.* Provide relevant clinical information related to PTSD symptoms and treatment history.Following the initial study visits, participants will enter an optional open label phase of the study in which qualifying participants who initiate antidepressant treatment through routine clinical care will be invited back for a follow-up ERG recording., conditionsModule conditions: PTSD, conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: RETeval, outcomesModule primaryOutcomes measure: ERG b-wave amplitude response to SSRI, secondaryOutcomes measure: Total Clinician Administered PTSD Scale for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; CAPS-5) score, secondaryOutcomes measure: Total PTSD Checklist for DSM-5 (PCL-5), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Puget Sound Health Care System, status: RECRUITING, city: Seattle, state: Washington, zip: 98108, country: United States, contacts name: Rebecca C Hendrickson, MD, PhD, role: CONTACT, phone: 206-277-5054, email: [email protected], contacts name: Katharine J Liang, MD, PHD, role: SUB_INVESTIGATOR, contacts name: Rebecca C Hendrickson, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
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protocolSection identificationModule nctId: NCT06363955, orgStudyIdInfo id: INTM-PMCF-UNIMOUTH, secondaryIdInfos id: 750/13.02.2023, type: OTHER, domain: National and Kapodistrian University of Athens, briefTitle: Assessing the Efficacy of a Hydrogen Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, collaborators name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A., descriptionModule briefSummary: The aim of this study is to evaluate the efficacy and safety of a hydrogen carbamide/peroxide mouthwash, named UNISEPT® MOUTHWASH, regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures).Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Participants randomly get the hydrogen carbamide/peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical.Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed., conditionsModule conditions: Wound Heal, conditions: Oral Dryness, conditions: Postoperative Pain, conditions: Sjogren's Syndrome, conditions: Biopsy Wound, conditions: Mouth; Wound, conditions: Mouth Dryness, conditions: Dental Plaque, conditions: Gingival Inflammation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide mouthwash or placebo mouthwash, made by the same manufacturer., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Hydrogen Carbamide/Peroxide Mouthwash, interventions name: Placebo mouthwash, outcomesModule primaryOutcomes measure: Assessment of wound healing based on the modified Landry Healing Index on day 14, primaryOutcomes measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14, primaryOutcomes measure: Assessment of wound healing based on the modified Landry Healing Index on day 7, primaryOutcomes measure: Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home), secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7, secondaryOutcomes measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14, secondaryOutcomes measure: Wound healing based on the incision/wound length, secondaryOutcomes measure: Subjective oral dryness symptoms (8-item VAS questionnaire), secondaryOutcomes measure: Observed (objective) signs of oral dryness, secondaryOutcomes measure: Change in Unstimulated Saliva Flow Rate, secondaryOutcomes measure: Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index, secondaryOutcomes measure: Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index, secondaryOutcomes measure: Oral Health Related Quality of Life, secondaryOutcomes measure: Assessment of swelling in the biopsy area, otherOutcomes measure: Adverse Events, otherOutcomes measure: Participant's comments and satisfaction regarding the provided treatment/use of the products, otherOutcomes measure: Compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens, city: Athens, state: Attiki, zip: 11527, country: Greece, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False
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protocolSection identificationModule nctId: NCT06363942, orgStudyIdInfo id: 2024-5973, briefTitle: A Personalized Video-based Exercise Program for Fall Prevention in Frail and Pre-frail Older Adult, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: This is a randomized interventional clinical trial, whereby 100 participants will be randomized to either follow the SAFE exercise program (experimental group) or not (control group). At the end of the intervention, the experimental group will be encouraged to continue doing the exercises, and the control group will have the opportunity to participate in the SAFE exercises. 12 weeks post-intervention, the investigators will follow up with participants by telephone to follow up whether they are still following the SAFE program or not., conditionsModule conditions: Fall Injury, conditions: Frailty, conditions: Old Age; Atrophy, conditions: Age-Related Atrophy, conditions: Age-Related Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: SAFE program (exercise intervention), outcomesModule primaryOutcomes measure: Objective 1, primaryOutcomes measure: Objective 2, secondaryOutcomes measure: Objective 4, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Victoria Hospital - Glen site, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06363929, orgStudyIdInfo id: 341-23, briefTitle: Continuous Glucose Monitoring in Neonatal Hyperinsulinism, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: MemorialCare Health System, class: OTHER, collaborators name: DexCom, Inc., descriptionModule briefSummary: The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly., conditionsModule conditions: Hyperinsulinism, conditions: Hypoglycemia Neonatal, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Dexcom G6 continuous glucose monitor, outcomesModule primaryOutcomes measure: Mean absolute relative difference (MARD), secondaryOutcomes measure: Mean absolute difference (MAD), eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: Miller Children's Hospital, status: RECRUITING, city: Long Beach, state: California, zip: 90806, country: United States, contacts name: Erin Okawa, role: CONTACT, phone: 310-825-6244, email: [email protected], geoPoint lat: 33.76696, lon: -118.18923, hasResults: False
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protocolSection identificationModule nctId: NCT06363916, orgStudyIdInfo id: 2023-A00335-40, briefTitle: Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System, acronym: SEECLOOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Medtrum France, class: INDUSTRY, collaborators name: Axonal-Biostatem, descriptionModule briefSummary: The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study.The main question it aims to answer is :• Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ?Participants will be :* Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system* Randomized to the Open Loop or Closed Loop group* Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire statusResearchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group., conditionsModule conditions: Type 1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Insulin Management System in Manual mode of operation, interventions name: Insulin Management System in Automatic mode of operation, outcomesModule primaryOutcomes measure: Superiority of the algorithm on Time In Range (TIR) between the 2 randomised groups, secondaryOutcomes measure: Evolution of TIR, secondaryOutcomes measure: Evolution of coefficient of glycemic variation, secondaryOutcomes measure: Superiority in Glycated Haemoglobin (HbA1c) improvement, secondaryOutcomes measure: Evolution of Time spent Above Range (TAR), secondaryOutcomes measure: Evolution of Time spent Below Range (TBR), secondaryOutcomes measure: Body Mass Index change, secondaryOutcomes measure: Glucose sensor measurement change, secondaryOutcomes measure: Percentage of patients with TIR > 70%, secondaryOutcomes measure: Percentage of patients with TIR > 70% and TBR < 4%, and with TIR > 70% and TBR < 1%, secondaryOutcomes measure: Evolution of glucose management indicator (GMI), secondaryOutcomes measure: Evolution of dosage of insulin, secondaryOutcomes measure: Time of device usage and time in automatic mode of insulin delivery (hybrid closed loop), secondaryOutcomes measure: Evolution of Self-administered Questionnaires scores, secondaryOutcomes measure: Evolution of Diabetes Treatment Satisfaction score, secondaryOutcomes measure: Safety Events, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TIR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on glucose sensor measurements, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TAR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on TBR, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on GMI, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on dosage of insulin, otherOutcomes measure: Extension phase: Assessment of Automatic Meal Management function in Hybrid Closed Loop group on Self-administered Questionnaires scores, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Angers, city: Angers, country: France, contacts name: Regis COUTANT, role: CONTACT, contacts name: Regis COUTANT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: CHU Besançon, city: Besançon, country: France, contacts name: Sophie BOROT, role: CONTACT, contacts name: Sophie BOROT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Bordeaux, city: Bordeaux, country: France, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU Caen, city: Caen, country: France, contacts name: Michael JOUBERT, role: CONTACT, contacts name: Michael JOUBERT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: Centre Hospitalier Sud-Francilien, city: Corbeil-Essonnes, country: France, contacts name: Freddy PENFORNIS, role: CONTACT, contacts name: Freddy PENFORNIS, role: PRINCIPAL_INVESTIGATOR, contacts name: Thanh-Lan DANG DUY, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.60603, lon: 2.48757, locations facility: Centre Hospitalier de Gonesse, city: Gonesse, country: France, contacts name: Jennifer ALLAIN, role: CONTACT, contacts name: Jennifer ALLAIN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.98693, lon: 2.44892, locations facility: Centre Hospitalier Saint-Louis, city: La Rochelle, country: France, contacts name: Didier GOUET, role: CONTACT, contacts name: Didier GOUET, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.16667, lon: -1.15, locations facility: Hôpital Hôtel-Dieu, city: Le Creusot, country: France, contacts name: Sylvaine CLAVEL, role: CONTACT, contacts name: Sylvaine CLAVEL, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.80714, lon: 4.41632, locations facility: Hospices Civils de Lyon, city: Lyon, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Hôpital Européen, city: Marseille, country: France, contacts name: Denis RACCAH, role: CONTACT, contacts name: Denis RACCAH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: Hôpital La Timone, city: Marseille, country: France, contacts name: Rachel REYNAUD, role: CONTACT, contacts name: Rachel REYNAUD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, locations facility: CHU Montpellier, city: Montpellier, country: France, contacts name: Fabienne DALLA VALE, role: CONTACT, contacts name: Fabienne DALLA VALE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.61092, lon: 3.87723, locations facility: CHU Nantes, city: Nantes, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Hôpital Lariboisière, city: Paris, country: France, contacts name: Jean-Pierre RIVELINE, role: CONTACT, contacts name: Jean-Pierre RIVELINE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Necker, city: Paris, country: France, contacts name: Jacques BELTRAND, role: CONTACT, contacts name: Jacques BELTRAND, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Robert Debré, city: Paris, country: France, contacts name: Elise BISMUTH, role: CONTACT, contacts name: Elise BISMUTH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Rangueil, city: Toulouse, country: France, contacts name: Vincent MELKI, role: CONTACT, contacts name: Vincent MELKI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
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protocolSection identificationModule nctId: NCT06363903, orgStudyIdInfo id: 2022-MMC-051, briefTitle: ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-09, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Maxima Medical Center, class: OTHER, collaborators name: Amsterdam UMC, collaborators name: Maastricht University Medical Center, descriptionModule briefSummary: In the present pilot study, a possible relation between the implantation of PP mesh for inguinal hernia, vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome. Additional value of MAT is investigated and effectiveness of (partial) PP mesh removal for these complaints is assessed. If so, a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics., conditionsModule conditions: Autoimmunity, conditions: Inguinal Hernia, conditions: Stress Urinary Incontinence, conditions: Pelvic Organ Prolapse, conditions: Implant Complication, conditions: Systemic Autoimmune Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: mesh allergy test, interventions name: blood tests, interventions name: Mesh removal, outcomesModule primaryOutcomes measure: Positive diagnostic tests, secondaryOutcomes measure: Autoimmune complaints and objective findings in immunologic blood test, secondaryOutcomes measure: Autoimmune complaints and objective findings in mesh allergy test (MAT), secondaryOutcomes measure: Mesh removal and subjective complaints, secondaryOutcomes measure: Mesh histopathology, secondaryOutcomes measure: Patient demographics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Centre, status: ACTIVE_NOT_RECRUITING, city: Maastricht, state: Limburg, zip: 6229HX, country: Netherlands, geoPoint lat: 50.84833, lon: 5.68889, locations facility: Maxima Medical Centre, status: RECRUITING, city: Veldhoven, state: Noord-Brabant, zip: 5504DB, country: Netherlands, contacts name: Willem AR Zwaans, MD PhD, role: CONTACT, phone: +31408888550, email: [email protected], contacts name: Maurits JC Gielen, MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.41833, lon: 5.40278, locations facility: Amsterdam UMC, status: NOT_YET_RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: Prof. Dr. J.P. Roovers, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06363890, orgStudyIdInfo id: TD02, briefTitle: Etiology of Travelers' Diarrhea in Australian Tourists Traveling to Southeast Asia, acronym: AusTD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Lumen Bioscience, Inc., class: INDUSTRY, descriptionModule briefSummary: The study proposed here will determine the frequency and etiology of diarrhea in Australian adult tourists traveling to Southeast Asia, including Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Thailand, Timor-Leste, and Vietnam. The results from this study will inform the feasibility and design of subsequent clinical trials of travelers' diarrhea interventions in this population., conditionsModule conditions: Travelers Diarrhea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: TAQMan Array Card, outcomesModule primaryOutcomes measure: Characterize the frequency and etiology of travelers' diarrhea in this participant population of Australian adult tourists traveling to Southeast Asia., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363877, orgStudyIdInfo id: 5220078, briefTitle: Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Loma Linda University, class: OTHER, descriptionModule briefSummary: This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds., conditionsModule conditions: Surgical Site Infection, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1100, type: ESTIMATED, armsInterventionsModule interventions name: Povidone-Iodine, interventions name: Normal Saline, outcomesModule primaryOutcomes measure: Surgical Site Infection, secondaryOutcomes measure: Readmission, secondaryOutcomes measure: Return to the Operating Room, secondaryOutcomes measure: Ileus, secondaryOutcomes measure: Small Bowel Obstruction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loma Linda University Health, city: Loma Linda, state: California, zip: 92354, country: United States, contacts name: Martin G Rosenthal, MD, role: CONTACT, email: [email protected], contacts name: Martin Rosenthal, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Mohamed H El-Farra, MD, role: SUB_INVESTIGATOR, geoPoint lat: 34.04835, lon: -117.26115, hasResults: False
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protocolSection identificationModule nctId: NCT06363864, orgStudyIdInfo id: LL-IRB-2401, briefTitle: Investigation of Metabolomics Differences Between Metabolic Syndrome and Healthy Individuals in Taiwan, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-14, primaryCompletionDateStruct date: 2029-10-31, completionDateStruct date: 2029-10-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Leeuwenhoek Laboratories Co. Ltd., class: INDUSTRY, descriptionModule briefSummary: The prevalence of metabolic syndrome in Taiwan has been increasing yearly. In this project, the database of blood test results from healthy and metabolic syndromes individuals will be analyzed to identify the small molecules related to the severity of metabolic syndrome. These identified small molecules could be used as biomarkers to predict the development of metabolic syndromes in the future., conditionsModule conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Concentration changes of small molecules in blood., eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06363851, orgStudyIdInfo id: Kylo-11-I-C01, briefTitle: Single-ascending Dose Study of Kylo-11 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Kylonova (Xiamen) Biopharma co., LTD., class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects., conditionsModule conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Kylo-11, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax), secondaryOutcomes measure: PK parameter of time of maximum observed concentration (Tmax), secondaryOutcomes measure: PK parameter of area under the concentration time curve (AUC), secondaryOutcomes measure: Change in serum Lp(a) over time, secondaryOutcomes measure: Percent change in serum Lp(a) over time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chengdu Xinhua Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Xiaolan Yong, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06363838, orgStudyIdInfo id: ordu eah, briefTitle: Evaluation of Neuromuscular Morphometry of the Vaginal Wall, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-12-01, primaryCompletionDateStruct date: 2020-06-25, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Gaziosmanpasa Research and Education Hospital, class: OTHER_GOV, collaborators name: T.C. ORDU ÜNİVERSİTESİ, descriptionModule briefSummary: In this prospective study, women aged between 40 and 75 years who had not undergone any vaginal surgery and had not undergone any abdominal prolapse surgery were included. Thirty-one women diagnosed with rectocele on examination were included in the study group. Thirty-one patients who underwent vaginal intervention and hysterectomy for reasons other than rectocele (colposcopy, conization, etc.) without anterior or posterior wall prolapse were included in the control group., conditionsModule conditions: Pelvic Organ Prolapse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 62, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: epithelial thickness, primaryOutcomes measure: smooth muscle density, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hakan Timur, city: Ordu, country: Turkey, geoPoint lat: 40.97782, lon: 37.89047, hasResults: False
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protocolSection identificationModule nctId: NCT06363825, orgStudyIdInfo id: MRCTA,ECFAH Of FMU[2024]373, briefTitle: A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-04-11, completionDateStruct date: 2027-05-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load, conditionsModule conditions: Advanced Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ESTIMATED, armsInterventionsModule interventions name: camrelizumab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Tumor progression time (TTP), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinhua Chen, status: RECRUITING, city: Fuzhou, country: China, contacts name: Yiping Chen, role: CONTACT, phone: 13805066904, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06363812, orgStudyIdInfo id: The POST, briefTitle: Probability of OncotypeDx to Reallocate as Low or High Risk of Recurrence Breast Cancer Patients With Uncertain Biology, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-03-08, primaryCompletionDateStruct date: 2021-05-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Sandro Pitigliani, class: OTHER, collaborators name: Genomic Health®, Inc., collaborators name: Istituto Toscano Tumori, descriptionModule briefSummary: In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 258, type: ACTUAL, outcomesModule primaryOutcomes measure: the proportion of tumor samples with a useful OncotypeDx, secondaryOutcomes measure: the proportion of patients in which the result of the test has induced a modification in the initial treatment plan, secondaryOutcomes measure: the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital of Prato, city: Prato, zip: 59100, country: Italy, geoPoint lat: 43.8805, lon: 11.09699, hasResults: False
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protocolSection identificationModule nctId: NCT06363799, orgStudyIdInfo id: OST1_010, briefTitle: Osteopathic Protocol for Insomnia in College Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Escola Superior de Tecnologia da Saúde do Porto, class: OTHER, descriptionModule briefSummary: In this randomized controlled experimental trial, it is aimed to determine the effectiveness of an osteopathic protocol treatment for insomnia in college students. In this study, will be used the Compression of 4th ventricle (CV4) and the diaphragmatic breathing technique., conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: 4th ventricle compression technique and diaphragmatic breathing, interventions name: Sham Technique, outcomesModule primaryOutcomes measure: Change from the baseline insomnia episodes and symptoms through Pittsburgh questionnaire score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 28 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363786, orgStudyIdInfo id: GOOSEBERRY, briefTitle: Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Essity Hygiene and Health AB, class: INDUSTRY, descriptionModule briefSummary: The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and qPCR. In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of pathces. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with approproate statistical tests on 5% level for varaibles. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed., conditionsModule conditions: Incontinence-associated Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameteres and skin mictrobiome is measured on day 3., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Test patches, outcomesModule primaryOutcomes measure: Changes in skin microbiome as measured by molecular sequencing, primaryOutcomes measure: Changes in skin microbiome diversity as measured by qPCR, primaryOutcomes measure: Skin surface pH, secondaryOutcomes measure: Change in Trans Epidermal Water loss, secondaryOutcomes measure: Change in skin hydration, secondaryOutcomes measure: Change in Skin water profile, secondaryOutcomes measure: Presence of low pH formula on the skin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Essity Study Site, city: Gothenburg, zip: SE40503, country: Sweden, contacts name: Fredrik Agholme, PhD, role: CONTACT, phone: +46730323634, email: [email protected], contacts name: Ulrika Husmark, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
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protocolSection identificationModule nctId: NCT06363773, orgStudyIdInfo id: RESTO-IMMUNO, secondaryIdInfos id: 2023-A02451-44, type: OTHER, domain: ANSM, briefTitle: A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer., acronym: RESTO-IMMUNO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Elsan, class: OTHER, descriptionModule briefSummary: This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression.In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases., conditionsModule conditions: Metastatic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Pilot, exploratory, prospective, monocentric study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Radiotherapy, outcomesModule primaryOutcomes measure: Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy., secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy., secondaryOutcomes measure: Duration until new systemic treatment start., secondaryOutcomes measure: Incidence of Adverse Events (safety), secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria on the irradiated lesion only., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria on the irradiated lesion only., secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria on all untreated lesion(s) (abscopal effect)., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria on all untreated lesion(s) (abscopal effect)., secondaryOutcomes measure: Objective Response Rate according to iRECIST criteria on each untreated lesion taken independently from others (abscopal effect)., secondaryOutcomes measure: Objective Response Rate according to RECIST 1.1 criteria on each untreated lesion taken independently from others (abscopal effect)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Clinical, city: Soyaux, state: Charente, zip: 16800, country: France, geoPoint lat: 45.65, lon: 0.2, hasResults: False
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protocolSection identificationModule nctId: NCT06363760, orgStudyIdInfo id: EDIT-301-LTFU-001, briefTitle: A Long-Term Follow-Up Study of Participants With Sickle Cell Disease or Transfusion Dependent β-Thalassemia Who Received EDIT-301, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-04, primaryCompletionDateStruct date: 2040-08, completionDateStruct date: 2040-08, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Editas Medicine, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the long-term safety and efficacy of EDIT-301 in participants with severe sickle cell disease (SCD) or transfusion-dependent β-thalassemia (TDT) who have received EDIT-301., conditionsModule conditions: Sickle Cell Disease, conditions: Transfusion-dependent Beta-Thalassemia, conditions: Hemoglobinopathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Safety and efficacy assessments, outcomesModule primaryOutcomes measure: Adverse events of special interest (AESI), primaryOutcomes measure: Adverse events of interest (AEI), primaryOutcomes measure: All-cause mortality, primaryOutcomes measure: Adverse events (AEs) related to EDIT-301, primaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Proportion of SCD participants with severe vaso-occlusive events (sVOEs) over time post-EDIT-301 infusion, secondaryOutcomes measure: Proportion of SCD participants with vaso-occlusive events (VOEs) over time post-EDIT-301 infusion, secondaryOutcomes measure: Frequency of SCD-related transfusions over time post-EDIT-301 infusion for SCD participants, secondaryOutcomes measure: Proportion of TDT participants with sustained transfusion independence (TI) over time, secondaryOutcomes measure: Proportion of TDT participants with sustained transfusion reduction (TR) over time, secondaryOutcomes measure: Frequency of TDT-related transfusions over time post-EDIT-301 infusion for TDT participants, secondaryOutcomes measure: SCD and TDT: Percent of peripheral red blood cells (RBCs) containing HbF (F-cells) over time, secondaryOutcomes measure: SCD and TDT: Total hemoglobin (Hb) concentration (g/dL) over time, secondaryOutcomes measure: SCD and TDT: Proportion of alleles with intended genetic modification present in peripheral blood nucleated cells and bone marrow derived CD34+ over time, secondaryOutcomes measure: Average HbF (pg) per RBC over time for SCD participants, secondaryOutcomes measure: Complete Blood Count (CBC) red cell indices assay over time for SCD participants, secondaryOutcomes measure: Average HbF (pg) per F-cell over time for SCD participants, secondaryOutcomes measure: HbF and HbS concentration (g/dL) over time for SCD participants, secondaryOutcomes measure: The level of HbF production determined by fractionation of different forms of Hb (including but not limited to HbA, HbA2, HbC, HbD, HbE, and HbS) over time for SCD participants., secondaryOutcomes measure: Percentage of HbF over total non-transfused total Hb (non-transfused total Hb refers to the total g/dL of all Hb variants, excluding HbA) over time for TDT participants., secondaryOutcomes measure: HbF concentration (g/dL) over time for TDT participants, secondaryOutcomes measure: Iron overload of TDT participants, secondaryOutcomes measure: Proportion of TDT participants receiving iron chelation therapy over time., eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06363747, orgStudyIdInfo id: 123456, briefTitle: The Medically Reproducing Bariatric Surgery (MRB) II Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2025-06-03, completionDateStruct date: 2025-06-03, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Durham VA Medical Center, class: FED, collaborators name: Société des Produits Nestlé (SPN), descriptionModule briefSummary: Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB.The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB., conditionsModule conditions: Type 2 Diabetes, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Control--\[GLP-1 agonist +/- DM2 meds + medical management + nutritional/behavioral counseling\] Experimental---\[Optifast + GLP-1 agonist + medical management + nutritional/behavioral counseling\], primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Very Low Calorie Diet, outcomesModule primaryOutcomes measure: Glycemic Control, secondaryOutcomes measure: Weight lost, secondaryOutcomes measure: Medication Intensity, secondaryOutcomes measure: Health Related Quality of Life, otherOutcomes measure: Symptom Item Checklist, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Greenville VA Health Care Center, city: Greenville, state: North Carolina, zip: 27834, country: United States, geoPoint lat: 35.61266, lon: -77.36635, hasResults: False
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protocolSection identificationModule nctId: NCT06363734, orgStudyIdInfo id: DAL20240409, briefTitle: Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2025-12-15, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI., conditionsModule conditions: Non-small Cell Lung Cancer, conditions: EGFR Activating Mutation, conditions: Cell Cycle Deregulation, conditions: EGFR-TKI Resistant Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Osimertinib plus Dalpiciclib, outcomesModule primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300060, country: China, contacts name: Peng Chen, M.D., role: CONTACT, phone: +86-22-23340123, phoneExt: 3201, email: [email protected], contacts name: Peng Chen, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06363721, orgStudyIdInfo id: DFH00125, briefTitle: A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Designs for Health, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices.A 12-week pilot study will be conducted to achieve the purpose of this study. The research team hypothesizes that PerioPull™ will improve a variety of validated markers of dental health that are commonly used in clinical practice., conditionsModule conditions: Oral Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist. All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice. All study outcomes are described in detail in an ensuing section., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: PerioPull™, outcomesModule primaryOutcomes measure: Plaque Index, primaryOutcomes measure: Gingival Index, primaryOutcomes measure: Pocket Depth, secondaryOutcomes measure: Intraoral Photos, secondaryOutcomes measure: MyPerioPath®, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Julian Center for Comprehensive Dentistry, status: RECRUITING, city: Ellicott City, state: Maryland, zip: 21042, country: United States, contacts name: Eugene Sambataro, DDS, role: CONTACT, phone: 410-834-0796, email: [email protected], contacts name: Eugene Sambataro, DDS, role: PRINCIPAL_INVESTIGATOR, contacts name: Chris D'Adamo, PhD, role: SUB_INVESTIGATOR, contacts name: Michael Jurgelewicz, DC, role: SUB_INVESTIGATOR, contacts name: David Brady, ND, DC, role: SUB_INVESTIGATOR, geoPoint lat: 39.26733, lon: -76.79831, hasResults: False
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protocolSection identificationModule nctId: NCT06363708, orgStudyIdInfo id: 2024050, briefTitle: Tislelizumab in Combination With Chemotherapy as a Neoadjuvant Treatment for Advanced Endometrial Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of tislelizumab in combination with chemotherapy as a neoadjuvant treatment for advanced endometrial cancer., conditionsModule conditions: Endometrial Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab, interventions name: Paclitaxel, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: R0 resection rate (R0 %), secondaryOutcomes measure: Pathological complete response rate (pCR%）, secondaryOutcomes measure: Objective Response Rate (ORR%), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Recurrence free survival (RFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence and severity of adverse events as assessed by the NCI-CTCAE v5.0, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Central Hospital of Wuhan, city: Wuhan, state: Hubei, zip: 430014, country: China, contacts name: Xun Tian, MD,PhD, role: CONTACT, phone: 15327205656, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, locations facility: Zhongnan Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430062, country: China, contacts name: Zheng Hu, MD,PhD, role: CONTACT, phone: 13632120686, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hubei maternal and child health care hospital, city: Wuhan, state: Hubei, zip: 430070, country: China, contacts name: QuanFu Ma, MD,PhD, role: CONTACT, phone: 13728133014, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06363695, orgStudyIdInfo id: 131-22, secondaryIdInfos id: 1R01HD112043-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HD112043-01, briefTitle: Building Community Health Volunteers' Capacity to Support Parents With Young Children With SafeCare Kenya, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Pacific University, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), collaborators name: Africa Mental Health Research and Training Foundation, collaborators name: Georgia State University, descriptionModule briefSummary: The goal of this clinical trial is to implement and examine the impact of SafeCare Kenya, an adapted parenting program, to improve parents' skills and knowledge related to the care of their children between the ages of 18 months and 5 years old. The main questions it aims to answer are:* Will SafeCare Kenya improve child and parent outcomes?* Is virtual delivery as effective as in-person delivery of SafeCare Kenya?* Is SafeCare Kenya feasible to deliver by community health volunteers?Mothers will:* Complete study assessments at three timepoints: baseline, 6 months and 18 months* Mothers in the SafeCare Kenya group will receive the program from their community health volunteerResearchers will compare SafeCare Kenya to care as usual by community health volunteers to see if SafeCare Kenya families show improvements in parent interaction skills, safety and health knowledge, potential for child abuse, child behavior problems, child injuries, parenting stress, and child and parent quality of life., conditionsModule conditions: Child Maltreatment, conditions: Parenting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 369, type: ESTIMATED, armsInterventionsModule interventions name: SafeCare Kenya, interventions name: Care as Usual by Community Health Volunteers, outcomesModule primaryOutcomes measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 6 months, primaryOutcomes measure: Change from Baseline in score on Child Planned Activities Training (cPAT) at 18 months, primaryOutcomes measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 6 months, primaryOutcomes measure: Change from Baseline in scores on Parenting Young Children (PARYC) at 18 months, primaryOutcomes measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 6 months, primaryOutcomes measure: Change from Baseline in score on How to Keep your Child Safe and Healthy Quiz at 18 months, primaryOutcomes measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 6 months, primaryOutcomes measure: Change from Baseline in score on Brief Child Abuse Potential Inventory (BCAPI) at 18 months, secondaryOutcomes measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 6 months, secondaryOutcomes measure: Change from Baseline in score on Child Behavior Checklist (CBCL) at 18 months, secondaryOutcomes measure: Change from Baseline in scores on Parenting Stress Index at 6 months, secondaryOutcomes measure: Change from Baseline in scores on Parenting Stress Index at 18 months, secondaryOutcomes measure: Change from Baseline in score on Childhood injuries at 6 months, secondaryOutcomes measure: Change from Baseline in score on Childhood injuries at 18 months, secondaryOutcomes measure: Change from Baseline in score on Child Quality of Life at 6 months, secondaryOutcomes measure: Change from Baseline in score on Child Quality of Life at 18 months, secondaryOutcomes measure: Change from Baseline in score on Parent Quality of Life at 6 months, secondaryOutcomes measure: Change from Baseline in score on Parent Quality of Life at 18 months, otherOutcomes measure: Client satisfaction, otherOutcomes measure: Provider fidelity, otherOutcomes measure: Parent Interview, otherOutcomes measure: Provider Interview, otherOutcomes measure: Trainer Interview, otherOutcomes measure: Stakeholder Interview, otherOutcomes measure: Readiness Assessment for the Prevention of Child Maltreatment (RAP-CM), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Africa Mental Health Research and Training Foundation, status: RECRUITING, city: Nairobi, country: Kenya, contacts name: Victoria Mutiso, PhD, role: CONTACT, phone: (254) 202 651 360, email: [email protected], contacts name: Christine Musyimi, PhD, role: CONTACT, phone: (254) 202 651 360, email: [email protected], contacts name: David Ndetei, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -1.28333, lon: 36.81667, hasResults: False
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protocolSection identificationModule nctId: NCT06363682, orgStudyIdInfo id: 2023PI225, briefTitle: Interventional Reference Levels (IRL) in Digestive Endoscopy, acronym: EndoscopX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-11, completionDateStruct date: 2024-06-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.Secondary objective(s) :* Application of regulatory texts* Assessment of patient radiation protection* Radiation protection assessment for workers, conditionsModule conditions: Each Endoscopic Intervention Using X-rays, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: ERCP, interventions name: endoscopic ultrasound, interventions name: gastroscopy, interventions name: Colonoscopy, interventions name: placement of a nasojejunal tube, outcomesModule primaryOutcomes measure: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure., secondaryOutcomes measure: Application of regulatory texts, secondaryOutcomes measure: Assessment of patient radiation protection, secondaryOutcomes measure: Radiation protection assessment for workers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital University of Nancy, city: Nancy, state: Meurthe-et-Moselle, zip: 54000, country: France, contacts name: MUNIER W Munier Wendy, role: CONTACT, phone: +3383155457, email: [email protected], contacts name: CHEVAUX JB Doctor CHEVAUX Jean-Baptiste, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
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protocolSection identificationModule nctId: NCT06363669, orgStudyIdInfo id: 1_CAF_AWF, briefTitle: Effects of Caffeine-based Supplement on Physical Performance, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-15, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University School of Physical Education, Krakow, Poland, class: OTHER, descriptionModule briefSummary: The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men, conditionsModule conditions: Muscle Power, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: multi-ingredient pre-workout dietary supplement (caffeine-based), outcomesModule primaryOutcomes measure: anaerobic power, primaryOutcomes measure: aerobic power, eligibilityModule sex: MALE, minimumAge: 19 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University School of Physical Education in Cracow, city: Krakow, zip: 31-571, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
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protocolSection identificationModule nctId: NCT06363656, orgStudyIdInfo id: 76455623.5.0000.0068, briefTitle: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol, acronym: SLEEP-EX2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-05-28, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, collaborators name: Samsung Eletrônica da Amazônia Ltda, collaborators name: Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP, descriptionModule briefSummary: The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality.The main question it aims to answer is:- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?, conditionsModule conditions: Insomnia, conditions: Sleep Initiation and Maintenance Disorders, conditions: Health Status, conditions: Wearable Electronic Devices, conditions: Sleep, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires, outcomesModule primaryOutcomes measure: Concordance between the smartwatch application and clinical assessment, eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, status: RECRUITING, city: São Paulo, zip: 05403-900, country: Brazil, contacts name: ARO-InCor Academic Research Organization Office, role: CONTACT, phone: +55 11 2661-5795, email: [email protected], contacts name: Daniel Queiroz, PhD, role: CONTACT, phone: +55 11 9-4138-5473, email: [email protected], contacts name: Geraldo Lorenzi Filho, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
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protocolSection identificationModule nctId: NCT06363643, orgStudyIdInfo id: Prehab01, briefTitle: Lower Limb Arthroplasty: Effects of a Tele Prehabilitation Program With Indirect Electrostimulation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-07-26, completionDateStruct date: 2024-07-26, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: Preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity.Prehabilitation (Prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. Patients who participate in Prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. However, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. In the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the Prehab. Electrostimulation (ESM) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. In addition, it has already been used for Prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. Also Exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. Therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a Tele Prehab program, based on the ESM, and compare them with those of an Tele Prehab exercise program, equal in dose and duration. The proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations., conditionsModule conditions: Osteo Arthritis Knee and Hip, conditions: Lower Limb Arthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: ELECTROSTIMULATION (ES), interventions name: EXERCISE (C), outcomesModule primaryOutcomes measure: Change from baseline in functional capacities on 30 Seconds Chair Stand Test (30CST) at week 4, secondaryOutcomes measure: Change from baseline in functional capacities on Timed Up and Go test (TUG) at week 4., eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: "Città di Pavia Healthcare Institute", city: Pavia, zip: 27100, country: Italy, contacts name: Luca Marin, role: CONTACT, phone: 0382 433658, phoneExt: +39, email: [email protected], contacts name: Luca Marin, role: PRINCIPAL_INVESTIGATOR, contacts name: Matteo Chiodarono, role: SUB_INVESTIGATOR, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06363630, orgStudyIdInfo id: CA073-1000, briefTitle: A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-08-19, completionDateStruct date: 2024-08-19, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Celgene, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Itraconazole, interventions name: Rifampin, interventions name: Golcadomide, outcomesModule primaryOutcomes measure: Maximum observed plasma concentration (Cmax), primaryOutcomes measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)), primaryOutcomes measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with physical exam abnormalities, secondaryOutcomes measure: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Number of participants with clinical laboratory safety test abnormalities, secondaryOutcomes measure: Number of participants with electrocardiogram abnormalities, secondaryOutcomes measure: Number of participants with concomitant medications, secondaryOutcomes measure: Number of participants with concomitant procedures, secondaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), secondaryOutcomes measure: Apparent terminal phase half-life (T-HALF), secondaryOutcomes measure: Apparent total body clearance (CLT/F), secondaryOutcomes measure: Apparent volume of distribution (Vz/F), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Local Institution - 0001, city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: Site 0001, role: CONTACT, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False
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protocolSection identificationModule nctId: NCT06363617, orgStudyIdInfo id: CSAPG-58, briefTitle: Implementation of the Fatty Liver Index in Primary Care, acronym: FLI-AP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de l'Alt Penedès i Garraf, class: OTHER, descriptionModule briefSummary: This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared., conditionsModule conditions: Hepatic Steatosis, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 434, type: ESTIMATED, armsInterventionsModule interventions name: FLI, outcomesModule primaryOutcomes measure: Lifestyle Intervention, secondaryOutcomes measure: Low-density lipoprotein cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Gamma-glutamyl transpeptidase, secondaryOutcomes measure: Medical and nursing visits, secondaryOutcomes measure: Analytical checks in the first year, secondaryOutcomes measure: Lipid-lowering drugs, secondaryOutcomes measure: Healthcare spending, secondaryOutcomes measure: FLI administration, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, city: Vilanova I La Geltrú, state: Barcelona, country: Spain, contacts name: M Carmen Rosas, MD, role: CONTACT, phone: +34 938 10 30 03, email: [email protected], contacts name: Noemí Casaponsa, role: CONTACT, phone: +34 938960026, phoneExt: 43197, email: [email protected], contacts name: M Carmen Rosas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.22392, lon: 1.72511, hasResults: False
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protocolSection identificationModule nctId: NCT06363604, orgStudyIdInfo id: XHEC-C-2023-128-2, briefTitle: Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio.Group 0 (Control): VOMEI + PVI + linear ablation of mitral isthmus. Group 1 (Experimental): VOMEI + PVI + linear ablation of mitral isthmus + PWI, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation., whoMasked: PARTICIPANT, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: VOMEI + PVI + linear ablation of mitral isthmus, interventions name: Posterior wall isolation, outcomesModule primaryOutcomes measure: Recurrence of atrial arrhythmias, secondaryOutcomes measure: Procedural complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinhua Hospital, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200092, country: China, contacts name: Mu Chen, role: CONTACT, phone: +86 021 25077275, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06363591, orgStudyIdInfo id: Wise vs wide, briefTitle: Single- vs Two-staged Excisions of Thin Melanoma, acronym: WvW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2034-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, collaborators name: Stockholm Region, collaborators name: Region Skane, collaborators name: Region Västerbotten, collaborators name: Region Örebro County, collaborators name: Blekinge County Council Hospital, collaborators name: Region Östergötland, collaborators name: Dalarna County Council, Sweden, descriptionModule briefSummary: The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period., conditionsModule conditions: Melanoma (Skin), conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with thin (≤1.0 mm) invasive melanomas excised with a histopathological margin ≥1.5 mm will be offered to participate following informed consent and randomization (1:1) to either:1. Standard treatment with a WLE of the diagnostic excision scar with a lateral clinical surgical margin of 10 mm and a deep clinical surgical margin down to the muscular fascia as recommended by the Swedish national guidelines. or2. Experimental treatment with no WLE., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2486, type: ESTIMATED, armsInterventionsModule interventions name: Wise vs wide, outcomesModule primaryOutcomes measure: Recurrence rate at 5 years., secondaryOutcomes measure: Recurrence rate at 10 years., secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Scar length, width and quality, secondaryOutcomes measure: Scar length, width and quality, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Direct and indirect costs per patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363578, orgStudyIdInfo id: 36264PR604/3/24, briefTitle: Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy., conditionsModule conditions: Dexmedetomidine, conditions: External Oblique Intercostal Plane Block, conditions: Splenectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine 0.5 μg/kg, interventions name: Dexmedetomidine 1 μg/kg, outcomesModule primaryOutcomes measure: Time to the 1st rescue analgesia, secondaryOutcomes measure: Intraoperative fentanyl consumption, secondaryOutcomes measure: Total morphine consumption, secondaryOutcomes measure: Degree of pain, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: The incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University, city: Tanta, state: El-Gharbia, zip: 31527, country: Egypt, contacts name: Mohammed S Elsharkawy, MD, role: CONTACT, phone: 00201148207870, email: [email protected], contacts name: Saad A Moharam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06363565, orgStudyIdInfo id: MN-2022-11, briefTitle: Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L., conditionsModule conditions: Homocysteine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: supplementation of compound nutrients, interventions name: placebo control, outcomesModule primaryOutcomes measure: levels of homocysteine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SunYat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Zhu Huilian, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06363552, orgStudyIdInfo id: WETARI, briefTitle: A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Tianshu Liu, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer., conditionsModule conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: SC0191, interventions name: SC0191 + Bevacizumab, interventions name: SC0191 + 5-FU/LV, outcomesModule primaryOutcomes measure: Objective Response Rate, primaryOutcomes measure: Incidence and Severity of Dose Limiting Toxicities (DLTs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital Affiliated to Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06363539, orgStudyIdInfo id: Adeel5, briefTitle: Silver Nitrate Versus Topical Steroid For Umbilical Granuloma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-20, primaryCompletionDateStruct date: 2023-03-20, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Children Hospital and Institute of Child Health, Lahore, class: OTHER, descriptionModule briefSummary: Umbilical granuloma is most frequent abnormality of umbilicus in infants that is defined as a moist, fleshy and pink granulation tissue at the center of umbilicus. The most commonly used treatment for umbilical granuloma is silver nitrate cauterization. Various other treatment options for umbilical granuloma include dressing with alcohol and antiseptic solutions, topical table salt, topical steroid application, suture ligation, surgical excision, electrocautery and cryotherapy. Topical steroid ointment is easily available in market, it is cheaper and safer than silver nitrate. OBJECTIVE: To compare the outcome of treatment with silver nitrate versus topical steroid for umbilical granuloma in terms of healing after 3 weeks of treatment. MATERIALS AND METHODS Study Design: Randomized Controlled Trial Setting: Department of Pediatric Surgery, Children Hospital, Lahore Duration: 6 months after approval of synopsis \[Sept 20, 2022 till March 20, 2023\] DATA COLLECTION PROCEDURE 2 After approval of study from hospital Ethical committee \& CPSP, all patients fulfilling the inclusion criteria were admitted through the pediatric surgery outpatient department of The Children's Hospital Lahore. 354 Patients were divided in two equal groups randomly, using lottery method Group A (control group) in which silver nitrate was applied to the lesion once a week and Group B (experimental group) in which topical steroid ointment was applied to the lesion twice a day. Patients were followed after 3 weeks to see healing of umbilical granuloma. Photographs were taken before start of treatment and on regular intervals at each follow up visit. All data was collected by myself., conditionsModule conditions: Umbilical Granuloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized control trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 354, type: ACTUAL, armsInterventionsModule interventions name: Clobetasol Propionate .05 Mg in 100 mL TOPICAL LOTION, interventions name: Silver Nitrate, outcomesModule primaryOutcomes measure: healing, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 1 Year, stdAges: CHILD, contactsLocationsModule locations facility: Children Hospital, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06363526, orgStudyIdInfo id: UMalagaDRIP, briefTitle: Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy., acronym: DMDrespy2024, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Malaga, class: OTHER, descriptionModule briefSummary: The purpose of this study is to analyze the effectiveness of a 5-weeks respiratory digital intervention program in patients with Duchenne muscular dystrophy and Becker muscular dystrophy., conditionsModule conditions: Duchenne Muscular Dystrophy, conditions: Becker Muscular Dystrophy, conditions: Muscular Dystrophy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 12 participants were randomized to follow a digital respiratory physiotherapy program for 5 weeks. The participants were evaluated at the beginning and at the end of the study, and the results will be measured before and after each intervention during the study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Digital respiratory intervention program, outcomesModule primaryOutcomes measure: Analyze the improvement of the forced vital capacity (FVC)., secondaryOutcomes measure: Perform an anthropometric study of the patient's characteristics, taking into account weight; and also a general physical examination., secondaryOutcomes measure: Perform an anthropometric study of the patient's characteristics, taking into account age., secondaryOutcomes measure: Perform an anthropometric study of the patient's characteristics, taking into account height., secondaryOutcomes measure: Perform an anthropometric study of the patient's characteristics, taking into account sex., secondaryOutcomes measure: Examine changes in forced expiratory pressure, secondaryOutcomes measure: Analyze changes in maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)., secondaryOutcomes measure: Check if there are changes in the sniff nasal inspiratory pressure (SNIP), secondaryOutcomes measure: Evaluate the fatigue in patients using an EPInfant test., secondaryOutcomes measure: Evaluate the quality of life of patients using a scale called "Kindscreen-52"., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Rocío Martín-Valero, city: Málaga, country: Spain, geoPoint lat: 36.72016, lon: -4.42034, hasResults: False
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protocolSection identificationModule nctId: NCT06363513, orgStudyIdInfo id: SUR2567-0150, briefTitle: The Efficacy of Aescin in Combination With MPFF in the Early Control of Bleeding From Acute Internal Hemorrhoids, A Randomized Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chiang Mai University, class: OTHER, descriptionModule briefSummary: Hemorrhoidal disease, characterized by symptomatic enlargement and distal displacement of anal cushions, has been a subject of recognition and management for centuries. The etymology of "hemorrhoid" is traced back to the Greek words haima (blood) and rhoos (flow). Prevalent in over 20% of the population across various life stages, this anorectal condition impacts both genders. The multifaceted development of the disease incorporates theories encompassing abnormal dilation of hemorrhoidal plexuses, distension of arteriovenous anastomoses, prolapse of anal pads, and a myriad of genetic, anatomical, dietary, and lifestyle factors. Manifestations range from venous distension to bleeding and thrombosis, with classification based on location (internal/external/combined) and degree of prolapse (grade 1-4).Upon comprehensive history-taking and examinations, including digital rectal and proctoscope assessments, a definitive diagnosis is established, leading to the treatment phase. Although outpatient procedures demonstrate efficacy, patients may persist with pain and discomfort. Medical intervention assumes significance for stages 1 and 2, incorporating approaches such as rubber-band ligation, injection sclerotherapy, and dietary modifications. Micronized Purified Flavonoid Fraction (MPFF), integral to hemorrhoid treatment, has been scrutinized for its ability to mitigate pathogenic processes culminating in acute bleeding. The stagnation of blood in vascular plexuses prompts an inflammatory response, activating white cells and increasing vessel wall permeability. MPFF's flavonoid compounds are posited to alleviate bleeding by augmenting venous tone, reducing stasis, inhibiting inflammatory mediators, and enhancing lymphatic drainage\[8\]. Multiple trials substantiate MPFF's efficacy in ceasing bleeding, alleviating symptoms, and preventing hemorrhoid relapse.Aescin, a saponin mixture found in Aesculus hippocastanum (horse chestnut). The primary active component, β-aescin, contributes to the plant's medicinal attributes. Experimental investigations in animal models underscore its anti-edematous, anti-inflammatory, and venotonic properties, attributed to molecular mechanisms facilitating ion entry into channels and elevating venous tension. While the therapeutic benefits of aescin for hemorrhoids are acknowledged, the absence of randomized control trials impedes the conclusive validation of its efficacy. In the realm of diverse treatment options, this proposed randomized controlled trial aims to assess the comparative effectiveness of combining aescin with MPFF versus MPFF alone in managing hemorrhoid-related symptoms. The study aspires to furnish valuable insights for refining therapeutic strategies in the management of hemorrhoids and enhancing patient outcomes., conditionsModule conditions: Anorectal Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Aescin in Horse Chestnut, interventions name: Flavonoid, outcomesModule primaryOutcomes measure: Cessation of bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maharaj Chiang Mai hospital, city: Chiangmai, state: Maung, zip: 50200, country: Thailand, contacts name: WITCHA VIPUDHAMORN, FRCS, role: CONTACT, phone: 0863645085, email: [email protected], geoPoint lat: 18.79038, lon: 98.98468, hasResults: False
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protocolSection identificationModule nctId: NCT06363500, orgStudyIdInfo id: ChantalIRCB, briefTitle: Characterization of HIV-1 Reservoirs in HIV-1 Non-B Infected Adolescents on ART in Cameroon, acronym: AVIR, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chantal Biya International Reference Centre for Research on Prevention and Management of HIV/AIDS, class: OTHER_GOV, descriptionModule briefSummary: Background: Combination antiretroviral therapy (cART) can bring HIV-1 in blood plasma to level undetectable by standard tests and allow a near-normal life expectancy for HIV-infected individuals. Unfortunately, cART is not curative, as within a few weeks of treatment cessation, HIV viremia in most patients rebounds except for rare elite or post-treatment controllers of viremia. The primary source of this rebound is the highly stable reservoir of latent yet replication-competent HIV-1 proviruses integrated into the genomic DNA of resting memory CD4+ T cells. To achieve a cure for HIV, understanding the cell reservoir environment is of paramount importance. The size and nature of viral reservoir might vary per timing of therapy, therapeutic response, ART duration, and immune response. Mechanisms of reservoir maintenance generally depend on levels/type of immune recognition, dynamics of viral persistence are different between pediatric and adult populations, owing to, but not limited to, types/numbers of target cells, efficiency in clearing HIV-infected cells, plasma viremia and HIV drug resistance patterns. This difference could become more evident as these children grow toward adolescence (increasing population due to ART benefits), a stage during which suboptimal adherence is frequent, leading to viral rebound and archiving of resistant patterns.Objectives: We plan to conduct a cross sectional study with the aim to characterize HIV reservoirs and their variability according to virological and immunological profiles of non-B HIV-1 vertically infected adolescents receiving antiretroviral therapy. Specifically, we shall (1) evaluate the size of HIV reservoir; (2) Determine HIV-1 genetic variability and drug resistance in cellular reservoirs; (3) Characterize immune activation/inflammation of HIV infected adolescents.Methods: We plan to conduct an observational and comparative study involving 90 HIV-1 non-B infected adolescents aged 10-19 years vertically infected, have been on ART for at least 12 months selected from a cohort of the ongoing EDCTP-READY study; intravenous blood will be collected for CD4/CD8 count, plasmatic viral load, PBMCs isolation, immune activation/inflammatory markers, genotyping and Viral reservoir quantification. We will as well recruit a group of 30 HIV-negative adolescents as control for immunological profiling.Overall impact: Our findings will help in advancing knowledge on HIV reservoir, in terms of size and genetic variability in adolescents living with HIV (ADLHIV). Such evidence will also help in understanding the effects of ART timing and duration on the size of reservoirs among ADLHIV, a unique population from whom findings generated will largely contribute in designing functional cure strategies in this vulnerable population., conditionsModule conditions: Characterization of HIV Reservoirs in Adolescents, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: non applicable, outcomesModule primaryOutcomes measure: Archived HIV drug resistance mutations, secondaryOutcomes measure: HIV-1 reservoirs measurement, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Chantal Biya International Reference Centre, city: Yaounde, state: Centre, zip: 99999, country: Cameroon, geoPoint lat: 3.86667, lon: 11.51667, hasResults: False
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protocolSection identificationModule nctId: NCT06363487, orgStudyIdInfo id: R87970/RE001, briefTitle: Semaglutide and Cognition in Healthy Volunteers, acronym: OxSENSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-04-08, completionDateStruct date: 2024-06-08, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, collaborators name: NIHR Oxford Health Biomedical Research Centre, descriptionModule briefSummary: Semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA). It is a safe medication approved for use in type-2 diabetes mellitus (T2DM) and obesity. Primarily, it works by counteracting insulin-resistance and inducing weight loss. It also acts on several other interconnected neurobiological, immunological (esp. inflammatory), endocrine-metabolic, and gut-brain axis processes that play a role in depressive symptoms. Its effects on cognition and energy are currently unknown. In this study we are using semaglutide as an experimental tool to further investigate these relationships., conditionsModule conditions: Cognitive Change, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide, 0.5 mg/mL, interventions name: Placebo, 0.9% NaCl 1.5mL, outcomesModule primaryOutcomes measure: Reward (learning), primaryOutcomes measure: Reward (effort-based), primaryOutcomes measure: Reward (primary), secondaryOutcomes measure: Emotional processing, secondaryOutcomes measure: Emotional impulsivity, secondaryOutcomes measure: Memory (short- and medium-term) processing, secondaryOutcomes measure: Memory (working) processing, secondaryOutcomes measure: Energy/activity, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Psychiatry, University of Oxford, city: Oxford, state: Oxfordshire, zip: OX3 7JX, country: United Kingdom, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False
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protocolSection identificationModule nctId: NCT06363474, orgStudyIdInfo id: UHS 5532, briefTitle: Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University of Health Sciences Lahore, class: OTHER, descriptionModule briefSummary: The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation.This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied.It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months, conditionsModule conditions: Severe Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention model of this study is a parallel model. Patients meeting inclusion criteria are enrolled from the neurosurgery department of Punjab Institute of Neurosciences, Lahore. After obtaining consent, patients undergo detailed assessments and investigations. They're randomly assigned to Group A (decompressive craniectomy) or Group B (cisternostomy). Both procedures are performed by a single surgical team under anesthesia. Postoperatively, patients are monitored for mechanical ventilation duration, ICU and hospital stay lengths, and Glasgow Outcome Scale at discharge. This model enables outcome comparison between intervention groups while controlling confounding variables., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Decompressive Craniectomy, interventions name: Cisternostomy, outcomesModule primaryOutcomes measure: comparison of patient outcomes between the two intervention groups (Decompressive Craniectomy and Cisternostomy) in terms of the Glasgow Outcome Scale (GOS)., eligibilityModule sex: ALL, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363461, orgStudyIdInfo id: 239-13851-202, briefTitle: Study of TDM-180935 in Atopic Dermatitis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Technoderma Medicines Inc., class: INDUSTRY, collaborators name: Therapeutics, Inc., descriptionModule briefSummary: Randomized, Vehicle-controlled, Parallel Group Study of TDM-180935 in Atopic Dermatitis Patients, conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: TDM-180935 topical ointment 1.0%, interventions name: TDM-180935 topical ointment 2.0%, interventions name: TDM-180935 topical vehicle ointment 1, interventions name: TDM-180935 topical vehicle ointment 2, outcomesModule primaryOutcomes measure: Change in m-EASI (modified Eczema Area and Severity Index) score, secondaryOutcomes measure: Proportion of patients with a ≥ 2 point improvement in vIGA-AD score (validated Investigator's Global Assessment for Atopic Dermatitis score), secondaryOutcomes measure: Change in m-EASI (modified Eczema Area and Severity Index) score, secondaryOutcomes measure: Proportion of patients with a 50% improvement in m-EASI (modified Eczema Area and Severity Index) score, secondaryOutcomes measure: Proportion of patients with a 75% improvement in m-EASI (modified Eczema Area and Severity Index) score, secondaryOutcomes measure: Proportion of patients with a 90% improvement in m-EASI (modified Eczema Area and Severity Index) score, secondaryOutcomes measure: Change in BSA (body surface area) affected, secondaryOutcomes measure: Proportion of patients with a 4-point improvement from Baseline in WI-NRS (Worst Itch-Numeric Rating Scale) score, otherOutcomes measure: Incidence (severity and causality) of any local and systemic AEs (adverse events), otherOutcomes measure: Number of patients with presence (and severity) of the following LSRs (local skin reactions): skin pigmentation (hyperpigmentation and hypopigmentation), edema, erosion,scaling, and burning/stinging, otherOutcomes measure: Changes from Baseline in vital signs (temperature), otherOutcomes measure: Changes from Baseline in vital signs (systolic and diastolic blood pressure), otherOutcomes measure: Changes from Baseline in vital signs (heart rate), otherOutcomes measure: Changes from Baseline in vital signs (respiration rate), otherOutcomes measure: Changes from baseline in clinical laboratory tests (including Blood Chemistries, Hematology, and Urinalysis), otherOutcomes measure: Number of participants with abnormal ECG readings, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 3, city: Rolling Meadows, state: Illinois, zip: 60008, country: United States, geoPoint lat: 42.08419, lon: -88.01313, locations facility: Site 7, city: Covington, state: Louisiana, zip: 70433, country: United States, geoPoint lat: 30.47549, lon: -90.10042, locations facility: Site 5, city: New Brighton, state: Minnesota, zip: 55112, country: United States, geoPoint lat: 45.06552, lon: -93.20189, locations facility: Site 6, city: Anderson, state: South Carolina, zip: 29621, country: United States, geoPoint lat: 34.50344, lon: -82.65013, locations facility: Site 1, city: Austin, state: Texas, zip: 78759, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Site 4, city: College Station, state: Texas, zip: 77845, country: United States, geoPoint lat: 30.62798, lon: -96.33441, locations facility: Site 2, city: Norfolk, state: Virginia, zip: 23502, country: United States, geoPoint lat: 36.84681, lon: -76.28522, hasResults: False
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protocolSection identificationModule nctId: NCT06363448, orgStudyIdInfo id: Soh-Med-24-3-04PD, briefTitle: Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The study aims to describe a new method of sulcus fixation of intraocular lenses (IOLs) using a prolene mesh and to compare its outcomes with Yamani technique., conditionsModule conditions: Aphakia, Postcataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Yamani Technique versus Prolene Mesh for Intraocular Lens Scleral Fixation in Aphakia, outcomesModule primaryOutcomes measure: Best corrected visual acuity (BCVA) in LogMAR, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ophthalmology department, Sohag University, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Elshimaa A.Mateen, role: CONTACT, phone: 0201282223427, email: [email protected], geoPoint lat: 26.55695, lon: 31.69478, locations facility: Elshimaa A.Mateen, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Elshimaa A.Mateen, Doctor, role: CONTACT, phone: 0201282223427, email: [email protected], geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06363435, orgStudyIdInfo id: #2022-01302-02-PSMA, briefTitle: AI-based Measurements of Tumour Burden in PSMA PET-CT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2031-03, completionDateStruct date: 2033-03, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Elin Tragardh, class: OTHER, collaborators name: Lund University, descriptionModule briefSummary: The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence)., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans, outcomesModule primaryOutcomes measure: Tumour burden (cm3) in relation to overall survival, secondaryOutcomes measure: Tumour burden (cm3) in relation to biochemical recurrence, secondaryOutcomes measure: Number of tumours/metastases in relation to OS, secondaryOutcomes measure: Comparing two different segmentation methods in relation to OS, secondaryOutcomes measure: Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skåne University Hospital, status: RECRUITING, city: Lund, country: Sweden, contacts name: Elin Tragardh, Prof, role: CONTACT, phone: +4640338724, email: [email protected], geoPoint lat: 55.70584, lon: 13.19321, locations facility: Skåne university hospital, status: RECRUITING, city: Malmö, country: Sweden, contacts name: Elin Tragardh, Prof, role: CONTACT, phone: +4640338724, email: [email protected], geoPoint lat: 55.60587, lon: 13.00073, hasResults: False
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protocolSection identificationModule nctId: NCT06363422, orgStudyIdInfo id: JY2024-012, briefTitle: The Value of Epicanthoplasty on the Modification of Upper-eyelid Appearance, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-15, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, class: OTHER, descriptionModule briefSummary: In East Asian populations, the combination of an epicanthic fold and mono-eyelid is one of their anatomical characteristics. Misalignment of the orbicularis oculi muscle and fibrous connections leads to longitudinal tension, forming the epicanthic fold. The epicanthic fold may diminish the aesthetic effects of eyelid cosmetic surgery, shorten the horizontal length, and affect the postoperative shape of double eyelids. As upper eyelid cosmetic surgery is one of the most common cosmetic procedures in Asia, there is increasing attention on the modification of the epicanthic fold and its impact on the formation of double eyelids., conditionsModule conditions: Patient Satisfaction, conditions: Epicanthus; Fold, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Epicanthoplasty, outcomesModule primaryOutcomes measure: inter-epicanthal distance (IED), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai ninth people's hospital, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06363409, orgStudyIdInfo id: 2023-1353, briefTitle: The Acute and Accumulative Effects of Snack Foods on Exercise Recovery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: San Diego State University, class: OTHER, descriptionModule briefSummary: The purpose of the research is two-fold. One goal is to determine if post-exercise almond or cereal bar consumption can promote muscle gain as well as increasing muscular strength throughout an eight-week weight training program. The other goal is to assess the short-term effects of almonds or cereal bar on recovery that may explain the overall long-term adaptations., conditionsModule conditions: Muscle Strength, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Cereal Bar as a recovery food snack, interventions name: Almond, outcomesModule primaryOutcomes measure: delayed onset of muscle soreness, primaryOutcomes measure: markers of muscle damage, primaryOutcomes measure: changes in strength, primaryOutcomes measure: changes in body composition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363396, orgStudyIdInfo id: K 2023-7081, briefTitle: Fatigue and Cognitive Dysfunction After Allogeneic Stemcell Transplantation, Prospective PET Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2026-02-22, completionDateStruct date: 2027-02-22, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Karolinska Institutet, class: OTHER, collaborators name: Karolinska University Hospital, descriptionModule briefSummary: This study is the academic study and continuation and further development of a prior project under the leadership of Professor LeBlanc. Patients undergoing allogenic stem cell transplantation are followed up in the outpatient clinic. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Previous study by Boberg et al suggested distinct mRNA and proteomic profiles segregating fatigued from non-fatigued patients as well as patients with or without cognitive impairment. A larger well-defined patient cohort is necessary to confirm these results. Investigators aim to identify specific sets of proteins in the CSF that can serve as potential biomarkers of cognitive dysfunction and/or fatigue. This will be performed with two methods:* by using mass spectrometry-based proteomics approaches* Olink technologyPET examinations will be performed on both fatigued and non-fatigued. We will utilize the second generation TSPO radioligand \[ 11C\]PBR28 as well as the SV2A radioligand \[ 11C\]UCB-J, both showing high signal-to-noise ratio and adequate test-retest properties., conditionsModule conditions: Fatigue, conditions: Cognitive Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Results of cognitive tests, primaryOutcomes measure: Potential biomarkers for fatigue and cognitive dysfunction, primaryOutcomes measure: PET results, secondaryOutcomes measure: Global analyses of the neural connections, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska, status: RECRUITING, city: Stockholm, zip: 14186, country: Sweden, contacts name: Ksenia Boriskina, MD, role: CONTACT, phone: 0858580675, email: [email protected], contacts name: Kirsti Niemelä, study nurse, role: CONTACT, contacts name: Katarina Le Blanc, professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
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protocolSection identificationModule nctId: NCT06363383, orgStudyIdInfo id: MB-001-101, briefTitle: A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Mage Biologics, class: INDUSTRY, collaborators name: Alimentiv Inc., descriptionModule briefSummary: The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy volunteers. The main questions it aims to answer are:Is the drug safe when administered orally at increasing doses? Researchers will compare the drug with placebo to see if there are more side effects in those receiving the drug.Participants will receive a single or five daily doses of the drug or placebo and will be asked to stay in the clinic for five days following the last dose., conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two-stage, single-center, double-blinded, randomized, placebo-controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: double-blinded using matching placebo capsules containing matching pellets, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: MB-001, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AEs), primaryOutcomes measure: Clinically significant changes from baseline in vital signs, primaryOutcomes measure: Clinically significant changes from baseline in physical examination findings, primaryOutcomes measure: Clinically significant changes from baseline in clinical laboratory assessments, primaryOutcomes measure: Clinically significant changes from baseline in ECG parameters, secondaryOutcomes measure: Area under the concentration-time curve, secondaryOutcomes measure: Maximum plasma concentration, secondaryOutcomes measure: Time to reach observed maximum plasma concentration after administration, secondaryOutcomes measure: Trough concentration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CMAX, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Jessica Lehman, role: CONTACT, phone: +61 8 7088 7900, email: [email protected], geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
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protocolSection identificationModule nctId: NCT06363370, orgStudyIdInfo id: KXZY-GB05-201, briefTitle: Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Kexing Biopharm Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To evaluate the efficacy and safety of interferon α1b (GB05) in the treatment of children under 2 years of age with respiratory syncytial virus infection., conditionsModule conditions: Respiratory Syncytial Virus Infections, 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: 322, type: ESTIMATED, armsInterventionsModule interventions name: Human interferon α1b Inhalation Solution, interventions name: Inhalation Solution Placebo, outcomesModule primaryOutcomes measure: Wang bronchiolitis score chanced by percentage from baseline, primaryOutcomes measure: Wang bronchiolitis score chanced by percentage from baseline, primaryOutcomes measure: Wang bronchiolitis score of 0 in proportion, primaryOutcomes measure: Wang bronchiolitis score total score < 5 points, primaryOutcomes measure: Wang bronchiolitis score, the first time the total score reaches < 5 points, secondaryOutcomes measure: RSV viral load, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 2 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital, Capital Institute of Pediatrics, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Ling Cao, MD, role: CONTACT, phone: 13910610319, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06363357, orgStudyIdInfo id: 24B-007-0000, briefTitle: The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Duchenne Muscular Dystrophy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with Duchenne muscular dystrophy.The main questions it aims to answer are:* What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with Duchenne muscular dystrophy?* Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not?Participants will:* Receive education on how to wear and use the shoulder orthosis.* Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues.Researchers will compare Duchenne muscular dystrophy patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography., conditionsModule conditions: Muscular Dystrophy, Duchenne, conditions: Orthotic Devices, conditions: Upper Extremity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This study compares variables before and after wearing the shoulder orthosis in patients with Duchenne muscular dystrophy., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Shoulder orthosis, outcomesModule primaryOutcomes measure: Performance of the upper limb module 2.0 (PUL 2.0), primaryOutcomes measure: Active Range of motion, primaryOutcomes measure: Functional workspace, primaryOutcomes measure: Goal Attainment Scale (GAS), primaryOutcomes measure: Surface electromyography (sEMG), eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, state: Jongno-gu, zip: 03080, country: Korea, Republic of, contacts name: Woo Hyung Lee, MD, Ph.D, role: CONTACT, phone: +82-2-2072-4178, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06363344, orgStudyIdInfo id: APHP231022, secondaryIdInfos id: IDRCB: 2023-A00660-45, type: REGISTRY, domain: IDRCB ANSM, briefTitle: Follow-up in Pediatric Intensive Care Unit, acronym: APRELAREA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Background In developed countries, mortality rates in pediatric intensive care units (PICUs) are around 4% and thus, most children admitted to these units survive. However, some pediatric survivors experience long-term morbidity (cognitive, psychological, social and/or physical disorders) associated with their intensive care stay. Currently in France, there are no recommendations for the management of these patients and most of them do not have standardized follow-up.Objectives Main objective: To assess the feasibility of implementing systematic and comprehensive management of pediatric patients who have been admitted to the PICU.Intermediate objectives are to study:* The needs of the children and their families which should be met by this management* The acceptability of this organizational innovation for all the actors involved* The cooperation between actors of the hospital and city health system + social professionals involved* The costs of implementation and the budgetary impact of such a systemMethods Needs assessment: questionnaires and interviews with patients and their families (parents and possibly siblings if involved) to collect the medico-psycho-social impact of the PICU stay at the time of discharge and 3 months later.Study of acceptability: quantitative survey of health professionals involved in the care of these children and expected care modalities. This includes pediatric intensivists, professionals from the children's usual care services (if applicable), attending physician.Study of cooperation: analysis of needs and of the network usually solicited for the children benefiting from this care: who is identified, who remains to be identified, obstacles. Quantitative analysis of consultation reports and survey of professionals.Budgetary impact analysis: study of the cost of setting up consultations for the health care system, and study of its financial and health consequences for the main needs identified, on the basis of data from the literature and expert opinionsPerspectives Compare the benefit of this systematic, multi professional and comprehensive management of pediatric patients after PICU discharge versus standard of care, conditionsModule conditions: Intensive Care Psychosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires : PHQ-9 (Kroenke, 2001), the PSC (Sheldrick, 2012), the ASQ-SE (Squires, 2015), the PedsQL (Varni, 1999), outcomesModule primaryOutcomes measure: Emotional and behavioral problem of the children measured by the PSC questionnaire (Sheldrick, 2012), secondaryOutcomes measure: Mental disorders measured by the PHQ-9 (Kroenke, 2001) questionnaire, secondaryOutcomes measure: Social-emotional development measured by the ASQ-SE (Squires, 2015) questionnaire, secondaryOutcomes measure: Pediatric Quality of Life measured by the the PedsQL (Varni, 1999) questionnaire, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Robert Debre Hospital, status: RECRUITING, city: Paris, zip: 75019, country: France, contacts name: Michaël LEVY, MD, PhD, role: CONTACT, phone: +33.1.40.03.40.98, email: [email protected], contacts name: Enora LE ROUX, PhD, role: CONTACT, phone: +33.1.40.03.23.66, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06363331, orgStudyIdInfo id: 2020I054, briefTitle: Efficacy of the Social Cognition Rehabilitation Program E-motional Training in the Treatment of Patients With Substance-related Disorders, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Fundacin Biomedica Galicia Sur, class: OTHER, descriptionModule briefSummary: Drug use, substance use disorders (SUD) and other addictive behaviors are problems of enormous socio-health impact that still require a great research effort to improve the diagnostic and therapeutic procedures used in healthcare practice.Since addictive behaviors have been consistently associated with the presence of alterations in cognitive and executive functions, it is necessary to be able to detect, evaluate and have specific therapies for these dysfunctions and investigate, among other issues, the role they play in the onset and course evolutionary. After implementing neuropsychological evaluation techniques for diagnostic improvement, addresses the search for procedures that allow working on cognitive and executive deficits, as a specific therapeutic target.To characterize the presence of alterations in the domains that make up social cognition (SC) in patients with SUD and test in our healthcare units the ET® program already tested both experimentally and at beta level. It is an online self-training program for CS rehabilitation that includes modules for emotion recognition (RE), Theory of Mind (ToM) and attributional style (AS).To replicate the RCT carried out in schizophrenia in patients with SUD with difficulties in RE or ToM, in addition to searching for a biomarker or a pattern of them that predict the patient profile that will benefit from the training, using advanced LC-ESI proteomics techniques. MS/MS in saliva since previous studies in a population with schizophrenia, subjected to different neurorehabilitation therapies. It is also intended to subsequently improve the instrument (ET®) through the implementation of big data analysis and machine learning and the introduction of automated user management. At this level, the objective is to determine, after the first games, the type of game and the intensity required to improve the user's performance until it reaches normality.From the perspective of the State Plan for Scientific and Technical Research and Innovation, this project combines CLINICAL AND TRANSLATIONAL RESEARCH, based on the evidence of scientific and technological knowledge, and the use of ENABLING TECHNOLOGIES of e-health in the area of Health Services. Health for people with SUD., conditionsModule conditions: Social Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 231, type: ACTUAL, armsInterventionsModule interventions name: Emotional Training, outcomesModule primaryOutcomes measure: Assess the presence of dysfunctions in the subdomains of social cognition, secondaryOutcomes measure: Accuracy and efficacy of ET® in patients with SDB, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Galicia Sur Health Research Institute (IISGS) - Hospital Álvaro Cunqueiro, city: Vigo, state: Pontevedra, zip: 36213, country: Spain, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Galicia Sur Health Research Institute, city: Vigo, state: Pontevedra, zip: 36213, country: Spain, geoPoint lat: 42.23282, lon: -8.72264, hasResults: False
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protocolSection identificationModule nctId: NCT06363318, orgStudyIdInfo id: 0003, briefTitle: Comparison of Open and Laparoscopic Appendectomy in Pediatric Population, acronym: Appendicitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-01, primaryCompletionDateStruct date: 2019-11-30, completionDateStruct date: 2019-11-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: King Edward Medical University, class: OTHER, descriptionModule briefSummary: Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy.Objectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay., conditionsModule conditions: Appendicitis Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Laparoscopic appendicectomy, outcomesModule primaryOutcomes measure: Operative time, primaryOutcomes measure: wound infection, primaryOutcomes measure: Hospital stay, primaryOutcomes measure: Postoperative pain, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Muhammad Sharif, city: Lahore, state: Punjab, zip: 53711, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06363305, orgStudyIdInfo id: 2402-1139, briefTitle: Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Skidmore College, class: OTHER, collaborators name: American Heart Association, descriptionModule briefSummary: The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (NO) bioavailability, its effect on key markers of cardiovascular (CV) health, including BP, macro- and microvascular function, and arterial stiffness. This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials., conditionsModule conditions: Pre Hypertension, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Dietary capsules, outcomesModule primaryOutcomes measure: Blood Pressure and Vascular Stiffness, primaryOutcomes measure: Heart Rate (HR) and HR variability (HRV), primaryOutcomes measure: Flow Mediated Dilation, primaryOutcomes measure: Passive Leg Movement Hyperemia, primaryOutcomes measure: Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test, secondaryOutcomes measure: Urinary Capsaicinoids, secondaryOutcomes measure: Blood Lipids, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skidmore College, city: Saratoga Springs, state: New York, zip: 12866, country: United States, contacts name: Stephen Ives, Ph.D., role: CONTACT, phone: 518-580-8366, email: [email protected], geoPoint lat: 43.08313, lon: -73.78457, hasResults: False
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protocolSection identificationModule nctId: NCT06363292, orgStudyIdInfo id: SOPH231-1221/I, briefTitle: Study to Evaluate the Safety and Tolerability of PRO-231 Ophthalmic Solution Versus VIGAMOXI® on the Ocular Surface of Healthy Subjects., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Laboratorios Sophia S.A de C.V., class: INDUSTRY, descriptionModule briefSummary: This is a phase I clinical study evaluating the safety and tolerability of PRO-231 ophthalmic solution through the incidence of unexpected adverse events, incidence of conjunctival hyperemia and chemosis, changes in Best Corrected Visual Acuity (BCVA), changes in ocular surface integrity, compared to VIGAMOXI®., conditionsModule conditions: Ophthalmological Agent Toxicity, conditions: Bacterial Conjunctivitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase I, controlled, comparative, parallel-group, single-blind, single-center, controlled clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Single-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: PRO-231, interventions name: VIGAMOXI®, outcomesModule primaryOutcomes measure: Incidence of unexpected adverse events related to the interventions, primaryOutcomes measure: Incidence of conjunctival hyperemia and chemosis, primaryOutcomes measure: Changes in Best Corrected Visual Acuity (BCVA), primaryOutcomes measure: Changes in the integrity of the ocular surface (fluorescein staining), primaryOutcomes measure: Changes in the Ocular Comfort Index (OCI) score between interventions., secondaryOutcomes measure: Incidence of unexpected adverse events (excluding conjunctival hyperemia and chemosis), secondaryOutcomes measure: To assess the tolerability of PRO-231 ophthalmic solution, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: IIMET Investigación e Innovación en Medicina Traslacional, status: RECRUITING, city: Guadalajara, state: Jalisco, zip: 44610, country: Mexico, contacts name: Alejandro González, MD, role: CONTACT, geoPoint lat: 20.66682, lon: -103.39182, hasResults: False
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protocolSection identificationModule nctId: NCT06363279, orgStudyIdInfo id: 2024/24JAN/044, briefTitle: Validation of the French ATI Scale and Predisposition to Use Technological Tools in Rehabilitation., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain, class: OTHER, descriptionModule briefSummary: Aim of the study: The first aim of this study is to validate the translation of the Affinity for Technology Interaction (ATI) questionnaire. This questionnaire was developed in English by Franke, Attig and Wessel in 2019. It consists of 9 items and was developed to assess a person's tendency to actively engage in technological interaction, or the ease with which a person uses technological tools. Currently, the questionnaire has been translated into French by our research team according to good practice recommendations (Guillemin, Bombardier and Beaton, 1993; Tsang et al., 2017), but this French version has not yet been validated. To validate the translation of a questionnaire, it is necessary to have it completed by a large number of subjects from the population of interest. In neurorehabilitation, measuring this affinity will make it possible to better identify patients who are more likely to adhere to tele-rehabilitation and thus direct them towards this type of treatment as a complement to conventional rehabilitation.The second objective is to determine the extent to which the general population is prepared to use technological tools as part of their rehabilitation. The aim is to gain a better understanding of the profile of people who could potentially benefit from tele-rehabilitation. Accessibility to the technologies, their expectations and barriers will also be explored as part of this study., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Conducting questionnaires, outcomesModule primaryOutcomes measure: ATI - affinity technology interaction scale, secondaryOutcomes measure: Scale for assessing a person's readiness to use technological tools as part of their rehabilitation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinique Universitaires Saint-Luc, status: RECRUITING, city: Brussel, state: Woluwé-Saint-Lambert, zip: 1200, country: Belgium, contacts name: Thierry Lejeune, MD, PhD, role: CONTACT, phone: +3227641648, email: [email protected], contacts name: Mathilde Van Durme, role: CONTACT, phone: +3227641675, email: [email protected], geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
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protocolSection identificationModule nctId: NCT06363266, orgStudyIdInfo id: 190211_1, briefTitle: A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: St. Mary's Research Center, Canada, class: OTHER, collaborators name: Princess Margaret Hospital, Canada, collaborators name: University of Calgary, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: University of British Columbia, collaborators name: McGill University, collaborators name: Simon Fraser University, collaborators name: Université de Sherbrooke, collaborators name: Memorial University of Newfoundland, collaborators name: Université de Montréal, collaborators name: Centre intégré de santé et de services sociaux (CISSS) de Laval, descriptionModule briefSummary: Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes., conditionsModule conditions: Cancer of the Prostate, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 376, type: ESTIMATED, armsInterventionsModule interventions name: TEMPO, interventions name: Active Monitoring dyads' anxiety, outcomesModule primaryOutcomes measure: HADS-Anxiety, secondaryOutcomes measure: TEMPO's key mechanisms of action, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Mary's Research Centre, city: Montreal, state: Quebec, zip: H3T1M5, country: Canada, contacts name: Sylvie Lambert, PhD, role: CONTACT, phone: 514-398-3685, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, locations facility: St Mary's Hospital Research Centre, city: Montréal, country: Canada, contacts name: Manon de Raad, role: CONTACT, email: [email protected], geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06363253, orgStudyIdInfo id: CIRB Ref: 2023/2073, briefTitle: Pilot Study of the Human Metagenome in Metabolic Diseases, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-14, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sengkang General Hospital, class: OTHER, collaborators name: Singapore General Hospital, collaborators name: Lee Kong Chian School of Medicine, Nanyang Technological University, collaborators name: Duke-NUS Graduate Medical School, descriptionModule briefSummary: This is a cohort study to understand the role of the human metagenome, and associated metabolites, in health and in various diseased states, in particular obesity as well as sarcopenia.Recruited participants will have their fecal, salivary, urine, serum, and in certain instances, mucosal samples taken, for metagenomic sequencing and metabolite testing.We hope to uncover various differences and signatures in the metagenome and metabolome in various diseased states, with potential future therapeutic applications in personalised medicine., conditionsModule conditions: Obesity, conditions: Sarcopenia, conditions: Sarcopenic Obesity, conditions: Chronic Inflammation, conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: No specific intervention, outcomesModule primaryOutcomes measure: Metagenomic alterations, primaryOutcomes measure: Metabolomic alterations, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sengkang General Hospital, status: RECRUITING, city: Singapore, zip: 544886, country: Singapore, contacts name: Koy Min Chue, role: CONTACT, phone: 69305000, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06363240, orgStudyIdInfo id: CBBLCIP001, briefTitle: Evaluation of Broadband Light Treatment for Solar Lentigines, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-01-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sciton, class: INDUSTRY, descriptionModule briefSummary: Broadband light treatment for Solar Lentigines, conditionsModule conditions: Solar Lentigo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Broadband Light, outcomesModule primaryOutcomes measure: Changes in skin post treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sanctuary Plastic Surgery, status: RECRUITING, city: Boca Raton, state: Florida, zip: 33431, country: United States, contacts name: Jonathan Cook, MD, role: CONTACT, geoPoint lat: 26.3669, lon: -80.13033, hasResults: False
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protocolSection identificationModule nctId: NCT06363227, orgStudyIdInfo id: ANEST-0003, briefTitle: Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients, acronym: PAIN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Schulthess Klinik, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery., conditionsModule conditions: Postoperative Pain, Acute, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 12000, type: ESTIMATED, armsInterventionsModule interventions name: Standardized pain management, outcomesModule primaryOutcomes measure: Perioperative pain trajectories, primaryOutcomes measure: Increased risk for postoperative pain, secondaryOutcomes measure: Total amount of opioids administered, secondaryOutcomes measure: Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363214, orgStudyIdInfo id: ANEST-0002, briefTitle: Impact of Patient Blood Management (PBM) at the Schulthess Clinic, acronym: PBM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Schulthess Klinik, class: OTHER, descriptionModule briefSummary: Aim of this study is to analyze the transfusion requirements of allogenic blood products at the Schulthess Clinic for patients that had major orthopedic or major spine surgery between 2019 and 2024 order to identify patients at risk for transfusion. Moreover, impact of transfusion requirements and other measures of PBM on patient outcomes will be assessed. These data are required to further improve PBM at the Schulthess Clinic., conditionsModule conditions: Patient Blood Management, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 16000, type: ESTIMATED, armsInterventionsModule interventions name: Patient blood management, outcomesModule primaryOutcomes measure: Perioperative transfusion rates, primaryOutcomes measure: Risk factors for perioperative transfusion Risk factors for perioperative transfusion Risk factorsfor perioperative transfusion, secondaryOutcomes measure: Perioperative rates of coagulation products administered, secondaryOutcomes measure: Clinical outcomes, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06363201, orgStudyIdInfo id: CAT2024/PED01, briefTitle: Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Catalysis SL, class: INDUSTRY, descriptionModule briefSummary: Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours., conditionsModule conditions: Advanced Cancer, conditions: Advanced Solid Tumor, conditions: Lymphoma, Hodgkin, conditions: Central Nervous System Tumor, conditions: Sarcoma, conditions: Germ Cell Tumor, conditions: Pediatric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ocoxin Oral solution, outcomesModule primaryOutcomes measure: Quality of Life, secondaryOutcomes measure: Degree of toxicity related to oncospecific treatment, secondaryOutcomes measure: Nutritional Status, secondaryOutcomes measure: Presence of Adverse Events (AE), secondaryOutcomes measure: Metabolic Status, secondaryOutcomes measure: Physical Status, secondaryOutcomes measure: Response to oncospecific treatment, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Escuela, Tegucigalpa (Honduras), city: Tegucigalpa, state: Francisco Morazan, zip: 504, country: Honduras, contacts name: Ingrid C. Arambú Elvir, Dr., role: CONTACT, phone: 50498878486, email: [email protected], contacts name: Ingrid C. Arambú Elvir, Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Alejandra Elonor Zapata, Dr., role: SUB_INVESTIGATOR, contacts name: Clarissa L. Aguilar Molina, Dr., role: SUB_INVESTIGATOR, contacts name: Darío Vinicio Cáceres, Dr., role: SUB_INVESTIGATOR, contacts name: Gerardo Ismael Castro, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 14.0818, lon: -87.20681, hasResults: False
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protocolSection identificationModule nctId: NCT06363188, orgStudyIdInfo id: effect of ESWT on fractures, briefTitle: The Impact of ESWT on Healing of Fractured Mandible, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: studying if using extracorporeal radial shockwave therapy as an adjuvant therapy help in accelerating the bone healing and regeneration in mandibular fractures by comparing it with the standard protocol for fractures fixation by plates and screws., conditionsModule conditions: Fractured Mandible Due to Trauma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Radial Extracorporeal shockwave, outcomesModule primaryOutcomes measure: bone healing (denisty of bone), secondaryOutcomes measure: pain sensation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo Univeristy, status: RECRUITING, city: Cairo, country: Egypt, contacts name: khloud nasr eldin, GP, role: CONTACT, phone: 01014919174, email: [email protected], contacts name: Emad Saied, prof., role: CONTACT, phone: 01222117986, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06363175, orgStudyIdInfo id: 8737, secondaryIdInfos id: 343073, type: OTHER, domain: Integrated Research Application system (IRAS), briefTitle: PREMs In Vascular SurgERy Enhancement Study, acronym: PREMIERE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Cardiff and Vale University Health Board, class: OTHER_GOV, collaborators name: Welsh Value in Health Centre (WViHC), collaborators name: Centre for Healthcare Evaluation, Device Assessment, and Research (CEDAR), descriptionModule briefSummary: THE PROBLEM:Patient Reported Experience Measures (PREMs) ask patients about their healthcare service experience. It gives them a voice to share their views. PREMs allow healthcare providers (HCPs) to see where care is good, and where they could improve. Vascular surgery is a surgical speciality looking after people's blood vessels (arteries and veins).There is no PREM available for vascular patients. The research team want to create a PREM for this patient group.WHY IT IS IMPORTANT:A PREM allows HCPs to record and understand patients' experiences of their treatment. It gives patients a way to provide feedback on their healthcare experience. PREMs can help HCPs make changes to patients' care, identifying areas of good practice and areas for improvement. The Welsh Government is keen to support the use of PREMs.AIMS:To develop a PREM specific to vascular surgery patients.RESEARCH PLAN:The research team will summarise the literature about PREMs in surgery. The research team will then run focus groups and interviews with patients and staff to create a 'draft' PREM for vascular patients in Wales. The 'draft' PREM will be translated into Welsh.In the second phase, a larger number of vascular patients (100-300 depending on how long the 'draft' PREM is) from hospitals across Wales will complete the questionnaire. Statistical tests will look at the results to see if the questionnaire works well to capture patients' experiences. Based on these results, small changes will be made to make the 'draft' PREM better. This will make sure the 'final PREM' is ready for widespread use in Wales and beyond.PATIENT AND PUBLIC INVOLVEMENT:The patients' experience team at CAVUHB has reviewed our patients' materials. Our research team includes PPI co-applicants (DC and AH). DC a double amputee who has had many vascular operations. DC has experience raising awareness about vascular disease through public forums like the Limbless Association Charity and BBC Radio Wales. AH has issues with her leg due to smoking and had a keyhole operation to help with that. She had some problems after the procedure This is her first time as a PPI representative. DC and AH supported our research design and will be steering group members. Also, our research focuses on giving patients a voice and will include patients across Wales. A diverse group of patients will be involved across all stages of the PREM development., conditionsModule conditions: Vascular Diseases, conditions: Patient Empowerment, conditions: Patient Satisfaction, conditions: Patient Engagement, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 330, type: ESTIMATED, outcomesModule primaryOutcomes measure: Degree of Validity of the PREM, primaryOutcomes measure: Degree of Reliability of the PREM, primaryOutcomes measure: Degree of Responsiveness of the PREM, primaryOutcomes measure: Degree of Feasibility of implementing the PREM in clinical practice, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southeast Wales Vascular Network-Cardiff and Vale University Health Board, city: Cardiff, state: Wales, country: United Kingdom, geoPoint lat: 51.48, lon: -3.18, hasResults: False
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protocolSection identificationModule nctId: NCT06363162, orgStudyIdInfo id: LRR202404, briefTitle: Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: West China Hospital, collaborators name: The First Affiliated Hospital of Zhengzhou University, collaborators name: Capital Medical University, collaborators name: Jiangsu Raman Medical Equipment Co., Ltd., descriptionModule briefSummary: To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples., conditionsModule conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer., enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Immunohistochemistry or genetic test, outcomesModule primaryOutcomes measure: Area Under the Curve, primaryOutcomes measure: Accuracy, secondaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Kappa coefficient, secondaryOutcomes measure: Time consumption for the Raman analyzer in detection, secondaryOutcomes measure: Adverse Event Incidence Rate, secondaryOutcomes measure: Serious Adverse Event Incidence Rate, secondaryOutcomes measure: Operator adverse events, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100071, country: China, contacts name: Yinyan Wang, MD and PhD, role: CONTACT, phone: +86 13581698953, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06363149, orgStudyIdInfo id: 2024-11-DM-136, briefTitle: Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Sanjay Gandhi Postgraduate Institute of Medical Sciences, class: OTHER_GOV, descriptionModule briefSummary: Septic shock is common complication in patients with critical illnesses, with higher incidence in low and medium income countries like ours. Disseminated intravascular coagulation (DIC) is also common in patients presenting to intensive care units. Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock.Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold. Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply. DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC.Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention. Also, there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock., conditionsModule conditions: Septic Shock, conditions: Disseminated Intravascular Coagulation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7, secondaryOutcomes measure: Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 14, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences, status: RECRUITING, city: Lucknow, state: Uttar Pradesh, zip: 226014, country: India, contacts name: Mohan Gurjar, MD, PDCC, role: CONTACT, contacts name: Dinesh Chandra, MD, DM, role: CONTACT, contacts name: Mohan Gurjar, MD, PDCC, role: PRINCIPAL_INVESTIGATOR, contacts name: Sanjay Chaudhary, MD, role: SUB_INVESTIGATOR, contacts name: Dinesh Chandra, MD, DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.83928, lon: 80.92313, hasResults: False
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protocolSection identificationModule nctId: NCT06363136, orgStudyIdInfo id: 14.06.2023-111176, briefTitle: Foot Posture, Strength, Performance, and Postural Control in Isolated Gastrocnemius Tightness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: Studies on gastrocnemius tightness in healthy children are limited, but there is evidence that ankle dorsiflexion decreases with increasing age in children. It is not known whether gastrocnemius tightness is a normal finding in children, but recurrent leg pain is common in children. It is also known that flexible flatfoot is a normal observation in developing children and that the medial longitudinal arch develops during the first decade of life. Both foot morphology and ankle dorsiflexion change in developing children; however, it is not known whether there is a relationship between them or not.In the literature, there is no study evaluating foot posture, muscle strength, functional performance, and postural control in children with isolated gastrocnemius muscle tightness. It was planned to evaluate postural control using computerized dynamic posturography (Biodex Balance System), lower extremity muscle strength using a hand-held dynamometer, foot posture using the Foot Posture Index (FPI-6), and functional performance using single-foot-double-foot jump tests in healthy children with isolated gastrocnemius muscle tightness., conditionsModule conditions: Gastrocnemius Tightness, conditions: Postural Control, conditions: Muscle Strength, conditions: Functional Performance, conditions: Foot Posture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Postural Control Assessment, primaryOutcomes measure: Lower extremity muscle strength measurement, secondaryOutcomes measure: Foot posture assessment, secondaryOutcomes measure: Functional performance assessment, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Bezmialem Vakif University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Deniz Tuncer, PhD, PT, role: CONTACT, contacts name: Fatma Eren, PT, role: CONTACT, contacts name: Fatma Eren, PT, role: SUB_INVESTIGATOR, contacts name: Deniz Tuncer, PhD, PT, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06363123, orgStudyIdInfo id: BFHHZML20240009, briefTitle: Plasma Metabolic Biomarkers for Multi-Cancer Diagnosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to comprehensively analyze the metabolites in plasma samples from multi-cancer patients using advanced mass spectrometry detection technology, in conjunction with metabolomics approaches. The goal is to construct a plasma metabolite database for multi-cancer patients. Simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early multi-cancer diagnosis. The objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of multi-cancer., conditionsModule conditions: Lung Cancer, conditions: Breast Cancer, conditions: Colorectal Cancer, conditions: Thyroid Cancer, conditions: Gastric Cancer, conditions: Cervical Cancer, conditions: Liver Cancer, conditions: Pancreatic Cancer, conditions: Cholangiocarcinoma, conditions: Prostate Cancer, conditions: Esophageal Cancer, conditions: Ovarian Cancer, conditions: Renal Cell Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2700, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Plasma metabolite content, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100021, country: China, contacts name: Yibin Xie, Ph.D., role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Li Min, Ph. D., role: CONTACT, phone: +86 13552652141, email: [email protected], contacts name: Bilian Kang, Ph.D., role: CONTACT, phone: +86 18001218793, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: Hebei Tumor Hospital, status: RECRUITING, city: Shijiazhuang, state: Hebei, zip: 050010, country: China, contacts name: Lianmei Zhao, Ph.D., role: CONTACT, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310022, country: China, contacts name: Qian Song, Ph.D., role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06363110, orgStudyIdInfo id: 22724, briefTitle: An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States, acronym: HOVER, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied.In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.Chronic HFrEF is a long-term condition in which the heart becomes weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen, which the body requires to function properly.The study treatment, vericiguat, works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow. As a result, the heart can pump better.It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:* starting dose of vericiguat* daily changes in dosage pattern* time taken to reach the target dose* number and percentage of participants:* with specific changes in dosage pattern* reaching the target dose of vericiguatThey will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.Researchers will only look at the health records of participants in the US.Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.In this study, only available data from routine care are collected. No visits or tests are required as part of this study., conditionsModule conditions: Chronic Heart Failure With Reduced Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1400, type: ESTIMATED, armsInterventionsModule interventions name: Vericiguat (Verquvo, BAY1021189), outcomesModule primaryOutcomes measure: Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date, primaryOutcomes measure: Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation, primaryOutcomes measure: Days from index date to first occurrence of 10 mg/day dose, primaryOutcomes measure: Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period, primaryOutcomes measure: Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation, primaryOutcomes measure: Number of patients having specific titration scenarios within the 90 days after vericiguat initiation, secondaryOutcomes measure: Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, city: Whippany, state: New Jersey, zip: 07981, country: United States, geoPoint lat: 40.82454, lon: -74.4171, hasResults: False
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protocolSection identificationModule nctId: NCT06363097, orgStudyIdInfo id: ΔΔ5032, briefTitle: Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Aristotle University Of Thessaloniki, class: OTHER, descriptionModule briefSummary: In chronic kidney disease (CKD), hypertension is characterized by the phenomenon of sodium-sensitivity, i.e., the disproportionate increase in blood pressure (BP) due to an increase in dietary sodium consumption to maintain homeostasis through urinary sodium excretion. Impaired renal circulation, blunt suppression of renin-angiotensin-aldosterone system, sympathetic nervous system overactivity, paradoxically reduced levels of atrial natriuretic peptide and hyperinsulinemia represent the main pathophysiologic mechanisms. Accumulated evidence has suggested that uromodulin plays a central role in the development of sodium-sensitive hypertension. Uromodulin is a kidney-specific glycoprotein which is exclusively produced by the epithelial cells lining the thick ascending limb and early distal convoluted tubule. It is currently recognized as a multifaceted player in kidney physiology and disease, with discrete roles for intracellular, urinary, interstitial and serum uromodulin. Among these, urinary uromodulin modulates renal sodium handling through regulating tubular transporters that reabsorb sodium and are targeted by diuretics, i.e., the loop diuretic-sensitive Na+-K+-2Cl- cotransporter type 2 (NKCC2) and the thiazide-sensitive Na+/Cl- cotransporter (NCC). Given these roles, the contribution of uromodulin to sodium-sensitive hypertension has been proposed. In preclinical models, uromodulin deficiency causes decreased BP that is resistant to dietary salt, while uromodulin overexpression causes hypertension due to increased tubular sodium reabsorption that is responsive to furosemide. Genetic human studies have identified robust associations of specific UMOD gene variants with sodium sensitivity and incident hypertension risk, while comprehensive Mendelian randomization studies have affirmed these associations by highlighting the causal relationship between UMOD variants, urinary uromodulin levels and hypertension. Furthermore, clinical studies in both healthy individuals and hypertensive patients have indicated a link between sodium sensitivity and uromodulin, directly affecting mean BP levels and BP response to salt intake. With regards to CKD population, solid data on the link of uromodulin with sodium sensitivity are currently missing from the literature. There is only a pediatric study in the setting of CKD (stages 2-3), which failed to show an association between urinary uromodulin levels indexed to urinary creatinine (UMOD/uCr) and either 24-hour or office BP; however, this study has several limitations, and its results should be interpreted with caution. To best of our knowledge, there is no study up to date investigating the effect of dietary sodium intake on 24-hour ambulatory blood pressure depending on urinary uromodulin levels in adult CKD patients., conditionsModule conditions: Chronic Kidney Disease, conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory systolic blood pressure., primaryOutcomes measure: Effect of urinary uromodulin levels on the relationship between 24-hour urinary sodium excretion and 24-hour ambulatory diastolic blood pressure., secondaryOutcomes measure: Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory systolic blood pressure., secondaryOutcomes measure: Effect of urinary uromodulin levels on the relationship between nighttime/daytime ratio of urinary sodium excretion and 24-hour ambulatory diastolic blood pressure., secondaryOutcomes measure: Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory systolic blood pressure., secondaryOutcomes measure: Effect of urinary uromodulin levels on the relationship between urinary sodium-to-potassium (Na+/K+) ratio and 24-hour ambulatory diastolic blood pressure., secondaryOutcomes measure: The difference in 24-hour ambulatory brachial SBP/DBP between patients with high and low urinary uromodulin excretion., secondaryOutcomes measure: The difference in 24-hour ambulatory brachial SBP/DBP standard deviation (SD) between patients with high and low urinary uromodulin excretion., secondaryOutcomes measure: The difference in 24-hour ambulatory brachial SBP/DBP weighted SD (wSD) between patients with high and low urinary uromodulin excretion., secondaryOutcomes measure: The difference in 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV) between patients with high and low urinary uromodulin excretion., secondaryOutcomes measure: The difference in 24-hour ambulatory brachial SBP/DBP average real variability (ARV) between patients with high and low urinary uromodulin excretion., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD)., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD)., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV)., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV)., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP standard deviation (SD)., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD)., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV)., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on 24-hour ambulatory brachial SBP/DBP average real variability (ARV)., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP standard deviation (SD)., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP weighted SD (wSD)., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP coefficient of variation (CV)., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on 24-hour ambulatory brachial SBP/DBP average real variability (ARV)., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on hydration status (US-B lines)., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on hydration status (US-B lines)., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on hydration status (US-B lines)., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on MMSE score., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on MMSE score., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on MMSE score., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on PSQI score., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on PSQI score., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on PSQI score., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on ESS score., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on ESS score., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on ESS score., secondaryOutcomes measure: Effect of 24-hour urinary sodium excretion on nocturnal urinations., secondaryOutcomes measure: Effect of nighttime/daytime ratio of urinary sodium excretion on nocturnal urinations., secondaryOutcomes measure: Effect of urinary sodium-to-potassium (Na+/K+) ratio on nocturnal urinations., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 1st Department of Nephrology, status: RECRUITING, city: Thessaloníki, state: Central Macedonia, zip: 54642, country: Greece, contacts name: Artemios G Karagiannidis, MD, MSc, role: CONTACT, phone: +30 6970362392, email: [email protected], geoPoint lat: 40.64361, lon: 22.93086, hasResults: False
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protocolSection identificationModule nctId: NCT06363084, orgStudyIdInfo id: IST-Nim-PC-6, briefTitle: A Retrospective Study for Nimotuzumab Plus Postoperative Adjuvant Chemotherapy for Resectable Pancreatic Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-05-01, primaryCompletionDateStruct date: 2022-07-31, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Ruijin Hospital, class: OTHER, descriptionModule briefSummary: This trial is a retrospective, observational study, patients who underwent surgical resection of the pancreas for non-metastatic pancreatic cancer between 2016 and 2022 were selected and divided into two groups according to with (study arm) or without (control arm) nimotuzumab. The primary efficacy endpoint was overall survival (OS)., conditionsModule conditions: Resectable Pancreatic Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Nimotuzumab, outcomesModule primaryOutcomes measure: overall survival (OS）, secondaryOutcomes measure: disease-free survival (DFS), secondaryOutcomes measure: locoregional recurrence-free survival (LRRFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06363071, orgStudyIdInfo id: 202000495A3, briefTitle: APA and PAS Training for Gait Initiation in Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-13, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chang Gung University, class: OTHER, descriptionModule briefSummary: Our research focused on understanding the interplay between brain excitability and balance function in patients with Parkinson's disease (PD), alongside evaluating effective physical therapy methods. It highlights the prevalence of non-motor disorders and cognitive impairments among PD patients, including balance and postural issues, cognitive function decline, and gait instability. Additionally, it notes that PD patients exhibit abnormal electrophysiological responses, indicating altered central excitability., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Weight shift training and APA feedback, interventions name: Paired associative stimulation, outcomesModule primaryOutcomes measure: Balance Performance, primaryOutcomes measure: COP Path Length in Balance Tasks, primaryOutcomes measure: COP Displacement in Balance Tasks, primaryOutcomes measure: Motor Evoked Potentials (MEPs), primaryOutcomes measure: Intracortical Facilitation (ICF), primaryOutcomes measure: Intracortical Inhibition (ICI), primaryOutcomes measure: Walking Speed, primaryOutcomes measure: Step Length, primaryOutcomes measure: Step Time, secondaryOutcomes measure: COP Velocity in Balance Tasks, secondaryOutcomes measure: COP Area in Balance Tasks, secondaryOutcomes measure: Double Support Time, secondaryOutcomes measure: Single Support Time, secondaryOutcomes measure: Swing Time, secondaryOutcomes measure: Stance Time, secondaryOutcomes measure: Cadence, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung University, status: RECRUITING, city: Taoyuan, zip: 333, country: Taiwan, contacts name: Ya-Ju Chang, PhD, role: CONTACT, phone: 88632118800, phoneExt: 5515, email: [email protected], geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06363058, orgStudyIdInfo id: 201902166B0, briefTitle: Electrical Stimulation Cycling Training Effects on SCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-08, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Chang Gung University, class: OTHER, descriptionModule briefSummary: To focuses on the challenges faced by individuals with spinocerebellar ataxia (SCA), highlighting the major clinical sign of ataxia that affects their stability and ability to perform daily activities, thereby impacting their quality of life. It outlines the concept of neural plasticity, which is the brain's ability to adapt through changes in excitability, and notes that these changes are more enduring in the central nervous system (CNS) than in the peripheral nervous system (PNS). This adaptability, crucial for memory and motor learning, is compromised in SCA patients due to impaired brain areas and pathways. The summary further delves into motor learning, distinguishing between explicit and implicit learning, and points out that SCA patients exhibit deficiencies in procedural learning and cerebellar function. It also introduces the concept of priming as a preparatory mechanism that can enhance the effectiveness of physical therapy by modifying subsequent responses to stimuli. The document suggests that cycling, as an aerobic exercise, could prime the brain for improved blood flow and oxygenation, thereby supporting synaptic plasticity and the release of beneficial neurotrophic factors. Finally, the project aims to deepen the understanding of motor performance and learning mechanisms in SCA patients and apply these insights to clinical rehabilitation strategies., conditionsModule conditions: Spinocerebellar Ataxia (SCA), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 145, type: ESTIMATED, armsInterventionsModule interventions name: ES Cycling Training, outcomesModule primaryOutcomes measure: Overall Response Time, primaryOutcomes measure: Overall Error Rate, primaryOutcomes measure: Motor Evoked Potentials (MEPs), primaryOutcomes measure: Intracortical Facilitation (ICF), primaryOutcomes measure: Intracortical Inhibition (ICI), primaryOutcomes measure: Total Scale for the Assessment and Rating of Ataxia (SARA) Score, primaryOutcomes measure: Total Berg Balance Scale (BBS) Score, primaryOutcomes measure: Total Time to Complete the Time Up and Go test (TUG test), primaryOutcomes measure: Walking Speed, primaryOutcomes measure: Step Length, primaryOutcomes measure: Step Time, secondaryOutcomes measure: Double Support Time, secondaryOutcomes measure: Single Support Time, secondaryOutcomes measure: Swing Time, secondaryOutcomes measure: Stance Time, secondaryOutcomes measure: Cadence, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung University, status: RECRUITING, city: Taoyuan, zip: 333, country: Taiwan, contacts name: Ya-Ju Chang, PhD, role: CONTACT, phone: 88632118800, phoneExt: 5515, email: [email protected], geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
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protocolSection identificationModule nctId: NCT06363045, orgStudyIdInfo id: NIDEK-TONOREF-UK-0001, briefTitle: Comparative Study of the NIDEK TONOREF III With Predicate Devices, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Nidek Co. LTD., class: INDUSTRY, descriptionModule briefSummary: The primary objective of this clinical study is to prove that tonometry values for NIDEK TONOREF III are comparable to the predicate device and to prove that the pachymeter function of NIDEK TONOREF III is equivalent to the predicate device. The secondary objective is to demonstrate that the test device is as safe as the predicate devices., conditionsModule conditions: Intraocular Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: NIDEK TONOREF III, interventions name: Haag-Streit, PERKINS HAND-HELD APPLANATION TONOMETER, interventions name: NIDEK CEM-530, outcomesModule primaryOutcomes measure: Equivalent to legally-marketed devices, primaryOutcomes measure: Equivalent to the pachymeter function, secondaryOutcomes measure: The numbers of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aston University, city: Birmingham, zip: B4 7ET, UK, country: United Kingdom, geoPoint lat: 52.48142, lon: -1.89983, hasResults: False
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protocolSection identificationModule nctId: NCT06363032, orgStudyIdInfo id: 202110104RINB, briefTitle: Elastography in Predicting Renal Outcome, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-27, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: There are two types of elastography: strain elastography assesses the degree of strain when applying a given amount of force to the skin. Shear-wave elastography assesses the velocity of shear wave propagation within the target lesion. A part of the tissue is deformed by a "push pulse", the velocity of the shear waves propagating within the tissue is detected, and the stiffness of the tissue is assessed based on the detected shear velocity. Shear-wave elastography has been intensively studied in thyroid, breast, liver, cervical lymph nodes, and musculoskeletal diseases with promising result.Transthoracic shear-wave ultrasound is also used for the prediction of lung malignancy.In progressive renal disease, renal function decline correlates with the extent of interstitial fibrosis, irrespective of the original pathology. Experience and research in using shear-wave elastography to study the stiffness of renal parenchyma and renal fibrosis are scanty. The investigators will conduct a prospective observational study. This study aims to provide the information of tissue elasticity in different etiologies of renal diseases and to validate the predictive value of shear-wave elastography in predicting renal function and renal fibrosis.By assuming a power of 0.8, a two-side p value of 0.05, a ratio of 0.2 (sample sizes in negative/positive groups) to detect the difference between area under ROC curve and null hypothesis value (0.8 and 0.7), a target sample of 273 (with a 5% cushion, 260\~290) patients is required., conditionsModule conditions: Kidney Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: elastography, outcomesModule primaryOutcomes measure: collect medical record of blood urea nitrogen and Creatinine, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Taipei, country: Taiwan, contacts name: Fan-Chi Chang, role: CONTACT, phone: 886-0223123456, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06363019, orgStudyIdInfo id: 2023/00158, briefTitle: Supporting At-Risk Mothers Across Perinatal Period, acronym: SMART, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-02-26, completionDateStruct date: 2026-07-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: National University of Singapore, class: OTHER, collaborators name: Ministry of Health, Singapore, descriptionModule briefSummary: The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants.The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period.The main questions this study aims to answer are:1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes?3. What is the cost-effectiveness of using SMART as compared to standard routine care?Researchers will compare results with a control group that will undergo standard routine care., conditionsModule conditions: Perinatal Depression, conditions: Parents, conditions: Anxiety, conditions: Self Efficacy, conditions: Stress, conditions: Infant Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-group parallel-armed randomized controlled trial with a pretest and repeated post-test experimental design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Supporting at-risk Mothers Across perinatal period: a Randomized controlled Trial (SMART) mobile application, outcomesModule primaryOutcomes measure: Postnatal depression, secondaryOutcomes measure: Infant physical development, secondaryOutcomes measure: Infant cognitive development, secondaryOutcomes measure: Infant emotional development, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Perceived social support, secondaryOutcomes measure: Maternal-infant bonding, secondaryOutcomes measure: Parental satisfaction, secondaryOutcomes measure: Parental efficacy, secondaryOutcomes measure: Objective stress, secondaryOutcomes measure: Emotional availability, secondaryOutcomes measure: Health services and utilization, secondaryOutcomes measure: Infant Physical Development, secondaryOutcomes measure: Infant Social Development, secondaryOutcomes measure: Infant Social Development, secondaryOutcomes measure: Infant Social Development, secondaryOutcomes measure: Infant Emotional Development, eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alice Lee Centre for Nursing Studies, National University of Singapore, status: RECRUITING, city: Singapore, zip: 117597, country: Singapore, contacts name: Shefaly Shorey, PhD, role: CONTACT, phone: 66011294, phoneExt: +(65), email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, locations facility: National University of Singapore, status: RECRUITING, city: Singapore, zip: 117597, country: Singapore, contacts name: Shefaly Shorey, role: CONTACT, phone: +6566011294, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
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protocolSection identificationModule nctId: NCT06363006, orgStudyIdInfo id: K23C3280, briefTitle: Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are:* Objective response rate (ORR) for evaluation* Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。, conditionsModule conditions: 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: TKI+Cardunilimab, outcomesModule primaryOutcomes measure: ORR Full single-arm, open, multicenter prospective clinical study, primaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Stable Disease (SD), secondaryOutcomes measure: Progression free survival rate, otherOutcomes measure: Any adverse events related with treatment with TKI plus Cardonizumab., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH), status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Haitao Zhao, Professor, role: CONTACT, phone: +861069156042, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06362993, orgStudyIdInfo id: STUDY00021561, briefTitle: Breast Cancer Screening in Ghana, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Penn State University, class: OTHER, collaborators name: University of Ghana, descriptionModule briefSummary: This study is designed to test the feasibility of two intervention on promoting early screening for breast cancer in rural Ghana. In one intervention, screening for breast cancer, diabetes and hypertension will be offered together. In another intervention, a series of sessions with men will be conducted with a goal to change gender attitudes and increase support to women. The investigators' long-term goal is to test these interventions in a large-scale randomized controlled trial. The specific aims of this feasibility study are to: 1) refine the study materials, including the curriculum for the sessions with men, by consulting with an expert advisory committee and a local committee, and 2) determine the feasibility of the two interventions in four clinic zones in Yilo-Krobo district in eastern Ghana (1 clinic in control, 1 clinic in the first intervention, and 2 in the second intervention). This trial registration is for the second specific aim., conditionsModule conditions: Breast Cancer Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Bundling, interventions name: MEGH, outcomesModule primaryOutcomes measure: Clinical breast exam (CBE) utilization at the local clinic, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06362980, orgStudyIdInfo id: BPI-1178-IIT01, briefTitle: A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations, acronym: EGFR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: National Cancer Center, China, class: OTHER, descriptionModule briefSummary: BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations., conditionsModule conditions: NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: BPI-1178, interventions name: Osimertinib, outcomesModule primaryOutcomes measure: Number of patients with dose-limiting toxicity (DLT), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Intracranial ORR (iORR), secondaryOutcomes measure: Intracranial DCR (iDCR), secondaryOutcomes measure: Intracranial DoR (iDoR), secondaryOutcomes measure: Intracranial Time to Progression (iTTP), secondaryOutcomes measure: Intracranial PFS (iPFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06362967, orgStudyIdInfo id: Anti-HLA antibody, briefTitle: The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Anhui Provincial Hospital, class: OTHER_GOV, descriptionModule briefSummary: Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation, conditionsModule conditions: High Titers of Anti-HLA Antibody (MFI ≥5000), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Immunoadsorption or plasma exchange combined with rituximab, high-dose IVIG, outcomesModule primaryOutcomes measure: Incidence of reduction of anti-HLA antibody MFI values to less than 5000 in subjects at the end of treatment, secondaryOutcomes measure: Incidence of primary graft failure, secondaryOutcomes measure: Incidence of TRM after allo-HSCT, secondaryOutcomes measure: Incidence of ineffective platelet transfusion after allo-HSCT, secondaryOutcomes measure: Cumulative incidence of neutrophil engraftment after allo-HSCT, secondaryOutcomes measure: Cumulative incidence of II-IV° acute GVHD, secondaryOutcomes measure: Cumulative incidence of relapse at 1 year post-transplant, secondaryOutcomes measure: Probability of overall survival post transplantation, secondaryOutcomes measure: Incidence of allergies and allergic reactions, secondaryOutcomes measure: Incidence of haemorrhagic events, secondaryOutcomes measure: Incidence of viral, bacterial and fungal infections, secondaryOutcomes measure: Incidence of hypocalcaemia, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), city: Hefei, state: Anhui, zip: 230036, country: China, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06362954, orgStudyIdInfo id: AnkaraMedipolU-FTR-SS-01, briefTitle: The Relationship Between Muscle Oxygenation and Spasticity in Hemiparetic Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-31, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Ankara Medipol University, class: OTHER, collaborators name: Gazi University, descriptionModule briefSummary: Conditions such as hemiparesis, sensory and motor impairment, perceptual impairment, cognitive impairment, aphasia, and dysphagia may be observed after stroke. Motor impairment after stroke may occur due to damage to any part of the brain related to motor control. There is much clinical evidence that damage to different parts of the sensorimotor cortex in humans affects other aspects of motor function. Loss of strength, spasticity, limb apraxia, loss of voluntary movements, Babinski sign, and motor neglect are typical motor deficits following a cortical lesion (upper motor neuron lesion). Post-stroke spasticity can be seen in 19% to 92% of stroke survivors. Post-stroke hemiparesis is a significant cause of morbidity and disability, along with abnormal muscle tone. It has also been recognized that post-stroke hemiparesis may occur without spasticity. Spasticity seen after stroke causes loss of movement control, painful spasms, abnormal posture, increased muscle tone, and a general decrease in muscle function, and may affect limb blood flow. Studies in the literature show that spasticity can affect limb blood flow.This study aims to investigate the relationship between muscle oxygenation and spasticity in post-stroke hemiparetic patients based on the idea that oxygenation may be insufficient as a result of restriction of blood flow on the affected side due to spasticity in stroke patients., conditionsModule conditions: Stroke, conditions: Hemiparesis;Poststroke/CVA, conditions: Spasticity as Sequela of Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Assessment, outcomesModule primaryOutcomes measure: Plantar Flexors Muscle Oxygenation, secondaryOutcomes measure: Spasticity, secondaryOutcomes measure: Motor Function, secondaryOutcomes measure: 6-Minute Walk Test, secondaryOutcomes measure: Stair Climbing Test, secondaryOutcomes measure: Adipose tissue thickness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gazi University, Faculty of Health, Department of Physiotherapy and Rehabilitation, status: RECRUITING, city: Ankara, state: Çankaya, country: Turkey, contacts name: Gökhan Yazıcı, Assos. Prof., role: CONTACT, phone: +90 506 316 0572, email: [email protected], contacts name: Gökhan Yazıcı, Assos. Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Taylan Altıparmak, Asst. Prof., role: SUB_INVESTIGATOR, contacts name: Çağla Çağatay, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06362941, orgStudyIdInfo id: NW-HGN-01, briefTitle: Evaluation of an Oral Hair Supplement to Improve Hair Strength and Support Growth in Women and Men, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Nutraceutical Wellness Inc., class: INDUSTRY, descriptionModule briefSummary: A single-center, open-label, prospective study to demonstrate the efficacy of an oral supplement to improve the strength and support the growth of thinning hair in men and women with self-perceived hair thinning., conditionsModule conditions: Hair Thinning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single Group Assignment 6-month, single-center, prospective interventional study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Nutrafol Women's Hair Growth Supplemnt, interventions name: Nutrafol Women's Balance Hair Growth Supplement, interventions name: Nutrafol Women's Vegan Hair Growth Supplement, interventions name: Nutrafol Women's Postpartum Hair Growth Supplement, interventions name: Nutrafol Men's Hair Growth Supplement, outcomesModule primaryOutcomes measure: Change in hair shaft diameter compared to baseline at Day 180., primaryOutcomes measure: Change in hair shaft diameter compared to baseline at Day 90., secondaryOutcomes measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 180, secondaryOutcomes measure: Change in broken hairs recovered from the hair pull test compared to baseline at Day 90, secondaryOutcomes measure: Change in hair breakage during the hair pull test compared to baseline at Day 180, secondaryOutcomes measure: Change in hair breakage during the hair pull test compared to baseline at Day 90, secondaryOutcomes measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 180, secondaryOutcomes measure: Change in the number of hairs recovered from the hair pull test compared to baseline at Day 90, secondaryOutcomes measure: Subject Self-Perceived Improvement in Hair Quality at Day 180, secondaryOutcomes measure: Subject Self-Perceived Improvement in Hair Quality at Day 90, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dermatology Consulting Services, city: High Point, state: North Carolina, zip: 27262, country: United States, contacts name: Zoe Draelos, role: CONTACT, phone: 336-841-2040, email: [email protected], geoPoint lat: 35.95569, lon: -80.00532, hasResults: False
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protocolSection identificationModule nctId: NCT06362928, orgStudyIdInfo id: CP-60005, briefTitle: Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Akura Medical, class: INDUSTRY, descriptionModule briefSummary: This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE)., conditionsModule conditions: Pulmonary Embolism Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: ATC System, outcomesModule primaryOutcomes measure: Effectiveness, primaryOutcomes measure: Safety: Composite of Major Adverse Device-Related Events, secondaryOutcomes measure: Safety: Composite of Major Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06362915, orgStudyIdInfo id: FMASUR66/2024, briefTitle: Analgesic Effect of Illiohypogastic & Ilioinguinal Nerve Block in TAVR - TF (Prospective Randomized Study), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The purpose of the study is to compare the effect of illiohypogastric and ilioinguinal nerve block with the local infiltration with lidocaine in patients undergoing TAVI, conditionsModule conditions: Anesthesia, Local, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: * Group (A): will receive blind local infiltration in femoral region on the operation side by an experienced anesthesiologist using 20 ml lidocaine 1% (9).* Group (B): will receive ultrasound-guided ilioinguinal/iliohypogastric nerve block using 20 ml Bupivicane 0.25% by an experienced anesthesiologist., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Lidocaine, interventions name: Bupivacain, outcomesModule primaryOutcomes measure: Extra Demand of sedation, secondaryOutcomes measure: Patient and surgeon satisfaction, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: maha sadek El Derh, status: RECRUITING, city: Cairo, state: Heliopolis, zip: 11721, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Ain Shams University, status: RECRUITING, city: Cairo, country: Egypt, contacts name: maha S elDerh, Ass.prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06362902, orgStudyIdInfo id: NOSES-VIII B, briefTitle: Laparoscopic Right Hemicolectomy With Transrectal Specimen Extraction for Colon Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: National Cancer Center, China, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the preliminary surgical outcomes of laparoscopic right hemicolectomy with transrectal specimen extraction. The hypothesis is that this type of natural orifice specimen extraction surgery (NOSES) could achieve good short-term and oncological outcomes for right colon cancer patients., conditionsModule conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Laparoscopic right hemicolectomy with transrectal specimen extraction, outcomesModule primaryOutcomes measure: The rate of postoperative complications, secondaryOutcomes measure: Operating time, secondaryOutcomes measure: Estimated blood loss, secondaryOutcomes measure: The time of first flatus, secondaryOutcomes measure: Postoperative hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, status: RECRUITING, city: Beijing, state: Beijing, zip: 100000, country: China, contacts name: Haitao Zhou, M.D., role: CONTACT, phone: +8613381167333, email: [email protected], contacts name: Yueyang Zhang, M.D., role: CONTACT, phone: +8613552910035, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06362889, orgStudyIdInfo id: HealMD-CBD-1, briefTitle: Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Rejuva Medical Aesthetics, class: OTHER, collaborators name: HealMD, LLC, descriptionModule briefSummary: This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne., conditionsModule conditions: Acne Vulgaris (Disorder), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Microneedling with CBD, outcomesModule primaryOutcomes measure: Primary efficacy endpoints, secondaryOutcomes measure: Secondary efficacy endpoints, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rejuva Medical Aesthetics, city: Los Angeles, state: California, zip: 90025, country: United States, contacts name: LaRyel A Waldon, B.S., role: CONTACT, phone: 424-644-2400, email: [email protected], contacts name: Margaux Oldfield, role: CONTACT, phone: 4246442400, email: [email protected], geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06362876, orgStudyIdInfo id: BAlis, briefTitle: The Effect of Breastfeeding Counseling Based on Motivational Interviewing, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: This research was planned to determine the effect of breastfeeding counseling based on motivational interviewing method and standard breastfeeding counseling on breastfeeding self-efficacy and breastfeeding results in women who had a cesarean section., conditionsModule conditions: Breastfeeding Counseling Based on Motivational Interviewing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Breastfeeding Counseling Based on Motivational Interviewing, interventions name: Standard Breastfeeding Consultancy, outcomesModule primaryOutcomes measure: Level of breastfeeding self-efficacy, primaryOutcomes measure: Level of breastfeeding self-efficacy, primaryOutcomes measure: Level of breastfeeding self-efficacy, primaryOutcomes measure: Level of breastfeeding self-efficacy, primaryOutcomes measure: Level of breastfeeding self-efficacy, primaryOutcomes measure: Breastfeeding Results Evaluation Form, primaryOutcomes measure: Breastfeeding Results Evaluation Form, primaryOutcomes measure: Breastfeeding Results Evaluation Form, primaryOutcomes measure: Breastfeeding Results Evaluation Form, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mersin University, city: Mersin, zip: 33180, country: Turkey, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
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protocolSection identificationModule nctId: NCT06362863, orgStudyIdInfo id: WDRY2024-K027, briefTitle: Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Ping An, class: OTHER, descriptionModule briefSummary: By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions., conditionsModule conditions: Crohn's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective randomized controlled study divided into intervention and control groups., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: enteral nutrition biscuits, outcomesModule primaryOutcomes measure: Crohn's disease activity index, CDAI, secondaryOutcomes measure: Induced remission success rate, secondaryOutcomes measure: Gastrointestinal Symptom Rating Scale (GSRS) score, secondaryOutcomes measure: Gastrointestinal symptom remission, secondaryOutcomes measure: Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics, secondaryOutcomes measure: Incidence and severity of perianal lesions in both groups, secondaryOutcomes measure: Rate of endoscopic remission of small bowel and colon lesions in both groups, secondaryOutcomes measure: Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups, secondaryOutcomes measure: Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06362850, orgStudyIdInfo id: 1253/2023, briefTitle: Tele-Support for Emergency Medical Technicians, acronym: POHCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, collaborators name: Ludwig Boltzmann Institute Digital Health and Patient Safety, descriptionModule briefSummary: In this manikin-based simulation study the impact of tele-support during a simulated pediatric out-of-hospital cardiac arrest scenario on emergency medical technicians' guideline adherence, on gaze behavior as well as on performance of resuscitation management and cognitive load will be analyzed., conditionsModule conditions: Cardiac Arrest, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In a manikin-based simulation study, the participants will be randomized to either performing the scenario with tele-support or without tele-support (80 participants 40 groups, 20 groups with tele-support, 20 groups without tele-support)., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Tele-support, outcomesModule primaryOutcomes measure: guideline adherence, secondaryOutcomes measure: gaze behavior, secondaryOutcomes measure: teamwork performance, secondaryOutcomes measure: cognitive load, secondaryOutcomes measure: Performance of cardiopulmonary resuscitation, secondaryOutcomes measure: Technical feasibility, secondaryOutcomes measure: Usability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Christina Hafner, MD, PhD, role: CONTACT, phone: 004314040041020, email: [email protected], geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
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protocolSection identificationModule nctId: NCT06362837, orgStudyIdInfo id: P0117910-001, briefTitle: Evaluation of REACTS-IN, an Intervention to Improve Nutrition, Hygiene, and Sexual and Reproductive Health Services, acronym: REACTS-IN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-06-30, completionDateStruct date: 2030-05-24, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: McGill University, class: OTHER, collaborators name: World Vision Canada, collaborators name: Global Affairs Canada, descriptionModule briefSummary: This is an independent evaluation of World VIsion's 7-year quasi-experimental intervention to improve nutrition, nutrition-related rights and gender equality for women, adolescent girls, and children under five years of age in rural Bangladesh, Kenya, and Tanzania. The evaluation will collect baseline, midline, and end-line data from intervention and comparison communities, schools, and health facilities. The evaluation objectives are to test if the intervention improved indicators for (i) child anthropometry, (ii) maternal and child dietary practices, (iii) women's empowerment, and (iv) equitable health service access for nutrition and sexual and reproductive needs. The evaluation analysis will take into account gender differences in the indicators., conditionsModule conditions: Stunting, conditions: Gender Equality, conditions: Acceptability of Health Care, conditions: Diet; Deficiency, conditions: Empowerment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a quasi-experimental design for the evaluation of an intervention that is in the community (including schools) as well as in the local health service facilities. The data collection at baseline, midline, and end-line will occur simultaneously in the intervention and comparison selected communities., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 13500, type: ESTIMATED, armsInterventionsModule interventions name: Education intervention on nutrition, gender equity, WASH, sexual and reproductive health rights, interventions name: school-based iron-folic acid supplement program, interventions name: Health service training on equitable access to nutrition, health, and sexual and reproductive services, interventions name: bio-fortified crops, outcomesModule primaryOutcomes measure: Gender equality, primaryOutcomes measure: Child anthropometry, secondaryOutcomes measure: Antenatal care, secondaryOutcomes measure: Contraception use by women and partners, secondaryOutcomes measure: Child diet, secondaryOutcomes measure: Sexual and reproductive health services for adolescents, secondaryOutcomes measure: Gender equitable health services for nutrition, health, and sexual and reproductive health, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brac University, city: Dhaka, country: Bangladesh, contacts name: Malay K Mridha, PhD, role: CONTACT, email: [email protected], geoPoint lat: 23.7104, lon: 90.40744, locations facility: Connar Consultants, city: Nairobi, country: Kenya, contacts name: Elizabeth Kamau, PhD, role: CONTACT, email: [email protected], geoPoint lat: -1.28333, lon: 36.81667, locations facility: Ifakara Health Institute, city: Ifakara, country: Tanzania, contacts name: Ester Elisaria, PhD, role: CONTACT, email: [email protected], geoPoint lat: -8.13333, lon: 36.68333, hasResults: False
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protocolSection identificationModule nctId: NCT06362824, orgStudyIdInfo id: 2094138, briefTitle: Promoting Physical Activity in Older Hispanic/Latino(a) Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Kaiser Permanente, class: OTHER, collaborators name: University of California, San Diego, descriptionModule briefSummary: In this randomized controlled trial, study staff will randomize 130 Hispanic/Latino adults without dementia and over age 55 from Southern California to either the culturally adapted De Pie physical activity intervention or an active comparison program focusing on general brain health topics. The purpose of this study is to determine if 12 weeks of the culturally adapted and fully remote De Pie y a Movernos intervention improves self-efficacy, habit strength, social support, and enjoyment for physical activity (PA), thus promoting adherence to moderate-intensity physical activity (MIPA) guidelines (150 minutes/week)., conditionsModule conditions: Sedentary Behavior, conditions: Physical Inactivity, conditions: Alzheimer Disease, Protection Against, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: De Pie Intervention, interventions name: Active Comparison Group: Healthy Actions And Lifestyles To Avoid Dementia (HALT-AD), outcomesModule primaryOutcomes measure: Change in Moderate Intensity Physical Activity (MIPA) minutes/day, secondaryOutcomes measure: Meet MIPA guidelines of 150 minutes physical activity per week, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California San Diego, city: San Diego, state: California, zip: 92093, country: United States, contacts name: Zvinka Z Zlatar, PhD, role: CONTACT, email: [email protected], contacts name: Zvinka Z Zlatar, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
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protocolSection identificationModule nctId: NCT06362811, orgStudyIdInfo id: 483730, briefTitle: Assessment of Efficacy of Sacral Erector Spinae Plane Block for Postoperative Analgesia in Pediatric Rectal Biopsies, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate how sacral erector spinae block changed the postoperative analgesia requirements in pediatric patients undergoing rectal biopsies under general anesthesia., conditionsModule conditions: Analgesia, conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Sacral Erector Spinae Plane Block, outcomesModule primaryOutcomes measure: Postoperative pain scores, primaryOutcomes measure: Analgesia requirement, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istanbul University Cerrahpasa, city: Istanbul, zip: 34098, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06362798, orgStudyIdInfo id: IRB22-0729, secondaryIdInfos id: 1R01HD109293-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01HD109293-01, secondaryIdInfos id: 6-23FY-0012, type: OTHER_GRANT, domain: March of Dimes, briefTitle: Effect of Support for Low-Income Mothers of Preterm Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2028-12-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Harvard School of Public Health (HSPH), class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 33 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development., conditionsModule conditions: Preterm Birth, conditions: Low; Birthweight, Extremely (999 Grams or Less), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two-arm single-blind 1:1 randomized controlled trial of financial transfers ($160 per week) versus usual care. Mothers in the intervention arm will access videos that explain the impact of the cash on their availability for benefits and social supports. They will also be able to ask questions to a benefits counselor about how the transfers affect their benefits during the trial., primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.), whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Financial Transfers, outcomesModule primaryOutcomes measure: Provision of breast milk (proportion), primaryOutcomes measure: Provision of skin-to-skin care, secondaryOutcomes measure: Duration of mother's milk expression, secondaryOutcomes measure: Gestational weight-for-age, secondaryOutcomes measure: Gestational length-for-age z-score, secondaryOutcomes measure: Gestational head circumference, secondaryOutcomes measure: Necrotizing enterocolitis (NEC), secondaryOutcomes measure: Late-onset bacterial or fungal sepsis (LOS), secondaryOutcomes measure: NICU Visitation, secondaryOutcomes measure: Postpartum Bonding, secondaryOutcomes measure: Provision of breast milk (volume), secondaryOutcomes measure: Breastfeeding episode, secondaryOutcomes measure: Maternal physical health, secondaryOutcomes measure: Maternal mental health (anxiety), secondaryOutcomes measure: Maternal mental health (depression), secondaryOutcomes measure: Reaction Time Modified Flanker Task, secondaryOutcomes measure: Accuracy Performance Modified Flanker Task, secondaryOutcomes measure: Reaction Time Psychomotor Vigilance Task, secondaryOutcomes measure: Accuracy Psychomotor Vigilance Task, secondaryOutcomes measure: Happiness, secondaryOutcomes measure: Life satisfaction, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Routine postpartum care, secondaryOutcomes measure: Financial distress, secondaryOutcomes measure: Financial hardship, secondaryOutcomes measure: Food insecurity, secondaryOutcomes measure: Housing instability, secondaryOutcomes measure: Housing insecurity, secondaryOutcomes measure: Transportation insecurity, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Mother readmission between 4-8 weeks post-discharge, secondaryOutcomes measure: Baby readmission between 4-8 weeks post-discharge, secondaryOutcomes measure: Mother emergency department visit between 4-8 weeks post-discharge, secondaryOutcomes measure: Baby emergency department visit between 4-8 weeks post-discharge, secondaryOutcomes measure: Sleep position, secondaryOutcomes measure: Sleep location, secondaryOutcomes measure: Breastfeeding expression continuation, secondaryOutcomes measure: Skin-to-skin care knowledge, secondaryOutcomes measure: Breastfeeding knowledge, secondaryOutcomes measure: Perception of hospital experience, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children's Healthcare of Atlanta and Emory University, city: Atlanta, state: Georgia, zip: 30322, country: United States, contacts name: Michelle-Marie Peña, MD, role: CONTACT, email: [email protected], geoPoint lat: 33.749, lon: -84.38798, locations facility: Boston Medical Center, city: Boston, state: Massachusetts, zip: 02118, country: United States, contacts name: Gabriela Cordova Ramos, MD, role: CONTACT, email: [email protected], geoPoint lat: 42.35843, lon: -71.05977, locations facility: Baystate Medical Center, city: Springfield, state: Massachusetts, zip: 01199, country: United States, contacts name: Laura Madore, MD, role: CONTACT, email: [email protected], geoPoint lat: 42.10148, lon: -72.58981, locations facility: UMass Memorial Medical Center, city: Worcester, state: Massachusetts, zip: 01605, country: United States, contacts name: Margaret Parker, MD, role: CONTACT, email: [email protected], geoPoint lat: 42.26259, lon: -71.80229, hasResults: False
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protocolSection identificationModule nctId: NCT06362785, orgStudyIdInfo id: Virtual Reality-Seniors, briefTitle: Musculoskeletal Pain, Motor Control, Risk of Falls and Virtual Reality, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Universidade da Coruña, class: OTHER, collaborators name: Centre for Information and Communications Technology Research (CITIC), descriptionModule briefSummary: The goal of this clinical trial is to learn about musculoskeletal pain, functionality, and risk of falls in community-dwelling adults aged 60 years and older. The main questions it aims to answer are:* What are the characteristics of a community-dwelling population over 60 years and older in terms of musculoskeletal pain, functionality, and risk of falls?* Does an intervention with virtual reality lower musculoskeletal pain, raise functionality and prevent falls in community-dwelling adults aged 60 years and older, compared to a control group that does not receive such intervention?Participants will:* Answer questionnaires.* Perform physical laboratory tests through a camera-based motion capture system.* Execute task-based exercises in a virtual environment through virtual reality.Researchers will compare community-dwelling adults aged 60 years and older who execute task based exercises in a virtual environment through virtual reality and community-dwelling adults aged 60 years and older without any intervention to see if virtual reality improves musculoskeletal pain, functionality, and lowers fall risk., conditionsModule conditions: Musculoskeletal Pain, conditions: Task Performance and Analysis, conditions: Accidental Falls, conditions: Virtual Reality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, outcomesModule primaryOutcomes measure: Presence of musculoskeletal pain, primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Initial positioning, primaryOutcomes measure: Final positioning, primaryOutcomes measure: Angular velocity, primaryOutcomes measure: Acceleration, primaryOutcomes measure: Movement execution time, primaryOutcomes measure: Range of joint movement, secondaryOutcomes measure: Neck disability, secondaryOutcomes measure: Lower back disability, secondaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Falls history, secondaryOutcomes measure: General health status, secondaryOutcomes measure: Date of birth, secondaryOutcomes measure: Gender, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: Depressive symptoms, secondaryOutcomes measure: Cognitive capacity, secondaryOutcomes measure: Amount and type of medication consumed, secondaryOutcomes measure: Existence of comorbidity, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06362772, orgStudyIdInfo id: MR-36-24-010944, briefTitle: Clinical Efficacy of 125I Seed Implantation in the Treatment of Refractory Differentiated Thyroid Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Jiangxi Provincial Cancer Hospital, class: OTHER, descriptionModule briefSummary: A retrospective analysis was conducted on RAIR-DTC patients who underwent radioactive 125I seed implantation from January 2015 to February 2022 at Jiangxi Cancer Hospital. Prescription dose: 80\~120 Gy. All cases were followed up at 1, 3, and 5 months postoperatively to monitor changes in tumor size, serum thyroglobulin (Tg), and serum anti-thyroglobulin antibody levels in thyrotropin-inhibited states, pain scores, and postoperative adverse reactions. The data were processed and analyzed using IBM SPSS 26.0. Pairwise comparisons were conducted using the Wilcoxon signed-rank test, and a p-value of less than 0.05 indicated statistical significance., conditionsModule conditions: Thyroid Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Iodine-125 brachytherapy, outcomesModule primaryOutcomes measure: Tumor size, primaryOutcomes measure: Serological assessment, primaryOutcomes measure: Pain score, primaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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