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protocolSection identificationModule nctId: NCT06283433, orgStudyIdInfo id: NL83813.078.23, briefTitle: A Dried Blood Spot Sampling Method for Vancomycin and Creatinine Monitoring for OPAT, acronym: ADVANCEDOPAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: The Outpatient Parenteral Antibiotic Therapy (OPAT) service consists of providing antimicrobial therapy through parenteral infusion without hospitalization. This service is provided to stable patients otherwise ready for hospital discharge. Generally, the clinical monitoring for this patient population is minimal. However, clinical monitoring of vancomycin, an antibiotic widely used during OPAT, can be intensive primarily due to therapeutic drug monitoring. To ensure optimal treatment and minimize nephrotoxicity and microbial resistance, TDM and monitoring of serum creatinine levels are crucial during vancomycin therapy. TDM of vancomycin with OPAT presents a challenge for patients who must frequently travel to blood sampling facilities or the hospital for measurements. An alternative sampling method for TDM is the dried blood spot (DBS) method, which involves collecting a small drop of capillary blood from a finger prick onto filter paper. By implementing the DBS sampling method, the amount of outpatient visits regarding vancomycin treatment in OPAT can be reduced. Furthermore, the addition of measuring a biochemical parameter, such as renal function with serum creatinine, could lead to even less outpatient visits during OPAT. To date, studies investigating the effectiveness of DBS sampling of vancomycin and creatinine in terms of reducing outpatient visits have not yet been conducted in the OPAT population., conditionsModule conditions: Infection, Bacterial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Finger Prick, interventions name: Venipuncture, outcomesModule primaryOutcomes measure: To compare the number of outpatient visits in the control group versus the intervention group at day 28, secondaryOutcomes measure: Outcomes regarding outpatient visit, secondaryOutcomes measure: Sampling outcomes, secondaryOutcomes measure: Satisfaction with blood sampling based on the theoretical framework of acceptability questionnaire (TFA), secondaryOutcomes measure: Cost outcomes, secondaryOutcomes measure: Clinical outcomes, secondaryOutcomes measure: TDM outcomes, secondaryOutcomes measure: Logistical outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, country: Netherlands, contacts name: Birgit Koch, PharmD, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False |
protocolSection identificationModule nctId: NCT06283420, orgStudyIdInfo id: CarDia_WP5_P1_IRB:25059/23, briefTitle: Metabolic Response to Iniciation of Heart Failure Therapy, acronym: GliF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-12-20, completionDateStruct date: 2026-12-20, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Vojtech Melenovsky, MD, PhD, class: OTHER_GOV, descriptionModule briefSummary: This protocol is part of the CarDia project - National Institute for Metabolic and Cardiovascular Disease Research (EXCELES Program, ID: LX22NPO5104), funded by the European Union - Next Generation EU. The protocol is part of Work Package 5 (WP5): metabolic disorders in heart failure.The goal of this observational protocol is to monitor the biochemical and metabolomic response to the initiation of therapy for heart failure with standard drugs (SGLT2i, sGC stimulators, ARNI) and whether this early response (within first 3 months) predicts the further course of the disease.The protocol will examine how parameters reflecting neurohumoral activation, response to hypoxia, systemic metabolism of energy substrates, parameters of iron metabolism, HIF1A activation in peripheral blood behave over time after starting standard heart failure terapiy (baseline, 1 day, 1 week, 1 month, 3 month). This project can provide valuable information on how to identify people who respond more poorly to the treatment being introduced and are more at risk of an adverse course of the disease. Patients will be compared to patients who have no change of therapy over early observation period (3 mo), who will serve as controls. This is observational study, so decision to inicialize therapy will be based on medical indication.Patients with heart failure treated at the IKEM Cardiocenter will have blood drawn at several defined intervals before and after the start of clinically indicated treatment. Some patients will also undergo genetic DNA testing to determine the variability of genes regulating the metabolic neurohumoral response to heart failure. Patients will be contacted at intervals of 1 and 2 years and the incidence of clinical events will be monitored. The study is observational in nature and inclusion in the study does not affect the course of care provided or the choice of pharmacotherapy., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: hematocrit, secondaryOutcomes measure: HIF response, secondaryOutcomes measure: hepcidin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Clinical end Experimental Medicine - IKEM, city: Prague, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False |
protocolSection identificationModule nctId: NCT06283407, orgStudyIdInfo id: ICF, briefTitle: ICF-based Comparison on Musculoskeletal Health in Poland and Spain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-06-03, completionDateStruct date: 2024-11-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Rzeszow, class: OTHER, collaborators name: Sanidad de Castilla y León, descriptionModule briefSummary: Musculoskeletal conditions are a major cause of disability worldwide. These conditions are often associated with chronicity, which is a challenge for healthcare systems to address. Health care must be person-centred and take into account the individual perspective from which the disease is experienced. The lived experience of health conditions depends to a large extent on contextual factors. Comparison between different contexts helps to identify which aspects are most relevant in the experience of the disease. The International Classification of Functioning, Disability and Health (ICF) provides a unified language that allows such comparisons to be made. The aim of this study is to identify differences in musculoskeletal health between the Polish and Spanish populations using the ICF as a frame of reference., conditionsModule conditions: Musculoskeletal Diseases or Conditions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: ICF-based cross-country comparative analysis, outcomesModule primaryOutcomes measure: Brief International Classification of Functioning, Disability and Health (ICF) core set for post-acute musculoskeletal conditions, secondaryOutcomes measure: Sociodemographic data of the sample (nationality, age, sex, education level, work status, number of comorbidities), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Rzeszow, city: Rzeszów, zip: 35-959, country: Poland, contacts name: Agnieszka Wiśniowska-Szurlej, role: CONTACT, geoPoint lat: 50.04132, lon: 21.99901, hasResults: False |
protocolSection identificationModule nctId: NCT06283394, orgStudyIdInfo id: 854803, briefTitle: AHA (American Heart Association) Food is Medicine Test of Choice Architecture and Salience of Incentives, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to test ways to improve the effectiveness of a healthy foods prescription program in increasing the purchase of healthy foods for patients who have both obesity (BMI \> 30) and diabetes (last A1C\>8 in the last 90 days). The main questions it aims to answer are:Aim 1: Examine feasibility and engagement among participants by assessing percent enrollment among those identified as eligible, rates of Instacart platform use, amount of the subsidy used each week, and amounts of healthy foods ordered.Aim 2: Examine strategies to optimize the user experience of trial participation, including communication strategies and on-boarding, to increase uptake and engagement in this and subsequent studies.Usual Care (Control): Participants in the usual care arm will not receive weekly subsidies on Instacart, and they will not receive any modifications to the virtual storefront on Instacart. They will have access to the standard Instacart platform and Instacart + memberships with $5 per week to cover service and delivery fees and delivery tips for 3 months.Intervention Arms: The four treatment groups will also each receive a $160 subsidy per month for 3 months to be used on produce (fruits and vegetables)., conditionsModule conditions: Obesity, conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Storefront Choice Architecture, interventions name: Fresh Funds, interventions name: Loss Framing, outcomesModule primaryOutcomes measure: The primary outcome will be the percentage of food purchasing expenditures spent on eligible healthy foods., secondaryOutcomes measure: Percentage of the $160 subsidy used each month in the intervention arms., secondaryOutcomes measure: Change in hemoglobin A1c, secondaryOutcomes measure: Qualitative results, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283381, orgStudyIdInfo id: 4264, briefTitle: The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty, acronym: ESGIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms:* Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure.* Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment).The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Esomeprazole, outcomesModule primaryOutcomes measure: The structural integrity of the sutures after Endoscopic sleeve gastroplasty (ESG), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: IVO BOSKOSKI, role: CONTACT, phone: +390630155701, email: [email protected], contacts name: IVO BOSKOSKI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06283368, orgStudyIdInfo id: 2021/11-06, briefTitle: Red Blood Cell Distributions (RDW, RDW-CW) and Lymphocyte Monocyte Ratios (LMR) for the Malignant Thyroid Nodules, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2021-01, completionDateStruct date: 2021-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: Thyroid surgery is the most common type of surgery among endocrine surgeries. This surgery is performed for patients with suspected malignancy, patients diagnosed with malignancy, and toxic nodular goiter. In addition to vocal cord injury, which is the most important complication of thyroid surgery, hypocalcemia due to hypoparathyroidism and surgical wound complications (such as hematoma, and fistula) can also be observed, and malignancy surgery increases the risk of recurrent laryngeal nerve injury. Therefore, it is important to differentiate these groups using non-invasive methods before surgery.Tumor-related inflammation is activated as a result of bone marrow and inflammation induced by malignancies. Insufficiently controlled or uncontrolled inflammatory activity may be responsible for malignant transformation. Lymphocyte monocyte ratio and red blood cell distribution are parameters (RDW, RDW-CW) previously studied in terms of cancers.Our aim in this study is to reveal the RDW, RDW-CW, and LMR calculated from complete blood count parameters in the preoperative period, as an indicator of malignant inflammatory response, in a non-invasive and inexpensive way before surgery or biopsy is performed to distinguish nodular goiter and thyroid malignancy., conditionsModule conditions: Thyroid Neoplasms Benign, conditions: Thyroid Nodule, conditions: Thyroid Cancer, conditions: Thyroid Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 172, type: ACTUAL, armsInterventionsModule interventions name: Thyroidectomy, Bilaterally Total, interventions name: Thyroidectomy, Unilaterally Total, interventions name: Thyroidectomy, Complementary, interventions name: Thyroidectomy, Near Total, outcomesModule primaryOutcomes measure: Determining benign thyroid nodules, primaryOutcomes measure: Determining malignant thyroid nodules, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06283355, orgStudyIdInfo id: IRB00433691, briefTitle: Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, descriptionModule briefSummary: This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity., conditionsModule conditions: Staphylococcus Aureus, conditions: Microbial Colonization, conditions: Neonatal Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 175, type: ESTIMATED, armsInterventionsModule interventions name: Nasal Microbiota Transplant (NMT), interventions name: Placebo, outcomesModule primaryOutcomes measure: Neonatal nasal microbiome diversity after intervention, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Johns Hopkins University, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Danielle Koontz, role: CONTACT, phone: 443-287-9040, email: [email protected], contacts name: Aaron Milstone, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06283342, orgStudyIdInfo id: Konya Pediatric Hematology, briefTitle: Prophylactic Iron and Nutrition in Preventing Infant Iron Deficiency, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2019-01-01, completionDateStruct date: 2019-02-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Konya Meram State Hospital, class: OTHER, descriptionModule briefSummary: This study aimed to reveal the effects of prophylactic iron preparations, adequate breast milk intake, and iron-rich supplementary food intake in the prevention of IDA (iron deficiency anemia) and ID (iron deficiency) in infancy., conditionsModule conditions: Iron Deficiency Anemia in Childbirth, conditions: Infant Nutrition Disorders, conditions: Iron Deficiencies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Ferritine level, secondaryOutcomes measure: Hemoglobin level, secondaryOutcomes measure: Prophylactic iron use rate, secondaryOutcomes measure: Iron-sufficient supplementary food intake rate of babies, secondaryOutcomes measure: Breast milk usage rate, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Konya Training and Research Hospital, city: Konya, zip: 42090, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False |
protocolSection identificationModule nctId: NCT06283329, orgStudyIdInfo id: echographic VC curarization, briefTitle: Residual Vocal Cords Curarization Correlation Between Clinical and Ultrasound Endpoints, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: General Administration of Military Health, Tunisia, class: NETWORK, descriptionModule briefSummary: Through recent studies residual curarization (RC) remains frequent but serious event, that could be easily avoided in the presence of a paraclinical monitoring and by antagonization of curares. However, conventional monitors focus only on peripheral muscles, whereas ultrasonography allows direct visualization of laryngeal muscles, particularly the vocal cords, which are directly influenced by neuromuscular blocking agents. The aim of the study was to evaluate the ultrasound mobility of the vocal cords after awakening and extubation of general anesthesia compared to their preoperative mobility and its correlation with clinical and paraclinical diagnostic criteria (DG) for RC., conditionsModule conditions: Residual Curarization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: vocal cords echography, outcomesModule primaryOutcomes measure: Echographic mobility of vocal cords at different times in post extubation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elaskri Haythem, city: Tunis, zip: 1008, country: Tunisia, geoPoint lat: 36.81897, lon: 10.16579, hasResults: False |
protocolSection identificationModule nctId: NCT06283316, orgStudyIdInfo id: 11347, briefTitle: Systemic Treatments for Alopecia Areata Registry, acronym: STA2R, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2099-12-31, completionDateStruct date: 2099-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: A multicenter prospective registry (STA2R) is conducted to assess systemic treatments for alopecia areata, focusing on effectiveness, safety, and long-term outcomes., conditionsModule conditions: Alopecia Areata, conditions: Alopecia Totalis, conditions: Alopecia Universalis, conditions: Hair Loss, conditions: Hair Diseases, conditions: Alopecia, conditions: Alopecia Drugs, conditions: Autoimmune Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Effectiveness of systemic treatments, primaryOutcomes measure: Safety of systemic treatments, secondaryOutcomes measure: Epidemiological data, secondaryOutcomes measure: Physician Reported - Severity of Alopecia Tool (SALT Score), secondaryOutcomes measure: Dermatology Life Quality Index (DLQI, 10 items), secondaryOutcomes measure: Alopecia Areata Symptom Impact Scale (AASIS, 13 items), eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus University Medical Center, status: RECRUITING, city: Rotterdam, country: Netherlands, contacts name: DirkJan Hijnen, MD, PhD, role: CONTACT, phone: 0031 10 704 01 10, email: [email protected], geoPoint lat: 51.9225, lon: 4.47917, hasResults: False |
protocolSection identificationModule nctId: NCT06283303, orgStudyIdInfo id: MVR-T3011-HAI-01, briefTitle: A Clinical Study of T3011 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, collaborators name: Immvira Co., Limited, descriptionModule briefSummary: This is a phase I, open-label clinical study of T3011 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: T3011 hepatic artery infusion, interventions name: toripalimab, interventions name: regorafenib, outcomesModule primaryOutcomes measure: Treatment Emergent Adverse Event（TEAE）, secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283290, orgStudyIdInfo id: D3250R00122, briefTitle: PROPE Severe Asthma Study in Egypt, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: Asthma is a syndrome characterized by airway inflammation, reversible airway obstruction, and airway hyper-responsiveness. Patients present clinically with recurrent wheezing, shortness of breath, cough, and chest tightness. Asthma is a leading cause of morbidity with a global prevalence of approximately 300 million; it is estimated that the number of people with asthma may increase to 400 to 450 million people worldwide by 2025.Severe asthma is not considered a single disease; instead, it is divided into several phenotypes, owing to the variety of inflammatory, clinical, and functional characteristics that it can present with. One of the proposed and most studied phenotypes is severe eosinophilic asthma. Patients with severe asthma that is accompanied by a high concentration of eosinophils require greater healthcare resource use, greater disease management costs, and a much more impaired QoL than those who do not present with raised eosinophilia.While the number of targeted treatments for asthma management has been growing in recent years, the heterogeneity of clinical presentations, treatment responses, and inflammatory processes involved represent an added challenge for health care professionals. Thus, severe asthma management is a complex endeavor, and a thorough and up-to-date understanding of the pathophysiologic characteristics of the patient population promotes effective therapeutic decision-making.This cross-sectional, multicenter study aims to determine the prevalence of oral corticosteroid (OCS) use among severe asthma patients who attend to different sites specialized in the management of severe asthma across Egypt. In addition, the prevalence of eosinophilic phenotype of blood eosinophil count ≥ 150 cells/mm3, prevalence of atopic phenotype, and asthma control will also be studied., conditionsModule conditions: Severe Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: To describe the prevalence (frequency) of OCS use among severe asthma patients as defined by chronic treatment and/or bursts of OCS use., secondaryOutcomes measure: To describe the demographic characteristics of severe eosinophilic asthma patients., secondaryOutcomes measure: To describe the clinical characteristics of severe eosinophilic asthma patients., secondaryOutcomes measure: To discover the average OCS dose per year used among severe asthma patients., secondaryOutcomes measure: To determine the prevalence of the eosinophilic phenotype, secondaryOutcomes measure: To determine the prevalence of the eosinophilic phenotype, secondaryOutcomes measure: To determine the prevalence of the total serum IgE, secondaryOutcomes measure: To determine the annual severe asthma exacerbation rate in the past twelve months among severe asthma patients in Egypt, secondaryOutcomes measure: To evaluate asthma control of severe asthma patients, secondaryOutcomes measure: To evaluate comorbidities related to OCS use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mansoura, state: Dakahlia, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, locations facility: Research Site, status: RECRUITING, city: Zagazig, state: Sharkia, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, locations facility: Research Site, status: RECRUITING, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, locations facility: Research Site, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06283277, orgStudyIdInfo id: fetal macrosomia, briefTitle: Fetal Clavicular Measurement to Predict Fetal Macrosomia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. The accurate diagnosis of macrosomia is often difficult before birth. There are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. There are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect.The aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and Hadlock formula IV for prediction of fetal macrosomia., conditionsModule conditions: Macrosomia, Fetal, conditions: Large for Gestational Age, conditions: Shoulder Dystocia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Obstetric Ultrasound, outcomesModule primaryOutcomes measure: Third trimester clavicle length measurement, secondaryOutcomes measure: Establish the relationship between third-trimester clavicle length and shoulder dystocia, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Gestational age at the time of delivery., secondaryOutcomes measure: Neonatal Apgar score., secondaryOutcomes measure: Neonatal bi-acromial diameter, secondaryOutcomes measure: Neonatal birth weight, secondaryOutcomes measure: Neonatal need for NICU, secondaryOutcomes measure: Neonatal actual clavicle length, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283264, orgStudyIdInfo id: Coeliac Disease in type2 DM, briefTitle: Assessment of Coeliac Disease in Patients With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: This study aims to screen and diagnose coeliac disease in patients with type 2 diabetes and monitor the effect of gluten-free diet on the metabolic status, conditionsModule conditions: Celiac Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: 1-Prevalence of coeliac disease among diabetic type 2 patient 2-its effect on glycemic control, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283251, orgStudyIdInfo id: 23-590, briefTitle: PediRISE Feasibility, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: American Cancer Society, Inc., collaborators name: Children's Cancer Research Fund, descriptionModule briefSummary: The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.The names of the study groups in this research study are:* PediRISE Program Group* Usual Care Group, conditionsModule conditions: Pediatric Cancer, conditions: Financial Stress, conditions: Financial Hardship, conditions: Disparities, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PediRISE Resource Program, outcomesModule primaryOutcomes measure: Rate of Participant Consent, primaryOutcomes measure: 6-Month Follow Up Rate for PediRISE Program Group, primaryOutcomes measure: 6-Month Follow Up Rate for Usual Care Group, eligibilityModule sex: ALL, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Boston Children's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Kira Bona, MD, MPH, role: CONTACT, phone: 617-632-4688, email: [email protected], contacts name: Kira Bona, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Kira Bona, MD, MPH, role: CONTACT, phone: 617-632-4688, email: [email protected], contacts name: Kira Bona, MD, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False |
protocolSection identificationModule nctId: NCT06283238, orgStudyIdInfo id: Pro00115121, briefTitle: Biobanking Upper Gastrointestinal Tumors to Evaluate Response (BURGER With BACON), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2026-03-25, completionDateStruct date: 2027-03-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to examine genetic changes that may contribute to immunotherapy resistance in gastroesophageal cancer. This information can potentially lead to the identification of new immunotherapeutic targets as well as improve the ability to identify those patients more likely to respond to immunotherapy.This study does not include any treatment or investigational drugs.Participants will be asked:* to enroll before beginning standard care of treatment for their cancer* for blood, archived tumor tissue, and fresh tumor tissue Researchers will compare participants who are not getting immunotherapy to identify potential differences in expression levels of a gene., conditionsModule conditions: GastroEsophageal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Immune checkpoint inhibitor (ICI) or chemotherapy alone, outcomesModule primaryOutcomes measure: Number of participants with Complete Response (CR), primaryOutcomes measure: Number of participants with Partial Response (PR), primaryOutcomes measure: Number of participants with Stable Disease, primaryOutcomes measure: Number of participants with Progressive Disease, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False |
protocolSection identificationModule nctId: NCT06283225, orgStudyIdInfo id: RCT004_PilotPia, briefTitle: Pilot Study to Investigate the Effect of a Dysmenorrhoea App, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Endo Health GmbH, class: INDUSTRY, descriptionModule briefSummary: The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants., conditionsModule conditions: Dysmenorrhea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: intervention group and control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Pia-App, outcomesModule primaryOutcomes measure: Dysmenorrhea Symptom Interference Scale (DSI), primaryOutcomes measure: Moos Menstrual Distress Questionnaire, Form C (MDQ), primaryOutcomes measure: Visual analog scale (VAS), primaryOutcomes measure: Depression Anxiety Stress Scale mit 21 Items (DASS-21), primaryOutcomes measure: German Version of Pain Self-Efficacy Questionnaire (FESS), primaryOutcomes measure: Fatigue Severity Scale (FSS), primaryOutcomes measure: Pain Disability Index (PDI), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283212, orgStudyIdInfo id: ETX-DS-005, briefTitle: A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome, acronym: UK Only, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Encoded Therapeutics, class: INDUSTRY, descriptionModule briefSummary: EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design., conditionsModule conditions: Dravet Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: ETX101, outcomesModule primaryOutcomes measure: Proportions of participants experiencing any treatment-emergent adverse events (AEs), serious adverse events (SAEs), related AEs, AEs with severity Grade ≥ 3, AEs resulting in study discontinuation, and AEs with fatal outcome., primaryOutcomes measure: Change from baseline in the standard score of the Vineland Adaptive Behavior Scales - Third Edition Adaptive Behavior Composite at Week 52., secondaryOutcomes measure: Percent change in monthly countable seizure frequency (MCSF) to Week 52, with countable seizures defined as generalized tonic-clonic/clonic, focal motor with clearly observable clinical signs, tonic bilateral, and atonic seizures., secondaryOutcomes measure: Change from baseline in the raw score of the Bayley Scales of Infant and Toddler Development® 4th Edition receptive language sub-domain at Week 52., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 47 Months, stdAges: CHILD, contactsLocationsModule locations facility: Queen Elizabeth Hospital, status: RECRUITING, city: Glasgow, zip: G51 4TF, country: United Kingdom, contacts name: Patricia Clark, role: CONTACT, phone: 0141 232 7600, email: [email protected], geoPoint lat: 55.86515, lon: -4.25763, locations facility: Great Ormond Street Hospital, status: NOT_YET_RECRUITING, city: London, zip: WC1N3JH, country: United Kingdom, contacts name: Helen Cross, MD, role: CONTACT, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, locations facility: Sheffield Children's Hospital, status: NOT_YET_RECRUITING, city: Sheffield, zip: S10 2TH, country: United Kingdom, contacts name: Research Team, role: CONTACT, email: [email protected], geoPoint lat: 53.38297, lon: -1.4659, hasResults: False |
protocolSection identificationModule nctId: NCT06283199, orgStudyIdInfo id: ORL-ORT-025, briefTitle: Comparing Reports Recorded by the Patients at the Time at Which They Feels Pain to What Patients Report at Monthly Visits to Assess Symptoms of Musculoskeletal Diseases., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-06, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ente Ospedaliero Cantonale, Bellinzona, class: OTHER, descriptionModule briefSummary: Patients will be introduced to the use of a mobile application for their smartphone to record the Ecological Momentary Assessment (EMA). This app will ask the patients to assess their pain and function two times daily for 2 months.After 1 month and at the end of the 2 months, follow-up visits will be performed and patients will be asked to retrospectively evaluate the pain that they suffered and the level of function they had during the last month., conditionsModule conditions: Musculoskeletal Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Difference in pain level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, country: Italy, contacts name: Alessandro Di Martino, MD, role: CONTACT, phone: 0039 051 6366567, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, locations facility: EOC - Orthopaedics and Traumatology Service, status: RECRUITING, city: Lugano, zip: 6900, country: Switzerland, contacts name: Christian Candrian, Prof.Dr.med, role: CONTACT, phone: +41 (0) 91 811 61 23, email: [email protected], geoPoint lat: 46.01008, lon: 8.96004, hasResults: False |
protocolSection identificationModule nctId: NCT06283186, orgStudyIdInfo id: CSEULS-PI-004/2024, briefTitle: Comparative Exercise-Induced Hypoalgesia in Upper and Lower Limbs: A Randomized Controlled Trial in Healthy Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Centro Universitario La Salle, class: OTHER, descriptionModule briefSummary: This randomized controlled trial with healthy subjects aims to compare exercise-induced hypoalgesia among three groups: one utilizing a lower limb cycle ergometer, another using an upper limb cycle ergometer, and a control group. The exercise protocol involves 30 minutes of aerobic activity at 70-80% of the heart rate reserve. Exercise-induced hypoalgesia will be assessed by measuring pressure pain thresholds in the thigh and elbow. Additionally, a secondary objective is to compare the lower limb and upper limb cycle ergometer groups in terms of their effects on pressure pain thresholds in the thigh and elbow. Thus, the study anticipates observing differences in local and distal hypoalgesia based on the trained region., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise, interventions name: Aerobic exercise, outcomesModule primaryOutcomes measure: Pressure pain threshold (PPT) on dominant quadriceps and dominant lateral epicondyle, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ), secondaryOutcomes measure: Fatigue Assessment Scale (FAS), secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Rate of perceived exertion (RPE), secondaryOutcomes measure: Physical Activity Readiness Questionnaire (PAR-Q), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: CSEU LaSalle, status: RECRUITING, city: Madrid, zip: 28023, country: Spain, contacts name: Álvaro Reina-Varona, MSc, role: CONTACT, phone: 0034 + 649001863, email: [email protected], contacts name: Álvaro Reina-Varona, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False |
protocolSection identificationModule nctId: NCT06283173, orgStudyIdInfo id: 23-401, briefTitle: HRIPT for Collagen Dressing, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-03-22, completionDateStruct date: 2024-03-22, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Covalon Technologies Inc., class: INDUSTRY, collaborators name: ALS Beauty and Personal Care, descriptionModule briefSummary: The objectives of this study are to determine by repetitive epidermal contact, the primary or cumulative irritation and the allergic contact sensitization potential of the ColActive Plus Collagen Matrix Dressing, under maximized conditions, with controlled product quantity and application site., conditionsModule conditions: Skin Sensitisation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This will be a single center, with no randomization or blinding, study design in 50 healthy adult subjects, age 18-70 years. Based on prior experience approximately 75 subjects will be enrolled to ensure 50 subjects complete the study., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 57, type: ACTUAL, armsInterventionsModule interventions name: ColActive Plus Collagen Matrix Dressing, outcomesModule primaryOutcomes measure: Skin sensitization reaction using Berger and Bowman scale, primaryOutcomes measure: Skin irritation reaction using Berger and Bowman scale, otherOutcomes measure: Skin sensitization reaction using Berger and Bowman scale, otherOutcomes measure: Skin sensitization reaction using Berger and Bowman scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ALS Beauty and Personal Care, city: Torrance, state: California, zip: 90501, country: United States, geoPoint lat: 33.83585, lon: -118.34063, hasResults: False |
protocolSection identificationModule nctId: NCT06283160, orgStudyIdInfo id: 2023/834, briefTitle: Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy, acronym: PROMETHEE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: Pancreaticoduodenectomy is the standard surgical operation for benign or malign pancreatic lesions. Pancreatic Fistula (PF) or Postpancreatectomy Acute Pancreatitis (PPAP) are the major complications associated with that type of surgery. We need to develop preventive measures for these complications, which requires a better understanding of their physiopathology.The aim of this prospective monocentric and observational study is to identify predictive biomarkers and/or risk factors for PF or PPAP using metabolomics. The Profiling of circulating metabolites is indeed an original and promising approach for this purpose. We will also investigate the patient's immune status and its association with the occurrence of post-surgical complications.Participants will be adult patients scheduled to undergo elective pancreaticoduodenectomy. Surgery and patient's management will be as usual. During surgery, a fragment (0.1-0.2 g) of non-tumoral pancreatic tissue will be removed and frozen at -80°C for metabolomic analysis. For immunological assessment, 4 blood samples will be collected (before surgery and then 7 days, 1 and 3 months after, blood sampling)., conditionsModule conditions: Pancreatic Fistula, conditions: Acute Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: occurrence of clinically significant FP and/or PAPP during hospitalization following pancreaticoduodenectomy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital of Besançon, status: RECRUITING, city: Besançon, zip: 25000, country: France, contacts name: Alexandre Doussot, MD, PhD, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, hasResults: False |
protocolSection identificationModule nctId: NCT06283147, orgStudyIdInfo id: 2023.530, briefTitle: Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):1. RAMP Knee-OA group2. Usual care groupOutcomes will be measured at baseline, week 16, week 32, and week 52., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 228, type: ESTIMATED, armsInterventionsModule interventions name: Risk assessment and Management Programme - Knee Osteoarthritis, outcomesModule primaryOutcomes measure: Knee pain, secondaryOutcomes measure: Physical Function, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Lower limb muscle mass, secondaryOutcomes measure: Level of physical activity, secondaryOutcomes measure: Self-Management efficacy, secondaryOutcomes measure: Level of Anxiety, secondaryOutcomes measure: Level of Depression, secondaryOutcomes measure: Insomnia, secondaryOutcomes measure: Loneliness, secondaryOutcomes measure: Health related Quality of Life, secondaryOutcomes measure: Demographic data, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lek Yuen GOPC, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Cheryl Fung, role: CONTACT, phone: 26095050, phoneExt: +852, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False |
protocolSection identificationModule nctId: NCT06283134, orgStudyIdInfo id: BJCT-CMU1H-02, briefTitle: A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, collaborators name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd, descriptionModule briefSummary: This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: BioTTT001 hepatic artery infusion, interventions name: toripalimab, interventions name: regorafenib, outcomesModule primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: MTD, secondaryOutcomes measure: Overall survival(OS), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Plasma adenovirus (ADV) copies, secondaryOutcomes measure: ADV copies in various sites, secondaryOutcomes measure: Serum IL-12 level, secondaryOutcomes measure: Serum neutralizing antibody level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283121, orgStudyIdInfo id: BJCT-CMU1H-01, briefTitle: A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-11-30, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: China Medical University, China, class: OTHER, collaborators name: Beijing Bio-Targeting Therapeutics Technology Co., Ltd, descriptionModule briefSummary: This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer., conditionsModule conditions: Gastric Cancer, Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BioTTT001 intraperitoneal infusion, interventions name: SOX regimen, interventions name: toripalimab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06283108, orgStudyIdInfo id: 23-1183, briefTitle: Gurney Journey: Virtual Reality Distraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Colorado, class: OTHER, descriptionModule briefSummary: The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program., conditionsModule conditions: Dental Caries in Children, conditions: Dental Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience), interventions name: Standard Child Life Preparation and Support, outcomesModule primaryOutcomes measure: Induction Compliance Checklist, primaryOutcomes measure: modified Yale Preoperative Anxiety Scale, secondaryOutcomes measure: The Pediatric Behavioral Induction Assessment, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital Colorado, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Claire Simonsen, BA, role: CONTACT, phone: 720-777-5313, email: [email protected], contacts name: Joseph Albietz, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jennifer Staab, MS, role: SUB_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06283095, orgStudyIdInfo id: OSA, briefTitle: Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: ET Zarief, class: OTHER, descriptionModule briefSummary: The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS., conditionsModule conditions: Obstructive Sleep Apnea of Adult, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: expansion palatoplasty, outcomesModule primaryOutcomes measure: Evaluation the outcome of expansion palatoplasty in management of OSAS., secondaryOutcomes measure: Expansion palatoplasty in Obstructive sleep apnea patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASSUIT, status: RECRUITING, city: Assuit, zip: 1, country: Egypt, contacts name: Enas T Zarief, physician, role: CONTACT, phone: 01226270800, email: [email protected], geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06283082, orgStudyIdInfo id: 69HCL23_0617, secondaryIdInfos id: ID-RCB, type: OTHER, domain: 2023-A01406-39, briefTitle: Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene, acronym: HETEROX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure. PH1 is linked to a deficiency in glyoxylate amino transferase (AGXT), which leads to increased endogenous oxalate synthesis and hyperoxaluria. In the urine, urinary oxalate precipitates with calcium, forming insoluble crystals, leading to lithiasis and the development of nephrocalcinosis.Non-genetic etiologies of oxalic nephropathy are well known, in particular enteric causes (malabsorptions, bypass, calcium deficiencies, etc.) and sometimes linked to increased oxalate intake in the form of nutritional or vitamin supplements, reinforcing the hypothesis of probably underestimated favouring factors of hyperoxaluria.Until now, heterozygous patients with a mutation in the AGXT gene were considered asymptomatic. However, there have been several cases of patients with heterozygous AGXT mutations presenting with lithiasis.Consequently, the characteristics of symptomatic and asymptomatic heterozygous patients will be studied in order to define the elements that would explain the expression of the disease (particularities of the AGXT mutation, presence of another heterozygous mutation or favorable living conditions).The hypothesis is that there is an increase in hepatic oxalate production in heterozygous patients, which explains why they remain asymptomatic under usual conditions, but could favor stone formation under favorable conditions such as severe calcium deficiency or malabsorption., conditionsModule conditions: Hyperoxaluria (Disorder), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Lithiasis assessment, outcomesModule primaryOutcomes measure: Urinary oxalate and glycolate excretion, secondaryOutcomes measure: The prevalence of stones, secondaryOutcomes measure: Lithiasis disease severity, secondaryOutcomes measure: Lithiasis disease severity, secondaryOutcomes measure: Lithiasis disease severity, secondaryOutcomes measure: Lithiasis disease severity, secondaryOutcomes measure: Predisposing conditions for lithiasis disease, secondaryOutcomes measure: Predisposing conditions for lithiasis disease, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CLIMA, pavillon R, Hôpital Edouard Herriot, city: Lyon, zip: 69003, country: France, contacts name: Laurence Derain, MD,PhD, role: CONTACT, phone: 04 72 11 91 17, phoneExt: +33, email: [email protected], geoPoint lat: 45.74848, lon: 4.84669, hasResults: False |
protocolSection identificationModule nctId: NCT06283069, orgStudyIdInfo id: 45C301, briefTitle: Relationship Between Lifestyle Indicators and Cardiovascular Clinical Parameters, acronym: RICH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2033-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The goal of the study is to build a Register accruing data derived from the compilation of the questionnaire about LifeStyle for a population both of adults and of young boys and girls. The investigators are confident that in this way they will be able to expand the database they already have. The investigators will be able to increase the strength of the correlations between LS indices and health indicators. In particular, the investigators will emphasize the relationship between physical activity, stress, and diet quality on one hand, and on the other, they will focus on physiological parameters, like arterial pressure, gluco-lipid profile, and possible pathologies., conditionsModule conditions: Cardiovascular Diseases, conditions: Lifestyle, conditions: Nutrition, Healthy, conditions: Physical Inactivity, conditions: Stress, conditions: Sleep, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: compilation of a questionnaire about LifeStyle, outcomesModule primaryOutcomes measure: weekly physical activity volume, secondaryOutcomes measure: nutrition quality, secondaryOutcomes measure: weight, secondaryOutcomes measure: height, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: perception of stress, fatigue, and somatic symptoms, secondaryOutcomes measure: glycemia, secondaryOutcomes measure: cholesterol, secondaryOutcomes measure: creatinine, secondaryOutcomes measure: waist circumference, secondaryOutcomes measure: heart rate, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, country: Italy, contacts name: Luca Giovanelli, MD, role: CONTACT, phone: +3902619112808, email: [email protected], contacts name: Daniela Lucini, Prof, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06283056, orgStudyIdInfo id: DO611073A, briefTitle: RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of Cellulite, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-16, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: InMode MD Ltd., class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate the safety and efficacy of Morpheus 8 Body 40-pin tip up to 7mm depth Applicator for subdermal treatment of cellulite appearance, skin laxity, and subcutaneous fat deposits., conditionsModule conditions: Cellulitis of Leg, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, open-label clinical study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Device treatment, outcomesModule primaryOutcomes measure: Cellulite assessment based on Clinician Reported Photonumeric Cellulite Severity Scale, primaryOutcomes measure: Cellulite assessment based on DiBernardo Photonumeric Cellulite Severity Scale, secondaryOutcomes measure: Subject assessment of improvement, secondaryOutcomes measure: Subject assessment of improvement, secondaryOutcomes measure: Subject assessment of improvement, secondaryOutcomes measure: Subject assessment of satisfaction, secondaryOutcomes measure: Subject assessment of satisfaction, secondaryOutcomes measure: Subject assessment of satisfaction, secondaryOutcomes measure: Investigator assessment of the skin appearance improvemen, secondaryOutcomes measure: Investigator assessment of the skin appearance improvement, secondaryOutcomes measure: Investigator assessment of the skin appearance, secondaryOutcomes measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment, secondaryOutcomes measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment, secondaryOutcomes measure: Investigator assessment of the cellulite following subdermal Morpheus8 treatment, otherOutcomes measure: Adverse Event rate, otherOutcomes measure: Pain Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dermatology & Laser Surgery Center of New York, status: ACTIVE_NOT_RECRUITING, city: New York, state: New York, zip: 10028, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Dallas Plastic Surgeon, status: RECRUITING, city: Dallas, state: Texas, zip: 75225, country: United States, contacts name: Lily Hays, role: CONTACT, phone: 214-821-9114, email: Lily Hays <[email protected]>, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06283043, orgStudyIdInfo id: 2022/3749, briefTitle: Effect of Motor Function, Depression and Sleep Quality on Attention in Parkinson's Disease, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: Our study was planned to analyze motor function, endurance and sleep attention information in Parkinson's patients with detailed and objective measurements., conditionsModule conditions: Movement Disorders (Incl Parkinsonism), conditions: Parkinsonian Disorders, conditions: Attention Impaired, conditions: Movement Disorders, Functional, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: TUG, primaryOutcomes measure: 10 m walking test, primaryOutcomes measure: 30 sec sit-stand test, primaryOutcomes measure: berg balance test, primaryOutcomes measure: one leg stance test, primaryOutcomes measure: functional reach test, primaryOutcomes measure: hand dinamometer, primaryOutcomes measure: mobil application, primaryOutcomes measure: Pittsburg Sleep Quality İndex, primaryOutcomes measure: Beck Depression, primaryOutcomes measure: P300, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inonu University, city: Malatya, state: Battalgazi, zip: 44280, country: Turkey, geoPoint lat: 38.35018, lon: 38.31667, hasResults: False |
protocolSection identificationModule nctId: NCT06283030, orgStudyIdInfo id: IM-001, briefTitle: Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2023-09-25, completionDateStruct date: 2023-09-25, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Invicta Medical Inc., class: INDUSTRY, collaborators name: Vanderbilt University Medical Center, descriptionModule briefSummary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed., conditionsModule conditions: Sleep Apnea, conditions: Sleep Apnea, Obstructive, conditions: Sleep Apnea Syndromes, conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Hypoglossal nerve stimulation, outcomesModule primaryOutcomes measure: Identification and access of the target outcomes, primaryOutcomes measure: Tongue protrusion outcomes, primaryOutcomes measure: Characterization of electrode array outcomes, primaryOutcomes measure: Electrode array placement and removal outcomes, primaryOutcomes measure: Safety outcomes, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vanderbilt Bill Wilkerson Centre, city: Nashville, state: Tennessee, zip: 37232, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False |
protocolSection identificationModule nctId: NCT06283017, orgStudyIdInfo id: IM-002, briefTitle: Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Invicta Medical Inc., class: INDUSTRY, collaborators name: Adelaide Institute for Sleep Health, Flinders University, descriptionModule briefSummary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed., conditionsModule conditions: Sleep Apnea, conditions: Sleep Apnea, Obstructive, conditions: Sleep Disorder, conditions: Sleep Apnea Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Hypoglossal nerve stimulation, outcomesModule primaryOutcomes measure: Target identification and access outcomes, primaryOutcomes measure: Tongue protrusion outcomes, primaryOutcomes measure: Characterization of lead placement outcomes, primaryOutcomes measure: Lead placement and removal outcomes, primaryOutcomes measure: Safety outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Adelaide Institute for Sleep Health, Flinders University, city: Adelaide, state: South Australia, zip: 5042, country: Australia, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False |
protocolSection identificationModule nctId: NCT06283004, orgStudyIdInfo id: 2024-1/30, briefTitle: Investigation of Walking Training With Different Slope Types in COPD Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, collaborators name: Bezmialem Vakif University, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD) is a disease that continues to generate a great deal of research and this research must continue, both because it is not completely curable and because of the large patient population. The importance and benefits of exercise training in COPD patients are clear. One of the most preferred types of exercise training is the so-called aerobic exercise training, which typically takes the form of walking. A typical walking training does not use a slope or may include an uphill slope. However, recently there have been publications about downhill walking and its benefits in COPD. Walking on a level, uphill, and downhill slope may have the potential to result in different gains by using different muscle groups more. Therefore, this study aimed to compare the effects of walking training on exercise capacity, respiratory functions, muscle strength, and functional status in COPD patients with three different slope types: level, uphill, and downhill., conditionsModule conditions: Pulmonary Disease, Chronic Obstructive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 51, type: ESTIMATED, armsInterventionsModule interventions name: Downhill walking training, interventions name: Level walking training, interventions name: Uphill walking training, outcomesModule primaryOutcomes measure: 6 Minutes Walking Distance (6MWD), primaryOutcomes measure: Spirometric measurements (Forced vital capacity), primaryOutcomes measure: Spirometric measurements (First second forced expiratory volume), primaryOutcomes measure: Spirometric measurements (FEV1/FVC ratio), primaryOutcomes measure: Spirometric measurements (Peak Expiratory Flow), primaryOutcomes measure: Spirometric measurements (Maximum Intermediate Expiratory Flow), primaryOutcomes measure: Muscle strength measurements (skeletal muscles), primaryOutcomes measure: Muscle strength measurements (respiratory muscles), primaryOutcomes measure: 30-second sit and stand test, primaryOutcomes measure: Functional performance inventory, secondaryOutcomes measure: Dyspnea, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Level of exertion, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282991, orgStudyIdInfo id: B7461028, briefTitle: A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-07-22, primaryCompletionDateStruct date: 2021-01-18, completionDateStruct date: 2021-01-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.This study is seeking participants who:* have lung cancer that could not be controlled.* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.* have received at least 1 treatment before.All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective., conditionsModule conditions: Non-Small Cell Lung Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 73, type: ACTUAL, armsInterventionsModule interventions name: Lorlatinib, outcomesModule primaryOutcomes measure: The treatment pattern from initial diagnosis to current lorlatinib treatment., secondaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: overall survival, secondaryOutcomes measure: progression-free survival, secondaryOutcomes measure: 1-year OS rate, secondaryOutcomes measure: time-to-treatment failure for all NSCLC, secondaryOutcomes measure: time-to-treatment failure of lorlatinib, secondaryOutcomes measure: The clinical nature, incidence, duration, and severity of lorlatinib-related safety profile, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch, city: Kaohsiung City, zip: 83301, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Chung Shan Medical University Hospital, city: Taichung, zip: 402, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: Taichung Veterans General Hospital, city: Taichung, zip: 407219, country: Taiwan, geoPoint lat: 24.1469, lon: 120.6839, locations facility: National Taiwan University Hospital, city: Taipei, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Taipei Veterans General Hospital, city: Taipei, zip: 11217, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Chang Gung Memorial Hospital - Linkou Branch, city: Taoyuan City, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False |
protocolSection identificationModule nctId: NCT06282978, orgStudyIdInfo id: GEM-RANTAB, secondaryIdInfos id: 2023-504273-21, type: EUDRACT_NUMBER, briefTitle: Study of Elranatamab for Relapsed or Refractory Myeloma in Patients Previously Exposed to Three-drug Classes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: PETHEMA Foundation, class: OTHER, descriptionModule briefSummary: The goal of this phase II, open-label, single-arm, multicenter study is to evaluate i) the efficacy and ii) safety of elranatamab monotherapy at the dose of 76 mg subcutaneously in participants with RRMM after at least one or two prior lines of therapy who have received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy, defined as progression while receiving treatment or in the first 60 days after the last dose of treatment.Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators.Safety refers to the measurement of:i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests).ii) Incidence and severity of Cytokine Release Syndrome (CRS) and Immune effector cell associated neurotoxicity syndrome (ICANS) according to the American Society for Transplantation and Cellular Therapy (ASTCT) criteria.iii) Incidence and severity of other neurotoxicities. iv) Incidence of cytopenias and infectionsThe study consists of a screening/baseline period, a treatment period, and a posttreatment follow-up period. The study includes a periodic review of safety data, that will be independently analyzed by the Data Safety Independent Committee (DSMC) and will recommend how to proceed with the study., conditionsModule conditions: Multiple Myeloma in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is an open label, multicenter, phase II study of Elranatamab as single agent. The primary aiming is to evaluate the efficacy of elranatamab monotherapy in participants with relapsed refractory multiple myeloma (RRMM) who had received prior treatment with immunomodulatory drugs, protease inhibitors, and anti-CD38 therapy and were refractory to the last line of therapy as evaluated with the rate of complete Response and Undetectable Measurable Residual Disease. Efficacy refers to the rate of Undetectable Measurable Residual Disease at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: None (Open Label), enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Elranatamab (PF-06863135), outcomesModule primaryOutcomes measure: To evaluate the rate of Undetectable Measurable Residual Disease (uMRD) at 6 and 12 months as per International Myeloma Working Group (IMWG) criteria evaluated by the investigators of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate annually by NGF until loss of response, the rate of Undetectable Measurable Residual Disease (% of patients with MRD negative by NGF method and with a sensitivity level of 10-5) of elranatamab in patients with R/R multiple myeloma., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in laboratory values in blood and biochemistry tests., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in physical examination and ECOG performance status scale (0-5)., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in vital sign measurements., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by pregnancy test., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in 12-lead ECG., secondaryOutcomes measure: Incidence and severity Adverse Events (AEs) and Serious Adverse Event (SAEs) as assessed by changes in Echocardiogram / MUGA., secondaryOutcomes measure: To determine Circulating Tumor Cells (CTC) at baseline to evaluate its prognostic value., secondaryOutcomes measure: To determine serum BCMA levels and its correlation with response., secondaryOutcomes measure: To do gene expression techniques (RNA sequencing and single cell sequencing studies) coupled with intelligent clinical and molecular data analysis (i.e. machine learning) to identify factors that could predict response to elranatamab., secondaryOutcomes measure: To determine MRD value with alternative methods, secondaryOutcomes measure: To characterize patients' immune system, secondaryOutcomes measure: To define genomic determinants of response/resistance, secondaryOutcomes measure: To evaluate Overall Response Rate of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Duration of Response of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Time to first and best response of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Progression-free survival (PFS) of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate Overall survival (OS) of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate PFS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate OS in those patients who stop treatment because of sustained MRD-positive for 12 months of elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate the Incidence of neurologic effects related to elranatamab in patients with relapsed/refractory multiple myeloma., secondaryOutcomes measure: To evaluate the Incidence of cytopenias and infections related to elranatamab in patients with relapsed/refractory multiple myeloma., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínico Universitario de Santiago ~ CHUS, status: NOT_YET_RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: Marta Sonia Gonzalez Perez, MD, role: CONTACT, contacts name: Marta Sonia Gonzalez Perez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Institut Catala d'Oncologia (ICO) Badalona - Hospital Universitari Germans Trias i Pujol, status: NOT_YET_RECRUITING, city: Badalona, state: Barcelona, zip: 08916, country: Spain, contacts name: Albert Oriol Rocafiguera, MD, role: CONTACT, contacts name: Albert Oriol Rocafiguera, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.45004, lon: 2.24741, locations facility: Institut Catala d'Oncologia (ICO) Hospital Duran i Reynals, status: NOT_YET_RECRUITING, city: L'Hospitalet De Llobregat, state: Barcelona, zip: 08908, country: Spain, contacts name: Ana Sureda, MD, role: CONTACT, contacts name: Ana Sureda, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, locations facility: Hospital Universitario Marqués de Valdecilla, status: NOT_YET_RECRUITING, city: Santander, state: Cantabria, zip: 39008, country: Spain, contacts name: Enrique M Ocio San Miguel, MD, role: CONTACT, contacts name: Enrique M Ocio San Miguel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Hospital Universitario de Jerez de la Frontera, status: NOT_YET_RECRUITING, city: Jerez De La Frontera, state: Cádiz, zip: 11407, country: Spain, contacts name: Sebastian Garzon Lopez, MD, role: CONTACT, contacts name: Sebastian Garzon Lopez, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.68645, lon: -6.13606, locations facility: Hospital Son Llàtzer, status: NOT_YET_RECRUITING, city: Palma De Mallorca, state: Illes Balears, zip: 07198, country: Spain, contacts name: Joan LL Bargay, MD, role: CONTACT, contacts name: Joan LL Bargay, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.56939, lon: 2.65024, locations facility: CHU de Gran Canaria Doctor Negrín, status: NOT_YET_RECRUITING, city: Las Palmas De Gran Canaria, state: Las Palmas, zip: 35010, country: Spain, contacts name: Alexia T Suarez Cabrera, MD, role: CONTACT, contacts name: Alexia T Suarez Cabrera, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.09973, lon: -15.41343, locations facility: Hospital HM Sanchinarro, status: NOT_YET_RECRUITING, city: Sanchinarro, state: Madrid, zip: 28050, country: Spain, contacts name: Jaime Perez de Oteysa, MD, role: CONTACT, contacts name: Jaime Perez de Oteysa, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clínico Universitario Virgen de la Arrixaca, status: NOT_YET_RECRUITING, city: El Palmar, state: Murcia, zip: 30120, country: Spain, contacts name: Begoña Navarro de Almenzar, MD, role: CONTACT, contacts name: Begoña Navarro de Almenzar, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.93939, lon: -1.16095, locations facility: Clinica Universidad Navarra (CUN), status: NOT_YET_RECRUITING, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Jesus San Miguel Izquierdo, MD, role: CONTACT, phone: +34 948 296 296, email: [email protected], contacts name: Paula Rodriguez Otero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.81687, lon: -1.64323, locations facility: H. Clínic i Provincial de Barcelona, status: NOT_YET_RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Joan Bladé, MD, role: CONTACT, phone: +34 932275428, email: [email protected], contacts name: Laura Rossiñol, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital de Cabueñes, status: RECRUITING, city: Gijón, zip: 33394, country: Spain, contacts name: María Esther González García, MD, role: CONTACT, phone: + 34 985 18 50 00, contacts name: María Esther González García, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.53573, lon: -5.66152, locations facility: Instituto de Investigación Sanitaria Hospital 12 de Octubre, status: NOT_YET_RECRUITING, city: Madrid, zip: 28041, country: Spain, contacts name: Juan Jose Lahuerta, MD, role: CONTACT, phone: +34 91 779 28 39, email: [email protected], geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Clínico Universitario Salamanca, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: Mª Victoria Mateos, MD, role: CONTACT, phone: +34 923 291 100, phoneExt: 55384, email: [email protected], contacts name: Verónica González de la Calle, MD, role: CONTACT, phone: +34 923 291 100, phoneExt: 55629, email: [email protected], contacts name: Mª Victoria Mateos, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.96882, lon: -5.66388, locations facility: C.H. de Toledo (Virgen de la Salud), status: NOT_YET_RECRUITING, city: Toledo, zip: 45005, country: Spain, contacts name: Luis Felipe Casado Montero, MD, role: CONTACT, contacts name: Luis Felipe Casado Montero, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.8581, lon: -4.02263, hasResults: False |
protocolSection identificationModule nctId: NCT06282965, orgStudyIdInfo id: AngT-001, briefTitle: Safety and Efficacy of Angiotensin (1-7) in Persons With Moderate to Severe Traumatic Brain Injury, acronym: ANGel T, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Arizona, class: OTHER, collaborators name: United States Department of Defense, descriptionModule briefSummary: The goal of this clinical trial is to test the safety of the drug Angiotensin (1-7) and learn whether it works well as a treatment in people who have suffered a moderate to severe traumatic brain injury (TBI).The main questions this trial aims to answer are:* Is Angiotensin (1-7) safe?* Does Angiotensin (1-7) improve mental functioning and reduce physical signs of brain damage in people who have suffered a moderate to severe TBI?Participants will:* Complete 21 days of study treatment consisting of a once-daily injection.* Provide blood samples.* Undergo two magnetic resonance imaging (MRI) scans of the brain.* Complete specific tasks and questionnaires that allow researchers to evaluate the participant's brain and psychological functioning.Researchers will compare three groups: two groups that receive different doses of Angiotensin (1-7) and one group that receives a look-alike treatment with no active drug. This will allow researchers to see if the drug has any negative effects and whether it improves mental functioning and physical signs of brain damage after a TBI., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Investigators, study site staff, participants, and caregivers will be unaware of the participant treatment assignments for the duration of the study. The pharmacist will prepare the study treatment and will be unmasked., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Angiotensin (1-7), interventions name: Sterile saline, outcomesModule primaryOutcomes measure: Number of participants with adverse events, primaryOutcomes measure: Performance on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog), secondaryOutcomes measure: Cognitive functions after Angiotensin (1-7) treatment as measured by the Montreal Cognitive Assessment (MoCA), secondaryOutcomes measure: Function after Angiotensin (1-7) treatment, as measured by the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL), secondaryOutcomes measure: Effects of Angiotensin (1-7) on acute CNS damage biomarker phosphorylated tau (p-tau), secondaryOutcomes measure: Effects of Angiotensin (1-7) on CNS damage biomarker phosphorylated tau (p-tau) after 90 days, secondaryOutcomes measure: Effects of Angiotensin (1-7) on brain white matter integrity, secondaryOutcomes measure: Effects of Angiotensin (1-7) on length of hospital stay, secondaryOutcomes measure: Incidence and duration of delirium as assessed by the Confusion Assessment Method (CAM), secondaryOutcomes measure: Change in suicidal ideation and behavior as assessed by the Patient Health Questionnaire (PHQ-9), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282952, orgStudyIdInfo id: 198/2023, briefTitle: NEwborn Infant of a Mother With Obesity - Fecal Microbiome Transplantation, RCT, acronym: NEMO-FMT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Oulu University Hospital, class: OTHER, collaborators name: University of Oulu, collaborators name: University of Turku, collaborators name: Turku University Hospital, collaborators name: University of Helsinki, collaborators name: Academy of Finland, collaborators name: Biocenter Oulu, descriptionModule briefSummary: The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section to obese mothers and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:* Could fecal transplant be used improve gut microbiota and prevent overweight or obesity.* Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant., conditionsModule conditions: Fecal Microbiota Transplantation, conditions: Cesarean Section, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The eligible women are randomized into two groups in which their newborns receive either fecal microbiota transplant from 1) their own mother (50 newborns) or 2) the Microbiome Biobank (50 newborns). The randomization 1:1 is done in blocks of 4 mothers. The study is double blinded. If mother has Group B streptococcus colonization or other infectious disease described in table 1, and microbiota transplant cannot be given or if mother will have non-elective-CS and the microbiome transplant is not available, the mother is included in 3) the observational cohort, which is "open" (not blinded)., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: The research statistician performs the computer-generated randomization. The study nurse prepares the fecal transplant according to the randomization. Study participants or investigators are not aware of study group., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Fecal transplant, outcomesModule primaryOutcomes measure: Microbial composition profiles in fecal sample, primaryOutcomes measure: Height in centimeters, primaryOutcomes measure: Height z-score, primaryOutcomes measure: Weight in kilograms, primaryOutcomes measure: Weight-for-length (%), secondaryOutcomes measure: The source of colonization by exclusively shared genes (ESGs), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282939, orgStudyIdInfo id: 20234314, briefTitle: Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry, acronym: OPTIMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: HCA Healthcare Research Institute, class: OTHER, collaborators name: Balt USA, descriptionModule briefSummary: This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System.The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures., conditionsModule conditions: Intracranial Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: OPTIMA and OPTIMAX Coils manufactured by Balt USA, outcomesModule primaryOutcomes measure: Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score, primaryOutcomes measure: Assess coiling alone or in combination with adjunctive devices for approximately 400 patients, primaryOutcomes measure: Evaluate Coiling with flow diversion for approximately 200 subjects, primaryOutcomes measure: Subgroup analyses will be performed examining:, primaryOutcomes measure: Analyze outcomes of small aneurysms defined as smaller than 5mm, secondaryOutcomes measure: Adequate occlusion, secondaryOutcomes measure: Packing density, secondaryOutcomes measure: Complete occlusion, secondaryOutcomes measure: Complete occlusion, secondaryOutcomes measure: Recanalization rate, secondaryOutcomes measure: Retreatment rate, secondaryOutcomes measure: Change in degree of disability, secondaryOutcomes measure: The number of coils used in an aneurysm, secondaryOutcomes measure: Procedural fluoroscopic time, otherOutcomes measure: Primary Safety Endpoint, otherOutcomes measure: Secondary Safety Endpoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Med City Plano, status: RECRUITING, city: Plano, state: Texas, zip: 75075, country: United States, contacts name: Albert Yoo, role: CONTACT, phone: 972-566-5411, email: [email protected], contacts name: Pauline Matheri, role: CONTACT, phone: 615-329-7274, email: [email protected], geoPoint lat: 33.01984, lon: -96.69889, hasResults: False |
protocolSection identificationModule nctId: NCT06282926, orgStudyIdInfo id: 324811, briefTitle: Role of 3D Echocardiography Knowledge-based Reconstruction in ACHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Guy's and St Thomas' NHS Foundation Trust, class: OTHER, collaborators name: Manchester Metropolitan University, descriptionModule briefSummary: The main objective of this study is to evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair.As part of the validation study, the reproducibility of the TTE-3DKBR in assessing RV volume and EF will also be tested in a group of healthy adult volunteers. Additionally, TTE-3DKBR evaluation will be compared in both groups to the conventional 2D echocardiography measurements used in routine clinical practice, such as tricuspid annular plane systolic excursion (TAPSE), tissue Doppler imaging (TDI), fractional area change (FAC), and global longitudinal strain (GLS).Another objective of the study is also to evaluate the effects of chronic RV volume overload with an interval of one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurements, particularly with GLS.The study will end when the required number of patients have been enrolled and when the last subject undergoes the research dataset acquisition. The study may be terminated prematurely if it becomes apparent that the recruitment target cannot be met within the projected recruitment phase., conditionsModule conditions: Tetralogy of Fallot, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography assessment, outcomesModule primaryOutcomes measure: Evaluate the reproducibility and accuracy of TTE-3DKBR in assessing RV volume and EF compared to the reference method of CMR in a group of ACHD patients with known moderate or severe PR after ToF repair., primaryOutcomes measure: Evaluate the effects of chronic RV volume overload in this population within one-year follow-up using TTE-3DKBR and compare it with the conventional non-geometric echocardiography measurement of GLS., secondaryOutcomes measure: Compare TTE-3DKBR evaluation to the conventional 2D echocardiography measurements used in routine clinical practice (TAPSE, TDI, FAC, and GLS)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282913, orgStudyIdInfo id: ---Oncology-Nursing-2024---, briefTitle: The Effect of Mindfulness Meditation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Gulhane Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: Cancer is a disease that causes the most deaths worldwide and is challenging for patients and caregivers both physically and psychosocially. Physicians and nurses working in oncology clinics perform a demanding profession providing compassionate care and treatment to patients struggling with life-threatening diseases. The emotional cost of caring for patients diagnosed with cancer can lead to compassion fatigue, burnout, and decreased psychological well-being among healthcare professionals. For this reason, this research is planned as a randomized controlled study to examine the effect of Mindfulness meditation practice on compassion fatigue, burnout, and psychological well-being in physicians and nurses working in oncology units., conditionsModule conditions: Burnout, conditions: Compassion Fatigue, conditions: Psychological Well-Being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness Meditation, outcomesModule primaryOutcomes measure: compassion fatigue, primaryOutcomes measure: burnout, primaryOutcomes measure: psychological well-being, secondaryOutcomes measure: compassion fatigue, secondaryOutcomes measure: burnout, secondaryOutcomes measure: psychological well-being, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06282900, orgStudyIdInfo id: 2024-1/15, briefTitle: Pain and Screen Addiction in University Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: One of the most important factors why young people spend inactive time is the time they spend in front of the screen. Sedentary screen time refers to time spent using a screen-based device, such as a computer, television, smartphone, or tablet while being sedentary in any environment. The last decade has seen a disturbing increase in the amount of time young people spend in front of screens. Research shows that musculoskeletal disorders in the hand, wrist, arm, and neck occur at a high rate due to long-term and repetitive use of the smartphone, one of the electronic devices. People with musculoskeletal pain often complain of more than one area of pain.The primary purpose of this study is to investigate the relationship between university students' use of various screen-based devices, the time they spend in front of the screen, and the number of painful areas they report on the body. Our secondary aim is to evaluate the relationship between pain, and screen time, and physical activity level., conditionsModule conditions: Student, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: University students, outcomesModule primaryOutcomes measure: Investigating the use of screen-based devices, primaryOutcomes measure: Musculoskeletal system evaluation, secondaryOutcomes measure: Physical activity assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Acibadem University, status: RECRUITING, city: Istanbul, state: None Selected, zip: 34752, country: Turkey, contacts name: Elif E Safran, asst. prof., role: CONTACT, phone: 500 4047, phoneExt: 216, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06282887, orgStudyIdInfo id: 2021-IIT-002, briefTitle: Effects of Music Therapy on Psychological States Among Cancer Patients Undergoing MRI Scans and A Relevant Mediator, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-09, primaryCompletionDateStruct date: 2024-11-10, completionDateStruct date: 2024-11-10, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Guangzhou Concord Cancer Center, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to examine the effects of a music therapy protocol on improving anxiety, symptom distress, and relaxation among cancer patients who are going through MRI scanning. Physiological data, such as pulse rates and respiration rates will be collected. Furthermore, data about scanning efficiency will be collected to assess if scanning efficiency is affected by the protocol implementation. The secondary study objective is to assess whether or not there is a relationship between patient attention to music during the intervention process and the changes in anxiety, symptom distress, and relaxation., conditionsModule conditions: Psycho-Oncology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: All participants will be wearing a headphone, and they will not know if there will be music until they experience and finish the scan process.Radiographers are blinding to avoid biases., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Music therapy, outcomesModule primaryOutcomes measure: Anxiety, primaryOutcomes measure: Symptom distress, primaryOutcomes measure: Relaxation, secondaryOutcomes measure: Pulse rates, secondaryOutcomes measure: Respiration rate, secondaryOutcomes measure: Scanning efficiency, secondaryOutcomes measure: Patient satisfaction level, secondaryOutcomes measure: Patient attention to music (only for the music therapy group), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: GuangZhou Concord Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510700, country: China, contacts name: Juan Nie, Masters, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06282874, orgStudyIdInfo id: CTONG2303, briefTitle: Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Guangdong Association of Clinical Trials, class: OTHER, descriptionModule briefSummary: This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases., conditionsModule conditions: Carcinoma, Non-Small-Cell Lung, conditions: Brain Metastases, conditions: Leptomeningeal Metastasis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Lorlatinib, outcomesModule primaryOutcomes measure: intracranial objective response rate（iORR）, secondaryOutcomes measure: Progression-free survival (PFS) and intracranial PFS（iPFS）, secondaryOutcomes measure: Obiective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR) and intracranial disease control rate (iDCR), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Number of participants with adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Provincial Perople's Hospital, city: Guangzhou, state: Other (Non U.s.), zip: 510080, country: China, contacts name: Chang Lu, role: CONTACT, phone: 02083827812, email: [email protected], contacts name: Jin-Ji Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06282861, orgStudyIdInfo id: ANTES B+, secondaryIdInfos id: 2023-507304-32, type: EUDRACT_NUMBER, briefTitle: ANTES B+ Clinical Trial, acronym: ANTES B+, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Fundacio Privada Mon Clinic Barcelona, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: Current guidelines recommend initial treatment with dual long-acting bronchodilator therapy (LABA-LAMA) in patients with Chronic Obstructive Pulmonary Disease (COPD) of group B (defined by CAT≥10 and none or 1 moderate exacerbation). However, the investigators hypothesize that there is a subgroup of B patients (B+) at a particularly high risk for poor clinical control, characterized by the following:* 1 moderate exacerbation in the previous year* CAT≥10 despite current treatment with LABA -LAMA* Blood eosinophil levels of ≥150 cells/mlthe investigators further hypothesize that B+ patients could benefit from triple therapy treatment (LABA-LAMA + Inhaled Corticosteroids). Therefore, the main goal of this clinical trial is to compare the efficacy of Trelegy (triple therapy) in improving clinical control in GOLD B+ patients with chronic obstructive disease when compared to standard double therapy (LABA -LAMA).The clinical control is a validated composite endpoint that includes two domains, the patient's stability, and the impact of the disease.1028 patients will be randomly allocated to receive either the standard therapy or Trelegy and will be monitored by the investigators for 1 year in 2 on-site visits + 2 remote visits., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month follow-up trial., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1028, type: ESTIMATED, armsInterventionsModule interventions name: Trelegy Ellipta 100/62.5/25Mcg Inh 30D, interventions name: Brimica, interventions name: Duaklir, interventions name: Ultibro, interventions name: Ulunar, interventions name: Xoterna, interventions name: Anoro, interventions name: Laventair, interventions name: Spiolto Respimat, interventions name: Yanimo, interventions name: Foradil, interventions name: Broncoral, interventions name: Formoterol stada, interventions name: Oxis, interventions name: Formatris, interventions name: Formoterol Aldo, interventions name: Onbrez, interventions name: Oslif, interventions name: Hirobriz, interventions name: Striverdi, interventions name: Beglan, interventions name: Betamican, interventions name: Inaspir, interventions name: Serevent, interventions name: Soltel, interventions name: Eklira, interventions name: Bretaris, interventions name: Seebri, interventions name: Tovanor, interventions name: Enurev, interventions name: Spiriva, interventions name: Tavulus, interventions name: Sirkava, interventions name: Braltus, interventions name: Gregal, interventions name: Incruse, interventions name: Rolufta, outcomesModule primaryOutcomes measure: Clinical Control (CC), secondaryOutcomes measure: Clinical Important Deterioration (CID), secondaryOutcomes measure: Patients persistently controlled, secondaryOutcomes measure: Time to deterioration, secondaryOutcomes measure: Time to no control event of CC - Stability Domain, secondaryOutcomes measure: Time to no control event of CC - Impact Domain, secondaryOutcomes measure: Time to deterioration event of CID-CAT Exacerbations, secondaryOutcomes measure: Time to deterioration event of CID-CAT Spirometry, secondaryOutcomes measure: Exacerbation rate, secondaryOutcomes measure: Time to first Exacerbation, secondaryOutcomes measure: Spirometry changes, secondaryOutcomes measure: Independent predictors, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic Barcelona, status: RECRUITING, city: Barcelona, state: Catalunya, zip: 08036, country: Spain, contacts name: Àlvar Agustí, role: CONTACT, phone: 93 227 57 79, email: [email protected], contacts name: Nestor Soler, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06282848, orgStudyIdInfo id: HongKongPU_Optometry4, briefTitle: Pharmacological and Non-pharmacological Treatment Effects on Children With Different Predicted Myopia Progression Rate, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: The University of Hong Kong, descriptionModule briefSummary: The goal of this clinical trial is to compare pharmacological and non-pharmacological treatment effects on the children with different predicted myopia progression rate measured by modified multifocal electroretinogram. The main questions it aims to answer are:* the effectiveness of using 0.05% atropine and prescribing DIMS lens for myopia control in children with different myopia progression rates* the contribution of L/M cones in juvenile myopia progression and changes of retinal activities under atropine and DIMS treatment.Participants will have baseline and follow-up eye examinations and given either pharmacological treatment with 0.05% atropine or non-pharmacological treatment with DIMS lens for myopia control.Researchers will compare the changes of refractive errors and axial length after different types of interventions and investigate the relations between the parameters of mfERG responses and the thicknesses of retinal layers and choroid., conditionsModule conditions: Myopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Double-blinded, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Atropine 0.05%, interventions name: DIMS lens, outcomesModule primaryOutcomes measure: Subjective refraction, primaryOutcomes measure: Axial length, secondaryOutcomes measure: mfERG responses, secondaryOutcomes measure: Retinal and choroidal thickness, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: School of Optometry, Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, zip: 00000, country: Hong Kong, contacts name: Henry HL Chan, PhD, role: CONTACT, phone: 85227667937, email: [email protected], contacts name: Kaiyip Choi, PhD, role: CONTACT, phone: 85234002934, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-03-02, uploadDate: 2024-02-21T22:59, filename: ICF_000.pdf, size: 234773, hasResults: False |
protocolSection identificationModule nctId: NCT06282835, orgStudyIdInfo id: 2023KY242, briefTitle: Eravacycline Combination Therapy for MRAB, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-26, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University Union Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the eravacycline combination therapy in multidrug-resistant acinetobacter gaumannii pneumonia. The main question is to evaluate the the effectiveness and safety.Participants will be given Eravacycline and Polymyxin，or other antibiotcs that the Investigator considered suitable. During the clinical trial, participants will be monitored for blood drug concentrations and drug concentrations in the ELF (Epithelial Lining Fluid。Clinical efficacy rate and microbiological clearance rate will be assessed at the same time, conditionsModule conditions: Pulmonary Infection, conditions: Pneumonia, Bacterial, conditions: Acinetobacter Baumannii, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Eravacycline Injection, outcomesModule primaryOutcomes measure: Clinical Responded Rate, secondaryOutcomes measure: The microbiological clearance rate, secondaryOutcomes measure: The all-cause mortality rate within 28 days, secondaryOutcomes measure: "Incidence Rate of Adverse Event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Medical University Union hospital, status: RECRUITING, city: Fuzhou, state: Fujian, zip: 350000, country: China, contacts name: Hui Zhang, Phd, role: CONTACT, phone: 13015723860, email: [email protected], geoPoint lat: 26.06139, lon: 119.30611, hasResults: False |
protocolSection identificationModule nctId: NCT06282822, orgStudyIdInfo id: HFpEF-SWE, briefTitle: Shear Wave Elastography for Diagnosis of Heart Failure With Preserved Ejection Fraction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: First Hospital of China Medical University, class: OTHER, descriptionModule briefSummary: The diagnosis of heart failure with preserved ejection fraction (HFpEF) is often complex. Echocardiography has the advantages of being a non-invasive, simple operation, low price, and high repeatability, and is of great value in the diagnosis of HFpEF. However, the current echocardiographic assessment of left ventricular diastolic dysfunction and elevated filling pressure is based on multi-parameter indirect judgment, and new parameters are urgently needed to achieve accurate judgment of left ventricular diastolic function and an accurate diagnosis of HFpEF. Myocardial stiffness refers to the ability of the myocardium to undergo stress and strain. It is an important part of the pathophysiology of cardiac diastolic dysfunction and an important parameter for clinical evaluation of the diastolic function of HFpEF. Shear-wave elastography is a novel ultrasound-based elastography technology. Based on the shear wave generated by the remote induction of the radiation force of the focused ultrasound beam, the hardness of myocardial tissue can be measured quantitatively, locally, and noninvasively, and the change in myocardial stiffness in patients with HFpEF can be directly reflected. Currently, no relevant studies have applied shear-wave elastography to the diagnosis of HFpEF. This study aims to identify changes in myocardial stiffness measured by shear-wave elastography in patients with HFpEF based on a multicenter study and apply myocardial stiffness parameters to the diagnosis of HFpEF., conditionsModule conditions: Shear Wave Elastography, conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Transthoracic echocardiography, outcomesModule primaryOutcomes measure: Shear wave velocity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06282809, orgStudyIdInfo id: CSP3325, briefTitle: The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using Histotripsy, acronym: GANNON, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: HistoSonics, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this trial is to evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy., conditionsModule conditions: Pancreas Cancer, conditions: Adenocarcinoma of the Pancreas, conditions: Pancreatic Cancer, conditions: Tumor of Pancreas, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective multi-center, single-arm, feasibility trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: HistoSonics Edison™ System for the treatment of pancreatic adenocarcinoma using histotripsy, outcomesModule primaryOutcomes measure: Evaluate the safety of the HistoSonics Edison System for the destruction of pancreatic adenocarcinomas using histotripsy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital de la Santa Creu i Sant Pau, city: Barcelona, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False |
protocolSection identificationModule nctId: NCT06282796, orgStudyIdInfo id: EPW-CABC-01, briefTitle: Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: First Hospital of China Medical University, class: OTHER, descriptionModule briefSummary: This multicenter clinical study aims to build an intelligent and accurate diagnosis and dynamic prediction and early warning model of cardiotoxicity due to anthracycline-based breast cancer chemotherapy, clarify the value of the early warning model in guiding the targeted prevention of myocardial protection, providing an important theoretical basis for reducing the mortality rate of breast cancer and improving the prognosis., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography, outcomesModule primaryOutcomes measure: Left ventricular ejection fraction(unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy., secondaryOutcomes measure: Left ventricular global longitudinal strain (unit: %) in all breast cancer patients treated with anthracycline-based chemotherapy., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Cancer Hospital, status: RECRUITING, city: Fuzhou, state: Fujian, country: China, contacts name: Weiqin Huang, role: CONTACT, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Dalian Friendship Hospital, status: RECRUITING, city: Dalian, state: Liaoning, country: China, contacts name: Bo Zhang, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Dalian Municipal Central Hospital, status: RECRUITING, city: Dalian, state: Liaoning, country: China, contacts name: Qingxiong Yue, role: CONTACT, geoPoint lat: 38.91222, lon: 121.60222, locations facility: Liaoning Cancer Hospital & Institute, status: RECRUITING, city: Shenyang, state: Liaoning, country: China, contacts name: Xiaoxue Zhang, role: CONTACT, geoPoint lat: 41.79222, lon: 123.43278, locations facility: The Third People's Hospital Of Chengdu, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Min Xu, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False |
protocolSection identificationModule nctId: NCT06282783, orgStudyIdInfo id: 2024-511532-27-00, briefTitle: Studying Topiramate for Re-Activating the HIV-1 Reservoir, acronym: STAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: Even with current HIV treatments, HIV is still a lifelong disease because it hides in some long-lasting cells in the body. One of the strategies to find a cure for HIV works by finding the virus in these cells, making it visible, and then getting rid of it. This is called the 'shock and kill' approach.So far, the drugs tested can find the virus, but they don't get rid of it completely. That's why there need to be new drugs that can do this more effectively. The Erasmus MC HIV Eradication Group (EHEG) has been testing new drugs in the lab and found a drug called topiramate can wake up the virus without harming the cells. The aim of this study is to test topiramate in people living with HIV.Most of the people that participate in HIV cure studies are men, even though most people living with HIV around the world are women. Previous research has shown that men and women might respond differently to these treatments. So, in this study, topiramate will be investigated in both men and women. This could help us find a cure that works for everyone., conditionsModule conditions: HIV-1-infection, conditions: Hiv, conditions: HIV Infections, conditions: HIV I Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Topiramate, outcomesModule primaryOutcomes measure: Effect of topiramate as measured by cell-associated HIV RNA, primaryOutcomes measure: Number of treatment-related adverse events as assessed by CTCAE v4.0, secondaryOutcomes measure: Influence of sex on the primary outcome measures, secondaryOutcomes measure: The effect of topiramate on the size of the HIV reservoir measured by relevant assays, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Centre, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False |
protocolSection identificationModule nctId: NCT06282770, orgStudyIdInfo id: IRB#23-000444, briefTitle: Photobiomodulation for Lower Back Pain Post Spinal Fusion and Decompression Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: After spinal fusion and decompression surgery there is a possible risk of developing chronic back pain. After surgery there is typically inflammation around the operation site and this inflammation can be painful and debilitating to patients.Many possible treatment plans have been incorporated to assist the patient with recovery - notably medications, physical therapy, and braces. However, few studies have looked at laser diodes that utilize high-power laser lights that are aimed at decreasing pain and inflammation. Investigators aim to look compare patients using a back brace with laser diodes within versus those who wear a normal brace used as a placebo. Investigators will also assess the patient's surgical wound to monitor the progression of wound healing while using the brace., conditionsModule conditions: Spinal Fusion, conditions: Chronic Lower Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients will come into clinic for consultation and enrollment in the study. They will have their first study visit where they will be given either and laser diode brace or a placebo brace. They will follow up with the physician after 2 weeks and then at 3, 6, 9 months and at 1 year to evaluate function and symptoms ., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants in this study will not be told which belt is the sham diode brace or which is the functional diode brace. The assessor of the study will also be blinded to which belt each subject has, and data will be analyzed blindly based on patient ID alone., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Laser Diode Brace, interventions name: Sham Laser Diode Brace, outcomesModule primaryOutcomes measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - VAS, primaryOutcomes measure: Self-reported patient outcome questionnaires after photobiomodulation therapy - ODI, secondaryOutcomes measure: Stony Brook Scar Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Semel Institute of Neuroscience at UCLA, status: RECRUITING, city: Los Angeles, state: California, zip: 90024, country: United States, contacts name: Daniel Lu, MD, PhD, role: CONTACT, phone: 310-267-2975, email: [email protected], contacts name: Mark Yamamoto, BS, role: CONTACT, phone: 424-535-9634, email: [email protected], geoPoint lat: 34.05223, lon: -118.24368, locations facility: UCLA Clinical and Translational Research Center, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Daniel Lu, MD, PhD, role: CONTACT, phone: 310-267-2975, email: [email protected], contacts name: Adreanne Rivera, BS, role: CONTACT, phone: 424-946-5712, email: [email protected], geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06282757, orgStudyIdInfo id: 202302, briefTitle: Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: HAN University of Applied Sciences, class: OTHER, descriptionModule briefSummary: Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMPStudy design: Web-based randomized controlled trial.Study population: 100 participantsIntervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ)., conditionsModule conditions: Communication, conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Video placebo communication, interventions name: Video nocebo communication, outcomesModule primaryOutcomes measure: Change in treatment expectancy measured using the Credibility and Expectancy Questionnaire (CEQ), primaryOutcomes measure: Change in treatment credibility measured using the Credibility and Expectancy Questionnaire (CEQ), secondaryOutcomes measure: Change in openness to VR measured using a single question, secondaryOutcomes measure: Change in pain intensity measured using the Numeric Pain Rating Scale (NPRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HAN University of Applied Sciences, city: Nijmegen, state: Overijssel, zip: 6525EN, country: Netherlands, contacts name: Syl Slatman, MSc, role: CONTACT, phone: +31629684200, email: [email protected], geoPoint lat: 51.8425, lon: 5.85278, hasResults: False |
protocolSection identificationModule nctId: NCT06282744, orgStudyIdInfo id: OPTIMAL Arabic version, briefTitle: Cross Cultural Adaptation, Validity and Reliability Test of the Arabic Version of the Outpatient Physical Therapy Improvement in Movement Assessment Log, acronym: OPTIMAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Purpose of the study:To translate, culturally adapt, and to test the validity and reliability of the Outpatient Physical Therapy Improvement in Movement Assessment Log in Arabic speaking language., conditionsModule conditions: Physical Performance, conditions: Outpatients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 880, type: ESTIMATED, armsInterventionsModule interventions name: Outpatient physical therapy improvement in movement assessment log, outcomesModule primaryOutcomes measure: validity and reliability of the Egyptian Arabic language version of Outpatient Physical Therapy Improvement Movement Assessment Log on physical therapy outpatients., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282731, orgStudyIdInfo id: ECKIRB1020407, briefTitle: The Changes of Urine Growth Factors Level, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-05-31, primaryCompletionDateStruct date: 2016-09-01, completionDateStruct date: 2017-04-27, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: En Chu Kong Hospital, class: OTHER, descriptionModule briefSummary: The Changes of Urine Growth Factors Level in Patients With Benigh Prostate Hyperplasia after medical treatment., conditionsModule conditions: Benign Prostatic Hyperplasia, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: Silodosin, outcomesModule primaryOutcomes measure: Urine growth factors level, secondaryOutcomes measure: Urine growth factors level, otherOutcomes measure: Urine growth factors level, eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: En Chu Kong Hospital, city: New Taipei City, zip: 23702, country: Taiwan, geoPoint lat: 25.01111, lon: 121.44583, hasResults: False |
protocolSection identificationModule nctId: NCT06282718, orgStudyIdInfo id: POS-ARI-PC CORE and AUDIT, secondaryIdInfos id: 965313, type: OTHER_GRANT, domain: European Union, secondaryIdInfos id: 10204126, type: REGISTRY, domain: ISRCTN, secondaryIdInfos id: 55487, type: OTHER, domain: NIHR CPMS, secondaryIdInfos id: 324504, type: OTHER, domain: IRAS, briefTitle: A Long-term Observational Study Evaluating the Presentation and Management of Acute Respiratory Tract Infections in Primary Care Across Europe, acronym: POS-ARI-PC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: European Clinical Research Alliance for Infectious Diseases (ECRAID), class: OTHER, collaborators name: UMC Utrecht, collaborators name: University of Oxford, collaborators name: Universiteit Antwerpen, descriptionModule briefSummary: Acute respiratory infection (ARI) is the commonest reason for consulting in community care. Furthermore, new and re-emerging pathogens are often first noticed in primary care (PC). The POS-ARI-PC study is a long-term study, with the aim of describing the nature of ARI in adults and children presenting to PC across Europe. The POS-ARI-PC study will provide critically important data on the presentation and management of ARI, and build a research-ready infrastructure for studies related to the treatment, diagnosis, and prevention of ARI in primary care settings. Additional observational studies will be embedded and use the infrastructure developed in POS-ARI-PC., conditionsModule conditions: Acute Respiratory Tract Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Age Bands, primaryOutcomes measure: The proportion with a preliminary diagnosis of various sub-categories of ARI (e.g. LRTI, URTI), primaryOutcomes measure: Overall illness severity rating, primaryOutcomes measure: Swab samples taken and retrospective viral/microbiological infection analysis performed (multiplex PCR) to identify potential causative pathogens., primaryOutcomes measure: Proportion undergoing POC (with results) and lab-based investigations, primaryOutcomes measure: Details of prescriptions given on presentation of ARI, primaryOutcomes measure: Details of tests ordered on presentation of ARI, primaryOutcomes measure: Return to usual daily activities, primaryOutcomes measure: Feeling recovered from RTI, primaryOutcomes measure: Use of prescription medication, primaryOutcomes measure: Use of over the counter medications, primaryOutcomes measure: Complications reported associated to ARI presentation, primaryOutcomes measure: Variation in practice and advice from national guidelines, to be fed back to national teams, secondaryOutcomes measure: Recommendations on how to improve study processes, recruitment and study communication based on shared understanding and insights from researchers, clinicians, and patients., secondaryOutcomes measure: An understanding of the meaning of study results for European primary care, from the perspectives of clinicians and patients, and recommendations regarding the implementation of findings., secondaryOutcomes measure: An understanding of changing health-seeking behaviour, management and expectations to inform clinical studies and trials, secondaryOutcomes measure: Approval for a study-specific appendix (SSA) or an intervention-specific appendix (ISA) of an embedded (non) randomised study for ARI in primary care associated with this POS, measured using the number of embedded studies to this POS-ARI-PC platform over, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282705, orgStudyIdInfo id: 306347, briefTitle: Dose Response Effect of Drop Jumps on Bone Characteristics, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-06, primaryCompletionDateStruct date: 2023-12-13, completionDateStruct date: 2023-12-13, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Nottingham Trent University, class: OTHER, descriptionModule briefSummary: The study aims to assess if a 16-week drop jump intervention from different heights shows different bone adaptations. Participants will complete four visits over a period of 16 weeks. An initial consultation will be conducted to ensure participants meet the inclusion criteria following participant recruitment. Estimated load being applied to the bone, will be assessed using non-invasive biomechanical procedures (Inertial Measurement Units, motion analysis, force plates) during drop jumps. Participants will be assigned a drop jump height of 0 cm, 30 cm or 60 cm based on a significant difference in external load at these heights or assigned to a control group where no jumps will be performed. Groups will be matched for body mass to ensure that jump height produces the load. The participants will be asked to perform 40 jumps (20 each side), 4 times per week ensuring jumping bouts are separated by 24 hours. Bone characteristics will be assessed via whole body dual-energy X-ray absorptiometry (DXA) scans and bilateral peripheral Quantitative Computed Tomography (pQCT) scans. Lab based jumping will take place on week 0, week 6, week 12, and week 16 to understand the loading applied during the different jump height groups. pQCT scans will take place on week 0, week 12, week 16 and DXA scans will take place week 0 and week 16. The reasoning of week 12 for pQCT being it may show a significant timepoint for bone formation during the remodelling cycle. During visits participants will complete a health screen, the Bone specific Physical Activity Questionnaire (BPAQ), a food frequency questionnaire and Pittsburgh sleep quality questionnaire alongside consent as tools to monitor any changes to participant lifestyle across the study. Differences in bone characteristics, lab measures and jump heights will be analysed between and within participants.The present study aims to use varied drop jump heights to identify an osteogenic dose response effect. Drop jumps have been previously used to expose osteogenic effects in research due to the load produced at impact. Is it possible to identify an optimum height for bone response during impact? If so do we then find anything above this height actually has negative or no effect on a group of individuals?, conditionsModule conditions: Healthy Participants, conditions: Low Activity Level, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Semi-randomised, matched model., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Diagonal Drop Jumps 0cm, interventions name: Diagonal Drop Jumps 40cm, interventions name: Diagonal Drop Jumps 60cm, outcomesModule primaryOutcomes measure: BMD as assessed by whole body dual-energy X-ray absorptiometry (DXA)., primaryOutcomes measure: BMC as assessed by whole body dual-energy X-ray absorptiometry (DXA)., primaryOutcomes measure: Total bone area as assessed by whole body dual-energy X-ray absorptiometry (DXA)., primaryOutcomes measure: Trabecular density as assessed by peripheral quantitative tomography (pQCT) of tibia., primaryOutcomes measure: Cortical thickness as assessed by peripheral quantitative tomography (pQCT) of tibia., primaryOutcomes measure: Periosteal circumference as assessed by peripheral quantitative tomography (pQCT) of tibia., primaryOutcomes measure: Axial bone strength (SSIX) as assessed by peripheral quantitative tomography (pQCT) of tibia., primaryOutcomes measure: Axial bone strength (SSIY) as assessed by peripheral quantitative tomography (pQCT) of tibia., primaryOutcomes measure: Polar bone strength (SSIPOL) as assessed by peripheral quantitative tomography (pQCT) of tibia., primaryOutcomes measure: Cortical density as assessed by peripheral quantitative tomography (pQCT) of tibia., secondaryOutcomes measure: Peak impact load as assessed by force plates., secondaryOutcomes measure: Impulse as assessed by force plates., secondaryOutcomes measure: Load rate as assessed by force plates., secondaryOutcomes measure: Jump height as assessed by force plates., secondaryOutcomes measure: Centre of Mass (CoM) velocity as assessed by force plates., secondaryOutcomes measure: Peak acceleration as assessed by Inertial measurement units (IMU)., secondaryOutcomes measure: Stiffness as assessed by motion capture., secondaryOutcomes measure: Moments as assessed by motion capture., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nottingham Trent University, city: Nottingham, state: Nottinghamshire, zip: Ng11 8NS, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False |
protocolSection identificationModule nctId: NCT06282692, orgStudyIdInfo id: UNAIR-MP-INAKTIF-R-005, briefTitle: INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-19, primaryCompletionDateStruct date: 2024-05-19, completionDateStruct date: 2024-07-19, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dr. Soetomo General Hospital, class: OTHER_GOV, collaborators name: Indonesia-MoH, collaborators name: Universitas Airlangga, collaborators name: PT Biotis Pharmaceuticals, Indonesia, descriptionModule briefSummary: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents., conditionsModule conditions: COVID-19 Pandemic, conditions: COVID-19 Vaccines, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose.The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval., enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg, outcomesModule primaryOutcomes measure: Vaccine Neutralizing Antibody Profile, secondaryOutcomes measure: Incidence of Adverse Events, secondaryOutcomes measure: Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum, secondaryOutcomes measure: Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA, secondaryOutcomes measure: Cellular Immunogenicity Profile, secondaryOutcomes measure: Persistence of Antibody Level, secondaryOutcomes measure: Whole Genome Sequencing (WGS) of SARS-CoV-2, eligibilityModule sex: FEMALE, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Dr. Soetomo General Hospital, status: RECRUITING, city: Surabaya, state: Jawa Timur, zip: 67161, country: Indonesia, contacts name: Dominicus Husada, MD, role: CONTACT, phone: +6281232266377, email: [email protected], contacts name: Damayanti Tinduh, MD, role: CONTACT, phone: +6281703293335, email: [email protected], contacts name: Dominicus Husada, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Damayanti Tinduh, MD, role: SUB_INVESTIGATOR, contacts name: Gatot Soegiarto, MD, role: SUB_INVESTIGATOR, contacts name: Leny Kartina, MD, role: SUB_INVESTIGATOR, contacts name: Laksmi Wulandari, MD, role: SUB_INVESTIGATOR, contacts name: Deasy Fetarayani, MD, role: SUB_INVESTIGATOR, contacts name: Novira Widajanti, MD, role: SUB_INVESTIGATOR, contacts name: Yudi H Oktaviano, MD, role: SUB_INVESTIGATOR, contacts name: Aryati Aryati, MD, role: SUB_INVESTIGATOR, contacts name: Fitriah Munawaroh, MD, role: SUB_INVESTIGATOR, contacts name: Neneng D Kurniati, MD, role: SUB_INVESTIGATOR, contacts name: Budi Utomo, MD, role: SUB_INVESTIGATOR, contacts name: Eko B Khoendori, MD, role: SUB_INVESTIGATOR, contacts name: Jusak Nugroho, MD, role: SUB_INVESTIGATOR, contacts name: Maria I Lusida, MD, role: SUB_INVESTIGATOR, geoPoint lat: -7.24917, lon: 112.75083, hasResults: False |
protocolSection identificationModule nctId: NCT06282679, orgStudyIdInfo id: KY20220701-03, briefTitle: Clinical Observation of Botulinum Toxin A Treatment in the Treatment of Rosacea, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: the goal of this study is to study the clinical efficacy and safety of botox in the treatment of rosacea., conditionsModule conditions: Rosacea, conditions: Botulinum Toxin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum Toxin Type A Injection [Botox], outcomesModule primaryOutcomes measure: CEA score, secondaryOutcomes measure: GAIS score, otherOutcomes measure: VISIA red zone score, otherOutcomes measure: Dermatology Quality of Life Score (DLQI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jie Dai, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: jie dai, role: CONTACT, phone: 02552271117, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06282666, orgStudyIdInfo id: KE-0254/150/2019, briefTitle: Lumbar ESPB in Hip Replacement Surgery, acronym: ESPB_HIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Medical University of Lublin, class: OTHER, descriptionModule briefSummary: In this study, continuous erector spinae plane block (ESPB) will be compared to continuous epidural analgesia in patients undergoing elective hip replacement surgery. Opioid consumption, pain severity, quadriceps femoris muscle strength, ability to walk, and quality of recovery will be evaluated. Moreover, chronic pain severity in months after the hospital discharge will be assessed., conditionsModule conditions: Coxarthrosis, conditions: Pain, Postoperative, conditions: Pain, Acute, conditions: Pain, Chronic, conditions: Postoperative Pain, Chronic, conditions: Analgesia, conditions: Quality of Life, conditions: Anesthesia, conditions: Spinal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups will be randomly allocated to Epidural and ESPB (1:1), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants will not be aware of the type of continuous blockade. Care providers, including doctors and nurses, will not be aware of patient allocation.Physiotherapists assessing outcomes will not be aware of patient allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Spinal anesthesia, interventions name: lumbar erector spinae plane block, interventions name: Epidural analgesia, interventions name: patient-controlled analgesia, interventions name: Timed Up and Go test, interventions name: neuropathic pain symptom inventory, interventions name: Lovett test, interventions name: Visual analog scale, interventions name: Quality of Recovery 40, interventions name: Ability to sit, stand upright, and walk, outcomesModule primaryOutcomes measure: Opiod consumtion with PCA, secondaryOutcomes measure: Pain at rest, secondaryOutcomes measure: Pain upon activity, secondaryOutcomes measure: Lovett test, secondaryOutcomes measure: TUG, secondaryOutcomes measure: QoR-40, secondaryOutcomes measure: NPSI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: II Department of Anesthesia and Intensive Care, city: Lublin, zip: 20-081, country: Poland, contacts name: Michał A Borys, M.D. Ph.D, role: CONTACT, phone: 506350569, phoneExt: +48, email: [email protected], contacts name: Paweł Kutnik, M.D., role: CONTACT, phone: 608769410, phoneExt: +48, email: [email protected], geoPoint lat: 51.25, lon: 22.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06282653, orgStudyIdInfo id: Endo-ergonomics, briefTitle: Postural and Muscle Fatigue Analysis of Endodontic Residents, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, descriptionModule briefSummary: Musculoskeletal disorders (MSDs) are a significant occupational health problem for dentists and have been linked to a decline in quality of life, often leading to stress-related illnesses and early retirement. Poor posture, poor movement or imbalances in the neck or shoulders can lead to the three most common pain syndromes in dentistry. The objectives of this study were to evaluate the working position adopted during an endodontic procedure and to determine the perception of symptoms of musculoskeletal disorders in first and second year students of the Master in Advanced Endodontics at the European University of Madrid (UEM), using the standardised Nordic Kuorinka questionnaire supplemented by a form with socio-demographic variables. This study has a descriptive cross-sectional observational design and included 10 students selected by convenience sampling. A video camera was used to record the procedures from three different angles for a maximum of 5 minutes. The information was processed using Microsoft Excel spreadsheet software, and the video recordings were assessed using Rodgers' Muscular Fatigue Analysis (RMFA) and Rapid Upper Limb Assessment (RULA)., conditionsModule conditions: Musculoskeletal System Disease, conditions: Position Sense Disorders, conditions: Symptoms and Signs, conditions: Postural; Defect, conditions: Endodontic Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Symptom Perception, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad Europea de Madrid, status: RECRUITING, city: Villaviciosa De Odón, state: Madrid, country: Spain, contacts name: Antonio Conde, PhD, role: CONTACT, geoPoint lat: 40.35692, lon: -3.90011, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-20, uploadDate: 2024-02-20T05:22, filename: Prot_000.pdf, size: 96217, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-20, uploadDate: 2024-02-20T05:30, filename: ICF_001.pdf, size: 77805, hasResults: False |
protocolSection identificationModule nctId: NCT06282640, orgStudyIdInfo id: 567, briefTitle: Comparıson Of Electromyography Results Before And After Vıtamın D Treatment In Patıents Wıth Carpal Tunnel Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-30, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-08-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Dr. Ayşe Güç, class: OTHER_GOV, collaborators name: Kayseri City Hospital, descriptionModule briefSummary: Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels., conditionsModule conditions: Carpal Tunnel Syndrome, conditions: Vitamin D Deficiency, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 87, type: ACTUAL, armsInterventionsModule interventions name: Vitamin D, outcomesModule primaryOutcomes measure: electrophysiological scale., secondaryOutcomes measure: monofilament test, otherOutcomes measure: Boston symptom severity scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kayseri City Hospital, city: Kayseri, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06282627, orgStudyIdInfo id: 10430012010023, briefTitle: The COVID HOME Study: Prospective Cohort Study of Non-hospitalised COVID-19 Patients, acronym: COVID-HOME, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-20, primaryCompletionDateStruct date: 2022-07-30, completionDateStruct date: 2022-08-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, descriptionModule briefSummary: Background. Guidelines on COVID-19 management are developed as we learn from this pandemic. However, most research has been done on hospitalised patients and the impact of the disease on non-hospitalised and their role in transmission are not yet well understood.The COVID HOME study conducts research among COVID-19 patients and their family members who were not hospitalised during acute disease, to guide patient care and inform public health guidelines for infection prevention and control in the community and household.Methods. An ongoing prospective longitudinal observational study of COVID-19 outpatients was established in March 2020 at the beginning of the COVID-19 pandemic in the Netherlands. Laboratory confirmed SARS-CoV-2 infected individuals of all ages that did not merit hospitalisation, and their household (HH) members, were enrolled after written informed consent. Enrolled participants were visited at home within 48 hours after initial diagnosis, and then weekly on days 7, 14 and 21 to obtain clinical data, a blood sample for biochemical parameters/cytokines and serological determination; and a nasopharyngeal/throat swab plus urine, stool and sperm or vaginal secretion (if consenting) to test for SARS-CoV-2 by RT-PCR (viral shedding) and for viral culturing. Weekly nasopharyngeal/throat swabs and stool samples, plus a blood sample on days 0 and 21 were also taken from HH members to determine whether and when they became infected. All participants were invited to continue follow-up at 3-, 6-, 12- and 18-months post-infection to assess long-term sequelae and immunological status., conditionsModule conditions: COVID-19, conditions: Post-COVID-19 Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 256, type: ACTUAL, armsInterventionsModule interventions name: Observational study, outcomesModule primaryOutcomes measure: SARS-CoV-2 infection, secondaryOutcomes measure: Long-term sequelae, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Groningen, city: Groningen, zip: 9713 GZ, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False |
protocolSection identificationModule nctId: NCT06282614, orgStudyIdInfo id: MUCO245, secondaryIdInfos id: 2023-A02081-44, type: OTHER, domain: ID-RCB, briefTitle: Performance and Safety of MUCOGYNE® Ovule as a Moisturizer, acronym: MOVHYDA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Biocodex, class: INDUSTRY, collaborators name: Voisin Consulting Life Science (VCLS), descriptionModule briefSummary: The aim of this post-Market Clinical Follow-up (PMCF) study is to confirm the efficacy and safety of MUCOGYNE® Ovule in the maintainance of natural moisture of the vulvovaginal mucosa and in the compensation for any natural secretions deficiencies, when used in accordance with its approved labeling, in the context of vulvovaginal dryness., conditionsModule conditions: Vaginal Dryness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, multicenter (France), open label without comparator study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Mucogyne Ovule, outcomesModule primaryOutcomes measure: Assessment of the efficacy of MUCOGYNE® Ovule intra vaginal applications on subjects' vaginal dryness irrespective of the cause over a 35-day period of use, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulva irritation, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing vulvo-vaginal discomfort, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing itching, secondaryOutcomes measure: Assessment of the local performance of MUCOGYNE® Ovule in reducing pain and/or dyspareunia related to vaginal dryness, secondaryOutcomes measure: Assessment of the patient's sexual function, secondaryOutcomes measure: Assessment of the patient's satisfaction, secondaryOutcomes measure: Assessment of changes in patient's clinical status, secondaryOutcomes measure: Assessment by investigator of changes in patient's clinical status, secondaryOutcomes measure: Assessment of the safety of MUCOGYNE® Ovule, secondaryOutcomes measure: Assessment of the device deficiencies of MUCOGYNE® Ovule, secondaryOutcomes measure: Assessment of the usability of MUCOGYNE® Ovule, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JEAN Christian's medical office, city: Nogent-sur-Marne, zip: 94130, country: France, geoPoint lat: 48.83333, lon: 2.48333, locations facility: Dr Ramez GHADRI's medical office, city: Orléans, zip: 45100, country: France, contacts name: Ramez GHADRI, MD, role: CONTACT, contacts name: Ramez GHADRI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.90289, lon: 1.90389, locations facility: Dr Raïssa APERANO-MAS's medical office, city: Rennes, zip: 35000, country: France, contacts name: Raïssa APERANO-MAS, MD, role: CONTACT, contacts name: Raïssa APERANO-MAS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, hasResults: False |
protocolSection identificationModule nctId: NCT06282601, orgStudyIdInfo id: GUIGOU - Defaye 2023, briefTitle: STUDY OF THE EFFECT OF RHYTHMIC AND NON-RHYTHMIC MUSICAL PRIMING ON THE SYNTAX CAPACITY OF PRESBYACOUSTIC OLDER ADULTS, acronym: AMORCAGE MUSIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire Dijon, class: OTHER, descriptionModule briefSummary: Presbyacusis, or age-related hearing loss, is a public health problem, affecting 20% of men and 30% of women over the age of 70 according to the WHO. In the most incapacitating cases, hearing aids are required. Numerous studies have evaluated the benefits of hearing aids, particularly in terms of improved hearing and quality of life.However, the specific effect of music on language skills has not yet been studied in hearing-impaired older adults.In this context, it was decided to study the effect of musical priming on the syntactic abilities of adults aged 70 or older with presbyacusis.This study is based on the hypothesis that music priming with regular music optimizes the syntax language skills of people with presbyacusis, as has already been proven in adults and normal-hearing children., conditionsModule conditions: Presbyacousie, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Audiogram, interventions name: Musical priming for the syntax test, interventions name: Test MMSE, interventions name: Barcelona Music Reward Questionnaire, outcomesModule primaryOutcomes measure: linguistic performance test focusing on syntax., eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282588, orgStudyIdInfo id: CTO21042GZA, briefTitle: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers, acronym: THUNDER, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-13, primaryCompletionDateStruct date: 2030-07-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cancer Research Antwerp, class: OTHER, collaborators name: Bayer, collaborators name: Veracyte, Inc., descriptionModule briefSummary: This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead of standard imaging which is limited by lower sensitivity and specificity.The hypothesis for the study is that treatment intensification based on a positive PSMA PET/ CT scan or Decipher high score (\> 0.6) improves time to new metastases detected on PSMA PET/ CT in high-risk PCa. In patients who are PSMA PET/ CT negative with a low/ intermediate Decipher score (≤ 0.6), it is hypothesized that treatment de-intensification will improve patient quality of life while maintaining a good oncological outcome.The study will be conducted at multiple centers across Europe. Participation in the study will comprise a screening period, where the screening assessments must be completed before subjects are enrolled and randomized (only for Phase 3 subjects). Eligible, consenting subjects will then undergo treatment according to their assigned study phase and treatment group, to occur over up to 96 weeks (24 months) with a post-treatment follow-up period to monitor safety and efficacy. The study will be closed when 96 events have been registered for the primary endpoint, which is expected to be at 7-8 years from the time of randomization of the first subject., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Phase 2: non randomised, 1 treatment arm, open label Phase 3: randomized 1:1 between two treatment arms, blinded, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Phase 3 trial: blinded Phase 2 trial: open label, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 493, type: ESTIMATED, armsInterventionsModule interventions name: Darolutamide, interventions name: Darolutamide matched placebo, interventions name: Radiotherapy, interventions name: Zoladex 3.6Mg Implant, interventions name: Zoladex LA, interventions name: Decapeptyl sustained release 22.5 mg, interventions name: Decapeptyl sustained release 11.25 mg, interventions name: Depo-Eligard 45 mg, interventions name: Depo-Eligard 22.5 mg, interventions name: Depo-Eligard 7.5 mg, interventions name: Firmagon 120 MG Injection, interventions name: Firmagon 80 MG Injection, interventions name: Docetaxel, outcomesModule primaryOutcomes measure: Phase 3: PSMA PET metastasis free survival (ppMFS), primaryOutcomes measure: Phase 2: quality of life (sexual subdomain), primaryOutcomes measure: Phase 2: quality of life (hormonal subdomain), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Prostate-cancer specific survival, secondaryOutcomes measure: Biochemical progression-free survival, secondaryOutcomes measure: Time to next systemic therapy, secondaryOutcomes measure: Frequency and severity of adverse events, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GZA Sint-Augustinus, status: RECRUITING, city: Wilrijk, state: Antwerp, zip: 2610, country: Belgium, contacts name: Piet Ost, MD, PhD, role: CONTACT, email: [email protected], contacts name: Piet Ost, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.16734, lon: 4.39513, locations facility: OLVZ Aalst, status: NOT_YET_RECRUITING, city: Aalst, zip: 9300, country: Belgium, contacts name: Samuel Br, role: CONTACT, contacts name: Samuel Bral, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.93604, lon: 4.0355, locations facility: AZ Sint-Jan, status: NOT_YET_RECRUITING, city: Brugge, zip: 8000, country: Belgium, contacts name: Sabine Meersschout, role: CONTACT, contacts name: Sabine Meersschout, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.20892, lon: 3.22424, locations facility: Saint Luc, status: NOT_YET_RECRUITING, city: Bruxelles, zip: 1200, country: Belgium, contacts name: Ad Vanderm, role: CONTACT, contacts name: Ad Vandermeulen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.85045, lon: 4.34878, locations facility: UZA, status: NOT_YET_RECRUITING, city: Edegem, zip: 2600, country: Belgium, contacts name: Karen Fransis, role: CONTACT, contacts name: Karen Fran, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.15662, lon: 4.44504, locations facility: UZ Gent, status: NOT_YET_RECRUITING, city: Gent, zip: 9000, country: Belgium, contacts name: Valérie Fonteyne, role: CONTACT, contacts name: Valérie Fonteyne, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: AZ Sint-Lucas, status: NOT_YET_RECRUITING, city: Gent, zip: 900, country: Belgium, contacts name: Lien Van De Voorde, role: CONTACT, contacts name: Lien Van De Voor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05, lon: 3.71667, locations facility: AZ Groeninge, status: NOT_YET_RECRUITING, city: Kortrijk, zip: 8500, country: Belgium, contacts name: Nick Liefhooghe, role: CONTACT, contacts name: Nick Liefhooghe, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.82803, lon: 3.26487, locations facility: CHU Liège, status: NOT_YET_RECRUITING, city: Liège, zip: 4000, country: Belgium, contacts name: Brieuc Suatois, role: CONTACT, contacts name: Brieuc Sautois, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: AZ Delta, status: NOT_YET_RECRUITING, city: Roeselare, zip: 8800, country: Belgium, contacts name: Benedikt Engels, role: CONTACT, contacts name: Benedikt Enge, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.94653, lon: 3.12269, locations facility: VITAZ, status: NOT_YET_RECRUITING, city: Sint-Niklaas, zip: 9100, country: Belgium, contacts name: Bart De Troyer, role: CONTACT, contacts name: Bart De Troyer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.16509, lon: 4.1437, hasResults: False |
protocolSection identificationModule nctId: NCT06282575, orgStudyIdInfo id: JZP598-302, secondaryIdInfos id: 2023-508219-21-00, type: OTHER, domain: CTIS, briefTitle: Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2028-07-01, completionDateStruct date: 2029-11-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Jazz Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer., conditionsModule conditions: Biliary Tract Cancer, conditions: HER2 Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 286, type: ESTIMATED, armsInterventionsModule interventions name: Zanidatamab, interventions name: Cisplatin, interventions name: Gemcitabine, interventions name: Pembrolizumab, interventions name: Durvalumab, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) in participants with Immunohistochemistry (IHC) 3+ tumors, secondaryOutcomes measure: Overall survival (OS) in participants with IHC 3+ tumors, secondaryOutcomes measure: Progression Free Survival for all participants, secondaryOutcomes measure: OS for all participants, secondaryOutcomes measure: Number of participants achieving Confirmed objective response rate (cORR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Number of Patients reporting Treatment-Emergent Adverse Events (TEAE), secondaryOutcomes measure: Maximum serum concentration of Zanidatamab, secondaryOutcomes measure: Number of participants who develop Anti-drug antibodies (ADAs) to Zanidatamab, secondaryOutcomes measure: Time to definitive deterioration (TDD) for participants with IHC 3+ tumors in patient-reported Physical Functioning (PF) domain score as measured by the EORTC QLQ-C30, secondaryOutcomes measure: TDD for all participants in patient-reported PF domain score as measured by the EORTC QLQ-C30, secondaryOutcomes measure: TDD for participants with IHC 3+ tumors in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain and Pruritis), secondaryOutcomes measure: TDD for all participants in patient-reported symptoms scores as measured by the EORTC QLQ-BIL21 (Pain, Jaundice, Abdominal Pain, and Pruritis), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rocky Mountain Cancer Centers, LLP, status: RECRUITING, city: Lone Tree, state: Colorado, zip: 80124, country: United States, geoPoint lat: 39.55171, lon: -104.8863, locations facility: Norton Cancer Institute - Audubon, status: NOT_YET_RECRUITING, city: Louisville, state: Kentucky, zip: 40217, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Minnesota Oncology Hematology, P.A., status: RECRUITING, city: Maple Grove, state: Minnesota, zip: 55369, country: United States, geoPoint lat: 45.07246, lon: -93.45579, locations facility: SCRI Oncology Partners, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Texas Oncology - DFW, status: RECRUITING, city: Dallas, state: Texas, zip: 75246, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Hospital Oncologico, Puerto Rico Medical Center, status: RECRUITING, city: Rio Piedras, zip: 00935, country: Puerto Rico, geoPoint lat: 18.39745, lon: -66.04989, hasResults: False |
protocolSection identificationModule nctId: NCT06282562, orgStudyIdInfo id: NL84223.018.23, briefTitle: FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients, acronym: FeelFit, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-08-15, completionDateStruct date: 2026-08-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients., conditionsModule conditions: Brain Tumor, Primary, conditions: Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: High-Intensity Interval Training (HIIT), outcomesModule primaryOutcomes measure: Self-reported physical fitness, secondaryOutcomes measure: Self-reported fitness, secondaryOutcomes measure: VO2max, otherOutcomes measure: Daily physical activity, otherOutcomes measure: Health-related quality of life questionnaire, otherOutcomes measure: Perceived functional impairments, otherOutcomes measure: Self-efficacy, otherOutcomes measure: Mastery, otherOutcomes measure: Brain tumor specific quality of life questionnaire, otherOutcomes measure: Subjective Happiness, otherOutcomes measure: Subjective cognitive functioning, otherOutcomes measure: Subjective cognitive failure, otherOutcomes measure: Fatigue questionnaire, otherOutcomes measure: Sleep questionnaire, otherOutcomes measure: Anxiety questionnaire, otherOutcomes measure: Self-reported depression questionnaire, otherOutcomes measure: Depression questionnaire, otherOutcomes measure: Muscle strength, otherOutcomes measure: Subjective physical fitness, otherOutcomes measure: Objective neurocognitive functioning, otherOutcomes measure: Objective neurological functioning, otherOutcomes measure: Brain imaging (optional), otherOutcomes measure: Brain activity (optional), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VU University Medical Centers, location VUmc, status: RECRUITING, city: Amsterdam, zip: 1081 HV, country: Netherlands, contacts name: Marieke Blom, Msc, role: CONTACT, phone: +31621522442, email: [email protected], geoPoint lat: 52.37403, lon: 4.88969, hasResults: False |
protocolSection identificationModule nctId: NCT06282549, orgStudyIdInfo id: YMC046, briefTitle: Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-08, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Yuhan Corporation, class: INDUSTRY, descriptionModule briefSummary: This study is to develop a predictive model for cardiocerebrovascular risk factors in elderly patients with essential hypertension with Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination., conditionsModule conditions: Essential Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1210, type: ESTIMATED, armsInterventionsModule interventions name: Telmisartan/Amlodipine/Chlorthalidone(Truset), outcomesModule primaryOutcomes measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events), secondaryOutcomes measure: Percentage of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) in patients with asymptomatic target organ damage, secondaryOutcomes measure: Mean Systolic Blood Pressure (MSBP)/ Diastolic Blood Pressure (MDBP), secondaryOutcomes measure: Patients Achieving the treatment goal in Mean Systolic Blood Pressure (MSBP), secondaryOutcomes measure: Percentage of patients who terminated the treatment, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Busan Veterans Hospital, status: RECRUITING, city: Busan, zip: 46996, country: Korea, Republic of, contacts name: Jonghyun Choi, role: CONTACT, geoPoint lat: 35.10278, lon: 129.04028, locations facility: Daegu Veterans Hospital, status: RECRUITING, city: Daegu, zip: 42835, country: Korea, Republic of, contacts name: Sangwook Kang, role: CONTACT, geoPoint lat: 35.87028, lon: 128.59111, locations facility: Gwangju Veterans Hospital, status: RECRUITING, city: Gwangju, zip: 62284, country: Korea, Republic of, contacts name: Seowon Choi, role: CONTACT, geoPoint lat: 35.15472, lon: 126.91556, locations facility: Konkuk University Medical Center, status: RECRUITING, city: Seoul, zip: 05030, country: Korea, Republic of, contacts name: Chanhee Kwon, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, locations facility: Veterans Health Service Medical Center, status: RECRUITING, city: Seoul, zip: 05368, country: Korea, Republic of, contacts name: Changhoon Lee, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06282536, orgStudyIdInfo id: LungMate-018, briefTitle: Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Shanghai Pulmonary Hospital, Shanghai, China, class: OTHER, descriptionModule briefSummary: Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression free survival. The perioperative research on ALK positive NSCLC was relatively late, and currently most studies mainly focus on early to mid stage ALK positive NSCLC patients. The results of two Phase III clinical trials showed that second-generation ALK targeted drugs, neoadjuvant and/or adjuvant therapy for ALK positive NSCLC, significantly prolonged DFS in patients, including increased pathological response rate, median response duration, and prolonged OS. For ALK positive advanced NSCLC patients who are resistant to second-generation ALK targeted drugs, there is currently limited exploration and there is an urgent need for new exploratory clinical studies.This trial aims to evaluate the effectiveness of Iruplinalkib neoadjuvant therapy for potentially resectable ALK positive non-small cell lung cancer., conditionsModule conditions: Potentially Resectable ALK Positive Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All enrolled patients received Iruplinalkib neoadjuvant therapy., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Iruplinalkib, interventions name: surgery, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Pathologic complete response (PCR) rate, secondaryOutcomes measure: Major pathologic response (MPR) rate, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Treatment-related adverse event (TRAE), secondaryOutcomes measure: 5-year overall survival (OS), secondaryOutcomes measure: 1-year event-free survival (EFS) rate, secondaryOutcomes measure: Health related quality of life (HRQol), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282523, orgStudyIdInfo id: 2023-1773, secondaryIdInfos id: A171600, type: OTHER, domain: UW- Madison, secondaryIdInfos id: EDUC/COUNSELING PSYCH, type: OTHER, domain: UW- Madison, secondaryIdInfos id: Protocol Version 12/27/23, type: OTHER, domain: UW- Madison, briefTitle: Healthy Minds Comparison Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to understand the difference between two versions of the Healthy Minds application, a digital well-being program. The main question it aims to answer is the differences between versions of the Healthy Minds application and their effects on well-being.Participants will complete a four-week well-being program and complete surveys via an app on their phone. Participants can expect to participate in the study for four months., conditionsModule conditions: Depression, conditions: Anxiety, conditions: Depression/Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 460, type: ESTIMATED, armsInterventionsModule interventions name: HMP app, interventions name: HMRP web app, outcomesModule primaryOutcomes measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and PROMIS Anxiety, secondaryOutcomes measure: HMP App Utilization: Days, secondaryOutcomes measure: HMP App Utilization: Number of Activities, secondaryOutcomes measure: HMP App Utilization: Minutes, secondaryOutcomes measure: Change in Healthy Minds Index (HM Index): Awareness, secondaryOutcomes measure: Change in Healthy Minds Index (HM Index): Connection, secondaryOutcomes measure: Change in Healthy Minds Index (HM Index): Purpose, secondaryOutcomes measure: Change in Healthy Minds Index (HM Index): Insight, secondaryOutcomes measure: Change in Subjective Happiness Scale, secondaryOutcomes measure: Change in Satisfaction with Life Scale (SWLS), secondaryOutcomes measure: Change in Perceived Stress Scale (PSS-10), secondaryOutcomes measure: Change in Flourishing Measure, secondaryOutcomes measure: Change in Digital Working Alliance Inventory (DWAI), secondaryOutcomes measure: Change in Experiences Questionnaire (EQ) Decentering Subscale, secondaryOutcomes measure: Change in Five Facet Mindfulness Questionnaire (FFMQ) Awareness Subscale, secondaryOutcomes measure: Change in NIH Toolbox Loneliness, secondaryOutcomes measure: Change in Wellbeing Growth Mindset, secondaryOutcomes measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Simon Goldberg, PhD, role: CONTACT, phone: 608-265-8986, email: [email protected], contacts name: Simon Goldberg, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False |
protocolSection identificationModule nctId: NCT06282510, orgStudyIdInfo id: 23053003, briefTitle: Nasal Antisepsis for C. Auris Prevention, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Mary K Hayden, class: OTHER, collaborators name: Rush University Medical Center, collaborators name: RML Specialty Hospital, descriptionModule briefSummary: This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris., conditionsModule conditions: Candida Auris Infection, conditions: Colonization, Asymptomatic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Povidone Iodine Topical, outcomesModule primaryOutcomes measure: Detection of C. auris from the anterior nares, secondaryOutcomes measure: Detection of C. auris from body sites other than anterior nares, secondaryOutcomes measure: Detection of C. auris from environmental surfaces, secondaryOutcomes measure: Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares, secondaryOutcomes measure: Detection of MRSA from environmental surfaces, otherOutcomes measure: Non-susceptibility of C. auris to povidone iodine, otherOutcomes measure: Change in microbiome community, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rush University Medical Center, status: RECRUITING, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Sarah E Sansom, DO, role: CONTACT, phone: 312-563-6201, email: [email protected], contacts name: Mary K Hayden, MD, role: CONTACT, phone: 312-942-8727, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, locations facility: RML Specialty Hospital, status: RECRUITING, city: Chicago, state: Illinois, zip: 60624, country: United States, contacts name: Nidhi Undevia, MD, role: CONTACT, phone: 630-286-4000, email: [email protected], contacts name: Lisa Duffner, role: CONTACT, phone: 630-286-4000, email: [email protected], geoPoint lat: 41.85003, lon: -87.65005, locations facility: RML Specialty Hospital, status: RECRUITING, city: Hinsdale, state: Illinois, zip: 60521, country: United States, contacts name: Nidhi Undevia, MD, role: CONTACT, phone: 630-286-4000, email: [email protected], contacts name: Lisa Duffner, role: CONTACT, phone: (630) 286-4000, email: [email protected], geoPoint lat: 41.80086, lon: -87.93701, hasResults: False |
protocolSection identificationModule nctId: NCT06282497, orgStudyIdInfo id: ZSCPH-003, briefTitle: Xerostomia-optimised IMRT Versus Standard IMRT in NPC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2026-10-23, completionDateStruct date: 2029-10-23, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Zhongshan People's Hospital, Guangdong, China, class: OTHER, descriptionModule briefSummary: This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients, conditionsModule conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 524, type: ESTIMATED, armsInterventionsModule interventions name: Optimised neck CTV, interventions name: standard neck CTV, outcomesModule primaryOutcomes measure: Regional recurrence free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Local recurrence free survival, secondaryOutcomes measure: Distant metastasis-free survival, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Acute toxicities, secondaryOutcomes measure: Late toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan City People's Hospital, status: RECRUITING, city: Zhongshan, state: Guangdong, zip: 528403, country: China, contacts name: Gui-qiong Xu, MD, role: CONTACT, phone: +8613528109888, email: [email protected], geoPoint lat: 21.31992, lon: 110.5723, hasResults: False |
protocolSection identificationModule nctId: NCT06282484, orgStudyIdInfo id: KY20232348-C-1, briefTitle: A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-06-01, completionDateStruct date: 2023-09-29, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital of Digestive Diseases, class: OTHER, descriptionModule briefSummary: To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer., conditionsModule conditions: Gastric Xanthoma, conditions: Helicobacter Pylori Infection, conditions: Gastric Cancer, conditions: Intestinal Metaplasia, conditions: Precancerous Lesions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 1260, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: corelation between the gastric xanthoma and gastric mucosa diseases, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hosipital of Digestive Disease, city: Xi'an, state: Shaanxi, zip: 710032, country: China, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False |
protocolSection identificationModule nctId: NCT06282471, orgStudyIdInfo id: MCC-23-20794, secondaryIdInfos id: HM20028614, type: OTHER, domain: Virginia Commonwealth University, briefTitle: EW and Self-Guided PST in Cancer Survivors and Caregivers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers, conditionsModule conditions: Cancer Survivors, conditions: Informal Caregivers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Expressive Writing and Problem-Solving Therapy (EW+PST), outcomesModule primaryOutcomes measure: Consent Rate, primaryOutcomes measure: Study Retention, primaryOutcomes measure: Completed Journal Entries, primaryOutcomes measure: Patient Satisfaction Questionnaire, secondaryOutcomes measure: Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks, secondaryOutcomes measure: Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks, secondaryOutcomes measure: Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks, secondaryOutcomes measure: Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Commonwealth University, status: RECRUITING, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Kendra Rowe, role: CONTACT, phone: 804-828-1965, email: [email protected], contacts name: Massey CPC Team, role: CONTACT, phone: 804-828-1965, email: [email protected], contacts name: Susan Hong, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False |
protocolSection identificationModule nctId: NCT06282458, orgStudyIdInfo id: V2000101, briefTitle: Dose-Finding Study Evaluating Effect on Body Composition of Enobosarm in Patients Taking a GLP-1 for Chronic Weight Mgmt, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Veru Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to assess the effect of enobosarm on total lean mass as measured by DEXA in patients maintained on GLP-1 receptor agonists., conditionsModule conditions: Muscle Loss, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomized to the three treatment arms (GLP-1 receptor agonist plus either enobosarm 3mg dose group, enobosarm 6mg dose group, or placebo group) in a 1:1:1 fashion. All patients randomized into this study will be medically indicated for use of GLP-1 receptor agonist for weight management. NOTE: First dose of GLP-1 receptor agonist will be Day 1 of this study.The primary efficacy endpoint of the study will be the change from baseline in total lean mass at 4 months (112 days). Subjects will continue enobosarm (or matching placebo) monotherapy treatment from Day 112 to Day 196 to assess the effect of enobosarm on total lean mass, total muscle mass, maintenance of weight loss, and rebound fat gain after discontinuation of GLP-1 receptor agonists. A safety follow-up visit will occur approximately 30 days after last dose of study drug., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double Blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Enobosarm, interventions name: Semaglutide, outcomesModule primaryOutcomes measure: The primary endpoint for the study is the percentage change from baseline in total lean body mass at 112 days., secondaryOutcomes measure: The percent change from baseline in total fat mass, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pinnacle Trials, city: Anniston, state: Alabama, zip: 36207, country: United States, contacts name: April Bolt, role: CONTACT, phone: 256-460-6379, email: [email protected], contacts name: Almena Free, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.65983, lon: -85.83163, locations facility: Cullman Clinical Trials, city: Cullman, state: Alabama, zip: 35055, country: United States, contacts name: Cheryl Hargrove, role: CONTACT, phone: 256-708-2826, email: [email protected], contacts name: Randall Quinn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.17482, lon: -86.84361, locations facility: Velocity Clinical Research, CA, city: Los Angeles, state: California, zip: 90057, country: United States, contacts name: Jenny Francisco, role: CONTACT, phone: 213-413-2500, email: [email protected], contacts name: David Guzman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Artemis Institute for Clinical Research, city: San Diego, state: California, zip: 92103, country: United States, contacts name: Analicia Murillo, role: CONTACT, phone: 858-867-3557, email: [email protected], contacts name: Stacy Layle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Universal Axom Clinical Research, city: Doral, state: Florida, zip: 33122, country: United States, contacts name: Diana Marinez, role: CONTACT, phone: 305-677-9267, phoneExt: 24, email: [email protected], contacts name: Luis Martinez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.81954, lon: -80.35533, locations facility: Altus Research, city: Lake Worth, state: Florida, zip: 33461, country: United States, contacts name: Junieth Leyes, role: CONTACT, phone: 561-641-0404, email: [email protected], contacts name: Samuel Lederman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.61708, lon: -80.07231, locations facility: MARC Research Center, city: Louisville, state: Kentucky, zip: 40213, country: United States, contacts name: Laken Heitz, role: CONTACT, phone: 502-214-3925, email: [email protected], contacts name: Harold Bays, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Pennington Biomedical, city: Baton Rouge, state: Louisiana, zip: 70810, country: United States, contacts name: Aubrey Windham, role: CONTACT, phone: 225-763-2618, email: [email protected], contacts name: Steven Heysmfield, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.45075, lon: -91.15455, locations facility: DelRicht Research - New Orleans, city: New Orleans, state: Louisiana, zip: 70115, country: United States, contacts name: Emily Krambeck, role: CONTACT, phone: 504-336-2667, email: [email protected], contacts name: Patrick Dennis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Centennial Medical Group (CMG), city: Elkridge, state: Maryland, zip: 21075, country: United States, contacts name: Tyler Stine, role: CONTACT, phone: 443-698-8678, email: [email protected], contacts name: Steven Geller, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.21261, lon: -76.71358, locations facility: SKY Integrative Medical Center, city: Ridgeland, state: Mississippi, zip: 39157, country: United States, contacts name: Bob Hutchins, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.42848, lon: -90.13231, locations facility: Clinvest Headlands LLC, city: Springfield, state: Missouri, zip: 65807, country: United States, contacts name: Kealon Cox, role: CONTACT, phone: 417-883-7889, email: [email protected], contacts name: David True, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.21533, lon: -93.29824, locations facility: Palm Research Center, city: Las Vegas, state: Nevada, zip: 89119, country: United States, contacts name: Sasha Sandry, role: CONTACT, phone: 702-736-5161, email: [email protected], contacts name: Samer Nakhle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: Lillestol Research LLC, city: Fargo, state: North Dakota, zip: 58104, country: United States, contacts name: Michael Lillestol, role: CONTACT, phone: 701-232-7705, email: [email protected], contacts name: Michael Lillestol, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.87719, lon: -96.7898, hasResults: False |
protocolSection identificationModule nctId: NCT06282445, orgStudyIdInfo id: K2024035, briefTitle: Efficacy and Safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of Chemotherapy With XELOX (Oxaliplatin + Capecitabine) and Bevacizumab in Combination With Adebrelimab in First-line Treatment of Microsatellite Stable (MSS) Initially Unresectable Metastatic Colorectal Cancer., conditionsModule conditions: Colorectal Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab, interventions name: Oxaliplatin, interventions name: Capecitabine, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Organ retention rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Surgical conversion rate, secondaryOutcomes measure: TRAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine, status: RECRUITING, city: Jinhua, state: Zhejiang, zip: 322000, country: China, contacts name: Qijia Xuan, MD&Phd, role: CONTACT, geoPoint lat: 29.10678, lon: 119.64421, hasResults: False |
protocolSection identificationModule nctId: NCT06282432, orgStudyIdInfo id: RP-L201-0121-LTFU, briefTitle: Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I), statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-03-09, primaryCompletionDateStruct date: 2037-03, completionDateStruct date: 2037-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Rocket Pharmaceuticals Inc., class: INDUSTRY, descriptionModule briefSummary: This Long-Term Follow-Up (LTFU) for Gene Therapy of Leukocyte Adhesion Deficiency-I (LAD-I) is a continuation of a Phase 1/2 clinical study to evaluate the safety and efficacy of the infusion of autologous hematopoietic stem cells transduced with a lentiviral vector encoding the ITGB2 gene, conditionsModule conditions: Leukocyte Adhesion Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Hematopoietic stem cell transplant (HSCT) free survival, secondaryOutcomes measure: Incidence of hospitalizations, secondaryOutcomes measure: Incidence of significant infections, secondaryOutcomes measure: Resolution of LAD-I-related skin rash, secondaryOutcomes measure: Resolution of LAD-I-related periodontal abnormalities, secondaryOutcomes measure: Event free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Long-term genetic correction in peripheral blood mononuclear cells (PBMCs), secondaryOutcomes measure: Long-term genetic correction in PB CD15+ granulocytes, secondaryOutcomes measure: Long-term CD18 neutrophil expression by flow cytometry, secondaryOutcomes measure: Long-term CD11 neutrophil expression by flow cytometry, secondaryOutcomes measure: Improvement or resolution of LAD-I related neutrophilia, secondaryOutcomes measure: Improvement or resolution of LAD-I-related leukocytosis., secondaryOutcomes measure: Incidence of Investigational Product (IP) related serious adverse events (SAEs), secondaryOutcomes measure: Incidence of hematologic malignancy, eligibilityModule sex: ALL, minimumAge: 3 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Los Angeles (UCLA), city: Los Angeles, state: California, zip: 90095-1489, country: United States, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Hospital Infantil Universitario Niño Jesús, city: Madrid, zip: 28009, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: University College London Great Ormond Street Institute of Child Health (GOSH), city: London, zip: WC1N 1EH, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06282419, orgStudyIdInfo id: B.30.2.ATA.0.01.00/542, briefTitle: The Effect of Visual and Audio Stimulus Offered to Father-to-be, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-21, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: It was aimed to evaluate the effect of visual and auditory stimuli presented to father candidates on postpartum breastfeeding success of mothers, perception of spousal support and postpartum depression. The study, which was carried out in a randomized controlled experimental design, consists of nulliparous pregnant women and their spouses who came to the relevant health center for prenatal control between May 2023 and May 2024. In the study, 132 pregnant women (Experimental group 1:44, Experimental group 2:44, control group:44) were recruited with a priori power analysis. In the study, women and their spouses were assigned to the experimental and control groups by randomization. For randomization, single-group columns between 1-165 were created in the system using the Random Integer Generator method in the Numbers subheading of the random.org website. Considering the numbers 1, 2 and 3 in the column, nulliparous pregnant women coming to the polyclinic were randomly assigned to these numbers. Which numbers constitute which group was determined by drawing lots at the beginning of the research. In data collection, Introductory Information Form for women, Women's Perceived Spousal Support Scale in Early Postpartum Process, Breastfeeding Self-Efficacy Scale-Short Form, Breastfeeding Adaptation Scale and Edinburgh Postpartum Depression Scale; Introductory Information Form for men, Fathers; Breastfeeding Attitude and Participation Scale and Edinburgh Postpartum Depression Scale (for Men) were used. Data; It was evaluated in the SPSS program., conditionsModule conditions: Ultrasonography Prenatal, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a study that evaluates the effects on mothers by involving fathers in the pregnancy follow-up process through the use of mobile ultrasound., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: USE OF MOBILE ULTRASOUND, interventions name: ultrasound image taken from the internet, outcomesModule primaryOutcomes measure: Introductory Information Form (For Women), primaryOutcomes measure: Spouse Support Scale Perceived by Women During Early Postpartum Period, primaryOutcomes measure: Breastfeeding Self-Efficacy Scale-Short Form, primaryOutcomes measure: Breastfeeding Adaptation Scale, primaryOutcomes measure: Edinburgh Postpartum Depression Scale, primaryOutcomes measure: Introductory Information Form (For Men), primaryOutcomes measure: Fathers' Breastfeeding Attitude and Participation Scale, primaryOutcomes measure: Edinburgh Postpartum Depression Scale for Men, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Atatürk University, status: RECRUITING, city: Erzurum, country: Turkey, contacts name: Merve Çakıl, role: CONTACT, phone: +905310854245, email: [email protected], contacts name: Ayla KANBUR, role: CONTACT, email: [email protected], geoPoint lat: 39.90861, lon: 41.27694, hasResults: False |
protocolSection identificationModule nctId: NCT06282406, orgStudyIdInfo id: N4532-R, secondaryIdInfos id: I0X1RX004532, type: OTHER_GRANT, domain: U.S. Department of Veterans Affairs, briefTitle: Pupil-Indexed Noninvasive Neuromodulation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2028-04-03, completionDateStruct date: 2028-08-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning., conditionsModule conditions: Paresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Electrical Stimulation, interventions name: Sham, outcomesModule primaryOutcomes measure: Force Control Change, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, city: Pittsburgh, state: Pennsylvania, zip: 15240, country: United States, contacts name: Elizabeth B Toth, BA, role: CONTACT, phone: 412-954-5382, email: [email protected], contacts name: Kimberly A Toland, role: CONTACT, phone: (412) 215-5084, email: [email protected], contacts name: Michael A. Urbin, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False |
protocolSection identificationModule nctId: NCT06282393, orgStudyIdInfo id: Z-2023072, briefTitle: FibriCheck Data Registry, acronym: FDR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Qompium NV, class: INDUSTRY, descriptionModule briefSummary: The goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (PPG) measurements with simultaneously recorded electrocardiography (ECG) data to evaluate the FibriCheck Algorithm in patients with heart rhythm disorders., conditionsModule conditions: Cardiac Arrhythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: FibriCheck recordings, outcomesModule primaryOutcomes measure: Alignment PPG measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ziekenhuis Oost Limburg, status: RECRUITING, city: Genk, state: Limburg, zip: 3600, country: Belgium, contacts name: Pieter Vandervoort, MD, role: CONTACT, phone: 089/325050, email: [email protected], geoPoint lat: 50.965, lon: 5.50082, hasResults: False |
protocolSection identificationModule nctId: NCT06282380, orgStudyIdInfo id: FDA-AF study, briefTitle: Fibricheck Detection cApabilities for Atrial Fibrillation, acronym: FDA-AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Qompium NV, class: INDUSTRY, descriptionModule briefSummary: Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: FibriCheck Mobile Application, outcomesModule primaryOutcomes measure: Accuracy of the FibriCheck Mobile Application, secondaryOutcomes measure: Sensitivity of the FibriCheck Mobile Application, secondaryOutcomes measure: Specificity of the FibriCheck Mobile Application, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282367, orgStudyIdInfo id: JOSE AGURTO TELLO HOSPITAL, briefTitle: Bowel Preparation for Colonoscopy With Oral Lactulose, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2023-04-01, completionDateStruct date: 2023-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Josue Aliaga, class: OTHER_GOV, descriptionModule briefSummary: Background and Aims: The quality of colonoscopy is critically influenced by bowel preparation. Polyethylene glycol (PEG) is considered the gold standard regimen for bowel preparation, however due to the necessity of large volume of patient's tolerance is impaired, especially in the elderly population. Lactulose has been adopted in a few centers as a novel alternative for colonoscopy preparation. This study aimed to investigate the efficacy-safety profile of a lactulose-based bowel preparation in comparison to PEG for colonoscopy.Methods: Prospective non-blinded comparative study, developed in two tertiary centers from July 2021 to April 2023. Outpatients undergoing colonoscopy were randomly divided into 2 groups: Group 1 (111 patients): PEG and Group 2 (111 patients): Lactulose. The following clinical outcomes were assessed for each group: degree of bowel clearance using the Boston Score, colorectal polyp detection rate, adenoma detection rate, tolerability and side effects., conditionsModule conditions: Colonoscopy, conditions: Colonoscopy Preparation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 222, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Degree of bowel cleansing using the Boston score, secondaryOutcomes measure: adenomas detection rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jose Agurto Tello Hospital, city: Lima, zip: 05001, country: Peru, geoPoint lat: -12.04318, lon: -77.02824, hasResults: False |
protocolSection identificationModule nctId: NCT06282354, orgStudyIdInfo id: NP4035/2023, briefTitle: Telemedicine for Postoperative Follow-up After Oncological Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Instituto do Cancer do Estado de São Paulo, class: OTHER, descriptionModule briefSummary: The study will be a prospective, randomized, non-inferiority, open-label study, to be carried out at the Cancer Institute of the State of São Paulo for 6 months and will include patients agreeing to voluntary participation upon signing an informed consent form., conditionsModule conditions: Urologic Cancer, conditions: Satisfaction, Patient, conditions: Surgery, conditions: Postoperative Adhesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Type of post-operative appointment, outcomesModule primaryOutcomes measure: Patient satisfaction in the post-operative return, secondaryOutcomes measure: unattended arrivals at the institution, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Appointment's time, secondaryOutcomes measure: Number of exams requested, secondaryOutcomes measure: Total cost involved per service, secondaryOutcomes measure: Environmental impact, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282341, orgStudyIdInfo id: 23CH132, briefTitle: Fatigue and Recovery: a Comparison Between Trail and Marathon, acronym: MARA-TRAIL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-28, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: Road marathon is a famous running race known for hundreds of years. Trail running is an emerging running discipline which count new runners every year. Trail running and road marathon are two running endurance disciplines which differed by variation of elevation and nature of the terrain. While marathon is essentially run on flat roads, trail races are realized on steep paths (mountain, desert...) with an important variation of elevation. Neuromuscular, biomechanical and physiological consequences are different depending on the discipline, especially with a greater eccentric contribution in trail running. In spite of this characteristic, trail runners take part in several races longer than 40 km per year, while road runners participate in one to two marathons per year., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective study on healthy volunteers, comparing the neurophysiological, physiological and biomechanical effects at the end of a marathon compared with an equivalent effort trail in the open air, or simulated on a treadmill, in runners specialising in each of the 2 disciplines, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Race: Simulated marathon, interventions name: Race: Simulated trail, interventions name: Race: Trail in nature, outcomesModule primaryOutcomes measure: Change in knee extensors maximal isometric torque output, secondaryOutcomes measure: Change in plantar flexor maximal isometric torque output, secondaryOutcomes measure: Recovery of quadriceps maximal isometric torque output the month after the race, secondaryOutcomes measure: Voluntary activation level, secondaryOutcomes measure: Force assessed in dynamic, secondaryOutcomes measure: Velocity assessed in dynamic, secondaryOutcomes measure: Power assessed in dynamic, secondaryOutcomes measure: Muscular power and stretch-shortening cycle assessed through squat jumps, secondaryOutcomes measure: Muscular power and stretch-shortening cycle assessed through countermovement jump, secondaryOutcomes measure: Muscular power and stretch-shortening cycle assessed through drop jump, secondaryOutcomes measure: Muscle electrical activity, secondaryOutcomes measure: The kinetics of energy cost, secondaryOutcomes measure: Racing kinematics, secondaryOutcomes measure: Ground reaction force (in Newton), secondaryOutcomes measure: Center of pressure (in Newton), secondaryOutcomes measure: Muscle damage blood markers, secondaryOutcomes measure: Resting heart rate variability parameters, secondaryOutcomes measure: Effort perception, secondaryOutcomes measure: fatigue assessment, secondaryOutcomes measure: Muscular pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Unités de Myologie et de Médecine du Sport, status: RECRUITING, city: Saint-Étienne, zip: 42055, country: France, contacts name: Léonard FEASSON, Phd, role: CONTACT, phone: 04 77 12 03 83, email: [email protected], contacts name: Diana RIMAUD, role: CONTACT, email: [email protected], contacts name: Clément FOSCHIA, Dr, role: SUB_INVESTIGATOR, contacts name: Pascal EDOUARD, Dr, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False |
protocolSection identificationModule nctId: NCT06282328, orgStudyIdInfo id: CET 26-2024, briefTitle: HIV HOspital TEsting: Bringing the Hidden to Light in the Hospital Setting, acronym: HIV-HOTE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Castagna Antonella, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the prevalence of previously undiagnosed HIV infection in the hospital setting (across various medical or surgical departments) among individuals exhibiting at least one HIV indicator condition (HIV-IC) and/or engaging in risky behaviors.This is a cross-sectional, single-center study with additional procedures. Data collection will involve clinical and laboratory data from individuals with at least one HIV-IC and/or behavioral risk factor for HIV infection admitted to the San Raffaele Hospital in Milan for any reason.The overall study duration is 24 months, with recruitment lasting 20 months. Individuals will be actively recruited from various medical or surgical units of the hospital. After obtaining informed consent, clinical and laboratory information related to the study will be collected, along with specific blood samples. The presence of at least one HIV-IC will be determined using available clinical, radiological, and laboratory parameters during hospitalization.Following informed consent, hospitalized individuals will complete a paper questionnaire, aimed at identifying behavioral risk factors for HIV infection. If at least one HIV-IC or behavioral risk factor is present, the person will be eligible for inclusion in the clinical study, and a rapid capillary HIV test will be conducted bedside.In case of a positive rapid capillary HIV test result, antigen/antibody testing and Western Blot for HIV confirmation will be performed on venous blood samples on the same day., conditionsModule conditions: Hiv, conditions: HIV Infections, conditions: AIDS, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: HIV test, outcomesModule primaryOutcomes measure: Prevalence of HIV infection, secondaryOutcomes measure: Number of HIV-IC, secondaryOutcomes measure: Number of Behavioral Risk Factors, secondaryOutcomes measure: CD4+ lymphocytes, secondaryOutcomes measure: HIV-RNA, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele Scientific Institute, status: RECRUITING, city: Milan, zip: 20127, country: Italy, contacts name: Elisabetta Carini, role: CONTACT, phone: +0039 0226437934, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06282315, orgStudyIdInfo id: REALISE, briefTitle: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Insud Pharma, class: INDUSTRY, collaborators name: Ghana Health Services, collaborators name: Kenya Medical Research Institute, collaborators name: Bridges to Development, collaborators name: Sanger Institute, collaborators name: Barcelona Institute for Global Health, collaborators name: European Union, collaborators name: Swiss Confederation, collaborators name: Mundo Sano, descriptionModule briefSummary: An open-label, randomized by school, two-arm pragmatic trial, will be conducted involving two study sites in Sub-Saharan-Africa (SSA), Ghana and Kenya, to evaluate safety and effectiveness of the newly developed fixed dose combination (FDC) of albendazole (ALB) and ivermectin (IVM) as a single dose to treat Soil-Transmitted Helminths (STH), compared to the standard dose ALB single dose for the treatment and control of STH (REALISE study: Real World Evaluation of an Albendazole-Ivermectin Coformulation Safety and Effectiveness). The general objectives are to validate the benefits of FDC through this pragmatic trial in a context of mass drug administration (MDA) programme to evaluate the safety as a primary endpoint and effectiveness profile as a secondary endpoint, in a large population of school-aged children., conditionsModule conditions: Soil-Transmitted Helminths, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open-label, randomized at the school level, and each eligible participant within a school will receive only one of the study treatments (ALB or IVM)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is an open study. Participants and the study investigators assessing drug safety will not be blinded to treatment arms. Only the laboratory-based effectiveness measurement will be performed by blinded operators., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Pre-screening Phase, interventions name: Screenig Phase, interventions name: Randomization, interventions name: Baseline Effectiveness Cohort, interventions name: Day 0 Trial Intervention, interventions name: Active Surveillance (study visit Day 1, Day 2 and Day 7), interventions name: Passive Surveillance, interventions name: Post-Treatment Effectiveness Evaluation, outcomesModule primaryOutcomes measure: AEs and SAEs record of participants treated with FDC compared to ALB., secondaryOutcomes measure: Reduction in T. trichiura prevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 1: Reduction in Strongyloides stercoralis seroprevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 2: Reduction in hookworms and A. lumbricoides prevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 3: Reduction in A. lumbricoides prevalence in participants treated with FDC compared with ALB., otherOutcomes measure: Exploratory 4: Describe the frequency of scabies before and after the intervention in the two treatment arms., otherOutcomes measure: Exploratory 5: (i) Genetic diversity within and between T. trichiura populations, relative to the FDC or ALB study participants., otherOutcomes measure: Exploratory 5: (ii) Genetic diversity in candidate genes and identification of genes and/or regions in the genome of T. trichiura under selective pressure due to the treatment with FDC and/or ALB;, otherOutcomes measure: Exploratory 5: (iii) Relative abundance of mixed parasite species within and between populations and in response to treatment in the FDC or ALB study participants., otherOutcomes measure: Exploratory 6: (i) Characterization of the microbiome composition at baseline and its implication in MDA effectiveness, otherOutcomes measure: Exploratory 6: (ii) Determine the Impact of MDA with ALB or FDC on the microbiome composition at population level, otherOutcomes measure: Exploratory 6: (iii) Measure the Recovery of the baseline microbiome composition at 11 months post-treatment and its role in reinfection with STH., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ghana Health Service (GHS), city: Accra, country: Ghana, contacts name: Abraham Oduro, PM, role: CONTACT, phone: +233 (0) 50 469 8534, email: [email protected], contacts name: Joseph Opare, PI, role: CONTACT, email: [email protected], geoPoint lat: 5.55602, lon: -0.1969, locations facility: Kenya Medical Research Institution (KEMRI), city: Nairobi, zip: 00200, country: Kenya, contacts name: Benson Singa, PI, role: CONTACT, phone: +254-720018880, email: [email protected]/[email protected], contacts name: Stella Kepha, PM, role: CONTACT, email: [email protected], geoPoint lat: -1.28333, lon: 36.81667, hasResults: False |
protocolSection identificationModule nctId: NCT06282302, orgStudyIdInfo id: 6030/22, briefTitle: Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2024-03-18, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Instituto de Cardiologia do Rio Grande do Sul, class: OTHER, descriptionModule briefSummary: Introduction: Adequate blood pressure control is necessary to reduce the risk of mortality from cardiovascular events. The effects of aerobic exercise on systemic arterial hypertension are already well known, however, to date, there is little evidence regarding the effect of an isometric exercise session for the lower limbs on blood pressure levels, especially when performed in elderly hypertensive individuals. Objective: To verify the effect of an isometric or aerobic exercise protocol for the lower limbs on 24-hour ambulatory blood pressure in elderly hypertensive individuals., conditionsModule conditions: Hypertension,Essential, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The RCT will involve thirty-six elderly volunteers (≥ 60 years of age) with systemic arterial hypertension, aiming to compare two types of physical exercise sessions, isometric wall squats and an aerobic exercise session on an exercise bike, on the 24-hour blood pressure levels., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Group control, interventions name: Isometric Exercise, interventions name: Aerobic Exercise, outcomesModule primaryOutcomes measure: 24-hour Ambulatory Blood Pressure Monitoring, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Cardiology, status: RECRUITING, city: Porto Alegre, state: RS, zip: 900.620-000, country: Brazil, contacts name: Lidiane P Stochero, role: CONTACT, phone: 5554981301920, email: [email protected], geoPoint lat: -30.03306, lon: -51.23, hasResults: False |
protocolSection identificationModule nctId: NCT06282289, orgStudyIdInfo id: 2023-077, secondaryIdInfos id: 2023-A01798-37, type: OTHER, domain: ID RCB, briefTitle: Elicitation of Steady-state Audiovisual Responses in 6- and 10-month-old Infants, acronym: AV-SSR-I, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09-21, completionDateStruct date: 2025-09-21, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Institut Pasteur, class: INDUSTRY, collaborators name: Institut de l'Audition, descriptionModule briefSummary: The goal of this study is to investigate the preferential responses of speech neural systems in infants.The main question it aims to answer is to determine whether the oscillatory synchronization capacity is associated with children's language level (i.e. vocabulary).Participants will be presented with synthetically modulated stimuli at three frequency scales: 4 Hz, 5 Hz and 30 Hz., conditionsModule conditions: Speech, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Magnetoencephalography (MEG), interventions name: Cognition development questionnaire, outcomesModule primaryOutcomes measure: Significance of correlation between the delta (i.e. difference) of synchronization power estimated at 10- and 6-months of age and the delta of vocabulary level measured at 18months of age., secondaryOutcomes measure: The equation for linear regression analysis used to estimate the amount of neuronal synchronization between auditory and visual perception systems according to the Coherence and the Synchrony of AV inputs, secondaryOutcomes measure: The equation for linear regression analysis used to estimate the variation in the amount of neuronal synchronization between 4 experimental conditions according to the Coherence and the Synchrony of AV inputs, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 10 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282276, orgStudyIdInfo id: 012922HYMC, briefTitle: Anti-fat Attitudes and Weight Stigma Among Orthopedic Surgeons, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Hillel Yaffe Medical Center, class: OTHER_GOV, descriptionModule briefSummary: Evidence shows that anti-fat attitudes and weight stigma are prevalent among healthcare professionals and may affect treatment decisions regarding patients with obesity. The present study aimed to examine the presence of anti-fat attitudes and weight stigma among orthopedic surgeons and their correlation to the therapeutic approach to patients with obesity. In this cross-sectional survey, 150 orthopedic surgeons will complete a web-based questionnaire. the questionnaire is based on Antifat Attitudes Questionnaire (AFA), developed by Crandall in 1994. In addition, the questionnaire will include a questionnaire developed by Bocquier in 200521 to explore weight stigma among physicians., conditionsModule conditions: Weight Stigma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: cross sectional survey, outcomesModule primaryOutcomes measure: anti fat attitudes, primaryOutcomes measure: Weight stigma, primaryOutcomes measure: Therapeutic approach, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hillel Yaffe Medical Center, city: Hadera, zip: 38000, country: Israel, geoPoint lat: 32.44192, lon: 34.9039, hasResults: False |
protocolSection identificationModule nctId: NCT06282263, orgStudyIdInfo id: 1292, briefTitle: The Effect of the Awareness Development Program on Suicide Prevention for Oncology Nurses, acronym: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-25, primaryCompletionDateStruct date: 2023-11-02, completionDateStruct date: 2023-11-02, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sevda Ozturk, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effect of the Awareness Development Programme on Suicide Prevention for Oncology Nurses on the levels of knowledge, stigma and perception of efficacy towards suicide in oncology nurses. The main questions it aims to answer are:1. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the knowledge levels of nurses about suicide according to the pre-programme and control group?2. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the perception of efficacy levels of nurses regarding suicide according to the pre-programme and control group.3. At the end of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology and at the end of the 3-month follow-up, is there a difference between the stigma levels of nurses towards suicide according to the pre-programme and control group.4. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test and post-test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.5. Is there a significant relationship between the levels of knowledge about suicide, perception of efficacy regarding suicide, and stigma towards suicide in the pre-test-follow-up test measurements of the Awareness Development Programme on Suicide Prevention for Oncology Nurses applied to nurses working in the field of oncology.Participants will participate the Awareness Development Programme on Suicide Prevention for Oncology Nurses. Oncology Nurses are expected to complete the pre-test, post-test and follow-up tests.Researchers will compare control group to see if effect of "the Awareness Development Programme on Suicide Prevention", conditionsModule conditions: Suicide Prevention, conditions: Nurses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study was a pre-test, post-test, follow-up design and control group intervention study conducted to examine the effect of "Awareness Development Programme on Suicide Prevention for Oncology Nurses" on oncology nurses' knowledge, stigma and perception of efficacy regarding suicide risk management., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 86, type: ACTUAL, armsInterventionsModule interventions name: "Awareness Development Program on Suicide Prevention for Oncology Nurses", outcomesModule primaryOutcomes measure: the Literacy of Suicide Scale, primaryOutcomes measure: Efficacy Perception Scale For Suicide Risk Management, primaryOutcomes measure: The Stigma of Suicide Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06282250, orgStudyIdInfo id: in progress, briefTitle: Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Geestelijke Gezondheidszorg Eindhoven (GGzE), class: OTHER, descriptionModule briefSummary: In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied.Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues., conditionsModule conditions: Bipolar Disorder, conditions: Mood Swing, conditions: Prodromal Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy, interventions name: Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy, interventions name: Psycho-education + Imagery focused Cognitive Therapy, outcomesModule primaryOutcomes measure: Change in depressive symptom scores on the IDS-SR, primaryOutcomes measure: Change in hyperactive symptom scores on the ASRM, primaryOutcomes measure: Change in anxiety symptom scores on the BAI, primaryOutcomes measure: Change in sleep quality subjective rating on 11-point Likert scale, primaryOutcomes measure: Change in activity levels subjective rating on 11-point Likert scale, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Geestelijke Gezondheidszorg Eindhoven (GGzE), status: RECRUITING, city: Eindhoven, state: Noord-Brabant, zip: 5626ND, country: Netherlands, contacts name: Else Treffers, MSc, role: CONTACT, phone: +31622559192, email: [email protected], geoPoint lat: 51.44083, lon: 5.47778, hasResults: False |
protocolSection identificationModule nctId: NCT06282237, orgStudyIdInfo id: 2022.143, briefTitle: Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study, acronym: 1206, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Campus Bio-Medico, class: OTHER, collaborators name: Fondazione Don Carlo Gnocchi Onlus, descriptionModule briefSummary: The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.Primary objectives:* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).Secondary endpoints will be:1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);• The change in walking performance before and after the rehabilitation treatment., conditionsModule conditions: Sarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 13, type: ESTIMATED, armsInterventionsModule interventions name: survey, outcomesModule primaryOutcomes measure: Improvement in the Toronto Extremity Salvage Score (TESS), secondaryOutcomes measure: Pain evaluation, secondaryOutcomes measure: Motor performance evaluation, secondaryOutcomes measure: Evaluation of Quality of Life, secondaryOutcomes measure: Pain evaluation, secondaryOutcomes measure: Pain evaluation, secondaryOutcomes measure: Evaluation of Quality of Life, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Campus Biomedico, status: RECRUITING, city: Roma, zip: 00128, country: Italy, contacts name: Sergio Valeri, MD, role: CONTACT, phone: 06225411626, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False |
protocolSection identificationModule nctId: NCT06282224, orgStudyIdInfo id: XMFHIIT-2023SL066, briefTitle: Application of Augmented Reality Neuronavigation in Transnasal Endoscopic Skull Base Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-01-11, completionDateStruct date: 2026-01-11, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xiamen University, class: OTHER, descriptionModule briefSummary: "For lesions in the skull base, including meningiomas, chordomas and pituitary tumors, endoscopic surgery has replaced traditional microscopes as the mainstream procedure. Although neurosurgeons can enlarge the surgical area using a neuroendoscope, it does not provide any information on the morphology and location of anatomical structures beneath visible surfaces. Due to the complex anatomical relationships of adjacent structures in the skull base, lesions occurring here are often located deep within anatomy that is difficult to fully expose and remove with endoscopic surgery alone. Especially when dealing with larger tumors that surround major arteries and nerves, limited visibility at surface level can easily damage blood vessels or nerves causing complications such as bleeding during or after surgery, deformities or functional impairments. The purpose of this study is to explore how augmented reality (AR) technology can highlight important anatomical structures in a neuroendoscope's field of view to optimize surgical visibility beyond what is possible with just an endoscope alone. This will make it easier for surgeons to distinguish deeper anatomical structures and reduce intraoperative and postoperative complications associated with endoscopic surgery.", conditionsModule conditions: Pituitary Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Performing endoscopic transnasal skull base surgery with AR-integrated endoscope, outcomesModule primaryOutcomes measure: Postoperative Recovery of Transnasal Surgery, primaryOutcomes measure: Postoperative complication, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282211, orgStudyIdInfo id: CHASE 005, briefTitle: the Efficacy and Safety of Ondansetron Oral Soluble Pellicles, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-12-29, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Xinxiang Medical College, class: OTHER, descriptionModule briefSummary: The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy., conditionsModule conditions: Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 184, type: ESTIMATED, armsInterventionsModule interventions name: Ondansetron Oral Soluble Pellicles, outcomesModule primaryOutcomes measure: Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups, secondaryOutcomes measure: Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups, secondaryOutcomes measure: Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups, otherOutcomes measure: Incidence of adverse events and serious adverse reactions throughout the study period, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Keya Zhi, status: RECRUITING, city: Weihui, state: None Selected, zip: 453100, country: China, contacts name: Yana Zhang, role: CONTACT, phone: 15093230340, email: [email protected], geoPoint lat: 34.79333, lon: 108.93833, hasResults: False |
protocolSection identificationModule nctId: NCT06282198, orgStudyIdInfo id: UCHCEU-13/02/24, briefTitle: Consequences on the Gait Pattern of Patients With Distal Femur Megaprostheses, acronym: IMU-DFM, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-02-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Cardenal Herrera University, class: OTHER, descriptionModule briefSummary: The primary aim of this study is to compare spatiotemporal gait parameters between participants with distal femur tumor prostheses and healthy individuals without prostheses., conditionsModule conditions: Distal Femoral Musculoskeletal Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Gait Symmetry index measured in percentage (%), secondaryOutcomes measure: Sagittal range of movement of the knee measured with a goniometer, secondaryOutcomes measure: Muscular strength, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad CEU Cardenal Herrera, status: RECRUITING, city: Valencia, country: Spain, contacts name: JF Lisón, PhD, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False |
protocolSection identificationModule nctId: NCT06282185, orgStudyIdInfo id: CanisiusWH, briefTitle: SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy, acronym: Superman, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Canisius-Wilhelmina Hospital, class: OTHER, descriptionModule briefSummary: The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:* What is the impact of exercise on quality of life* What is the impact of exercise on physical fitnessParticipants will have an individual training program with supervised training by physiotherapists.Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program., conditionsModule conditions: Prostatic Neoplasms, conditions: Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial with an intervention arm and an usual care group, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapy, outcomesModule primaryOutcomes measure: change of quality of life assessed with EPIC26 (0-100 points), primaryOutcomes measure: change of quality of life assessed with EPIC26 (0-100 points), primaryOutcomes measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale), primaryOutcomes measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale), secondaryOutcomes measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min, secondaryOutcomes measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min, secondaryOutcomes measure: change of physical fitness in fat percentage, secondaryOutcomes measure: change of physical fitness in fat percentage, secondaryOutcomes measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)), secondaryOutcomes measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06282172, orgStudyIdInfo id: BTL-785_CTUS1600, briefTitle: Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-25, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-12-18, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: BTL Industries Ltd., class: INDUSTRY, descriptionModule briefSummary: This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat., conditionsModule conditions: Fat Burn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Treatment with BTL-785-7, outcomesModule primaryOutcomes measure: Investigation of the effect of the BTL-785F device (with BTL-785-7 applicator) on submental subcutaneous fat tissue., secondaryOutcomes measure: Investigation of post-treatment adipocyte apoptosis, secondaryOutcomes measure: Incidence of Treatment-related Adverse Events, secondaryOutcomes measure: Comfort Evaluation Assessed by Therapy Comfort Questionnaire, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schweiger Dermatology PC, Research Division, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, hasResults: False |
protocolSection identificationModule nctId: NCT06282159, orgStudyIdInfo id: DNTH103-MG-201, briefTitle: A Phase 2 Study to Evaluate DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC), acronym: MAGIC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Dianthus Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG)., conditionsModule conditions: Myasthenia Gravis, Generalized, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: DNTH103, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity, and relationship of TEAEs (including treatment discontinuation due to adverse events [AEs]) [Time Frame: Baseline (Day 1) to Safety Follow-Up Visit (up to Week 40)], primaryOutcomes measure: Incidence, severity, and relationship of adverse events of special interest (AESI), primaryOutcomes measure: Number of participants with changes from baseline in ECG parameters, primaryOutcomes measure: Number of participants with changes in clinical laboratory values over time, secondaryOutcomes measure: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) scale score, secondaryOutcomes measure: Change from baseline in Quantitative Myasthenia Gravis (QMG) scale score, secondaryOutcomes measure: Serum concentrations of DNTH103, secondaryOutcomes measure: Change from baseline in complement total blood test (CH50), secondaryOutcomes measure: Antidrug antibody (ADA) levels against DNTH103, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bradenton Research Center, status: RECRUITING, city: Bradenton, state: Florida, zip: 34205, country: United States, contacts name: Gloria Carlbert, role: CONTACT, email: [email protected], geoPoint lat: 27.49893, lon: -82.57482, locations facility: Texas Neurology, status: RECRUITING, city: Dallas, state: Texas, zip: 75206, country: United States, contacts name: Haley Rucker, role: CONTACT, email: [email protected], geoPoint lat: 32.78306, lon: -96.80667, locations facility: West Texas Neurology Clinic, status: RECRUITING, city: Lubbock, state: Texas, zip: 79414, country: United States, contacts name: Christie Long, role: CONTACT, email: [email protected], geoPoint lat: 33.57786, lon: -101.85517, hasResults: False |
protocolSection identificationModule nctId: NCT06282146, orgStudyIdInfo id: 2024P000252, briefTitle: Testing a Transdiagnostic TMS Treatment Target, acronym: T5, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test a new brain stimulation treatment target for individuals with depression plus at least one additional psychiatric disorder. The main question is to understand the safety profile of a non-invasive form of brain stimulation called accelerated intermittent theta burst stimulation when it is targeting the posterior parietal cortex. Additional questions focus on whether this stimulation improves symptoms of depression and other psychiatric disorders as well as whether this stimulation changes brain function., conditionsModule conditions: Major Depressive Disorder, conditions: Depression, conditions: Psychiatric Disorder, conditions: Mood Disorders, conditions: Mental Disorder, conditions: Anxiety Disorders, conditions: OCD, conditions: PTSD, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: transcranial magnetic stimulation, outcomesModule primaryOutcomes measure: Tolerability as measured by incidence of side effects on an accelerated TMS sensations and adverse events questionnaire, primaryOutcomes measure: Feasibility as measured by number of the 50 treatments completed, secondaryOutcomes measure: Montgomery-Åsberg Depression Rating Scale (MADRS), secondaryOutcomes measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision, Level 1 Self-Rated Cross-Cutting Symptom Measure (DSM-5-XC), secondaryOutcomes measure: World Health Organization Disability Assessment Schedule II (WHODAS 2.0), otherOutcomes measure: Beck Depression Inventory (BDI), otherOutcomes measure: Beck Anxiety Inventory (BAI), otherOutcomes measure: Adult Attention Deficit/Hyperactivity Disorder Self-Report Scale (AARS), otherOutcomes measure: Clinical Global Impression Scale (CGI), otherOutcomes measure: Illness Intrusiveness Rating Scale (IIRS), otherOutcomes measure: Perceived Stress Scale (PSS), otherOutcomes measure: Positive and Negative Symptom Scale (PANSS), otherOutcomes measure: Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), otherOutcomes measure: Social Readjustment Rating Scale (SRRS), otherOutcomes measure: Yale Brown Obsessive-Compulsive Scale (Y-BOCS), otherOutcomes measure: Temperament and Character Inventory, Revised 140-item, otherOutcomes measure: Emotional Conflict Resolution Test, otherOutcomes measure: Learning, Multi-Source Interference Task (MSIT), otherOutcomes measure: Penn Emotion Recognition Task (ER-40), otherOutcomes measure: Death Suicide IAT, otherOutcomes measure: Young Mania Rating Scale (YMRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
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