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protocolSection identificationModule nctId: NCT06347159, orgStudyIdInfo id: EDG-7500-102, briefTitle: A Study of EDG-7500 in Adult Patients With Obstructive Hypertrophic Cardiomyopathy (CIRRUS-HCM), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Edgewise Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 either as a single or multiple dose in adult patients with obstructive hypertrophic cardiomyopathy., conditionsModule conditions: Hypertrophic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: EDG-7500, interventions name: EDG-7500, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events, secondaryOutcomes measure: Change from baseline in left ventricular outflow tract (LVOT) gradient, secondaryOutcomes measure: Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine), status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Edgewise Therapeutics, Inc., role: CONTACT, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06347146, orgStudyIdInfo id: R01HD112323, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HD112323, secondaryIdInfos id: R01HD112323, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HD112323, briefTitle: Bridges2Scale: Testing Implementation Strategies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: The goal of this clinical trial is to compare two multifaceted strategies (standard vs enhanced) for scaling Bridges in a two-arm Hybrid III effectiveness-implementation cluster randomized controlled trial (RCT) in adolescent and youths affected by AIDS \[AYaAIDS\] (ages 13-17 years) from 48 schools in the Greater Masaka region of Uganda. The main aims of the clinical trial are: Aim 1. Compare the implementation effectiveness of the standard implementation strategy vs. an enhanced implementation strategy. The investigators will assess fidelity to Bridges (primary implementation outcome) and sustainment of Bridges (exploratory implementation outcome).Aim 2. Determine the clinical effectiveness of Bridges implemented via a standard vs. enhanced implementation strategy. Aim 3: Explore implementation processes, mechanisms, and determinants. Aim 4. Compare the cost and cost-effectiveness of the two implementation strategies. Using an activity-based ingredients approach, the investigators will examine how much each strategy costs to achieve a unit of effect., conditionsModule conditions: HIV/AIDS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 1440, type: ESTIMATED, armsInterventionsModule interventions name: Financial Literacy Training (FLT) workshops, interventions name: Mentorship, interventions name: Income Generation Activity (IGA), interventions name: Youth Development Accounts (YDA), outcomesModule primaryOutcomes measure: Intervention Fidelity, primaryOutcomes measure: HIV prevalence, secondaryOutcomes measure: Sexual risk-taking behavior, secondaryOutcomes measure: Economic stability, secondaryOutcomes measure: School attainment, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Proportion of adolescents living with HIV who are virally suppressed, secondaryOutcomes measure: Proportion of HIV negative adolescents who use PrEP, secondaryOutcomes measure: Hopelessness, secondaryOutcomes measure: Self-Esteem, secondaryOutcomes measure: Self-concept, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 17 Years, stdAges: CHILD, hasResults: False
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protocolSection identificationModule nctId: NCT06347133, orgStudyIdInfo id: AROAPOC3-3009, secondaryIdInfos id: 2023-509302-30, type: EUDRACT_NUMBER, briefTitle: Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia, acronym: MUIR-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Arrowhead Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with hypertriglyceridemia (HTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo and be evaluated for efficacy and safety., conditionsModule conditions: Hypertriglyceridemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1328, type: ESTIMATED, armsInterventionsModule interventions name: Plozasiran Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo, secondaryOutcomes measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo, secondaryOutcomes measure: Proportion of Participants who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo, secondaryOutcomes measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment, secondaryOutcomes measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment, secondaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12, secondaryOutcomes measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347120, orgStudyIdInfo id: PI2024_843_0011, briefTitle: Place of Nasogastric Tube in Uncomplicated Adhesive Small Bowel Obstruction, acronym: BOWNTI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, collaborators name: Centre Hospitalier de Beauvais, collaborators name: CHU de Rouen - Accueil, collaborators name: Hospital Avicenne, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: University Hospital, Limoges, collaborators name: Saint Antoine University Hospital, collaborators name: Centre Hospitalier Universitaire de Besancon, collaborators name: Hôpital Cochin, collaborators name: University Hospital, Toulouse, collaborators name: CH Abbeville, collaborators name: University Hospital, Angers, descriptionModule briefSummary: Acute adhesive Small Bowel Obstruction (ASBO) is a public health issue: this is the 3rd cause of hospitalization in Digestive Surgery Departments, 20-30% of patients will be operated, the mortality rate per episode is 3%, the duration of hospitalization is 8 days (up to 16 if resection), and it is associated with a tremendous health care expenses.The working group on ASBO of the World Society of Emergency Surgery suggested two distinct approaches for the management of acute ASBO: non-operative management (NOM) which concerning around 85% of patients and operative management (OM) :* OM: if there is clinical signs of strangulation, peritonitis, bowel ischemia, or if IV CT Scan shows sign of ischemia, strangulation, peritonitis, or if the occlusion persists for more than 72 hours;* NOM in all other cases, including nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 72h.NGT is an old concept first describe for treatment of ASBO based on several studies made on the dog where he proved efficacy of NGT by aspirating gas in the stomach favorising venous decompression and survival of patients. Since, NGT became one of the pillars of NOM.However NGT is quite bad tolerated by patients (ranked the most painful hospital procedure), some of them refuse it, others put off after the beginning of the treatment and one of the most frequent complications of NGT is pneumonia, which is quite surprising when the first argument for its insertion is to avoid inhalation pneumonia.Four specific retrospectives studies showed that absence of NGT is possible in 20 to 80% of included patients and was associated with a decrease: in transit recovery time; in complications rate (including rates of pneumonia); in length of stay (LOS); without an increased risk of surgery or resection. 20-87% (a total of 922 patients) were managed successfully conservatively without NGT with a reduction LOS of 2-6 days compared with NGT. But none of this series focused on the patient relief as an endpoint. A retrospective critical analysis of our own management (January - December 2019, n=96) found that: only 17% of patients had a NGT during the IV CTscan, the presence of the NGT did not influence neither gastric volume nor the rate of full stomach, and gastric volume did not influence patient management.To summarize, the investigators therefore know that the insertion of a NGT is painful, does not relieve all patients, and has an unquantified therapeutic effect on the evolution of ASBO. That is why it is pertinent, in 2023, to question the useless of NGT in the treatment of ASBO, in selected patients. This study would be the first randomized controlled trial to focus on the absence of NGT for the NOM of patients with ASBO. The results of this study could lead to a change in the surgical practice. The absence of NGT in ASBO management appears to be an innovative practice, in rupture with the current practice. This is a part of the simplification of patients'care suffering from ASBO., conditionsModule conditions: Small Bowel Obstruction Adhesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 504, type: ESTIMATED, armsInterventionsModule interventions name: nasogastric tube, interventions name: NOM without NGT insertion, outcomesModule primaryOutcomes measure: Decrease of complication rate in patient without NGT group compared to control group, secondaryOutcomes measure: aspiration pneumonia rate in both patient groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amiens Universitary Hospital, city: Amiens, country: France, contacts name: jean marc Regimbeau, Pr, role: CONTACT, phone: +33 3 22 08 89 05, email: regimbeau.jean-marc@chu-amiens.fr, contacts name: charles sabbagh, Pr, role: SUB_INVESTIGATOR, contacts name: Aiham Ghazali, Pr, role: SUB_INVESTIGATOR, contacts name: Thierry Yzet, Pr, role: SUB_INVESTIGATOR, contacts name: François Mauvais, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lilian Schwarz, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Christophe Tresallet, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Pablo Ortega deballon, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Muriel Mathonnet, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jérémie Lefevre, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Zaher Lakkis, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: David Fuks, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Fabrice Muscari, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Corina Iederan, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Aurelien Venara, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.9, lon: 2.3, hasResults: False
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protocolSection identificationModule nctId: NCT06347107, orgStudyIdInfo id: S67215, briefTitle: Robotic Subretinal tPA Injection Study, acronym: RoTIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: DORC Dutch Ophthalmic Research Center International BV, descriptionModule briefSummary: In the RoTIS study, the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery. The surgical devices used during this procedure will be the following:* The robotic stabilizer (prototype - FAMHP approval received)* 41G subretinal needle (CE marked - used within label)* Inicio micro-injection system (CE marked - used within label) The Inicio system mounted with the 41G needle will be held by the robot, and guided by the surgeon towards the required position. When the tip of the needle is in the desired subretinal position, the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained, with a maximal duration of up to 3 minutes.As performed routinely, the surgical view through the microscope will be video-recorded and while the injection is being administered, the built-in iOCT of the Artevo surgical microscope (Zeiss, Oberkochen, Germany) will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review., conditionsModule conditions: Subretinal Hemorrhage, conditions: Age-Related Macular Degeneration, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Investigator-initiated, academic, mono-center, prospective, interventional case study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Robotic subretinal tPA injection, outcomesModule primaryOutcomes measure: Percentage of patients with succesful subretinal insertion of the robot-held 41G needle, primaryOutcomes measure: Percentage of patients with stable subretinal position of the needle for at least 3 minutes., secondaryOutcomes measure: Device-related adverse events, secondaryOutcomes measure: Functional outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Peter Stalmans, MD PhD, role: CONTACT, email: peter.stalmans@uzleuven.be, contacts name: Ivo De Clerck, MD, role: CONTACT, email: ivo.declerck@uzleuven.be, contacts name: Ivo De Clerck, MD, role: SUB_INVESTIGATOR, contacts name: Peter Stalmans, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False
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protocolSection identificationModule nctId: NCT06347094, orgStudyIdInfo id: 610/2023/SPER/UNIPR, briefTitle: Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols, acronym: PRE-CARE-DIET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Parma, class: OTHER, collaborators name: Azienda Ospedaliero-Universitaria di Parma, collaborators name: University of Milan, collaborators name: Foundation for Liver Research, collaborators name: National Research Council, Spain, descriptionModule briefSummary: This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping., conditionsModule conditions: Individual Variability in (Poly)Phenol Metabolism, conditions: Cardiometabolic Health, conditions: Personalized Dietary Intervention, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Metabotypes will also be masked to participants and investigators, while the dietary treatment will not., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: Personalized Dietary Plan, interventions name: Oral (Poly)phenol Challenge Test (OPCT), interventions name: General Dietary Advice, outcomesModule primaryOutcomes measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation, primaryOutcomes measure: Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons, secondaryOutcomes measure: Anthropometric measurements: weight, height and body mass index, secondaryOutcomes measure: Anthropometric measurements: waist and hip circumferences detection, secondaryOutcomes measure: Body composition: bioelectrical impedance analysis, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Biomarkers of cardiometabolic health: hematochemical and urine analysis, secondaryOutcomes measure: Biomarkers of cardiometabolic health: alanine aminotransferase, aspartate aminotransferase and gamma glutamyl transferase, secondaryOutcomes measure: Biomarkers of cardiometabolic health: homocysteine, secondaryOutcomes measure: Biomarkers of cardiometabolic health: insulin, secondaryOutcomes measure: Biomarkers of cardiometabolic health: glycated hemoglobin and glycated albumin, secondaryOutcomes measure: Biomarkers of cardiometabolic health: quantitative insulin-sensitivity check index, secondaryOutcomes measure: Biomarkers of cardiometabolic health: homeostasis model assessment beta-cell function, secondaryOutcomes measure: Biomarkers of cardiometabolic health: homeostasis model assessment of insulin resistance, secondaryOutcomes measure: Inflammatory status, secondaryOutcomes measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 10-years, secondaryOutcomes measure: Risk prediction scores: Framingham General Cardiovascular Risk Score - 30-years, secondaryOutcomes measure: Risk prediction scores: Hard Coronary Heart Disease - 10-years risk, secondaryOutcomes measure: Risk prediction scores: First Coronary Heart Disease - 2-years risk, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Diabetes, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Hypertension, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Stroke, secondaryOutcomes measure: Risk prediction scores: Framingham Heart Study for Fatty Liver Disease, secondaryOutcomes measure: Risk prediction scores: Atherosclerotic Cardiovascular Disease, secondaryOutcomes measure: Risk prediction scores: QRESEARCH risk estimator version 3, secondaryOutcomes measure: Risk prediction scores: QDiabetes Score, secondaryOutcomes measure: Risk prediction scores: Finnish Diabetes Risk Score, secondaryOutcomes measure: Risk prediction scores: Cuore Project - Calculating the individual risk score, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: the Healthy Eating Index, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: Italian Mediterranean Index, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: Greek Mediterranean Index, secondaryOutcomes measure: Evaluation of adherence to healthy and sustainable dietary models: DASH Index, secondaryOutcomes measure: Evaluation of adherence to Mediterranean diet, secondaryOutcomes measure: Nutritional and energy assessment: LARN, secondaryOutcomes measure: Nutritional and energy assessment: EPIC, secondaryOutcomes measure: Dietary intake assessment of plant bioactive compounds and dietary components related to gut microbiome, secondaryOutcomes measure: Lifestyle factors assessment: general information, secondaryOutcomes measure: Lifestyle factors assessment: sleep quality (PSQI), secondaryOutcomes measure: Lifestyle factors assessment: sleep quality (ESS), secondaryOutcomes measure: Lifestyle factors assessment: sleep quality (ISI), secondaryOutcomes measure: Lifestyle factors assessment: physical activity (IPAQ), secondaryOutcomes measure: Lifestyle factors assessment: state of health (BDI), secondaryOutcomes measure: Lifestyle factors assessment: state of health (SF-36), secondaryOutcomes measure: (Poly)phenol metabolites and changes in the prevalence of aggregate phenolic metabotypes, secondaryOutcomes measure: Other plant bioactive metabolites, secondaryOutcomes measure: Food/gut/host-derived metabolites, secondaryOutcomes measure: Biomarkers of food intake and of healthy dietary patterns, secondaryOutcomes measure: Untargeted metabolomics, secondaryOutcomes measure: Genetic differences, secondaryOutcomes measure: Gut microbiota composition, secondaryOutcomes measure: Oral microbiota composition, secondaryOutcomes measure: Biomarkers of adipose tissue function, secondaryOutcomes measure: Biomarkers of food intake regulation, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Parma - Plesso Biotecnologico Integrato, city: Parma, state: PR, zip: 43125, country: Italy, contacts name: Pedro M Mena Parreño, PhD, role: CONTACT, phone: +39 0521 903970, email: pedromiguel.menaparreno@unipr.it, contacts name: Joana M Santos Rebelo, MSc, role: CONTACT, phone: +39 0521902043, email: joanamaria.santosrebelo@unipr.it, contacts name: Pedro M Mena Parreño, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.79935, lon: 10.32618, locations facility: Azienda Ospedaliero-Universitaria di Parma, city: Parma, state: PR, zip: 43126, country: Italy, contacts name: Riccardo Bonadonna, MD, role: CONTACT, phone: +39 0521 033307, email: riccardo.bonadonna@unipr.it, geoPoint lat: 44.79935, lon: 10.32618, hasResults: False
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protocolSection identificationModule nctId: NCT06347081, orgStudyIdInfo id: P.T.REC/012/00449, briefTitle: Effect of Nd-YAG Laser on Hypertrophic Scar, acronym: Nd-YAG, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-02-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: A hypertrophic scar is a serious health concern in the industrialized world. Two groups of patients were treated with standard medical care. The experimental group received additional laser therapy. scar assessment was measured immediately before treatment, after 3, and 7 months.T test for comparison before-treatment between the control and study groups. ANOVA with repeated measures test for comparison among other measures., conditionsModule conditions: Hypertrophic Scar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: one treatment one control group, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Nd- YAG laser at 532nm wavelength, outcomesModule primaryOutcomes measure: hypertrophic scar maturation, primaryOutcomes measure: hypertrophic scar volume, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, city: Cairo, zip: 12613, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06347068, orgStudyIdInfo id: LCCC2128-ATL, briefTitle: Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: UNC Lineberger Comprehensive Cancer Center, class: OTHER, collaborators name: Bellicum Pharmaceuticals, descriptionModule briefSummary: This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC)., conditionsModule conditions: Breast Cancer, conditions: Relapse, conditions: Resistant Cancer, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: iC9-CAR.B7-H3 T Cell Therapy, interventions name: cyclophosphamide, interventions name: fludarabine, outcomesModule primaryOutcomes measure: Toxicity: NCI-CTCAE, primaryOutcomes measure: Toxicity: Cytokine Release Syndrome (CRS), primaryOutcomes measure: Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS), secondaryOutcomes measure: The recommended phase 2 dose (RP2D) NCI-CTCAE v5., secondaryOutcomes measure: The recommended phase 2 dose (RP2D) CRS Grading, secondaryOutcomes measure: The recommended phase 2 dose (RP2D), secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Duration of Response (DOR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Catherine Cheng, role: CONTACT, phone: 919-445-4208, email: catherine_cheng@med.unc.edu, contacts name: E. Claire Dees, MD, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06347055, orgStudyIdInfo id: 403690, briefTitle: NeuroControl of Nicotine Dependence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2030-03-25, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Missouri-Columbia, class: OTHER, descriptionModule briefSummary: The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours., conditionsModule conditions: Nicotine Dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Repetitive Transcranial Magnetic Stimulation (rTMS), outcomesModule primaryOutcomes measure: Acute effects of cTBS on cognitive control, secondaryOutcomes measure: Exploratory: Acute effects of cTBS on fMRI brain response, otherOutcomes measure: Safety and Tolerability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06347042, orgStudyIdInfo id: 012/004897, briefTitle: Effect of Qigong on Sleep Quality in Fibromyalgia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study aims to determine any significant efficacy of qigong exercise on sleep quality and heart rate variability in patients with fibromyalgia., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: qigong exercise + routine medical treatment +Anti-inflammatory diet, interventions name: routine medical treatment +Anti-inflammatory diet only, outcomesModule primaryOutcomes measure: Sleep quality, primaryOutcomes measure: Heart Rate variability, secondaryOutcomes measure: Quality of Life o measure the quality of life of patients with problems found fibromyalgia., secondaryOutcomes measure: pain self-administered questionnaire, secondaryOutcomes measure: Fatigue :prevalence and severity of fatigue, secondaryOutcomes measure: Depression and Anxiety assess Depression and Anxiety, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical therapy Cairo University, city: Cairo, state: Giza, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06347029, orgStudyIdInfo id: Endothelial dysfunction, briefTitle: Evaluation of Endothelial Dysfunction Using the "Flow Mediated Dilation" Test in a Population of Chronic Renal Failure Patients at Different Stages, and Evaluation of the Role of Antiphospholipid Antibodies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-17, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Brugmann University Hospital, class: OTHER, descriptionModule briefSummary: The vascular endothelium is an organ in its own right, playing, among other things, a primordial role in the control of vascular tone. This vascular tone is ensured by pro-dilator mediators (nitric oxide (NO), prostacyclins (PGI2)), or vasoconstrictors (endothelin, thromboxane A2 or PGH2).Uremic toxin accumulation in chronic kidney disease (CKD) is a well-known factor in endothelial dysfunction, often associated with higher cardiovascular risk. This association is also present for terminal chronic kidney disease characterized by the need to resort to an extra-renal purification technique (in-center hemodialysis (HD), daily home hemodialysis (HDQ), peritoneal dialysis) or to resort to renal transplantation.For HD to be effective, it is essential that the blood flow rate passing through the dialyzer is greater than 300ml/min. This imperative requires that any hemodialysis patient have specific vascular access (dialysis catheter or arteriovenous fistula (AVF)) to ensure these flow rates. The vascular access of choice is the arteriovenous fistula, because it is associated with a lower risk of infection and lower morbidity and mortality. Making an arteriovenous fistula consists of surgically creating an anastomosis between a vein and an artery.Complications of arteriovenous fistula are common. Arteriovenous fistula maturation may be delayed (maturation delay) or even absent. Drainage veins and/or anastomoses can also be the site of stenosis or thrombosis. The pathophysiology of these complications is complex and multifactorial. Among the risk factors for these complications (delay or absence of maturation, stenosis thrombosis), the positivity of antiphospholipid antibodies (aPL) can be cited, as well as endothelial dysfunction.Antiphospholipid syndrome (APS) is an autoimmune disease causing a thrombotic phenotype. This is an acquired thrombophilia. In the general population, the prevalence of antiphospholipid antibodies is around 0.5%; this prevalence is far from rare in hemodialysis, since it represents up to 37% in dialysis patients. In a retrospective study carried out at Brugmann University Hospital in 2023, on 115 patients with AVF and in whom aPL dosages were available, the prevalence of persistent positivity (2 positive dosages spaced more than 12 weeks apart) was 21%.Interestingly, a third of the cohort presented an antibody profile that did not allow them to be classified according to the classification criteria in force. This group corresponds to patients with a single positive dosage, either not recontrolled or recontrolled negative. This group was called Fluctuating. This fluctuating group was associated with arteriovenous fistula complications in a 2019 study.Endothelial dysfunction is also implicated in the pathophysiology of APS. In clinical practice, the "flow mediated dilation" (FMD) test makes it possible to assess endothelial dysfunction in vivo. It involves the phenomenon of post-occlusive hyperemia which is mainly linked to NO and endothelium-dependent vasodilation. In the brachial artery, NO is the sole mediator of FMD. Endothelial dysfunction according to FMD has been described in populations with advanced chronic kidney disease, as well as patients with cardiovascular diseases. Hemodialysis patients with delayed/absence of arteriovenous fistula maturation have more pathological FMDs compared to dialysis patients without fistula problems. However, the additive role of aPL in this different population has not been studied in terms of endothelial dysfunction by FMD.The objective of this study is to evaluate the weight of antiphospholipid biology on endothelial dysfunction in hemodialysis patients, using the FMD test.1. Compare endothelial dysfunction by FMD according to the stage of chronic kidney disease and in comparison to a control group without chronic kidney disease.2. Characterize the FMD pre or post dialysis and according to the duration of the long (for example between Thursday and Sunday) vs. short (between Tuesday and Thursday) inter-dialytic period.3. Evaluate the relationship between endothelial dysfunction according to FMD, aPL positivity and arteriovenous fistula complications in hemodialysis patients.4. Evaluate the risk factors associated with endothelial dysfunction according to FMD, and in particular evaluate the impact of antiphospholipid antibodies.5. Evaluate the correlation between endothelial dysfunction according to FMD and other markers of endothelial dysfunction (urinary NO and metabolites of urinary NO, PGI2, endothelin, PGH2)., conditionsModule conditions: Chronic Renal Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Urine sampling, interventions name: Blood sampling, interventions name: Flow mediated dilatation test, outcomesModule primaryOutcomes measure: Nitric oxide (NO) plasma level, primaryOutcomes measure: Endothelin 1 (ET-1) plasma level, primaryOutcomes measure: E-Selectine plasma level, primaryOutcomes measure: P-Selectine plasma level, primaryOutcomes measure: Intercellular Adhesion Molecule 1 (ICAM-1) plasma level, primaryOutcomes measure: Interleukin 6 (IL-6) plasma level, primaryOutcomes measure: Nitric oxide (NO) urine concentration, primaryOutcomes measure: Endothelin 1 (ET-1) urine concentration, primaryOutcomes measure: Tumour Necrosis Factor alpha (TNF alpha) urine concentration, primaryOutcomes measure: Interleukin 6 (IL-6) urine concentration, primaryOutcomes measure: Flow mediated dilatation test result (%), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brugmann University Hospital, status: RECRUITING, city: Brussels, zip: 1020, country: Belgium, contacts name: Maxime Taghavi, MD PhD, role: CONTACT, email: Maxime.TAGHAVI@chu-brugmann.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
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protocolSection identificationModule nctId: NCT06347016, orgStudyIdInfo id: AROAPOC3-3004, secondaryIdInfos id: 2023-509301-80, type: EUDRACT_NUMBER, briefTitle: Study of Plozasiran in Adults With Severe Hypertriglyceridemia, acronym: SHASTA-4, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Arrowhead Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol., conditionsModule conditions: Severe Hypertriglyceridemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Plozasiran Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo, secondaryOutcomes measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo, secondaryOutcomes measure: Proportion of Subjects Who Achieve Fasting TG Levels of < 500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12, secondaryOutcomes measure: Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12, secondaryOutcomes measure: Proportion of Subjects Who Achieve Fasting TG Levels of <150mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo, secondaryOutcomes measure: Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo, secondaryOutcomes measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment, secondaryOutcomes measure: Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment, secondaryOutcomes measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment, secondaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) and Other Glycemic Control Parameters During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in C-Peptide During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Initiation of New Medication for Hyperglycemia among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12, secondaryOutcomes measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Subjects Receiving Plozasiran Over Time Through Month 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06347003, orgStudyIdInfo id: AROAPOC3-3003, secondaryIdInfos id: 2023-509300-14, type: EUDRACT_NUMBER, briefTitle: Phase 3 Study of Plozasiran in Adults With Severe Hypertriglyceridemia, acronym: SHASTA-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Arrowhead Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This Phase 3 study will evaluate the safety and efficacy of plozasiran injection (ARO-APOC3) in adult participants with severe hypertriglyceridemia (SHTG). After providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. After month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol., conditionsModule conditions: Severe Hypertriglyceridemia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 405, type: ESTIMATED, armsInterventionsModule interventions name: Plozasiran Injection, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent Change in Fasting Serum Triglyceride (TG) Levels from Baseline to Month 12 Compared to Placebo, secondaryOutcomes measure: Percent Change in Fasting Serum TG Levels from Baseline to Month 10 Compared to Placebo, secondaryOutcomes measure: Proportion of Participants Who Achieve Fasting TG Levels of <500 mg/dL (<5.65 mmol/L) at Month 10 and Month 12 Compared to Placebo, secondaryOutcomes measure: Adjudicated Abdominal Clinical Event Rate (Including Emergency Room Visits or Hospitalizations for Abdominal Pain Attributed to Hypertriglyceridemia and Events of Documented Pancreatitis) During the Treatment Period Compared to Placebo at Month 12, secondaryOutcomes measure: Proportion of Participants Who Achieve Fasting TG Levels of <150 mg/dL (<1.69 mmol/L) at Month 10 and Month 12 Compared to Placebo, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Over Time through Month 12 as Compared to Placebo, secondaryOutcomes measure: Incidence Rates of New-Onset Diabetes Mellitus (NODM) Throughout the Course of Treatment, secondaryOutcomes measure: Incidence Rates of Impaired Glucose Tolerance Throughout the Course of Treatment, secondaryOutcomes measure: Incidence Rates of Worsening of Existing Diabetes Throughout the Course of Treatment, secondaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Fasting Blood Glucose During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in C-peptide During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Change from Baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Incidence Rates of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) Associated with Worsening Glycemic Control During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Initiation of New Medication for Hyperglycemia Among Study Participants Not Known to Have Pre-existing Diabetes Mellitus During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Adjudicated Major Adverse Cardiovascular Events (MACE) Rates During the Treatment Period Compared to Placebo, secondaryOutcomes measure: Incidence of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12, secondaryOutcomes measure: Titers of Anti-drug Antibodies (ADA) to Plozasiran in Participants Receiving Plozasiran Over Time Through Month 12, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346990, orgStudyIdInfo id: Faculty 2023-2024-2-2, briefTitle: The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-14, completionDateStruct date: 2025-05-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Applied Science Private University, class: OTHER, descriptionModule briefSummary: This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome., conditionsModule conditions: Coronary Artery Disease, conditions: Coronary Artery Bypass Graft Surgery, conditions: Delirium, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Taking into consideration that this was a RCT, blinding the participants was not possible. However, data collectors and data analyzer were blinded. Directly after the intervention, each day at 3pm and 9 pm, the participants were evaluated for development of delirium by the Research assistant how do not know in which group was the participant allocated, and if the result was positive the intervention was discontinued., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Holy Quran Recital, outcomesModule primaryOutcomes measure: Delirium, secondaryOutcomes measure: Length of stay-ICU, secondaryOutcomes measure: Length of stay-hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346977, orgStudyIdInfo id: DTO-20231214, briefTitle: Diagnosis of Leptomeningeal Metastasis and the Monitoring of Intrathecal Chemotherapy Efficacy in NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: Non-small cell lung cancer (NSCLC), occupying a disquieting position as the second most prevalent and deadliest neoplasm worldwide, afflicts an estimated 30% of its patients with intracranial metastatic spread. Among these, leptomeningeal metastasis (LM) is an exceptionally surreptitious and perilous manifestation, often evading timely and accurate diagnosis. The clinical landscape is further complicated by the presence of patients who, due to various reasons, are unable to undergo lumbar puncture, a procedure crucial for the investigation of LM. Moreover, even when cerebrospinal fluid (CSF) analysis via conventional cytological and immunohistochemical methods is attempted, a definitive diagnosis of LM may remain elusive in a subset of cases.Intrathecal chemotherapy, particularly via the administration of pemetrexed, which has demonstrated both notable efficacy and an acceptable safety profile when delivered directly into the cerebrospinal space, constitutes a cornerstone of treatment for NSCLC-LM. Despite its importance, the lack of robust, validated biomarkers to gauge the therapeutic response to such interventions represents a significant knowledge gap. This deficit is compounded by the inherent challenges associated with CSF samples, including their limited availability and the suboptimal sensitivity and high resource demands of current ctDNA assessment techniques.To address these pressing diagnostic and monitoring needs in NSCLC-LM management, the investigator proposes a forward-looking, non-interventional clinical study harnessing the power of cutting-edge proteomic technologies. These platforms, characterized by their high throughput, exquisite sensitivity, and minimal sample volume requirements, offer a promising avenue for elucidating the intricacies of chemotherapy response in intrathecal therapy. The study aims to provide valuable insights into improving diagnostic accuracy for LM in NSCLC patients and to establish a more rigorous framework for assessing treatment efficacy in individuals undergoing intrathecal chemotherapy, ultimately contributing to enhanced patient care and personalized therapeutic strategies., conditionsModule conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pemetrexed, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Union hospital, city: Wuhan, state: Hubei, zip: 430000, country: China, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06346964, orgStudyIdInfo id: 2024-341, briefTitle: Self-Care Management in Older Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-22, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Ankara Yildirim Beyazıt University, class: OTHER, descriptionModule briefSummary: Self-management of chronic diseases requires the ability to manage the symptoms, treatment, and lifestyle changes inherent in living with a chronic disease. Rational drug use by older adults is of particular importance. Mobile applications are being developed to facilitate the compliance of older adults with chronic diseases with medication treatment and to increase their disease self-management skills. The research was planned to strengthen participation in social life through rational drug use and disease self-care management in older adults with chronic diseases. The research will be conducted in a parallel group randomized controlled manner. In the research, a mobile application will be developed for the use of older adults. Older adults will be asked to use the mobile application for at least 6 months, and the scales will be re-administered face to face or online in the 3rd and 6th months of the intervention., conditionsModule conditions: Disease Self Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: mobile application, outcomesModule primaryOutcomes measure: Participation in social life (Social Inclusion Scale), primaryOutcomes measure: Participation in social life (Social Inclusion Scale), primaryOutcomes measure: Participation in social life (Social Inclusion Scale), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Yıldırım Beyazıt University, city: Ankara, state: Çubuk/Turkey, zip: 06760, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06346951, orgStudyIdInfo id: LPan, briefTitle: Survey on the Current Status of IFD Diagnosis and Treatment by Intensive Care Physicians in Sichuan Province (IFS), acronym: IFS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sichuan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this survey is to learn about the current status of the diagnosis and treatment of invasive fungal infections among intensive care physicians in Sichuan Province (IFS). Its primary focus lies on answering the following questions: ①awareness and proficiency in diagnosis and treatment; ②the use of antifungal medications; ③the application of microbiological identification and diagnostic methods. We aim to analyze the problems and deficiencies that existed among intensive care physicians in order to provide a basis for the development of targeted training and intervention measures., conditionsModule conditions: Invasive Fungal Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: The survey on the hospital's diagnostic and treatment standards and infrastructure for invasive fungal infections, primaryOutcomes measure: The survey on the awareness of an invasive fungal infection among intensive care physicians, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06346938, orgStudyIdInfo id: 2024WHXH001, briefTitle: The Clinical Significance of CT-based Biomarkers in the Classification and Prognosis of Bronchiectasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2027-03-26, completionDateStruct date: 2027-03-26, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: As the third major chronic airway disease in China, bronchiectasis has a wide range of patients. However, the involved sites, morphological features and airway obstruction of bronchiectasis are varied, and clinical heterogeneity is high, making prognosis and severity difficult to evaluate. CT plays an important role in the diagnosis and classification of ramadasis. Based on this, we analyzed the CT findings of patients with bronchiectasis and followed up patients with bronchiectasis to understand their disease progression and prognosis, so as to further analyze the role of CT biomarkers in the type and prognosis of bronchiectasis diseases., conditionsModule conditions: Bronchiectasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Frequency of acute exacerbations of bronchiectasis, secondaryOutcomes measure: Deterioration of lung function, secondaryOutcomes measure: Severity of dyspnoea, secondaryOutcomes measure: Degree of emphysema, secondaryOutcomes measure: Mucus plug score, secondaryOutcomes measure: Bhalla scores on CT of participants' lungs, secondaryOutcomes measure: Frequency of hospitalisation, secondaryOutcomes measure: Death, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wuhan Union Hospital, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Xiaorong Wang, role: CONTACT, phone: 18627195231, phoneExt: +86, email: rong-100@163.com, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
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protocolSection identificationModule nctId: NCT06346925, orgStudyIdInfo id: SHR8735-116, briefTitle: Study of the Food Effects of Herombopag Olamine Tablets in Healthy Subjects., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Jiangsu HengRui Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study was designed as a single-center, randomized, open, two-cycle, cross-over trial. It is planned to enroll 18 healthy subjects, conditionsModule conditions: Adult Patients With Chronic Primary ITP, conditions: Adult Patients With SAA Who do Not Respond Well to Immunosuppressive Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Herombopag Olamine Tablets, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: AUC0-t, primaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: V/F, secondaryOutcomes measure: Incidence and severity of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Second Hospital of Anhui Medical Uniersity, city: Hefei, state: Anhui, zip: 230601, country: China, contacts name: Wei Hu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.86389, lon: 117.28083, hasResults: False
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protocolSection identificationModule nctId: NCT06346912, orgStudyIdInfo id: TXB2023022, briefTitle: CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2027-04-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Shanghai YaKe Biotechnology Ltd., descriptionModule briefSummary: Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma., conditionsModule conditions: Acute Lymphoblastic Leukemia,B-Cell, conditions: Non-hodgkin Lymphoma,B Cell, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: CD19-BAFF Targeted CAR T-cells, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), secondaryOutcomes measure: Overall response rate ,ORR, secondaryOutcomes measure: Duration of remission ,DOR, secondaryOutcomes measure: Event-free survival, EFS, secondaryOutcomes measure: Overall survival, OS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The first affiliated hospital of medical college of zhejiang university, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: He Huang, MD, role: CONTACT, phone: 86-13605714822, email: hehuangyu@126.com, contacts name: Yongxian Hu, MD, role: CONTACT, phone: +8615957162012, email: huyongxian2000@aliyun.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06346899, orgStudyIdInfo id: TAK-743-4012, briefTitle: A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-14, primaryCompletionDateStruct date: 2025-08-13, completionDateStruct date: 2025-08-13, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The Chinese health authority has approved lanadelumab to prevent Hereditary Angioedema (HAE) attacks in persons of 12 years and older. It has also approved icatibant to treat acute HAE attacks in persons 2 years and older.One of the main aims of this study is to learn about the number of HAE attacks in 1 month in Chinese persons with HAE during their treatment with lanadelumab. The other main aim is to learn how much time is needed to resolve acute HAE attacks when treated with icatibant. Other aims of this study are to learn more about side effects of lanadelumab and icatibant treatment as well as to collect additional information on the treatment with lanadelumab, such as the dose and how often it needs to be given, reasons for stopping the treatment with lanadelumab and how long it was taken until stopping. Participants will be treated by their doctors according to routine medical practice. Only data already available in the medical records of the participants will be reviewed and collected during this study., conditionsModule conditions: Hereditary Angioedema (HAE), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Monthly Rate of HAE Attacks for Each Lanadelumab-treated Participant During the Lanadelumab Exposure Period, primaryOutcomes measure: Median Time to Complete Attack Resolution for Icatibant Treated Participants, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) During Lanadelumab and Icatibant Exposure Period, secondaryOutcomes measure: Dosage of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period, secondaryOutcomes measure: Frequency Administration of Lanadelumab Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period, secondaryOutcomes measure: Number of Participants with Reasons of Discontinuation of Lanadelumab During the Lanadelumab Exposure Period, secondaryOutcomes measure: Time to Lanadelumab Discontinuation Among Lanadelumab-treated Participant During the Lanadelumab Exposure Period, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346886, orgStudyIdInfo id: 23-011703, briefTitle: HTN App for HTN Control and Cardiovascular Health Among African-Americans, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: Miami Heart Research Institute Inc., descriptionModule briefSummary: The purpose of this study is to test the hypertension (HTN) app-based intervention to see if it is more effective in improving uncontrolled HTN and HTN self-care among Africian-Americans from baseline to post-intervention (immediate, 3 months and 6 months post-intervention) as compared to the standard of care., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: FAITH! HTN app, outcomesModule primaryOutcomes measure: Absolute Change in Systolic Blood Pressure (BP), primaryOutcomes measure: HTN Self-Care as reported by H-SCALE(HTN Self-Care Activity Level Effects), secondaryOutcomes measure: Proportion of subjects reaching BP control, secondaryOutcomes measure: Change in BP as assessed by home BP cuff measurements, secondaryOutcomes measure: CV Health Knowledge as measured by module assessment scores, secondaryOutcomes measure: Hypertension (HTN) Knowledge as assessed by 11-item questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Lainey Moen, role: CONTACT, phone: 507-266-7062, email: Moen.Lainey@mayo.edu, contacts name: Ashton Krogman, role: CONTACT, phone: (507) 266-2087, email: Krogman.Ashton@mayo.edu, contacts name: LaPrincess Brewer, M.D., M.P.H., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06346873, orgStudyIdInfo id: 23-008090, briefTitle: Demonstrating Efficacy of JOGO for the Treatment of Tremor, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This research is being done to determine the effectiveness of a new treatment, called JOGO, for patients with functional tremor (FT). JOGO is a biofeedback device that has been shown to help patients with several conditions, e.g., chronic pain, migraine, and Parkinson's disease (PD)-related tremor. JOGO provides biofeedback by using wireless adhesive stickers, called surface electromyography, to get information about muscle activity. This information is then used to modify symptoms through a series of training sessions with a physical therapist and individual practice., conditionsModule conditions: Functional Neurological Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: JOGO, outcomesModule primaryOutcomes measure: Change in TETRAS scores 1 month, secondaryOutcomes measure: Change in TETRAS scores 2 months, secondaryOutcomes measure: Change in QUEST scores, secondaryOutcomes measure: Tremor prevalence, secondaryOutcomes measure: Tremor resolution 1 month, secondaryOutcomes measure: Tremor resolution 2 months, secondaryOutcomes measure: Change in BDI-II scores, secondaryOutcomes measure: Change in BAI scores, secondaryOutcomes measure: Change in Intolerance of Uncertainty Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224, country: United States, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False
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protocolSection identificationModule nctId: NCT06346860, orgStudyIdInfo id: 09.2024.241, briefTitle: Comparing Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach., conditionsModule conditions: Opioid Use, conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Regional Block Comparison, outcomesModule primaryOutcomes measure: Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device, secondaryOutcomes measure: Postoperative pain assessment with Numeric Rating Scale (NRS), secondaryOutcomes measure: Comparison of the frequency of treatment related complications, secondaryOutcomes measure: Participant satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Marmara University School of Medicine, city: Istanbul, country: Turkey, contacts name: Beliz Bilgili, role: CONTACT, phone: 05362187927, email: belizbilgili@gmail.com, contacts name: Ayse Deniz Kayir, role: CONTACT, phone: 05465626316, email: kayir_95@hotmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06346847, orgStudyIdInfo id: TAC/231001/AKM/IBS, secondaryIdInfos id: IBS-D PAM, type: OTHER, domain: The Akkermansia Company, briefTitle: Study to Assess Effects of Pasteurized Akkermansia Muciniphila vs Placebo in Participants With Diarrhea-predominant IBS, acronym: PAM-DIGEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: A-Mansia Biotech S.A., class: INDUSTRY, collaborators name: Vedic Lifesciences Pvt. Ltd., descriptionModule briefSummary: The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of pasteurized Akkermansia muciniphila on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of pAkk on anxiety, low mood and stress of the participants, as well as its safety and tolerability.The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase)., conditionsModule conditions: Diarrhea-Predominant Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-blind, Placebo-controlled, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: Pasteurized Akkermansia muciniphila (pAKK), interventions name: Placebo, outcomesModule primaryOutcomes measure: To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome., secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12., secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12., secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS), secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS), secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: HCG Hospital, city: Ahmedabad, state: Gujarat, zip: 380006, country: India, contacts name: Dr. Manoj Vithalani, MBBS, MD, role: CONTACT, phone: 9825024355, email: drmvithalani@gmail.com, contacts name: Dr. Manoj Vithalani, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Anand Multispeciality Hospital, city: Vadodara, state: Gujarat, zip: 390016, country: India, contacts name: Dr. Himanshu Patel, MBBS, DNB, role: CONTACT, phone: 8141001672, email: dr.himanshuvpatel@gmail.com, contacts name: Dr. Himanshu Patel, MBBS, DNB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.29941, lon: 73.20812, locations facility: Stress Test Clinic, city: Mumbai, state: Maharashtra, zip: 400059, country: India, contacts name: Dr. Ramesh Dargad, MBBS, MD, role: CONTACT, phone: 9820152828, email: rohitdargad@outlook.com, contacts name: Dr. Ramesh Dargad, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Criticare Asia Multispeciality Hospital & Research Centre, city: Mumbai, state: Maharashtra, zip: 400069, country: India, contacts name: Dr. Sanjeev Khanna, MD, MNAMS, role: CONTACT, phone: 9820055090, email: dr.sanjeevkhanna@yahoo.com, contacts name: Dr. Sanjeev Khanna, MD, MNAMS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Surya Multispeciality Hospital, city: Nashik, state: Maharashtra, zip: 422003, country: India, contacts name: Dr. Gaurav Bachhav, MD, DM, role: CONTACT, phone: 9867111119, email: drgauravbachhav@gmail.com, contacts name: Dr. Gaurav Bachhav, MD, DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.99727, lon: 73.79096, locations facility: Astha Clinic, city: Nashik, state: Maharashtra, zip: 422011, country: India, contacts name: Dr. Mohit Chaudhary, MBBS, MD, role: CONTACT, phone: 7744825746, email: m.chaudhary8@gmail.com, contacts name: Dr. Mohit Chaudhary, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.99727, lon: 73.79096, locations facility: Apollo Hospital, city: Navi Mumbai, state: Maharashtra, zip: 400614, country: India, contacts name: Dr. Amey Sonavane, MBBS, DNB, role: CONTACT, phone: 9619879955, email: amey_max@yahoo.com, contacts name: Dr. Amey Sonavane, MBBS, DNB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.03681, lon: 73.01582, locations facility: Swara Hospital, city: Palghar, state: Maharashtra, zip: 401303, country: India, contacts name: Dr. Prashant Walke, MBBS, MD, role: CONTACT, phone: 9860844434, email: walkedrprashant@gmail.com, contacts name: Dr. Prashant Walke, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.69693, lon: 72.76543, locations facility: Gastrohub Hospital, city: Pune, state: Maharashtra, zip: 411027, country: India, contacts name: Dr. Mandar Doiphode, MBBS, DNB, role: CONTACT, phone: 9850077168, email: mandardoiphode22@gmail.com, contacts name: Dr. Mandar Doiphode, MBBS, DNB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Umarji Mother and Child Care Hospital, city: Pune, state: Maharashtra, zip: 411045, country: India, contacts name: Dr. Prasad Bhatte, MD DM, role: CONTACT, phone: 9920039265, email: prasadbhate07@gmail.com, contacts name: Dr. Prasad Bhatte, MD DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Lifeline Multispeciality Hospita, city: Pune, state: Maharashtra, zip: 412101, country: India, contacts name: Dr. Shrikant Kote, MBBS, MD, role: CONTACT, phone: 7506360679, email: shri.kote86@gmail.com, contacts name: Dr. Shrikant Kote, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Asian Institute of Medical sciences, city: Thāne, state: Maharashtra, zip: 421203, country: India, contacts name: Dr Vineet Chaudhari, MD, DNB, role: CONTACT, phone: 7337422597, email: chaudhari.vineet@gmail.com, contacts name: Dr Vineet Chaudhari, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.19704, lon: 72.96355, locations facility: Maharaja Agrasen Superspeciality Hospital, city: Jaipur, state: Rajasthan, zip: 302039, country: India, contacts name: Dr. Prabhat K Sharma, MBBS, MD, role: CONTACT, phone: 9983995050, email: pksharma.clinical@gmail.com, contacts name: Dr. Prabhat K Sharma, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Samvedna Hospita, city: Varanasi, state: Uttar Pradesh, zip: 221005, country: India, contacts name: Dr. Hemant K Gupta, MBBS, MD, DM, role: CONTACT, phone: 8573888800, email: drhemantg26@gmail.com, contacts name: Dr. Hemant K Gupta, MBBS, MD, DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.31668, lon: 83.01041, hasResults: False
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protocolSection identificationModule nctId: NCT06346834, orgStudyIdInfo id: PRO-sIPV-4002, briefTitle: Sequential Vaccination of Poliomyelitis Vaccine (Vero Cells), Inactivated, Sabin Strains From Different Manufacturers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sinovac Biotech Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: To evaluate the immunogenicity and safety of sequential vaccination with Sinovac sIPV among infants who have received two doses of Biological Products Co., Ltd. sIPV., conditionsModule conditions: Poliomyelitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: sIPV, outcomesModule primaryOutcomes measure: Geometric Mean Increase (GMI), primaryOutcomes measure: Geometric Mean Titer (GMT), primaryOutcomes measure: Seropositivity rate, primaryOutcomes measure: Seroconversion rate, primaryOutcomes measure: Adverse reaction incidence, primaryOutcomes measure: Serious adverse events incidence, eligibilityModule sex: ALL, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346821, orgStudyIdInfo id: WestChinaGBMTTFieldsV1.0, briefTitle: Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-04, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are:* The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients.* The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone.Participants will:* Receive or not receive TTFields.* Concomitantly or adjuvantly receive TTFields., conditionsModule conditions: Glioblastoma Multiforme, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Optune® (Tumor Treating Fields), outcomesModule primaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, contacts name: Lei Liu, PhD, MD, role: CONTACT, phone: +8618980606231, email: liuleihx@gmail.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06346808, orgStudyIdInfo id: PDAC-OV, briefTitle: Oncolytic Virus Plus Anti-PD1 and Chemotherapy as Preoperative Therapy for Patients With BRPC/LAPC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Oncolytic virus Plus Anti-PD1 and Chemotherapy as Preoperative therapy for Patients with Borderline Resectable and Locally Advanced Pancreatic Cancer, conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Oncolytic virus Plus Anti-PD1 and Chemotherapy, outcomesModule primaryOutcomes measure: Incidence of Treatment-Related Adverse Events [Safety and Tolerability], secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan University, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Zhong Wu, MD, role: CONTACT, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06346795, orgStudyIdInfo id: SelcukC, briefTitle: Class II Restorations With High-Filled Flowable Composites, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05)., conditionsModule conditions: Dental Caries, conditions: Class II Dental Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: High-filling flowable dental composite, outcomesModule primaryOutcomes measure: Retention, primaryOutcomes measure: Color match, primaryOutcomes measure: Marginal discoloration, primaryOutcomes measure: Marginal adaptation, primaryOutcomes measure: Secondary caries, primaryOutcomes measure: Surface texture, primaryOutcomes measure: Anatomical form, primaryOutcomes measure: Postoperative sensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06346782, orgStudyIdInfo id: IRB00370545, briefTitle: Feasibility and Acceptability of Internet-based Parent-child Interaction Therapy (I-PCIT) in Pediatric Cancer, acronym: I-PCIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins All Children's Hospital, class: OTHER, descriptionModule briefSummary: This study is being done to learn whether a telehealth intervention called "Internet-Based Parent Child Interaction Therapy," or I-PCIT," can help parents improve the child's behavior if the child currently or previously went through cancer treatment.Parents who choose to be in this study will complete a survey to help researchers figure out if the parent is eligible for the larger study. If a parent is eligible for the larger study and chooses to participate, if so, the participants will be randomly assigned to either receive the I-PCIT intervention now or to be on a waitlist and begin I-PCIT in 5-6 months. The whole study consists of completing I-PCIT sessions with a clinician and completing 3-4 follow-up surveys after the initial screener survey., conditionsModule conditions: Pediatric Cancer, conditions: Oncology, conditions: Disruptive Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a pilot feasibility trial. We are using a 2:1 (intervention: waitlist control) randomized controlled design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Internet-Based Parent-Child Interaction Therapy, outcomesModule primaryOutcomes measure: I-PCIT Feasibility as assessed by intervention completion, primaryOutcomes measure: I-PCIT Acceptability as assessed by the Treatment Evaluation Inventory Short form, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins All Children's Hospital, status: RECRUITING, city: Saint Petersburg, state: Florida, zip: 33701, country: United States, contacts name: Melissa Faith, Ph.D., role: CONTACT, phone: 727-295-8477, email: mfaith1@jhmi.edu, geoPoint lat: 27.77086, lon: -82.67927, hasResults: False
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protocolSection identificationModule nctId: NCT06346769, orgStudyIdInfo id: SelcukB, briefTitle: Composite Restorations Performed by Placing Polyethylene Fiber, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p\<0.05)., conditionsModule conditions: Endodontically Treated Teeth, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: Polyethylene Fiber, outcomesModule primaryOutcomes measure: Retention, primaryOutcomes measure: Color match, primaryOutcomes measure: Marginal Discoloration, primaryOutcomes measure: Marginal adaptation, primaryOutcomes measure: Secondary caries, primaryOutcomes measure: Surface texture, primaryOutcomes measure: Anatomical form, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, locations facility: Selcuk University, Faculty of Dentistry, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06346756, orgStudyIdInfo id: SelcukA, briefTitle: Clinical Evaluation of Class II Restorations, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-07-01, completionDateStruct date: 2023-07-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.The study included 62 patients and 147 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. GCI only in premolar teeth; GCA, TP, and FU have been used to restore premolar and molar teeth. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (p\<0.05)., conditionsModule conditions: Dental Caries, conditions: Dental Caries Class II, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 62, type: ACTUAL, armsInterventionsModule interventions name: Treatment of dental caries., outcomesModule primaryOutcomes measure: Retention, secondaryOutcomes measure: color match, secondaryOutcomes measure: marginal adaptation, secondaryOutcomes measure: marginal discoloration, secondaryOutcomes measure: surface texture, secondaryOutcomes measure: anatomical form, secondaryOutcomes measure: secondary caries, secondaryOutcomes measure: postoperative sensitivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selcuk University, Faculty of Dentistry, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06346743, orgStudyIdInfo id: IRB/2023/1119/SIMS, briefTitle: Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Muhammad Zark, class: OTHER_GOV, descriptionModule briefSummary: Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value \< 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia \& shortening the length of hospital stay., conditionsModule conditions: Physiological Neonatal Jaundice, conditions: Physiological Hyperbilirubinaemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: To compare the effects of Fenofibrate adjuvant to phototherapy with conventional phototherapy for exaggerated neonatal hyperbilirubinemia in the form of bilirubin reduction, duration of phototherapy, hospital stay \& observation of side-effects.After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Fenofibrate, interventions name: Phototherapy, outcomesModule primaryOutcomes measure: number of days needed for serum bilirubin to decrease below phototherapy range, secondaryOutcomes measure: Hospital length of Stay, eligibilityModule sex: ALL, minimumAge: 24 Hours, maximumAge: 14 Days, stdAges: CHILD, contactsLocationsModule locations facility: Services Institute of Medical Sciences, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: Noman Abdullah, role: CONTACT, phone: +923124100143, email: info@sims.edu.pk, contacts name: Muhammad Zark, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06346730, orgStudyIdInfo id: 142-18, briefTitle: The Effect of Virtual Reality Application on Anxiety and Patient Satisfaction During Intrauterine Insemination (IUI), acronym: (IUI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Suleyman Demirel University, class: OTHER, descriptionModule briefSummary: This study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (VRG) application during the IUI procedure on anxiety and patient satisfaction. The population of the research will consist of women who were treated with assisted reproductive techniques and underwent IUI at the infertility polyclinic of Ministry of Health Adana City Training and Research Hospital between May and December 2024 and who meet the research criteria. The research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. Data; Personal Information Form, Visual Assessment Scale (VAS), State Trait Anxiety Inventory (STAI) and Patient's Perception of Nursing Care Scale will be collected from women who agree to participate in the research. Virtual reality glasses will be applied to the intervention group., conditionsModule conditions: Virtual Reality, conditions: Anxiety, conditions: Patient Satisfaction, conditions: Intrauterine Insemination (IUI), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The sample will divide into intervention and control groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality glasses to intervention group, outcomesModule primaryOutcomes measure: State Trait Anxiety Inventory (STAI), primaryOutcomes measure: Patient's Perception of Nursing Care Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346717, orgStudyIdInfo id: SINOPU-elif 2, briefTitle: Mobile Application Based Care for Total Knee Prosthesis Patients, acronym: KneeMobilApp, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sinop University, class: OTHER, descriptionModule briefSummary: Total knee prosthesis (TKP); It is a surgical treatment used in the management of functional limitations and severe pain occurring on the degenerated joint surface as a result of rheumatoid arthritis, osteoarthritis, posttraumatic arthritis and other nonspecific arthritis. Nursing care is of great importance in the success of TKP surgery. Reducing pain, preventing complications, increasing self-care ability, and improving the quality of life by improving postoperative knee functions are the main goals of postoperative nursing care. In order to achieve these goals, patients and their relatives need to receive training on home care in the post-operative period before discharge. With the increasing use of mobile technologies in daily life and the increasing adoption of e-health, the opportunity for people to improve their self-management skills through e-health is increasing. Mobile Health (m-Health) provides convenience in many areas such as educating the public, warning about potential diseases and disease risks, and communicating with messages, notifications and video when necessary. It also affects the way nursing services are delivered and provides great benefits in the delivery of nursing services. For all these reasons, it was aimed to examine the effect of mobile application-supported care given to patients with total knee prosthesis on functional status and self-care ability., conditionsModule conditions: Knee Prosthesis, conditions: Mobile Application, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: "Knee Prosthesis-M" mobile application service, outcomesModule primaryOutcomes measure: Knee Injury and Osteoarthritis Outcome Score = KOOS, secondaryOutcomes measure: Exercise of Self-Care Agency=ESCA, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elif ALTINKAYNAK SARAL, status: RECRUITING, city: Merkez, state: Osmaniye Köyü, zip: 5700, country: Turkey, contacts name: ELİF ALTINKAYNAK SARAL, PhD, role: CONTACT, phone: 05436071986, email: ealtinkynk@hotmail.com, contacts name: Sonay GÖKTAŞ, PhD, role: CONTACT, phone: 05324567776, email: sonay.goktas@sbu.edu.tr, hasResults: False
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protocolSection identificationModule nctId: NCT06346704, orgStudyIdInfo id: PR5030-66, briefTitle: Prospective Longitudinal Monocentric Study to Evaluate the Syde® Digital Endpoint in Patients With Multiple Sclerosis, acronym: NHS-MS-EGYPT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: SYSNAV, class: INDUSTRY, descriptionModule briefSummary: The study aims to assess the validity of real-world activity monitoring by the Syde® wearable device in subjects with multiple slclerosis. The Syde® collected data will be compared to on-site conventional clinical endpoints for MS pathology (EDSS, FSS and T25FWT). Subjects with multiple sclerosis will be assessed every 6 months for 2 years., conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Digital HealthTechnology, outcomesModule primaryOutcomes measure: Longitudinal change of 95th centile of stride velocity, secondaryOutcomes measure: Correlation of the Syde® variables with the clinical assessments EDSS, FSS and T25FWT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346691, orgStudyIdInfo id: MTU-EC-IM-0-235/66, briefTitle: Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Thammasat University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs.The main questions it aims to answer are:* Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?* What medical problems do participants experience when taking doxofylline and procaterol?", conditionsModule conditions: COPD, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Crossover randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Doxofylline, interventions name: Procaterol, outcomesModule primaryOutcomes measure: Forced expiratory volume in 1 second (FEV1), primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: Forced expiratory flow at 25-75% of FVC (FEF25-75), secondaryOutcomes measure: modified Medical Research Council (mMRC) score, secondaryOutcomes measure: COPD Assessment Test (CAT), eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06346678, orgStudyIdInfo id: MTU-EC-IM-0-016/67, briefTitle: Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients With Chronic Obstructive Pulmonary Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Thammasat University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients?, conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Accuhaler tester, outcomesModule primaryOutcomes measure: Accuracy of Accuhaler tester, primaryOutcomes measure: Accuracy of Ellipta tester, primaryOutcomes measure: Accuracy of Turbutester, secondaryOutcomes measure: Prevalence of suboptimal peak inspiratory flow rate, secondaryOutcomes measure: Prevalence of insufficient peak inspiratory flow rate, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346665, orgStudyIdInfo id: DZIF Tx-Cohort, briefTitle: The Transplant Cohort of the German Center for Infection Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Technical University of Munich, class: OTHER, collaborators name: Hannover Medical School, collaborators name: University Hospital Heidelberg, collaborators name: Universität Tübingen, collaborators name: Klinikum der Universität München, collaborators name: Max von Pettenkofer-Institut München, collaborators name: Nierenzentrum Heidelberg, collaborators name: Helmholtz Centre for Infection Research, descriptionModule briefSummary: Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function., conditionsModule conditions: Infections, conditions: Transplant Complication, conditions: Transplant Failure, conditions: Immunosuppression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Realisation of studies that focus on the the medical needs of transplant patients, particularly with regard to their susceptibility to infection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Technische Universität München, status: RECRUITING, city: München, country: Germany, contacts name: Daniela Schindle, Dr., role: CONTACT, geoPoint lat: 48.13743, lon: 11.57549, hasResults: False
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protocolSection identificationModule nctId: NCT06346652, orgStudyIdInfo id: REC-UOL-216-03-2024, briefTitle: Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-04-22, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Lahore, class: OTHER, descriptionModule briefSummary: Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients., conditionsModule conditions: Chronic Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 73, type: ESTIMATED, armsInterventionsModule interventions name: Routine Physical Therapy, interventions name: Routine Physical Therapy+ PNF and Core Stregthening, outcomesModule primaryOutcomes measure: Static Standing Balance, secondaryOutcomes measure: Plantar Pressure, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Lahore Teaching Hospital, status: RECRUITING, city: Lahore, zip: 54000, country: Pakistan, contacts name: Safa Saleem, MSPTN, role: CONTACT, phone: 03354028864, email: safah.saleem@gmail.com, contacts name: Sameed Liaqat, MPhil, role: CONTACT, phone: 03249004200, email: samiliaqat3@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06346639, orgStudyIdInfo id: LithuananianSportsU-17, briefTitle: Effect of a 16-day Hot and Cold Acclimation on Adaptive Responses and Health-related Indicators, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2029-04-04, completionDateStruct date: 2029-04-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Lithuanian Sports University, class: OTHER, descriptionModule briefSummary: There are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. Thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: The researchers who will analyze the saliva and venous blood samples will be blinded., enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: 16-day hot and cold acclimation, outcomesModule primaryOutcomes measure: Change in body mass and body composition (kg), primaryOutcomes measure: Change in skinfold thickness (mm), primaryOutcomes measure: Change in body mass index (kg/m^2), primaryOutcomes measure: Change in body surface area (m^2), primaryOutcomes measure: Change in substrate oxidation, primaryOutcomes measure: Change in substrate oxidation (g/day), primaryOutcomes measure: Change in ventilation (l/min), primaryOutcomes measure: Change in breathing frequency (t/min), primaryOutcomes measure: Change in resting energy expenditure (kcal/day), primaryOutcomes measure: Change in metabolic heat production (W), primaryOutcomes measure: Change in heart rate (bpm), primaryOutcomes measure: Change in blood pressure (mmHg), primaryOutcomes measure: Change in mean arterial pressure (mmHg), primaryOutcomes measure: Change in heart rate variability (ms), primaryOutcomes measure: Change in heart rate variability (time domain) (ms), primaryOutcomes measure: Change in heart rate variability (time domain) (Ln), primaryOutcomes measure: Change in heart rate variability (frequency domain) (ms^2), primaryOutcomes measure: Change in heart rate variability (frequency domain) (Ln), primaryOutcomes measure: Change in stroke volume (ml), primaryOutcomes measure: Change in stroke volume index (ml/m^2), primaryOutcomes measure: Change in cardiac output index (l/min//m^2), primaryOutcomes measure: Change in cardiac output index (l/min), primaryOutcomes measure: Change in contractility index, primaryOutcomes measure: Change in ventricular ejection time (ms), primaryOutcomes measure: Change in ventricular ejection fraction (percent), primaryOutcomes measure: Change in end diastolic volume (ml), primaryOutcomes measure: Change in systemic vascular resistance (dyn.s/cm5.m^2), primaryOutcomes measure: Change in cardiac work index (kg.m/m^2), primaryOutcomes measure: Change in early diastolic filling ratio (percent), primaryOutcomes measure: Change in testosterone concentration (µg/dl), primaryOutcomes measure: Change in female sex hormones concentration (pg/mL), primaryOutcomes measure: Change in salivary cortisol concentration (µg/dl), primaryOutcomes measure: Change in cytokines concentrations (pg/ml), primaryOutcomes measure: Change in complete blood count (10^9/L), primaryOutcomes measure: Change in complete blood count (percent), primaryOutcomes measure: Change in lipid profile (mmol/l), primaryOutcomes measure: Change in catecholamines concentration (ng/ml), primaryOutcomes measure: Change in insulin concentration (μIU/ml), primaryOutcomes measure: Change in glucose tolerance (mmol/l), primaryOutcomes measure: Change in anxiety and depression (points), primaryOutcomes measure: Change in plasma metabolites of the kynurenine pathway (μm), primaryOutcomes measure: Change in body temperature (°C), primaryOutcomes measure: Change in physiological strain index, primaryOutcomes measure: Change in cold strain index, primaryOutcomes measure: Change in root mean square (RMS) amplitude (mV), primaryOutcomes measure: Change in pain sensations, primaryOutcomes measure: Change in thermal sensations (points), primaryOutcomes measure: Change in shivering/sweating (points), primaryOutcomes measure: Change in thermal comfort (points), secondaryOutcomes measure: Height (m), secondaryOutcomes measure: Change in physical activity (in h), secondaryOutcomes measure: Change in sleep (in h), secondaryOutcomes measure: Change in oxygen saturation (percent), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Lithuanian Sports University, status: RECRUITING, city: Kaunas, zip: LT-44221, country: Lithuania, contacts name: Diana Reklaitienė, PhD, role: CONTACT, geoPoint lat: 54.90272, lon: 23.90961, hasResults: False
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protocolSection identificationModule nctId: NCT06346626, orgStudyIdInfo id: 2WIN-S2024, briefTitle: To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: He Eye Hospital, class: OTHER, descriptionModule briefSummary: Myopia, also known as short-sightedness or near-sightedness, is a prevalent condition that typically emerges during childhood and early adulthood. It occurs when the eye elongates excessively, causing images of distant objects to focus in front of the retina, leading to blurred distance vision. The number of people with myopia is increasing every year, reaching half of the world's population by 2050. The global potential productivity loss due to uncorrected refractive errors was $244 billion in 2015. Due to the strong association between high myopia and pathological changes in the choroid, retina, and sclera, leading to irreversible vision loss, and the fact that correcting the refractive error does not halt the progression of pathology, the prevention of myopia, especially high myopia, has emerged as a crucial international public health concern. In ocular examinations of children under noncycloplegic conditions, the influence of accommodation cannot be disregarded.Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations. Moreover, due to children's decreased cooperation and unreliable responses, subjective refraction tests are less valued, and objective tests under cycloplegia are preferred. The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes. Along with measuring phorias/tropias in prismatic diopters and objective refraction in the range of -15D to +15D, 2WIN-S also captures additional features.This study employed the cycloplegic condition to measurements using 2WIN-S, ARK-1 and subjective testing, we wanted to test the reliability and accuracy of 2WIN-S., conditionsModule conditions: Optometry, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: The optometric result (2WIN-S), secondaryOutcomes measure: The optometric result(ARK-1), secondaryOutcomes measure: The optometric result(subjective refraction), secondaryOutcomes measure: The optometric result, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346613, orgStudyIdInfo id: B2024-076R, briefTitle: Prevalence and Affecting Factors of Sleep and Circadian Rhythm Disorders in ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Most ICU patients experience sleep and circadian disruption (SCD), which causes a profound negative impact on patients, such as prolonged mechanical ventilation, glucose intolerance, and the occurrence of delirium. In order to better promote the alignment of circadian rhythm in ICU patients, this project will explore the prevalence of SCD and a series of influencing factors contributing to SCD in ICU patients, to help construct targeted intervention programs in the future., conditionsModule conditions: Sleep Deprivation, conditions: Circadian Rhythm Disorders, conditions: Critical Illness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 56, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rhythmicity of melatonin levels., secondaryOutcomes measure: Overnight sleep duration, secondaryOutcomes measure: Wake after sleep onset(WASO), secondaryOutcomes measure: Overnight Rapid Eye Movement (REM) proportion, secondaryOutcomes measure: Overnight non-rapid eye movement stage 1 (NREM1) proportion, secondaryOutcomes measure: Overnight non-rapid eye movement stage 2 (NREM2) proportion, secondaryOutcomes measure: Overnight non-rapid eye movement stage 3 (NREM3) proportion, secondaryOutcomes measure: Sleep period time ratio (sleep continuity), secondaryOutcomes measure: Subject sleep quality, secondaryOutcomes measure: Activity counts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 180 Fenglin Road, status: RECRUITING, city: Shanghai, zip: 20032, country: China, contacts name: Shining Cai, MSc, role: CONTACT, phone: 86-021-64041990, phoneExt: 2724, email: cai.shining@zs-hospital.sh.cn, contacts name: Yuxia Zhang, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06346600, orgStudyIdInfo id: SKG0106-LF, briefTitle: A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2031-03, completionDateStruct date: 2031-03, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Skyline Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection., conditionsModule conditions: Neovascular (Wet) Age-related Macular Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 83, type: ESTIMATED, armsInterventionsModule interventions name: SKG0106, outcomesModule primaryOutcomes measure: Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), secondaryOutcomes measure: Mean change in best corrected visual acuity (BCVA) at each visit from baseline, secondaryOutcomes measure: Mean change in macular central subfield thickness (CST) at each visit from baseline, secondaryOutcomes measure: Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ophthalmic Consultants of Boston, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Retina Consultants of Texas, status: NOT_YET_RECRUITING, city: Katy, state: Texas, zip: 77494, country: United States, geoPoint lat: 29.78579, lon: -95.8244, locations facility: Wagner Macula & Retina Center, status: NOT_YET_RECRUITING, city: Norfolk, state: Virginia, zip: 23502, country: United States, geoPoint lat: 36.84681, lon: -76.28522, locations facility: The Second Hospital Of Anhui Medical University, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Zhejiang Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Hangzhou, state: Zhejiang, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Eye Hospital, WMU (Zhejiang Eye Hospital), status: NOT_YET_RECRUITING, city: Wenzhou, state: Zhejiang, country: China, geoPoint lat: 27.99942, lon: 120.66682, locations facility: Beijing Hospital, status: NOT_YET_RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking Union Medical College Hospital, status: RECRUITING, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: EYE & ENT Hospital of Fudan University, status: RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine, status: NOT_YET_RECRUITING, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06346587, orgStudyIdInfo id: VRU751-C001, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
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protocolSection identificationModule nctId: NCT06346574, orgStudyIdInfo id: STUDY-0004282, briefTitle: HEART at Head Start Pilot (Healthy Eating, Activity, Relaxation Trial), acronym: HEART, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-14, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: United States Department of Agriculture (USDA), collaborators name: National Head Start Association, descriptionModule briefSummary: With funding from the United States Department of Agriculture (USDA), the Tufts University's Friedman School of Nutrition Science and Policy will be implementing a new, health and wellbeing program for Head Start educators at ABCD Head Start Centers in the greater Boston area.The purpose of this study is to evaluate the combined impact of a health and wellness program and behavior change guides. The evaluation will focus on ABCD Head Start educators as the study population. Tufts University's Friedman School of Nutrition Science and Policy is responsible for implementing and evaluating this new intervention through surveys and analysis of administrative (health and wellness App) data.A paper and pencil survey will be used to gather information on dietary, physical activity, and sleep behaviors. The surveys will also include a module on satisfaction with the health and wellness App and Guides. Survey data will be combined with the administrative data about App utilization., conditionsModule conditions: Dietary Habits, conditions: Physical Inactivity, conditions: Sleep Hygiene, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study participants will be educators at Head Start centers where either the intervention is offered at the onset of the study (intervention group) or after six months (comparison condition)., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Experimental, outcomesModule primaryOutcomes measure: Use of health and wellness App, primaryOutcomes measure: Engagement with Guide, primaryOutcomes measure: Nutrition behaviors, primaryOutcomes measure: Physical activity behaviors, primaryOutcomes measure: Sleep habits, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Blood glucose, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tufts University, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02111, country: United States, contacts name: Katrina Sarson, MS, MEd, role: CONTACT, phone: 617-636-3737, email: katrina.sarson@tufts.edu, contacts name: Sujata Dixit-Joshi, MPH, PhD, role: CONTACT, phone: 617-636-3737, email: sujata.dixit_joshi@tufts.edu, contacts name: Christina Economos, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06346561, orgStudyIdInfo id: Soh-Med-24-02-10MS, briefTitle: The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery., conditionsModule conditions: Nasolacrimal Duct Obstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Labetalol, outcomesModule primaryOutcomes measure: Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension., secondaryOutcomes measure: Effectiveness of dexamedetomidine for prolongation of postoperative analgesia., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag University hospitals, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, Professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06346548, orgStudyIdInfo id: VF-ES-DIG, briefTitle: Study on the Chromatic Perception of Digital Systems in Aesthetic Field, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-27, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Paolone Gaetano, class: OTHER, descriptionModule briefSummary: The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice., conditionsModule conditions: Color Detection of Upper Central Incisors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: oral photography, outcomesModule primaryOutcomes measure: Comparison of chromatic values of the upper central incisors, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele, city: Milano, zip: 20132, country: Italy, contacts name: Federico Vannini, role: CONTACT, phone: +393450764177, email: f.vannini@studenti.unisr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06346535, orgStudyIdInfo id: 2022-05703-01, briefTitle: PrimeCog: Primary Care Cognitive Testing, acronym: PrimeCog, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Region Östergötland, class: OTHER, descriptionModule briefSummary: The PrimeCog study aims to describe the symptomatology and pathophysiology of stress-induced exhaustion disorder (SED) and major depressive disorder (MDD) compared to healthy controls (HC). The participants will be recruited at primary care centers, and samples of blood, saliva, and hair will be collected. Digital questionnaires covering psychosocial variables and screening instruments for the detection of depression, anxiety, etc., along with a digital cognitive test battery, will be performed at home. Subsequently, an MRI of the brain will be performed, and analysis of biomarkers for stress, inflammation, and neurodegeneration will be conducted. These procedures will be repeated after twelve and twenty-four months. The study will investigate differences in the biomarkers, neuroimaging findings, and cognitive abilities between patients with SED, MDD, and controls over time. Associations between the symptom severity of MDD/SED and psychosocial variables, cognition, MRI, and the biomarkers will also be examined. The aim is to provide new diagnostic tools for differentiation between MDD and SED and guide individualized treatment based on underlying pathophysiology and cognitive function. All necessary competences for conducting this extensive study are represented within the research group. The PrimeCog study is unique in its comprehensive design, addressing knowledge gaps, and directly comparing these diagnoses over time in primary care, where patients are typically treated., conditionsModule conditions: Mental Health Issue, conditions: Cognitive Symptom, conditions: Primary Health Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Testing, outcomesModule primaryOutcomes measure: Cognitive Test Results regarding attention and processing speed, primaryOutcomes measure: Cognitive Test Results regarding attention and processing speed, primaryOutcomes measure: Cognitive Test Results regarding attention and processing speed, primaryOutcomes measure: Cognitive Test Results regarding attention and processing speed, primaryOutcomes measure: Cognitive Test Results regarding memory, primaryOutcomes measure: Cognitive Test Results regarding memory, primaryOutcomes measure: Cognitive Test Results regarding executive function, primaryOutcomes measure: Cognitive Test Results regarding executive function, primaryOutcomes measure: Cognitive Test Results regarding executive function, primaryOutcomes measure: Cognitive Test Results regarding language, primaryOutcomes measure: Cognitive Test Results regarding language, primaryOutcomes measure: Cognitive Test Results regarding visuospatial capacity, secondaryOutcomes measure: MRI features, measured by morphological and quantitative MR sequences of the brain, secondaryOutcomes measure: Biochemical Profile in blood regarding inflammation, stress and neurodegeneration, secondaryOutcomes measure: Biochemical Profile in saliva regarding inflammation and stress, secondaryOutcomes measure: Biochemical Profile in hair regarding exposure to stress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Region Ostergotland, primary care centrum, status: RECRUITING, city: Linköping, state: Ostergotland, country: Sweden, contacts name: Hanna Israelsson Larsen, PhD, role: CONTACT, phone: 0738317008, email: hanna.israelsson.larsen@regionostergotland.se, contacts name: Anna Segernas, PhD, role: CONTACT, phone: +46733641430, email: anna.segernas@liu.se, contacts name: Hanna Israelsson Larsen, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Anna Segernäs, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 58.41086, lon: 15.62157, hasResults: False
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protocolSection identificationModule nctId: NCT06346522, orgStudyIdInfo id: FMASU R37/2024, briefTitle: Gabapentin Versus Trospium Chloride for Prevention of a Catheter-related Bladder Discomfort Inside the ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Catheter-related bladder discomfort (CRBD) is a frequent complaint after urinary bladder catheterization which is commonly done in the perioperative period. CRBD shows similar symptoms to overactive bladder (OAB); so, drugs used for the management of OAB could influence symptoms of CRBD. Trospium chloride and gabapentin are effective in managing patient with OAB even the resistant cases. We will evaluate and compare the efficacy of both oral trospium and gabapentin on prevention of CRBD in the postoperative period in the ICU in in patients undergoing spinal surgery and requiring intraoperative catheterization of the urinary bladder., conditionsModule conditions: Catheter-related Bladder Discomfort (CRBD), designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, randomized, comparative, clinical trial study, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Gabapentin (Gaptin ®) 400mg oral capsule once, interventions name: Trospium chloride slow release (Trospikan ® SR) 60mg oral capsule, outcomesModule primaryOutcomes measure: The incidence (yes/no) and severity of catheter-related bladder discomfort (CRBD) in 1,2,6,12,24 hours after the study drugs intake, secondaryOutcomes measure: Total fentanyl requirements in micrograms (µg), secondaryOutcomes measure: Numerical Pain Rating Scale (NPRS) (0-10), secondaryOutcomes measure: Side effects of the study drugs, secondaryOutcomes measure: Ramsay sedation score, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University-Faculty of Medicine, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Ahmed M Mohamed, MD, role: CONTACT, phone: 002 01121318459, email: drahmed.mostafa.mohamed@med.asu.edu.eg, contacts name: Wessam Z Selima, MD, role: CONTACT, phone: 002 01001958858, email: w.z.selima@med.asu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06346509, orgStudyIdInfo id: PORT-77-101, briefTitle: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of PORT-77 Administered to Healthy Adult Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-12-23, completionDateStruct date: 2024-12-23, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Portal Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: A First-in-Human 2-part, randomized, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and food effect, investigation of the administration of PORT-77 in healthy adult participants., conditionsModule conditions: Healthy Adult Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: PORT-77, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of PORT-77 (Part I), primaryOutcomes measure: Number of incidence and severity of AEs as a measure of safety and tolerability of PORT-77 (Part II), secondaryOutcomes measure: Plasma concentration of a single-dose of PORT-77 (Part I), secondaryOutcomes measure: Plasma concentration of the steady-state of PORT-77 (Part II), secondaryOutcomes measure: Plasma concentration of PORT-77 by effect of a standardized high-fat/high-calorie meal (Part I), secondaryOutcomes measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part I), secondaryOutcomes measure: Evaluate effects of single doses of PORT-77 on ECG parameters (Part II), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, city: Tempe, state: Arizona, zip: 85283, country: United States, contacts role: CONTACT, email: mara.baier@celerion.com, contacts name: Mara Baier, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.41477, lon: -111.90931, hasResults: False
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protocolSection identificationModule nctId: NCT06346496, orgStudyIdInfo id: H23133, briefTitle: Young People Aged 18-25 With Depression or Anxiety Mood Participate in an LLM-based Digital Dialogue Intervention Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2023-12-18, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Institute of Psychology, Chinese Academy of Sciences, class: OTHER, descriptionModule briefSummary: This study is a 28-day randomized controlled trial (RCT). Residents were randomly assigned to an intervention group or a waiting group according to the order in which they were successfully contacted by the staff, and each user was asked to engage in a total of 28 days of dialog intervention with the Douyin companion bot and complete three psychological questionnaires (on Days 1, 14, and 28); however, the intervention group began to receive the dialog intervention after completing the first questionnaire, and the waiting group began to receive the dialog intervention after completing the third questionnaire. During the first four weeks, the waiting group was treated as a blank control. The two groups of subjects completed the three questionnaires at exactly the same point in time. Each user's depression, anxiety, and positive and negative emotions were measured using the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Scale (GAD-7) and the Positive and Negative Affect Schedule (PANAS), respectively., conditionsModule conditions: LLM-based AI Dialogue Bot, conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 657, type: ACTUAL, armsInterventionsModule interventions name: Douyin Xinqing AI dialog bot, interventions name: Douyin Xinqing AI dialog bot for delayed intervention, outcomesModule primaryOutcomes measure: Depression, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Positive and negative moods, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Psychology, Chinese Academy of Sciences, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06346483, orgStudyIdInfo id: STU00218929, briefTitle: Ureteroscopy With High-powered Holmium:Yag Laser Lithotripsy With and Moses On or Moses Off, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-09, primaryCompletionDateStruct date: 2024-06-09, completionDateStruct date: 2025-06-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: Ohio State University, descriptionModule briefSummary: The purpose of this study is to compare Moses 2.0 pulse modulation technology and the standard high powered Holmium Laser lithotripsy and how it will affect time in the operating room, time using the laser, laser energy, and stone free rates.Currently Moses 2.0 laser technology is FDA approved and currently used in practice since 2021. No study to this date has compared Moses 2.0 without pulse modulation laser technology to Moses 2.0 with pulse modulation laser technology.The study will be including kidney and ureteral stones (a kidney stone located in the tube between the kidney and the bladder) that are 6mm and greater, but less than 20 mm in size undergoing ureteroscopic treatment. High powered lasers are used for "dusting". Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine., conditionsModule conditions: Kidney Stone, conditions: Ureteral Stone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Dusting, outcomesModule primaryOutcomes measure: Operative time, primaryOutcomes measure: Stone Free Rate, secondaryOutcomes measure: Lasing time, secondaryOutcomes measure: Total laser energy (kJ), secondaryOutcomes measure: Detection of postoperative strictures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern Medicine, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Alyssa McDonald, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06346470, orgStudyIdInfo id: 3430-12, briefTitle: The Effect of Web-Based Breast Self-Examination Education, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: Breast cancer is the most common type of cancer among women. Reasons such as diagnosing breast cancer at an early stage increases the chances of treatment and survival, and the fact that the masses are largely noticed by the individual themselves, point to the importance of breast self-examination (BSE) . BSE skill is among the nursing skills. When the literature was examined, it was seen that the web-based education method was frequently used for cognitive skills during nursing education, but its use was limited for psychomotor skills training. It was determined that in BSE training, in addition to traditional education, methods such as concept maps and peer-supported education were used, but web-based education methods were not used. It is thought that the study will contribute to the literature in these aspects., conditionsModule conditions: Education, conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Web-based breast self examination education, outcomesModule primaryOutcomes measure: Skill and Knowledge of BSE, primaryOutcomes measure: Attitude of Web-Based Education, primaryOutcomes measure: Self-Directed Learning Skills, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florence Nightingale Faculty of Nursing, status: RECRUITING, city: Istanbul, state: Şişli, zip: 34381, country: Turkey, contacts name: Olga İncesu, PhD, role: CONTACT, phone: 05334942989, email: olga.incesu@iuc.edu.tr, contacts name: Olga İncesu, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Öykü Kara, Msc, role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06346457, orgStudyIdInfo id: IRTG_P08, briefTitle: Breast Cancer & Antiestrogenic Therapy & Brain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: International Research Training Group 2804, class: OTHER, collaborators name: German Research Foundation, collaborators name: University Hospital Tuebingen, collaborators name: Uppsala University, descriptionModule briefSummary: The study aims to investigate the effect of anti-estrogenic therapy in breast cancer patients on neural reward processing, psychosexual health, and quality of life, in reproductive vs. menopausal women. The investigators are directly comparing four groups 1) premenopausal women diagnosed with breast cancer receiving anti-estrogenic therapy, 2) postmenopausal women diagnosed with breast cancer with and without previous hormonal replacement therapy, receiving anti-estrogenic therapy, 3) premenopausal healthy women, and 4) postmenopausal healthy women. Furthermore, via assessment and integration of various data including subjective/self-report data via questionnaires and a standardized interview, physiological/endocrine (via blood sample), psychological and neural data (including anatomical scans, Diffusion tensor imaging (DTI), resting state, and a reward processing paradigm), this project will shed light on the connection between the brain, anti-estrogenic therapy, and psychosexual health., conditionsModule conditions: Breast Cancer Female, conditions: Healthy Female, conditions: Menopause, conditions: Anti-estrogenic Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Tamoxifen, interventions name: Letrozole, interventions name: Letrozole + GnRH, outcomesModule primaryOutcomes measure: Correlations between antiestrogen hormone therapy and brain function & structure, primaryOutcomes measure: Correlations between antiestrogen hormone therapy and reward processing in both behavioral and neural aspects, primaryOutcomes measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls, primaryOutcomes measure: Reward Processing Disparities: Contrasting Breast Cancer Patients with Healthy Controls, primaryOutcomes measure: Brain Disparities: Contrasting Breast Cancer Patients with Healthy Controls, secondaryOutcomes measure: Correlation between antiestrogen hormone therapy and psychosexual health, secondaryOutcomes measure: Correlation between antiestrogen hormone therapy and quality of life, secondaryOutcomes measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls, secondaryOutcomes measure: Psychosexual Health Disparities: Contrasting Breast Cancer Patients with Healthy Controls, secondaryOutcomes measure: Correlation between antiestrogen hormone therapy and cognitive changes, secondaryOutcomes measure: Quality of Life Disparities: Contrasting Breast Cancer Patients with Healthy Controls, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Tuebingen; Department of Psychiatry & Psychotherapy Tuebingen, city: Tuebingen, state: BW, zip: 72076, country: Germany, geoPoint lat: 48.52266, lon: 9.05222, hasResults: False
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protocolSection identificationModule nctId: NCT06346444, orgStudyIdInfo id: 2.780.113, briefTitle: Biomarkers in Rett Syndrome, acronym: BIRS, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-08-03, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: Meyer Children's Hospital IRCCS, collaborators name: Azienda USL Toscana Nord Ovest, collaborators name: University of Dublin, Trinity College, descriptionModule briefSummary: Rett syndrome (RTT) is an X-linked genetic disorder that causes severe neurological development disorder. In its classic form, it seems to affect almost exclusively females with an incidence of up to one in 10,000 females. Patients affected by Rett Syndrome can present a wide range of symptoms, in different combinations and of varying intensity, such as slowed growth of head circumference, abnormalities in walking and balance, loss of functional use of the hands often replaced by repetitive and stereotyped hand movements like "hand washing", loss of communicative-relational skills including expressive language, epilepsy, breathing abnormalities, and osteo-muscular alterations. In light of the growing potential of clinical therapies, identification and early diagnosis are considered essential. Many disease modification strategies have been achieved through translational research studies and clinical trials that have allowed the recognition of the most effective therapeutic and clinical interventions to date.This study arises from the need to advance in the understanding of the pathogenesis of RTT through a multicentric collaboration in order to (a) identify early biomarkers of RTT (b) delve into the alterations of interconnectivity, crucial for understanding the loss of motor functions and language through systematic collection of anamnestic, genetic, and clinical-instrumental data. The aim is to provide a valuable contribution to the study of the clinical phenotype of Rett and the identification of early interventions., conditionsModule conditions: Rett Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic test and behavioral, outcomesModule primaryOutcomes measure: Age at diagnosis, primaryOutcomes measure: Mutation in MECP2, primaryOutcomes measure: Neuroscope alterations, primaryOutcomes measure: Electroencephalogram (EEG) alterations, primaryOutcomes measure: Brain magnetic resonance imaging (MRI) alteration, primaryOutcomes measure: Bone densitometry alterations, primaryOutcomes measure: Thoracic radiographic alterations, primaryOutcomes measure: Lumbosacral spine radiographic alterations, primaryOutcomes measure: Clinical Global Impression (CGI) scale, primaryOutcomes measure: The Rett Syndrome Behavioural Questionnaire (RSBQ), secondaryOutcomes measure: Alterations of neurovisual functions, secondaryOutcomes measure: Possibility of applying alternative forms of communication to verbal communication, eligibilityModule sex: FEMALE, minimumAge: 0 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Trinity College Institute of Neuroscience, Lloyd Building, D2, status: RECRUITING, city: Dublin, country: Ireland, contacts name: Daniela Tropea, role: CONTACT, email: daniela.tropea@tcd.ie, geoPoint lat: 53.33306, lon: -6.24889, locations facility: Ospedale Versilia Centro di Riferimento, status: RECRUITING, city: Lido Di Camaiore, state: Lucca, zip: 55049, country: Italy, contacts name: Ilaria Gemo, role: CONTACT, email: ilaria.gemo@uslnordovest.toscana.it, geoPoint lat: 43.90012, lon: 10.2269, locations facility: IRCCS Fondazione Stella Maris, status: RECRUITING, city: Calambrone, state: Pisa, zip: 56128, country: Italy, contacts name: Roberta Battini, role: CONTACT, phone: 050886282, email: rbattini@fsm.unipi.it, geoPoint lat: 43.58333, lon: 10.3, locations facility: AOU Meyer, status: RECRUITING, city: Firenze, zip: 50139, country: Italy, contacts name: Viola Doccini, role: CONTACT, email: viola.doccini@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, hasResults: False
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protocolSection identificationModule nctId: NCT06346431, orgStudyIdInfo id: 20240301, briefTitle: Efficacy of Digital Problem Solving Application in Reduction of Anxiety, Depression and Substance Use Disorder Symptoms, acronym: Efficacy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: 7 Generation Games, class: INDUSTRY, descriptionModule briefSummary: The focus of this study is the impact of usage of a mobile application to support problem-solving therapy on symptoms of anxiety, depression and substance use., conditionsModule conditions: Anxiety, conditions: Depressive Symptoms, conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: DSPT - Digital Support for Problem-solving Therapy, outcomesModule primaryOutcomes measure: Generalized Anxiety Disorder Scale-7, primaryOutcomes measure: Center for Epidemiological Studies Depression Scale, primaryOutcomes measure: Drug Abuse Screening Test, primaryOutcomes measure: Michigan Alcohol Screening Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346418, orgStudyIdInfo id: PNRR-MR1-2022-12376622, briefTitle: Maternal Genes and Epimutations: Beckwith-Wiedemann Syndrome & Reproductive Risks, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-19, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: Istituto Auxologico Italiano, collaborators name: Università degli Studi della Campania Luigi Vanvitelli, collaborators name: Federico II University, descriptionModule briefSummary: Pathogenic variants in subcortical maternal complex (SCMC) have been identified not only in mothers of Beckwith-Wiedemann syndrome (BWS) babies but also in women with reproductive disturbances such as failed pregnancy attempts and recurrent pregnancy loss. Based on the higher incidence of BWS in children born from Assisted Reproductive Technology (ART), this project aims to investigate incidence and molecular mechanism of pathogenic variants of SCMC in women with reproductive disorders. Study objectives will be (i) assess the incidence of these variants as a cause of differences in reproductive outcomes in the infertile female population and mothers of children with BWS; (ii) identify methylation changes in women with reproductive problems including those with offspring affected by BWS; (iii) determine the molecular causes underlying female infertility and imprinting disorder associated with damaging SCMC gene variants by employing a mouse model., conditionsModule conditions: Beckwith-Wiedemann Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule interventions name: WES analysis, interventions name: whole-genome methylation analysis, outcomesModule primaryOutcomes measure: MEG Incidence, secondaryOutcomes measure: Compare DNA methylation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Edgardo Somigliana, PhD, role: CONTACT, phone: +390255034303, email: edgardo.somigliana@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20145, country: Italy, contacts name: Silvia Russo, Phd, role: CONTACT, phone: +393493237520, email: s.russo@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-12-20, uploadDate: 2024-03-28T05:11, filename: Prot_SAP_000.pdf, size: 817568, hasResults: False
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protocolSection identificationModule nctId: NCT06346405, orgStudyIdInfo id: 10, briefTitle: Central Serous Chorioretinopathy and Micropulse Laser Treatment, acronym: LEVEO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-31, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone, conditionsModule conditions: Central Serous Chorioretinopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Subthreshold Micropulse Laser Treatment, outcomesModule primaryOutcomes measure: Vessel density changes, secondaryOutcomes measure: Choroidal thickness, secondaryOutcomes measure: Choroidal thickness and vessel density, secondaryOutcomes measure: Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern, secondaryOutcomes measure: Metamorphopsia, secondaryOutcomes measure: Metamorphopsia and BCVA, secondaryOutcomes measure: Ellipsoid Zone Integrity, secondaryOutcomes measure: Improvement in retinal function, secondaryOutcomes measure: Quality of life (QoL), secondaryOutcomes measure: Ellipsoid zone and BCVA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Agostino Gemelli, IRCCS, status: RECRUITING, city: Roma, state: R, zip: 00168, country: Italy, contacts name: Maria Cristina Savastano, MD, PhD, role: CONTACT, phone: (+39)063015, email: mariacristinasavastano@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06346392, orgStudyIdInfo id: D9802C00001, briefTitle: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-04-10, completionDateStruct date: 2026-10-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2., conditionsModule conditions: Gastric Cancer, conditions: Gastroesophageal Junction Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized in a 1:1:1 ratio to one of the following intervention arms until the dose selection decision is made:Arm 1: AZD0901 arm 1 IV, Q3W Arm 2: AZD0901 arm 2 IV, Q3W Arm 3: Participants in the Investigator's choice arm, including regionally accepted chemotherapies or targeted therapies 2L: Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W 2L: Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only) 2L: Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only) 3L+: Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W 3L+: TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China) 3L+: Apatinib 500-850 mg, orally once daily, Q4W (China only), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is an open-label study; however, it will be conducted 'sponsor-blind' and the specific treatment to be taken by a participant will be assigned using an IRT/RTSM. To maintain the integrity of the study, sponsor access to treatment records will be restricted, and, in particular, under no circumstances will the sponsor undertake any efficacy analysis by treatment arm during the study. A Study Integrity Plan will be generated in which nominated individuals who will be granted access to any treatment-revealing data will be pre-specified, with their reason for requiring access detailed., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 589, type: ESTIMATED, armsInterventionsModule interventions name: AZD0901, interventions name: AZD0901, interventions name: Ramucirumab+ paclitaxel, interventions name: Paclitaxel, interventions name: Docetaxel, interventions name: Irinotecan, interventions name: TAS-102, interventions name: Apatinib, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) in all randomized participants, primaryOutcomes measure: Overall Survival (OS) for 3L+ participants, secondaryOutcomes measure: OS in all randomized participants, secondaryOutcomes measure: PFS for 3L+ participants, secondaryOutcomes measure: Objective Response Rate (ORR) in all randomized participants, secondaryOutcomes measure: ORR for 3L+ participants, secondaryOutcomes measure: Duration of Response (DoR) in all randomized participants, secondaryOutcomes measure: Serum concentrations of AZD0901, total antibody and MMAE, secondaryOutcomes measure: Status of ADA to AZD0901, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs, secondaryOutcomes measure: PK parameters (such as peak concentration, as data allow) of AZD0901, total antibody and MMAE, secondaryOutcomes measure: PK parameters (such as trough concentration, as data allow) of AZD0901, total antibody and MMAE, secondaryOutcomes measure: Prevalence and incidence of ADA to AZD0901, secondaryOutcomes measure: Titer of ADA to AZD0901, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 130 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, status: NOT_YET_RECRUITING, city: Duarte, state: California, zip: 91010, country: United States, geoPoint lat: 34.13945, lon: -117.97729, locations facility: Research Site, status: WITHDRAWN, city: Santa Rosa, state: California, zip: 95403, country: United States, geoPoint lat: 38.44047, lon: -122.71443, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Marietta, state: Georgia, zip: 30060, country: United States, geoPoint lat: 33.9526, lon: -84.54993, locations facility: Research Site, status: WITHDRAWN, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kansas City, state: Missouri, zip: 64111, country: United States, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Site, status: WITHDRAWN, city: Saint Louis, state: Missouri, zip: 63110, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Saint Louis, state: Missouri, zip: 63128, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mineola, state: New York, zip: 11501, country: United States, geoPoint lat: 40.74927, lon: -73.64068, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Portland, state: Oregon, zip: 97239, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19111, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Charlottesville, state: Virginia, zip: 22908, country: United States, geoPoint lat: 38.02931, lon: -78.47668, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 4N2, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Barrie, state: Ontario, zip: L4M 6M2, country: Canada, geoPoint lat: 44.40011, lon: -79.66634, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, state: Ontario, zip: N6C 2R5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ottawa, state: Ontario, zip: K1H 8L6, country: Canada, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M5G 2M9, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Beijing, zip: 100210, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Changsha, zip: 410013, country: China, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Research Site, status: RECRUITING, city: Chengdu, zip: 610000, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Chengdu, zip: 610042, country: China, geoPoint lat: 30.66667, lon: 104.06667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fuzhou City, zip: 350001, country: China, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Fuzhou, zip: 350014, country: China, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Research Site, status: RECRUITING, city: Guangzhou, zip: 510060, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510120, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Guangzhou, zip: 510655, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: RECRUITING, city: Guangzhou, zip: 510700, country: China, geoPoint lat: 23.11667, lon: 113.25, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hangzhou, zip: 310020, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hangzhou, zip: 310022, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Harbin, zip: 150049, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hefei, zip: 230601, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jinan, zip: 250117, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Jining, zip: 272029, country: China, geoPoint lat: 35.405, lon: 116.58139, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lanzhou, zip: 730000, country: China, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lishui, zip: 323000, country: China, geoPoint lat: 28.46042, lon: 119.91029, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Luoyang, zip: 471003, country: China, geoPoint lat: 34.68361, lon: 112.45361, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanjing, zip: 210008, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nanjing, zip: 210009, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Qingdao, zip: 266003, country: China, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shanghai, zip: 200040, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shenyang, zip: 110042, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Shijiazhuang, zip: 050011, country: China, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Suzhou, zip: 215004, country: China, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tianjin, zip: 300060, country: China, geoPoint lat: 39.14222, lon: 117.17667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Urumqi, zip: 830000, country: China, geoPoint lat: 43.80096, lon: 87.60046, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuhan, zip: 430000, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Wuhan, zip: 430030, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Xi'an, zip: 710061, country: China, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Yinchuan, zip: 750004, country: China, geoPoint lat: 38.46806, lon: 106.27306, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zhengzhou, zip: 450003, country: China, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Besançon Cedex, zip: 25030, country: France, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Brest, zip: 29200, country: France, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lille, zip: 59037, country: France, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lyon, zip: 69008, country: France, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Nantes, zip: 44000, country: France, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Research Site, status: NOT_YET_RECRUITING, city: PARIS Cedex 12, zip: 75571, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Poitiers, zip: 86021, country: France, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 10249, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Berlin, zip: 13353, country: Germany, geoPoint lat: 52.52437, lon: 13.41053, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Dresden, zip: 1067, country: Germany, geoPoint lat: 51.05089, lon: 13.73832, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Essen, zip: 45130, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Frankfurt, zip: 60488, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Göttingen, zip: 37075, country: Germany, geoPoint lat: 51.53443, lon: 9.93228, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hamburg, zip: 20251, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Heidelberg, zip: 69120, country: Germany, geoPoint lat: 49.40768, lon: 8.69079, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Heilbronn, zip: 74078, country: Germany, geoPoint lat: 49.13995, lon: 9.22054, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Leipzig, zip: 04103, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Mainz, zip: 55131, country: Germany, geoPoint lat: 49.98419, lon: 8.2791, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Marburg, zip: 35043, country: Germany, geoPoint lat: 50.80904, lon: 8.77069, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Moers, zip: 47441, country: Germany, geoPoint lat: 51.45342, lon: 6.6326, locations facility: Research Site, status: NOT_YET_RECRUITING, city: München, zip: 81377, country: Germany, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hong Kong, zip: 150001, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Florence, zip: 50134, country: Italy, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milano, zip: 20162, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Milan, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Modena, zip: 41124, country: Italy, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Napoli, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Padova, zip: 35128, country: Italy, geoPoint lat: 45.40797, lon: 11.88586, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Pisa, zip: 56100, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vicenza, zip: 36100, country: Italy, geoPoint lat: 45.54672, lon: 11.5475, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kashiwa, zip: 227-8577, country: Japan, geoPoint lat: 35.86224, lon: 139.97732, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tokyo, zip: 104-0045, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Gdańsk, zip: 80-219, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Katowice, zip: 40-514, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kraków, zip: 31-501, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lublin, zip: 20-081, country: Poland, geoPoint lat: 51.25, lon: 22.56667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Szczecin, zip: 71-730, country: Poland, geoPoint lat: 53.42894, lon: 14.55302, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Tomaszów Mazowiecki, zip: 97-200, country: Poland, geoPoint lat: 51.53131, lon: 20.00855, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Warszawa, zip: 02-034, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Barcelona, zip: 08036, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Barcelona, zip: 8035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Madrid, zip: 28034, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Madrid, zip: 28041, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Orense, zip: 32005, country: Spain, geoPoint lat: 42.33669, lon: -7.86407, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Santander, zip: 39008, country: Spain, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Sevilla, country: Spain, geoPoint lat: 37.38283, lon: -5.97317, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Bern, zip: 3010, country: Switzerland, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Genève 14, zip: 1205, country: Switzerland, geoPoint lat: 46.20222, lon: 6.14569, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Lausanne, zip: 1011, country: Switzerland, geoPoint lat: 46.516, lon: 6.63282, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Zürich, zip: 8032, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Kaohsiung, zip: 00807, country: Taiwan, geoPoint lat: 22.61626, lon: 120.31333, locations facility: Research Site, status: RECRUITING, city: Tainan, country: Taiwan, geoPoint lat: 22.99083, lon: 120.21333, locations facility: Research Site, status: RECRUITING, city: Taipei, zip: 112, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taoyuan, zip: 333, country: Taiwan, geoPoint lat: 24.95233, lon: 121.20193, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Cambridge, zip: CB2 0QQ, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, zip: EC1A 7BE, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: London, zip: SW3 6JJ, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Manchester, zip: M20 4BX, country: United Kingdom, geoPoint lat: 53.48095, lon: -2.23743, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Oxford, zip: OX3 7LE, country: United Kingdom, geoPoint lat: 51.75222, lon: -1.25596, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Taunton, zip: TA1 5DA, country: United Kingdom, geoPoint lat: 51.01494, lon: -3.10293, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Hanoi, zip: 100000, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Ho Chi Minh city, zip: 700000, country: Vietnam, geoPoint lat: 10.82302, lon: 106.62965, locations facility: Research Site, status: NOT_YET_RECRUITING, city: Vinh, zip: 460000, country: Vietnam, geoPoint lat: 18.67337, lon: 105.69232, hasResults: False
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protocolSection identificationModule nctId: NCT06346379, orgStudyIdInfo id: 2023-K086-01, briefTitle: The Effect of Baduanjin on Physical Fitness and Bone Density in Maintenance Hemodialysis Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Affiliated Hospital of Nantong University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effect of 12-month Baduanjin exercise on physical fitness and bone density in maintenance hemodialysis (MHD) patients. 50 MHD patients aged 18-75 will included in this study and randomly divided into two groups (intervention group and control group). The intervention group will be led by a professional person and underwent Baduanjin exercise three times a week before hemodialysis. The control group maintained routine treatment and daily activities., conditionsModule conditions: Rehabilitation, conditions: Physical Fitness, conditions: Bone Density, conditions: Hemodialysis Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Baduanjin exercise, outcomesModule primaryOutcomes measure: Muscle strength measurement, primaryOutcomes measure: Five-times Sit-to-Stand Test (FTSST), primaryOutcomes measure: Timed "up and go" test (TUGT), primaryOutcomes measure: The sitting forward flexion test, primaryOutcomes measure: The Standing on one-leg with eyes closed test (SOLECT), primaryOutcomes measure: Bone mineral density test, secondaryOutcomes measure: Changes in the Short Form-36(SF-36), secondaryOutcomes measure: Changes in the Hospital Anxiety and Depression Scale （HADS）, secondaryOutcomes measure: European Quality of Life Five Dimension（EQ-5D-5L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Nantong University, status: RECRUITING, city: Nantong, state: Jiangsu, zip: 226000, country: China, contacts name: Li Yuan, role: CONTACT, phone: 0086-051381168416, email: yuanlint@163.com, contacts name: Yuan Zhang, role: CONTACT, phone: 0086-051381168411, email: 49260183@qq.com, geoPoint lat: 32.03028, lon: 120.87472, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-07-10, uploadDate: 2024-03-18T04:22, filename: Prot_SAP_000.pdf, size: 179776, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-07-10, uploadDate: 2024-03-28T03:53, filename: ICF_001.pdf, size: 247762, hasResults: False
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protocolSection identificationModule nctId: NCT06346366, orgStudyIdInfo id: NL.82557.018.22, briefTitle: Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy, acronym: PANORAMA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, \[IQR 71.05%-82.61%\] vs. 57.38% \[IQR 52.38%-81.35%\], p=0.03).Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over., conditionsModule conditions: Pancreatic Neoplasms, conditions: Type 3c Diabetes, conditions: Total Pancreatectomy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients are randomized to a 3-month treatment period with the bihormonal artificial pancreas (BIHAP) (preceded by a training period) or a 3-month treatment with their current diabetes care. Hereafter, all patients will cross over., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bihormonal artificial pancreas (BIHAP) / closed loop, outcomesModule primaryOutcomes measure: Time in range, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Adverse events and device issues associated with closed loop system with BIHAP, secondaryOutcomes measure: Patient reported outcomes on quality of life - WHO-5, secondaryOutcomes measure: Patient reported outcomes on quality of life - EQ-5D-5L, secondaryOutcomes measure: Patient reported outcomes on quality of life - DTSQc andDTSQs, secondaryOutcomes measure: Patient reported outcomes on quality of life - PAID-20, secondaryOutcomes measure: Patient reported outcomes on quality of life - HFS-II, secondaryOutcomes measure: Patient reported outcomes on quality of life - PSQI, secondaryOutcomes measure: Patient reported outcomes on quality of life - INSPIRE, secondaryOutcomes measure: Patient reported outcomes on quality of life - Hypoglycaemia unawareness, secondaryOutcomes measure: Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment, otherOutcomes measure: Other treatment endpoints - daily insulin and glucagon use, otherOutcomes measure: Other treatment endpoints - activity of BIHAP algorithm, otherOutcomes measure: Other treatment endpoints - daily insulin use, otherOutcomes measure: Other treatment endpoints - treatment related actions, otherOutcomes measure: Other treatment endpoints - demographics, otherOutcomes measure: Other treatment endpoints - demographics, otherOutcomes measure: Other treatment endpoints - concomitant medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, city: Amsterdam, zip: 1081 HV, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
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protocolSection identificationModule nctId: NCT06346353, orgStudyIdInfo id: Chess Cognition SUD, briefTitle: Substance Consumption, Personality, and Cognitive Functioning of Chess Players, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Central Institute of Mental Health, Mannheim, class: OTHER, descriptionModule briefSummary: The aim of this project is to find out if there is a difference in addictive behavior, personality traits, and cognitive abilities between chess players and non-chess players., conditionsModule conditions: Addiction, conditions: Alcohol, conditions: Nicotine, conditions: Drugs, conditions: Personality, conditions: Depression, conditions: Anxiety, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 910, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Substance Craving, primaryOutcomes measure: Alcohol Use, primaryOutcomes measure: Automatic Alcohol Craving, primaryOutcomes measure: Severity of Nicotine Dependence, primaryOutcomes measure: Automatic Cigarette Craving, primaryOutcomes measure: Smoking Consequences, primaryOutcomes measure: Drug Abuse, primaryOutcomes measure: Personality, primaryOutcomes measure: Depression, primaryOutcomes measure: Anxiety, primaryOutcomes measure: self-efficacy, primaryOutcomes measure: coping with stress, primaryOutcomes measure: Inhibition capacity, primaryOutcomes measure: Working Memory capacity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit, status: RECRUITING, city: Mannheim, country: Germany, contacts name: Sabine Vollstädt-Klein, role: CONTACT, geoPoint lat: 49.4891, lon: 8.46694, hasResults: False
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protocolSection identificationModule nctId: NCT06346340, orgStudyIdInfo id: 936, briefTitle: A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Bausch & Lomb Incorporated, class: INDUSTRY, descriptionModule briefSummary: A Phase 4, Multicenter, Open-Label Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/ Keratometry and Postoperative Refractive Accuracy, conditionsModule conditions: Dry Eye, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Miebo, outcomesModule primaryOutcomes measure: Mean difference between absolute deviations from predicted refractive error in the study eye., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Site 105, city: Laguna Hills, state: California, zip: 92655, country: United States, geoPoint lat: 33.61252, lon: -117.71283, locations facility: Site 102, city: Petaluma, state: California, zip: 92954, country: United States, geoPoint lat: 38.23242, lon: -122.63665, locations facility: Site 103, city: Largo, state: Florida, zip: 33770, country: United States, geoPoint lat: 27.90979, lon: -82.78842, locations facility: Site 104, city: Saint Louis, state: Missouri, zip: 63131, country: United States, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Site 101, city: Somersworth, state: New Hampshire, zip: 03878, country: United States, geoPoint lat: 43.26175, lon: -70.86534, hasResults: False
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protocolSection identificationModule nctId: NCT06346327, orgStudyIdInfo id: Absent End-Diastolic Flow, briefTitle: Clinical Significance Of Intermittently Absent End-Diastolic Flow Of The Fetal Umbilical Artery On Perinatal And Neonatal Outcomes Dr. Zeynep Kayaoğlu Yıldırım Dr. Alperen İnce Dr Gökhan Bayanmelek Dr Gökhan Bolluk, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-01, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Objective: This study aimed to estimate the risk of adverse perinatal outcomes among pregnant patients with intermittently absent (iAEDF) and persistently absent end-diastolic umbilical artery flow (pAEDF). The fetal risks associated with persistently absent end-diastolic flow have been described. However, the risks associated with intermittent absent end-diastolic flow are not well-known.Study design: We performed a retrospective cohort study of patients diagnosed with the iAEDF or pAEDF at our institution from 2020 to 2023. Fetuses were classified under two categories: iAEDF group and pAEDF group.Neonatal outcomes, demographic information, pregnancy outcomes and pregnancy complications were compared between patients with iAEDF and those with pAEDF., conditionsModule conditions: Absent End-Diastolic Flow Of The Fetal Umbilical Artery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 137, type: ACTUAL, outcomesModule primaryOutcomes measure: neonatal outcomes, primaryOutcomes measure: latency from the time of absent endiastolic flow diagnosis to delivery, primaryOutcomes measure: pregnancy complications (Number of Pregnancies complicated with IUMF, ablatio placenta, fetal distress, Intrauterine growth restriction and amniotic fluid abnormalities)., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: İstanbul Başakşehir Çam ve Sakura City Hospital, city: Istanbul, state: Türkiye, zip: 34480, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-08, uploadDate: 2024-04-02T18:47, filename: Prot_SAP_000.pdf, size: 410898, hasResults: False
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protocolSection identificationModule nctId: NCT06346314, orgStudyIdInfo id: 12241976, briefTitle: Is There an Immediate Effect on Pectoralis Minor Length After Performing a Prone Scapular Retraction Exercise, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-15, primaryCompletionDateStruct date: 2022-01-10, completionDateStruct date: 2022-01-10, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Andrews University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test normal participants.The main question it aims to answer is:• Do the participant's pectoralis minor muscles change length immediately after performing an exercise that recruits the scapular retractor muscles? Participants will have their pectoralis minor muscle measured, then perform an exercise recruiting the scapular retractor muscles, and then have their pectoralis muscle measured again., conditionsModule conditions: Pectoralis Minor Length, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Scapular retraction exercise, outcomesModule primaryOutcomes measure: Pectoralis Minor Length, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: North Idaho Physical Therapy, city: Hayden, state: Idaho, zip: 83835, country: United States, geoPoint lat: 47.76602, lon: -116.78658, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-30, uploadDate: 2023-11-30T13:36, filename: Prot_SAP_000.pdf, size: 341703, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-04-19, uploadDate: 2024-03-12T17:52, filename: ICF_001.pdf, size: 286800, hasResults: False
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protocolSection identificationModule nctId: NCT06346301, orgStudyIdInfo id: NL83374.018.23, briefTitle: Imagery Rescripting as a Stand-alone Treatment for OCD and BDD., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-21, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: The goal of this multiple baseline case series study is to test the effect of imagery rescripting (ImRs) in Obsessive Compulsive Disorder (OCD) and Body Dysmorphic Disorder (BDD).Primary objective :The course of schema or core beliefs and change in OCD and BDD. To investigate the effectiveness of imagery rescripting on factors presumed to underlie the disorder, according to schema theory, and on OCD and BDD symptoms.Secondary objective: The change in OCD and BDD symptoms (full questionnaire), schemata and modes, core emotions, mood, affect and obtrusiveness of intrusion.Other objectives are research into the working mechanisms of imagery rescripting by collecting qualitative data from patients and their practitioner in a qualitative interview.For this study, a multiple-baseline single-case experimental design (SCED) is used testing different outcome variables in 18 OCD patients and 18 BDD patients. After a variable baseline period of 3-8 weeks participants will start twice weekly with imagery rescripting for 12 sessions, followed by a 6 week follow up.Participants will rate schema- or core beliefs and OCD or BDD severity on a visual analogue scale. In addition participants will rate core emotions, affect and obtrusiveness of the intrusion. Secondary we will asses four times questionnaires about OCD of BDD symptoms, depression and schemas en modes. After treatment participants will be interviewed about their experiences., conditionsModule conditions: Obsessive-Compulsive Disorder, conditions: Body Dysmorphic Disorders, conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Multiple baseline case series design: Patients wil be randomized to different lengths of baseline period and the effectiveness of the treatment is tested by comparing means and slopes of daily reported schema- or core beliefs and OCD and BDD severity,, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Imagery rescripting, outcomesModule primaryOutcomes measure: Schema of core beliefs, primaryOutcomes measure: Obsessive Compulsive (OCD) and Body Dysmorphic (BDD)symptoms, secondaryOutcomes measure: Core Emotions, affect strength, obtrusiveness of intrusion., secondaryOutcomes measure: Yale Brown Obsessive Compulsive Scale (Y-BOCS(-BDD)), secondaryOutcomes measure: Hamilton Depression Rating Scale (HDRS), secondaryOutcomes measure: Young Schema Questionnaire (YSQ) and Schema Mode Inventory (SMI), otherOutcomes measure: Qualitative interview, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Psychiatry, AMC, status: RECRUITING, city: Amsterdam-Zuidoost, state: Noord-Holland, zip: 1105 AZ, country: Netherlands, contacts name: Tibor van Verseveld, role: CONTACT, phone: +31619624228, email: t.r.vanverseveld@amsterdamumc.nl, geoPoint lat: 52.3075, lon: 4.97222, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2023-06-23, uploadDate: 2024-02-27T15:21, filename: Prot_SAP_ICF_000.pdf, size: 672806, hasResults: False
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protocolSection identificationModule nctId: NCT06346288, orgStudyIdInfo id: M24-144, briefTitle: A Study to Assess the Concentrations of Risankizumab in the Breast Milk of Adult Lactating Women With Inflammatory Bowel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-01-20, completionDateStruct date: 2025-05-27, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: Inflammatory bowel disease (IBD) is a chronic inflammatory disease that requires lifelong treatment. This study will asses the concentrations of risankizumab in the breast milk of lactating women with IBDRisankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and Crohn's Disease. This is an open-label milk-only study lactation study to evaluate the presence of risankizumab in the milk of lactating women. Approximately 10 adult lactating women with IBD will be enrolled from approximately 3 sites in Israel and or the United States.Participants will receive risakizumab maintenance therapy every 8 weeks postpartum prior to start of participation in this study. The study duration is approximately 7 months.Participants will attend regular visits during the study at a hospital or clinic. The participants will also be completing questionnaires and will have medical assessments, checking for side effects., conditionsModule conditions: Inflammatory Bowel Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study will only include lactating women who are receiving treatment with risankizumab for IBD in accordance with their treating physician, although this study is non-interventional regarding treatment with risankizumab, it is considered interventional due to the collection of breast milk from the lactating mothers., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Breast Milk Sampling, interventions name: Risankizumab, outcomesModule primaryOutcomes measure: To determine the concentration of risankizumab in breastmilk, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346275, orgStudyIdInfo id: 3rdZhejiangCMU-11, briefTitle: Effect of Acupuncture on the Gait Disturbance and Hemodynamic Changes in the Prefrontal Cortex, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, descriptionModule briefSummary: Background: Alzheimer's disease (AD) is characterized by cognitive impairment and behavioral impairment, and increasing attention is paid in the gait of AD patients. The aim of this randomized controlled trial (RCT) is to explore the effect of acupuncture on the cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices.Methods: In this RCT, a total of 108 AD patients will be randomly assigned into acupuncture group or control group for 8 weeks. The primary outcome will be Three-dimensional gait analysis and cerebral hemodynamics using functional near-infrared spectroscopy (fNIRS). Secondary outcomes include Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Barthel Index (BI).Discussion: This trial is expected to explore the effect of acupuncture on cognitive function, gait performance, and hemodynamic changes in the prefrontal cortices for AD patients., conditionsModule conditions: Alzheimer Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Acupuncture, outcomesModule primaryOutcomes measure: Three-dimensional gait analysis, primaryOutcomes measure: Cerebral hemodynamics, secondaryOutcomes measure: Mini-Mental State Examination, secondaryOutcomes measure: Montreal Cognitive Assessment, secondaryOutcomes measure: Barthel Index, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06346262, orgStudyIdInfo id: STUDY20230921, briefTitle: Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Martha Sajatovic, class: OTHER, descriptionModule briefSummary: This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings.Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures., conditionsModule conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 43, type: ESTIMATED, armsInterventionsModule interventions name: SMART RM, interventions name: Valtoco Nasal Product, outcomesModule primaryOutcomes measure: Change in number of seizures as measured by patient report., secondaryOutcomes measure: Change in quality of life as measure by QOLIE-31, secondaryOutcomes measure: Change in functional status as measure by Short-Form Health Survey (SF-36), secondaryOutcomes measure: Change in depressive symptoms as measure by Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in epilepsy self management as measure by Epilepsy Self-Efficacy Scale (ESES), secondaryOutcomes measure: Change in epilepsy self management as measure by Multidimensional Scale of Perceived Social Support (MSPSS), secondaryOutcomes measure: Change in epilepsy self management as measure by Epilepsy Self-Management Scale (ESMS), secondaryOutcomes measure: Change in epilepsy self management as measure by Epilepsy Stigma Scale (ESS), secondaryOutcomes measure: Change in number of emergency room visit as measure by patient report, secondaryOutcomes measure: Change in number of hospitalizations as measure by patient report, secondaryOutcomes measure: Change in number of non study outpatient services utilization as measure by patient report, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Medical Center, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Kari M Zimmermann, MA, role: CONTACT, phone: 216-368-8775, email: kmz24@case.edu, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06346249, orgStudyIdInfo id: 49/2024, briefTitle: Workplace Based Physiotherapy of Elderly-care Workers With Non-specific Neck Pain., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Universidad de Extremadura, class: OTHER, descriptionModule briefSummary: The overall objective of this study is to determine the efficacy of a physical therapy intervention based on manual therapy, therapeutic exercise and application of electrotherapy in healthcare workers with non-specific neck pain., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Electrical Stimulation Therapy, interventions name: Manual Therapy, interventions name: Exercise Therapeutic, outcomesModule primaryOutcomes measure: Changes in Pain, primaryOutcomes measure: Changes Pressure Pain, primaryOutcomes measure: Changes in Disability, secondaryOutcomes measure: Changes in Range of Motion, secondaryOutcomes measure: General Health., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: María de los Ángeles Cardero Durán, status: RECRUITING, city: Badajoz, zip: 06006, country: Spain, contacts name: María de los Ángeles Cardero Durán, Doctor, role: CONTACT, email: mcarderod@unex.es, geoPoint lat: 38.87789, lon: -6.97061, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-27, uploadDate: 2024-04-01T16:35, filename: ICF_000.pdf, size: 253582, hasResults: False
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protocolSection identificationModule nctId: NCT06346236, orgStudyIdInfo id: 69HCL21_0843, secondaryIdInfos id: 401, type: OTHER, domain: AGORA HCL, briefTitle: Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity., acronym: NEO-TYR, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-01, primaryCompletionDateStruct date: 2021-07-01, completionDateStruct date: 2022-09-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis., conditionsModule conditions: Transient Hypothyroxinemia of Prematurity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 373, type: ACTUAL, armsInterventionsModule interventions name: L-thyroxine at a dose of 7.5 µg/kg/d for THOP, interventions name: THOP without treatment, interventions name: NoTHOP, outcomesModule primaryOutcomes measure: Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation., eligibilityModule sex: ALL, maximumAge: 2 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: HFME, city: Bron, zip: 69300, country: France, geoPoint lat: 45.73333, lon: 4.91667, locations facility: CHU Grenoble, city: Grenoble, zip: 38100, country: France, geoPoint lat: 45.16667, lon: 5.71667, locations facility: CHU Saint EtienneHopital, city: Saint-Étienne, zip: 42000, country: France, geoPoint lat: 45.43389, lon: 4.39, hasResults: False
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protocolSection identificationModule nctId: NCT06346223, orgStudyIdInfo id: HSEARS20230928006, briefTitle: Mindfulness-Based Intervention for Family Caregivers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, collaborators name: Health and Medical Research Fund, descriptionModule briefSummary: The aim of this study is to investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia. The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points., conditionsModule conditions: Caregiving Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A single-blinded, parallel-group, randomized-controlled trial (RCT) design., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness and psychoeducation, interventions name: Psychoeducation, outcomesModule primaryOutcomes measure: Perceived Caregiving Stress in the Family Caregiver, secondaryOutcomes measure: Depressive Symptoms in the Family Caregiver, secondaryOutcomes measure: Positive Aspect of Caregiving in the Family Caregiver, secondaryOutcomes measure: Dyadic Relationship Between the Family Caregiver and the Care Recipient, secondaryOutcomes measure: Trait Mindfulness in the Family Caregiver, secondaryOutcomes measure: Neuropsychiatric Syndromes in the Care Recipient, secondaryOutcomes measure: Feasibility of Eligibility and Enrollment, secondaryOutcomes measure: Feasibility of Attendance Rate, secondaryOutcomes measure: Feasibility of Adherence to Self-Practice, secondaryOutcomes measure: Feasibility of Retention Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06346210, orgStudyIdInfo id: UNT: U1111-1288-2037, briefTitle: Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-04-02, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Healthcare Region Dalarna, descriptionModule briefSummary: Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients., conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 4000, type: ACTUAL, armsInterventionsModule interventions name: Tracheostomy, outcomesModule primaryOutcomes measure: Ventilator free days alive, secondaryOutcomes measure: 60 day mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uppsala University, city: Uppsala, country: Sweden, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False
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protocolSection identificationModule nctId: NCT06346197, orgStudyIdInfo id: ET23-185, briefTitle: Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas, acronym: CIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2028-05-15, completionDateStruct date: 2028-05-15, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Centre Leon Berard, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm)., conditionsModule conditions: Gastric Cancer, conditions: MSI-H, conditions: Metastatic Cancer, conditions: Advanced Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 124, type: ESTIMATED, armsInterventionsModule interventions name: Balstilimab, interventions name: Botensilimab, interventions name: Folfox Protocol, interventions name: XELOX, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Survival of patients, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Duration of response, secondaryOutcomes measure: Adverse Event description as assessed by CTCAE V5.0, secondaryOutcomes measure: EORTC QLQ C30, otherOutcomes measure: Gene expression and genomic profile description, otherOutcomes measure: Gene expression and genomic profile description, otherOutcomes measure: Number of tumor samples with modification of tumor microenvironment under study treatments, otherOutcomes measure: Value of Tumor mutational Burden (Mutation/ Megabase) on tumor and blood (circulating tumor DNA) during treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Léon Bérard, city: Lyon, country: France, contacts name: Clélia COUTZAC, MD, role: CONTACT, email: clelia.coutzac@lyon.unicancer.fr, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
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protocolSection identificationModule nctId: NCT06346184, orgStudyIdInfo id: HM-EMMA-101, briefTitle: A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-06-08, completionDateStruct date: 2024-06-08, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Hanmi Pharmaceutical Company Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: HCP2303, interventions name: RLD2302, interventions name: RLD2102, outcomesModule primaryOutcomes measure: AUCt, primaryOutcomes measure: Cmax, secondaryOutcomes measure: AUCinf, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vd/F, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 54 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jeonbuk University Hospital, city: Jeonju, state: Jeollabuk-do, country: Korea, Republic of, contacts name: Jin A Lee, Researcher, role: CONTACT, phone: 063-259-3550, contacts name: Min-gul Kim, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.82194, lon: 127.14889, hasResults: False
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protocolSection identificationModule nctId: NCT06346171, orgStudyIdInfo id: 408/06.03.2024, briefTitle: VR Augmented Human Delivered Integrative Psychotherapy for Colonoscopy Procedural Anxiety and Pain, acronym: VRIPanx-COL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-28, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Grigore T. Popa University of Medicine and Pharmacy, class: OTHER, descriptionModule briefSummary: Colonoscopy is an invaluable tool for the diagnosis and management of colon diseases, especially colorectal cancer (CRC) - the third most common cancer worldwide. Its unmatched ability to detect CRC and premalignant growths makes it the gold standard; however, it is not without its challenges. Patients often experience pre-procedure anxiety and discomfort primarily related to anticipated pain, which negatively impacts both the procedure and its outcomes.Colonoscopy procedural anxiety not only exacerbates the experience of pain, but also may compromise the quality of bowel preparation, augment procedure and recovery room times, and increase the use of sedation, particularly among females, who report greater pre-procedural anxiety, and perceive the procedure to be more painful and harder to endure. This underscores the importance of interventions aimed at mitigating anxiety to improve patient experience and adherence to colonoscopy procedures.The profound positive corelation between anxiety and pain impact on outcomes of colonoscopy warrants an investigation of comprehensive patient care strategies. A growing body of evidence indicates that non-pharmacologic interventions, such as music therapy and immersive virtual reality (iVR), may effectively reduce anxiety, pain, and enhance overall patient satisfaction.Understanding barriers to colonoscopy compliance, such as fear of cancer diagnosis, the perception of invasiveness, and feelings of embarrassment is paramount to enhancing CRC screening uptake, therefore lowering mortality., conditionsModule conditions: Procedural Anxiety, conditions: Procedural Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The VRIPanx-COL study is an RCT investigating the efficacy of VR-facilitated integrative psychotherapy compared to VR distraction only and NSE-Col. Variance minimisation and propensity score matching are used to ensure that the groups are balanced and to supplement the internal validity of evaluating the efficacy of the intervention., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: To ensure credible outcomes, robust blinding for participants, care providers, and outcome assessors is vital to minimize bias. Participants will be briefed generally about participating in VR distraction research, with no details on psychotherapy inclusion. Gastroenterologists and outcome assessors remain blinded to intervention types, using standard tools for unbiased outcome evaluation. The principal investigator, aware of the intervention nature, conducts psychotherapy sessions or engages in simple discussion for control arm VR exposure. Another gastroenterologist oversees randomization to maintain blinding. Standardized VR distractions and pre-programmed randomization ensure unbiased participant allocation, reinforcing study validity through meticulous concealment and blinding protocols., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality Integrative Psychotherapy, interventions name: Virtual Reality Distraction, outcomesModule primaryOutcomes measure: Reduction in Procedure-Related Anxiety, primaryOutcomes measure: Pain perception, secondaryOutcomes measure: Feasibility and Acceptability of VRIP-Col Interventions, secondaryOutcomes measure: Qualitative Feedback on VRIP-Col Interventions, otherOutcomes measure: Trait anxiety, otherOutcomes measure: Quality of Life impact VRIP-Col, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Medicine and Pharmacy Grigore T Popa, city: Iaşi, state: Iasi, zip: 700115, country: Romania, geoPoint lat: 47.16667, lon: 27.6, hasResults: False
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protocolSection identificationModule nctId: NCT06346158, orgStudyIdInfo id: 2024-3615, briefTitle: Prediction of Propofol Effect-Site Concentration Associated With Deep Anesthesia, acronym: PRESCOD-AI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, collaborators name: CIUSSS du Nord de l'Ile de Montréal, descriptionModule briefSummary: The goal of this observational study is to explore the variability of the concentration at the effect site (Ce) of propofol to reach deep anesthesia (DA) during induction of general anesthesia in adults.The investigators hypothesized that there is a great variability in this Ce that could be precisely explained by* Electroencephalographic (EEG) features available prior to induction of anesthesia* Cognitive performance* Patients characteristics Participants will undergo preoperative cognitive testing and awake EEG. Then, induction of general anesthesia will be performed using continuous infusion of propofol. The Ce at which Deep anesthesia is observed will be recorded., conditionsModule conditions: Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive testing, interventions name: electroencephalogram, interventions name: High density electroencephalogram, interventions name: General anesthesia, outcomesModule primaryOutcomes measure: Concentration at the effect-site propofol associated with deep anesthesia (CeDA), secondaryOutcomes measure: Coefficient of determination between statistical, spectral, entropic features extracted from the electroencephalogram and the Concentration at the effect-site propofol associated with deep anesthesia, secondaryOutcomes measure: Coefficient of determination between multivariable model and the Concentration at the effect-site propofol associated with deep anesthesia, secondaryOutcomes measure: Mean absolute error between predicted Concentration at the effect-site propofol associated with deep anesthesia by the machine-learning model and observed Concentration at the effect-site propofol associated with deep anesthesia., otherOutcomes measure: Concentration at the effect-site propofol associated with loss of consciousness (CeLOC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346145, orgStudyIdInfo id: MIMS study, secondaryIdInfos id: 2023-00453, type: OTHER_GRANT, domain: Swdeish research council, briefTitle: Impact of Bariatric Surgery on Heart Disease Compared to Standard Care, acronym: MIMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: The 21 healthcare regions in Sweden, descriptionModule briefSummary: Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS., conditionsModule conditions: Obesity, Morbid, conditions: Bariatric Surgery Candidate, conditions: Heart Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Bariatric surgery, interventions name: Standard care, outcomesModule primaryOutcomes measure: MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis., secondaryOutcomes measure: Total event rate, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: Remission of type 2 diabetes (T2D) and hypertension, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Myocardial revascularization (not related to MI), secondaryOutcomes measure: hospital admission because of heart failure as a primary ICD diagnosis., secondaryOutcomes measure: hospital admission because of atrial fibrillation as a primary ICD diagnosis., otherOutcomes measure: Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity., otherOutcomes measure: Body weight change, otherOutcomes measure: Change in quality of life, otherOutcomes measure: All-cause hospitalizations, otherOutcomes measure: Change in quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346132, orgStudyIdInfo id: 2024-00043 CE 4516, briefTitle: Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Schlotterbeck Hervé, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the effect on patient's comfort of a virtual reality experience during a procedure of cardiac electronic device implantation under local anesthesia., conditionsModule conditions: Virtual Reality, conditions: Medical Device, conditions: Local Anesthesia, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality application, outcomesModule primaryOutcomes measure: Global pain intensity experienced during the procedure., secondaryOutcomes measure: Need for supplementary sedation and/or analgesia during the procedure., secondaryOutcomes measure: Global anxiety intensity experienced during the procedure., secondaryOutcomes measure: Patient's comfort during the procedure assessed by the surgeon and cardiologist., secondaryOutcomes measure: Incidence of motion sickness during the virtual reality experience., secondaryOutcomes measure: Patient's perceived procedure duration., secondaryOutcomes measure: Maximal systolic arterial blood pressure., secondaryOutcomes measure: Incidence of hypotensive or hypoxic events during procedure., secondaryOutcomes measure: Total dose of local anaesthetic used during the procedure., secondaryOutcomes measure: Change in anesthetic strategy during procedure., secondaryOutcomes measure: Interruption of virtual reality experience during the procedure., secondaryOutcomes measure: Intra- and post-procedure complications., secondaryOutcomes measure: Overall patient's comfort and satisfaction experienced during the procedure., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto CardioCentro, city: Lugano, state: Ticino, zip: 6900, country: Switzerland, contacts name: Herve Schlotterbeck, MD, role: CONTACT, phone: +41918115189, email: herve.schlotterbeck@eoc.ch, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False
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protocolSection identificationModule nctId: NCT06346119, orgStudyIdInfo id: PI-2023-01, briefTitle: Evaluation of the Impact of Touch Relaxation in Sedated Intubated Patients Hospitalized in Intensive Care at Niort Hospital, acronym: ETDR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-27, primaryCompletionDateStruct date: 2024-01-05, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier de Niort, class: OTHER, descriptionModule briefSummary: This is a randomized prospective study. This objective is the impact of "relaxing touch" on the use of chemical restraint for patients in intensive care from the lifting of sedation until extubation., conditionsModule conditions: Reaction Anxiety, conditions: Difficult or Failed Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study will be conducted in two parallel groups. At the inclusion, each patient will be assigned to one of two groups by randomization; one group will receive the "touch" and the second group will not receive it will be the control arm., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: It's a person external to the care service and to the randomization process will collect the possible prescription of a chemical restraint or the evolution of this chemical restraint by the resuscitator, in order to maintain the blind., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: this arm will received relaxing touch (hands, feet, head) during 30 minutes twice a day, outcomesModule primaryOutcomes measure: chemical restraint, secondaryOutcomes measure: self-extubations, secondaryOutcomes measure: patient discomfort, secondaryOutcomes measure: respiratory rate, secondaryOutcomes measure: Ratio chemical restraint use, secondaryOutcomes measure: cardiac frequency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Hospitalier de Niort, status: RECRUITING, city: Niort, zip: 79000, country: France, geoPoint lat: 46.32313, lon: -0.45877, hasResults: False
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protocolSection identificationModule nctId: NCT06346106, orgStudyIdInfo id: 23-0075, briefTitle: The Diagnostic Experience of Male Rett Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-24, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Children's Hospital Colorado, class: OTHER, collaborators name: University of Colorado, Denver, collaborators name: Vanderbilt University School of Medicine, collaborators name: University of Alabama at Birmingham, collaborators name: University of Pennsylvania, collaborators name: International Rett Syndrome Foundation, collaborators name: Rocky Mountain Rett Association, descriptionModule briefSummary: The Diagnostic Experience of Male Rett Syndrome collects information on the lived experiences of parents or caregivers to boys with Rett Syndrome. Key information examined includes the process of getting a male Rett syndrome diagnosis, your son's systems of care, and your priorities for his health needs.Enrolled participants will complete an online survey with questions about having a son with Rett Syndrome. The Diagnostic Experience of Male Rett Syndrome study is available to parents or caregivers to boys (alive or passed) with Rett Syndrome. Compensation is not provided., conditionsModule conditions: Rett Syndrome, conditions: RTT, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Male Rett, outcomesModule primaryOutcomes measure: Diagnostic experiences, primaryOutcomes measure: Attainment of developmental milestones and any regressions, primaryOutcomes measure: QI-disability, primaryOutcomes measure: Parent priorities for care and counseling, primaryOutcomes measure: Parenting experience, primaryOutcomes measure: Information regarding child's death, if applicable, secondaryOutcomes measure: Family demographics, secondaryOutcomes measure: Systems of supports, secondaryOutcomes measure: Healthcare preferences, eligibilityModule sex: MALE, minimumAge: 0 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Anschutz Medical Campus, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Natalia Klamut, role: CONTACT, phone: 720-277-9095, email: malerettstudy@cuanschutz.edu, contacts name: Timothy Benke, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Talia Thompson, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False
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protocolSection identificationModule nctId: NCT06346093, orgStudyIdInfo id: CHEC2024-089, briefTitle: Fecal Microbiota Transplantation (FMT) in Patients With Advanced Gastric Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Xiangyu Kong, class: OTHER, descriptionModule briefSummary: This study is a randomized, double-blind and placebo-controlled study. The purpose of this study is to evaluate the efficacy and safety of FMT capsules combined with chemotherapy and anti-PD-L1 therapy in the advanced gastric cancer., conditionsModule conditions: Advanced Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Fecal Microbiota Transplantation Capsules, interventions name: Placebo, outcomesModule primaryOutcomes measure: Objective response rate (ORR), primaryOutcomes measure: Rate of Disease Control, secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Incidence of Adverse Events Related to Treatment, secondaryOutcomes measure: Change in the intestinal microbiome community, secondaryOutcomes measure: Quality of life based on the questionnaire, secondaryOutcomes measure: Quality of life based on the questionnaire, secondaryOutcomes measure: Change in the immunity, otherOutcomes measure: Marker of nutritional status, otherOutcomes measure: Marker of nutritional status, otherOutcomes measure: Marker of nutritional status, otherOutcomes measure: Body Weight, otherOutcomes measure: Appetite, otherOutcomes measure: Marker of nutritional status, otherOutcomes measure: Marker of nutritional status, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Changhai Hospital, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06346080, orgStudyIdInfo id: s68670, briefTitle: Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment, acronym: MAGECmultiDiCE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, descriptionModule briefSummary: The goal of this survey is to investigate the participants' preference for a specific screening/diagnostic tool to detect and assess gastro-esophageal cancer.The main question it aims to answer are:* Which diagnostic modality is preferred by patients and the general population?* Which features of the diagnostic test are most detrimental in the decision-making for one or the other modality?* Are geographical differences present in regard to the preference for a diagnostic modality?Participants will be asked to complete a survey of 20-25min, including a brief intake regarding their socio-economic status. This approach will allow us to correct for confounding factors., conditionsModule conditions: Esophageal Cancer, conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A survey will be conducted in a single group of participants from different geographical regions and backgrounds, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 2200, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: The rate of contribution of diagnostic features to the preference of participants, primaryOutcomes measure: The percentage differences in preference of participants between geographical regions, secondaryOutcomes measure: Assess the rate patient-level demographics influence the importance of a test feature, expressed as an odds ratio, secondaryOutcomes measure: Assess the rate of trade-off demonstrated as odds ratio between cancer-related mortality reduction and costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346067, orgStudyIdInfo id: ERAS-254-02, briefTitle: A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Erasca, Inc., class: INDUSTRY, descriptionModule briefSummary: Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy)., conditionsModule conditions: Advanced or Metastatic NRAS-mutant Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: Naporafenib, interventions name: Dacarbazine, interventions name: Temozolomide, interventions name: Trametinib, outcomesModule primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 1:To select the optimal dose of naporafenib + trametinib to be studied in Stage 2, primaryOutcomes measure: Stage 2: To compare PFS and OS for patients who are randomized to receive the combination of naporafenib + trametinib to that of patients who receive physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy), secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Plasma concentration (Cmax):Stage 1 only, secondaryOutcomes measure: Area under the curve (AUC):Stage 1 only, secondaryOutcomes measure: Quality of Life: To assess disease and treatment-related QOL in patients with NRASm melanoma., otherOutcomes measure: Duration of Response (DOR) for CNS disease in participants, otherOutcomes measure: Overall Response Rate (ORR) for CNS disease in participants, otherOutcomes measure: Disease Control Rate (DCR) for CNS disease in participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SCRI Oncology Partners (formerly Tennessee Oncology), city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
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protocolSection identificationModule nctId: NCT06346054, orgStudyIdInfo id: s68669, briefTitle: Molecular Assessment for Gastro-Esophageal Cancer, acronym: MAGEC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2029-07-01, completionDateStruct date: 2029-07-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, descriptionModule briefSummary: The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.The main questions this study aims to answer:Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.Participants will provide a breath and blood sample during their routine standard of care visits., conditionsModule conditions: Esophageal Cancer, conditions: Gastric Cancer, conditions: Barrett Esophagus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Breath analysis, interventions name: Blood analysis, outcomesModule primaryOutcomes measure: Identification of the concentrations of oncometabolites, secondaryOutcomes measure: Assessment of incidence of early-stage cancer, secondaryOutcomes measure: Assessment of incidence of therapy response, secondaryOutcomes measure: Assessment of percentage change of therapy response, secondaryOutcomes measure: Assessment of incidence of recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346041, orgStudyIdInfo id: HJG-IDOV-SAFE-LYSW, briefTitle: Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors., conditionsModule conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 19, type: ESTIMATED, armsInterventionsModule interventions name: Oncolytic Virus injection(IDOV-SAFETM), outcomesModule primaryOutcomes measure: Dose Limiting Toxicities (DLT), primaryOutcomes measure: Incidence of adverse events and severe adverse events, primaryOutcomes measure: MTD/MFD, secondaryOutcomes measure: The Pharmacokinetics characteristics of IDOV-SAFETM((biological distribution and viral expulsion)), secondaryOutcomes measure: Immunogenicity of IDOV-SAFETM, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: DOR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346028, orgStudyIdInfo id: 2023/086, briefTitle: Implementation of Transcranial Magnetic Stimulation for Smoking Cessation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: Repetitive transcranial magnetic stimulation (rTMS) is an alternative non-invasive treatment to help people quit smoking. rTMS uses a magnetic field to stimulate regions of the brain that are involved in addiction. The two brain regions that are stimulated are the insula and the dorsolateral prefrontal cortex, which are involved in drug craving and decision-making, respectively.The goal of this clinical trial is to learn more about the feasibility of offering rTMS as a treatment in the Nicotine Dependence Clinic (NDC) to help daily smokers to quit smoking. The NDC is at the Center for Addiction and Mental Health (CAMH) at 1025 Queen Street West, in Toronto, Canada.Participants will be asked to come to CAMH to:* Complete surveys and optional interviews to learn more about their opinions and experiences with this treatment* Start a treatment course that includes 3 weeks of daily (Monday to Friday) rTMS sessions followed by 3 weeks of weekly rTMS sessions for a total of 6 weeks. Each session lasts about 25 minutes and is provided by an rTMS technician with medical supervision.Objectives• Learning about the feasibility of rTMS as a treatment option for patients in the NDC will help us improve the treatment when offering it in other clinics, which may help improve smoking quit rates and people's overall health., conditionsModule conditions: Smoking, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Brainsway H4 deep rTMS coil and Brainsway stimulator system, outcomesModule primaryOutcomes measure: The primary objective of the study is to evaluate the feasibility of implementing rTMS in the Nicotine Dependence Clinic (NDC) at CAMH, in Toronto. This is determine by reach, the extent to which patients are engaging in the rTMS treatment., primaryOutcomes measure: Identify rates of adoption of rTMS in Nicotine Dependence Clinic, primaryOutcomes measure: Identify contextual determinants of rTMS adoption and reach NDC through a qualitative approach., secondaryOutcomes measure: Evaluate the effectiveness of rTMS on smoking cessation rates in real world patients with common comorbidities seeking treatment at NDC., secondaryOutcomes measure: Explore patient-HCP communication about shared treatment decision-making for rTMS., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Addiction and Mental Health (CAMH), status: RECRUITING, city: Toronto, state: Ontario, country: Canada, contacts name: Alexandra S, BScH, role: CONTACT, phone: 416-535-8501, phoneExt: 31551, email: rtms.smoking@camh.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06346015, orgStudyIdInfo id: HX-A-2023050, briefTitle: Gamma Entrainment Stimulation for Cognitive Dysfunction After aSAH, acronym: GES-aSAH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: Shanghai Joyingmed Sensory Stimulation Lab, descriptionModule briefSummary: The goal of this clinical trial is to Explore and verify whether 40Hz audio and binaural beat 40Hz audio can improve the postoperative cognitive dysfunction seen in patients with aneurysmal subarachnoid hemorrhage. This study is a single-center, prospective, randomized, controlled clinical trial. Patients with aneurysmal subarachnoid hemorrhage were selected and randomized into intervention group (audio adjuvant group) and control group (conventional treatment group). Patients in the intervention group will receive audio therapy after surgery, and patients in the control group will receive usual care. EEG, fMRI and mRS scores were evaluated after 3 months of follow-up., conditionsModule conditions: Subarachnoid Hemorrhage, Aneurysmal, conditions: Cognitive Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The relevant neuroimaging evaluation process is blinded to the evaluator to ensure the objectivity of the evaluation results., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Gamma Entrainment Stimulation, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment (MoCA) scores < 22, primaryOutcomes measure: mini-mental state examiniation (MMSE) < 27, primaryOutcomes measure: modified Rankin Scales (mRS) > 2, secondaryOutcomes measure: electroencephalogram (EEG) indicators, secondaryOutcomes measure: functional Magnetic Resonance Imaging (fMRI) indicators, otherOutcomes measure: Safety indicator, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06346002, orgStudyIdInfo id: 2026_e_2017, briefTitle: Impact of a Mindfulness-based Intervention on Well-being and Mental Health of Elementary School Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-03-01, primaryCompletionDateStruct date: 2020-03-31, completionDateStruct date: 2020-03-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Bishop's University, class: OTHER, descriptionModule briefSummary: Background: Prevention programs for children such as mindfulness-based interventions (MBIs) are often implemented in schools to prevent psychological disorders from emerging and contribute to children' mental health.Aim: This study used a randomized cluster design and assessed the impact of a MBI on well-being and mental health of elementary school children's.Method: 13 elementary school classrooms were randomly allocated to the experimental condition (7 classrooms, n = 127 students) or the waitlist control condition (6 classrooms, n = 104 students). Participants in the experimental condition received a 10-week MBI., conditionsModule conditions: Mindfulness-based Intervention, conditions: Elementary School Children, conditions: Mental Health Wellness 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized cluster trial with a wait-list control, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 231, type: ACTUAL, armsInterventionsModule interventions name: Mindfulness-based intervention, outcomesModule primaryOutcomes measure: Symptoms of Mental Health Disorders, primaryOutcomes measure: Basic Psychological Needs Satisfaction, primaryOutcomes measure: Process Measure, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: École primaire Préville, city: Saint-Lambert, state: Quebec, zip: J4S 1M8, country: Canada, geoPoint lat: 45.50008, lon: -73.51028, hasResults: False
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protocolSection identificationModule nctId: NCT06345989, orgStudyIdInfo id: 187157, briefTitle: Time and Cost-implications of Intraoral Scans vs Alginate Impressions: A Randomised Controlled Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Sheffield, class: OTHER, collaborators name: Nottingham University Hospitals NHS Trust, descriptionModule briefSummary: This research project investigates the time and cost implications of two common techniques in orthodontics: alginate impressions and intraoral scans. Alginate impressions (putty moulds) are a traditional technique that has been used in orthodontic practice for many years. Intraoral scans are a more modern method and are becoming more commonly used in orthodontic practice. Both alginate impressions and intraoral scans are a means of recording a copy of a patient's teeth which aids in record keeping and treatment planning.Whilst the majority of the available literature reveals patient preference in favour of intraoral scanning, it remains common practice to use alginate impressions for orthodontic records. Considerations such as time implications, device costs, associated software expenses, and the need for clinician training pose challenges to widespread adoption of intraoral scanning. When comparing chairside time taken for intraoral scans versus alginate impressions, there are varying findings, requiring a thorough investigation.The main question being addressed is:- Are intraoral scans more time efficient than alginate impressions?The secondary question being addressed is:- Are intraoral scans more cost effective than alginate impressions?This research protocol outlines a clinical trial, evaluating the chairside time and costs associated with intraoral scanning versus alginate impressions. The sample population will be orthodontic patients ages 9 years and above attending the orthodontic department at a district general hospital.The outcomes of this study will provide important insights into the practicality and economic viability of intraoral scanning versus alginate impressions in orthodontic settings, thereby informing clinical practices within the United Kingdom. This research contributes to strengthening the evidence base surrounding orthodontic techniques and their implications for patient-centred care., conditionsModule conditions: Chairside Time and Costs Associated With Intraoral Scanning Versus Alginate Impressions, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective single-centre parallel arm randomised controlled trial, with an allocation ratio of 1:1 to investigate the difference in chairside time and cost of alginate impressions vs intraoral scans., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the study, blinding to intervention will not be possible for the participants or clinicians during data acquisition. All data analysis will be carried out blinded using a coded data set., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Alginate impression, interventions name: Intraoral scan, outcomesModule primaryOutcomes measure: Chairside time taken for alginate impressions vs intraoral scans., secondaryOutcomes measure: Cost implications of alginate impressions vs intraoral scans., eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Queens Medical Centre, Nottingham University Hospitals NHS Trust, city: Nottingham, state: Nottinghamshire, zip: NG7 2UH, country: United Kingdom, contacts name: Hannah Hook, BDS, role: CONTACT, phone: 07853993215, email: hannah.hook@nuh.nhs.uk, contacts name: Andrew Flett, BDS, role: CONTACT, email: andrew.flett@nuh.nhs.uk, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False
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protocolSection identificationModule nctId: NCT06345976, orgStudyIdInfo id: RLX_2023_10, briefTitle: Functional Impairment in Albinism, acronym: PLAIB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fondation Ophtalmologique Adolphe de Rothschild, class: NETWORK, descriptionModule briefSummary: Albinism is a genetic and hereditary anomaly that affects pigmentation. This pathology is characterized by a deficit in melanin production. In humans, the clinical diagnosis of albinism is based on a number of factors, including :* In the integumentary region: fair skin tone, with white hair, eyelashes and eyebrows.* Ophthalmological: reduced visual acuity, photophobia, nystagmus, transilluminated blue irises, hypopigmentation of the retina at the back of the eye with fovea plana.As treatment options begin to emerge for certain albinism-induced anomalies (including, for example, the depigmentation that causes photophobia), it is desirable to understand what these patients' complaints are, and to gather their views on the emergence of treatments targeting just one of their complaints, namely glare., conditionsModule conditions: Albinism, Ocular, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: questionnaire, outcomesModule primaryOutcomes measure: To determine whether patients with albinism would be interested in a treatment that could improve their glare without improving their visual acuity., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06345963, orgStudyIdInfo id: HSC-MS-23-1044, briefTitle: Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: The University of Texas Health Science Center, Houston, class: OTHER, descriptionModule briefSummary: Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: active H-coil delivered rTMS, outcomesModule primaryOutcomes measure: brain microstructural integrity from magnetic resonance imaging (MRI), primaryOutcomes measure: Resting-state functional connectivity (rsFC) from functional MRI, secondaryOutcomes measure: Electrophysiological responses measured by mismatch negativity and steady-state auditory evoked potentials from electroencephalography recording (EEG), secondaryOutcomes measure: Cognitive insight, depression, perception, and delusion measured from questionnaires, secondaryOutcomes measure: Cognitive functions measured by the MATRICS consensus cognitive battery (MCCB), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center, Houston, city: Houston, state: Texas, zip: 77054, country: United States, contacts name: Xiaoming Du, PhD, role: CONTACT, phone: 410-402-6036, email: Xiaoming.Du@uth.tmc.edu, contacts name: Victoria Acosta, role: CONTACT, phone: 713-486-2740, email: Victoria.Acosta@uth.tmc.edu, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06345950, orgStudyIdInfo id: 2022-04-003, briefTitle: Pharmacokinetics and Safety of a New Micellar Glutathione Formulation, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-21, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Factors Group of Nutritional Companies Inc., class: INDUSTRY, collaborators name: Isura, descriptionModule briefSummary: This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers.The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period., conditionsModule conditions: Bioavailability, conditions: Safety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Participants are randomly assigned to interventions in a crossover design to assess the pharmacokinetics over 24 hours; subsequently, the safety of one intervention with higher bioavailability is evaluated in an additional single-arm, 30-day trial., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Liposomal Glutathione, interventions name: Standard Glutathione, interventions name: New Micellar Glutathione (Lipomicel), outcomesModule primaryOutcomes measure: AUC: the area under the concentration-time curve, primaryOutcomes measure: Cmax: maximum plasma concentration, primaryOutcomes measure: Tmax: the time point of maximum plasma concentration, secondaryOutcomes measure: Alanine aminotransferase (ALT), secondaryOutcomes measure: Aspartate aminotransferase (AST), secondaryOutcomes measure: Alkaline phosphatase (ALP), secondaryOutcomes measure: Bilirubin, secondaryOutcomes measure: Serum creatinine, secondaryOutcomes measure: Blood urea nitrogen (BUN), secondaryOutcomes measure: Glomerular filtration rate (GFR), secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: White blood cell count (WBC), secondaryOutcomes measure: Hemoglobin (Hb), secondaryOutcomes measure: Hematocrit (Hct), secondaryOutcomes measure: Platelet count, secondaryOutcomes measure: Fasting blood glucose, secondaryOutcomes measure: Total cholesterol, secondaryOutcomes measure: Low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: High-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Triglycerides, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ISURA, city: Burnaby, state: British Columbia, zip: V2N 4S9, country: Canada, geoPoint lat: 49.26636, lon: -122.95263, hasResults: False
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protocolSection identificationModule nctId: NCT06345937, orgStudyIdInfo id: REB #44724, briefTitle: Multiple Risk Factor Intervention Trial (Ms. FIT), acronym: MsFIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Toronto, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: This study aims to produce new evidence, specific to women, on the efficacy and mechanisms of exercise and diet for cardiometabolic risk reduction in pre and postmenopausal women. Using a 3-arm randomized controlled trial (RCT) with equal recruitment and stratification by menopausal status to 6 months of: 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions:* How does the impact of exercise compare among each of the causal links between physical inactivity and cardiometabolic disease in women?* What is the effect modification of adding a diet quality intervention to exercise?* What is the effect modification by menopausal status?The investigators hypothesize that exercise adaptations will be: 1) largest peripherally, including Matsuda index (primary outcome), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), arteriovenous oxygen difference (avO2diff), and visceral fat, compared to centrally (stroke volume (SV), endothelial function, aortic stiffness), 2) blunted or absent in post vs premenopause; 3) enhanced by the addition of diet quality which will be essential or additive for Matsuda index, metabolic syndrome, Framingham cardiovascular disease (CVD) risk, cytokines and adipokines, thigh myosteatosis, muscle mass, peak oxygen uptake (VO2peak), 4) enhanced by adding diet quality in more outcomes postmenopause., conditionsModule conditions: Metabolic Disturbance, conditions: Sedentary Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 3-arm parallel-group randomized controlled trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: It is not possible to blind participants to their assigned intervention. Care providers are not involved. The outcome assessors for any assessments involving potential for subjectivity in data collection or analysis will be blinded to group assignment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Behavioural Experimental: guidelines-based physical activity, interventions name: Behavioural Experimental: guidelines-based physical activity and healthy eating, interventions name: Behavioural: Stretching exercise, outcomesModule primaryOutcomes measure: Insulin resistance, secondaryOutcomes measure: Hepatic insulin resistance, secondaryOutcomes measure: Metabolic syndrome severity, secondaryOutcomes measure: Framingham 10-year risk (%), otherOutcomes measure: Cardiorespiratory fitness, otherOutcomes measure: Heart Rate Recovery, otherOutcomes measure: Exercise stroke volume & cardiac output, otherOutcomes measure: Left ventricular ejection fraction, otherOutcomes measure: Left ventricular mass, otherOutcomes measure: Arteriovenous Oxygen Difference (avO2diff), otherOutcomes measure: Endothelial Function, otherOutcomes measure: Carotid Intima Media Thickness, otherOutcomes measure: Central & Peripheral Arterial stiffness, otherOutcomes measure: Blood Pressure, otherOutcomes measure: Resting Heart Rate & Heart Rate Variability, otherOutcomes measure: Thigh Myosteatosis, otherOutcomes measure: Knee flexion and extension (strength and endurance), otherOutcomes measure: Thigh Muscle Volume, otherOutcomes measure: Biochemical markers of skeletal muscle protein content, otherOutcomes measure: Biochemical markers of skeletal muscle structure, otherOutcomes measure: Biochemical markers of skeletal muscle enzyme activity, otherOutcomes measure: Whole-body fat and fat-free mass, otherOutcomes measure: Visceral adipose tissue, otherOutcomes measure: Liver fat fraction, otherOutcomes measure: Body circumferences, otherOutcomes measure: Concentration of inflammation biomarkers in blood, otherOutcomes measure: Lipid panel: high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, total Cholesterol, Triglycerides, otherOutcomes measure: Hemoglobin A1c, otherOutcomes measure: Dietary intake, otherOutcomes measure: Liver enzymes: alanine transaminase (ALT), aspartate aminotransferase (AST), and albumin, otherOutcomes measure: Liver fibrosis, otherOutcomes measure: Aerobic physical activity adherence, otherOutcomes measure: Resistance exercise adherence, otherOutcomes measure: Diet quality, otherOutcomes measure: Health-related quality of life, otherOutcomes measure: Menopausal symptom presence and severity, otherOutcomes measure: Psychosocial stress, otherOutcomes measure: Depression & Anxiety, otherOutcomes measure: Barriers and self-efficacy for physical activity, otherOutcomes measure: Physical activity motivation, otherOutcomes measure: Sleep quality - subjective, otherOutcomes measure: Sleep quantity and quality - device measured, otherOutcomes measure: Self-reported physical activity, otherOutcomes measure: Serum Estradiol, otherOutcomes measure: Salivary Estradiol, otherOutcomes measure: Hemoglobin, otherOutcomes measure: Free fatty acids, otherOutcomes measure: Body weight, otherOutcomes measure: Body mass index (BMI), otherOutcomes measure: Energy Balance, eligibilityModule sex: FEMALE, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Toronto, status: RECRUITING, city: Toronto, state: Ontario, zip: M5S 2C9, country: Canada, contacts name: Amy A. Kirkham, PhD, role: CONTACT, phone: 416-946-4069, email: amy.kirkham@utoronto.ca, contacts name: Jenna B. Gillen, PhD, role: CONTACT, phone: 416-978-3244, email: jenna.gillen@utoronto.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06345924, orgStudyIdInfo id: Meraki_Palliative Care, briefTitle: Music Therapy for Cancer Patients(Meraki_PC), acronym: Meraki_Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out., conditionsModule conditions: Cancer, conditions: Palliative Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: MERAKI_PC, outcomesModule primaryOutcomes measure: Change in Anxiety and Depression Symptomatology (T1, T2 and T4), primaryOutcomes measure: Change in Quality of Life (T1, T2 and T4), primaryOutcomes measure: Change in emotional distress (T1, T2, T3 and T4), secondaryOutcomes measure: Change in Social Suport (T1 and T4), secondaryOutcomes measure: Change in Resilience (T1 and T4), secondaryOutcomes measure: Change in Spirituality (T1 and T4), secondaryOutcomes measure: Change Knowledge of the disease (T1 and T4), secondaryOutcomes measure: Barthel Index, secondaryOutcomes measure: Pfeiffer Short Form Mental State Questionnaire, SPMSQ, secondaryOutcomes measure: Charlson Comorbidity Index (CCI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Dr. Moliner, status: RECRUITING, city: Serra, state: Valencia, country: Spain, contacts name: Miguel Fombuena, PhD, role: CONTACT, email: fombuena_mig@gva.es, contacts name: Selene Valero-Moreno, PhD, role: SUB_INVESTIGATOR, contacts name: Isabel Bellver Vercher, role: SUB_INVESTIGATOR, contacts name: Ana Alegre Soler, role: SUB_INVESTIGATOR, contacts name: José Jorge Botella Trellis, Dr., role: SUB_INVESTIGATOR, contacts name: Cristina Rocío Espejo Fernández, Dra., role: SUB_INVESTIGATOR, contacts name: María Carmen Badía Picazo, Dra., role: SUB_INVESTIGATOR, geoPoint lat: 39.68333, lon: -0.43333, hasResults: False
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protocolSection identificationModule nctId: NCT06345911, orgStudyIdInfo id: NEU-49/899, briefTitle: Do Vacutainers With Animal Characters Reduce Fear and Anxiety?, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2022-02-25, completionDateStruct date: 2022-03-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Burdur Mehmet Akif Ersoy University, class: OTHER, descriptionModule briefSummary: The study was designed as a randomized controlled experimental research with the purpose of determining the effect of distraction by using vacutainers of three different animal characters., conditionsModule conditions: Procedural Pain, conditions: Acute Pain, conditions: Fear, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ACTUAL, armsInterventionsModule interventions name: Experimental group, outcomesModule primaryOutcomes measure: Children's Fear Scale, primaryOutcomes measure: Wong-Baker FACES Pain Rating Scale, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Karaman Education and Research Hospital, city: Karaman, country: Turkey, geoPoint lat: 37.18111, lon: 33.215, hasResults: False
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protocolSection identificationModule nctId: NCT06345898, orgStudyIdInfo id: 2023-1479, briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2029-12-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002., conditionsModule conditions: X Linked Retinoschisis, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: JWK002, outcomesModule primaryOutcomes measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events), secondaryOutcomes measure: Best corrected visual acuity (BCVA), secondaryOutcomes measure: Full-field electroretinogram(ff-ERG), secondaryOutcomes measure: Macular structure as assessed by swept source optical coherence tomography, secondaryOutcomes measure: Visual field, eligibilityModule sex: MALE, minimumAge: 5 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610023, country: China, contacts name: Licong Liang, role: CONTACT, email: 932968425@qq.com, contacts name: Fang Lu, role: CONTACT, email: lufang@wchscu.cn, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06345885, orgStudyIdInfo id: PROPMHP002, briefTitle: Immunogenicity and Safety of One Dose of HPV Vaccine, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-23, primaryCompletionDateStruct date: 2024-01-17, completionDateStruct date: 2024-01-17, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Xiamen Innovax Biotech Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study will assess the immunogenicity and safety of one dose of Cecolin and one dose of Gardasil, conditionsModule conditions: Human Papillomavirus Vaccines, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: HPV vaccine, outcomesModule primaryOutcomes measure: Anti-HPV seropositivity, secondaryOutcomes measure: Anti-HPV Seropositivity, secondaryOutcomes measure: HPV Antibody Titers, secondaryOutcomes measure: Local and Systemic Reactions/Event, eligibilityModule sex: FEMALE, minimumAge: 9 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: Fujian Provincial Center for Disease Control and Prevention, city: Fuzhou, state: Fujian, zip: 350012, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06345872, orgStudyIdInfo id: STUDY005883, secondaryIdInfos id: 1R01DA054311, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01DA054311, briefTitle: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain., conditionsModule conditions: Chronic Pain, conditions: Chronic Insomnia, conditions: Opioid Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 165, type: ESTIMATED, armsInterventionsModule interventions name: CBT-I, interventions name: Treatment as usual, interventions name: Tapered Withdrawal, outcomesModule primaryOutcomes measure: Change in Insomnia Severity Index, primaryOutcomes measure: Change in Pain Intensity - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Wake After Sleep Onset - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Sleep Onset Latency- Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Sleep Efficiency- Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Fatigue - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Sleep and Pain Medication - Daily Electronic Sleep Diaries, primaryOutcomes measure: Change in Perceived Stress Scale, primaryOutcomes measure: Change in Peripheral Arousal, primaryOutcomes measure: Change in Neural Imaging: Structural/Functional MRI/Diffusion Weighted Imaging, primaryOutcomes measure: Change in Thermal Pain Response, primaryOutcomes measure: Change in Opioid Use (Quantitative), primaryOutcomes measure: Change in Opioid Use (Self-Report), secondaryOutcomes measure: Change in Objective Wake After Sleep Onset (Actigraph), secondaryOutcomes measure: Change in Objective Sleep Onset Latency (Actigraph), secondaryOutcomes measure: Change in Objective Sleep Efficiency (Actigraph), secondaryOutcomes measure: Change in Neural Connectivity: Structural/Functional MRI/Diffusion Weighted Imaging, secondaryOutcomes measure: Short Inventory of Problems, secondaryOutcomes measure: Change in Pain Catastrophizing Scale, otherOutcomes measure: Change in 36-Item Short Form Survey (SF-36), otherOutcomes measure: Change in Depression (Beck Depression Inventory-II), otherOutcomes measure: Change in State-Trait Anxiety Inventory (STAI), otherOutcomes measure: Medications/Substances Uses and Dosages, otherOutcomes measure: Change in Subjective Opioid Withdrawal Scale (SOWS), otherOutcomes measure: Change in Opioid Cravings Scale, otherOutcomes measure: Change in NIH Toolbox, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Christina S McCrae, PhD, role: CONTACT, phone: 813-974-1804, email: christinamccrae@usf.edu, contacts name: Jasmine L Niazi, MS, role: CONTACT, phone: (813) 906-0483, email: jlniazi@usf.edu, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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