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protocolSection identificationModule nctId: NCT06288633, orgStudyIdInfo id: FNWMRC, briefTitle: Cardioneuroablation for Bradyarrhythmia, acronym: CARDIOBOOST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, class: OTHER, collaborators name: Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, collaborators name: The Federal Centre of Cardiovascular Surgery, Russia, collaborators name: Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare, collaborators name: City Clinical Hospital No.52 of Moscow Healthcare Department, collaborators name: National Medical Research Center for Therapy and Preventive Medicine, collaborators name: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan, collaborators name: Tomsk National Research Medical Center of the Russian Academy of Sciences, collaborators name: Vishnevsky Center of Surgery, collaborators name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, descriptionModule briefSummary: This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation, conditionsModule conditions: Bradycardia, conditions: Syncope, conditions: Sick Sinus Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Ganglionated plexi ablation, interventions name: Electrophysiological study, outcomesModule primaryOutcomes measure: Implantation of a permanent cardiac pacemaker, secondaryOutcomes measure: Complications of cardioneuroablation, secondaryOutcomes measure: Presence of symptomatic or asymptomatic rhythm pauses >6 seconds, secondaryOutcomes measure: The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime, secondaryOutcomes measure: Transient or permanent atrioventricular block, secondaryOutcomes measure: Orthostatic hypotension and/or bradycardia during passive orthostasis test, secondaryOutcomes measure: Sinus tachycardia after cardioneuroablation, secondaryOutcomes measure: Implantation of a pacemaker by 24 months after randomization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Almazov National Medical Research Centre, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Shlyakhto, role: CONTACT, phone: +78127023749, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False |
protocolSection identificationModule nctId: NCT06288620, orgStudyIdInfo id: MA-EBC-II-024, briefTitle: Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2025-05-10, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 77, type: ESTIMATED, armsInterventionsModule interventions name: Microwave Ablation, outcomesModule primaryOutcomes measure: Complete ablation rate, secondaryOutcomes measure: Safety of microwave ablation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, contacts name: Wenbin Zhou, Professor, role: CONTACT, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06288607, orgStudyIdInfo id: 2023-SR-708, briefTitle: Safety and Efficacy of High Intensity Focused Ultrasound in Solar Lentigo: A Self-controlled Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-16, primaryCompletionDateStruct date: 2024-04-18, completionDateStruct date: 2024-04-18, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab\* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab\* values and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively., conditionsModule conditions: Solar Lentigo, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China), outcomesModule primaryOutcomes measure: Lab* values, primaryOutcomes measure: Physician Global Aesthetic Improvement Scale, primaryOutcomes measure: Subjective Global Aesthetic Improvement Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06288594, orgStudyIdInfo id: DEU-PSI-HA-001, briefTitle: TraumaRelief App: A Pilot RCT Assessing Feasibility and Acceptability, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: The world experiences a high rate of traumatic events. Even if PTSD is not diagnosed, traumatic events can significantly affect people's lives. Traditional face-to-face therapies often face challenges, such as financial constraints, expensive therapy sessions, time restrictions, fear of stigma, and difficulties in accessing clinical psychologists. These challenges motivated us to develop new methods. Particularly in Turkey, there is neither sufficient infrastructure nor existing applications dedicated to addressing trauma-related complications. The development of the 'TraumaRelief' app is a pioneering initiative aimed at bridging this gap, targeting the resolution of these prevalent issues by introducing an accessible, innovative solution. The newly developed "TraumaRelief" app aims to provide solutions to these issues. This app contains eight modules: online video talks, psychoeducation, coping with symptoms, mindfulness-based relaxation exercises, imagery exposure, CBT (Cognitive Behavioral Therapy)-based daily exercises, therapist messaging, emergency contact access. The purpose of this study is to test the feasibility and acceptability of this newly developed application through a pilot randomized controlled trial., conditionsModule conditions: Post-Traumatic Stress Disorder (PTSD), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a three-arm, parallel randomized controlled trial. Upon enrollment, participants are randomly assigned to one of three groups. The first group will use the "TraumaRelief" application in addition to weekly video calls with a psychologist. The second group will use the "TraumaRelief" mobile application exclusively. The third group will serve as a control and receive no intervention. The primary outcomes will be measured at baseline, five weeks, one month, and three months post-intervention to assess the efficacy and acceptability of the mobile application and the added benefit of psychological support., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: In this pilot randomized controlled trial, no masking is applied, as the nature of the interventions makes it impractical. Participants are informed of their group assignment since those in the second group are aware of their additional video call sessions with psychotherapists. The therapists conducting the sessions also need to be aware of the intervention they are delivering to properly adhere to the treatment protocol. This open-label approach is necessary to facilitate the intended psychotherapeutic interactions and to ensure that the intervention is delivered with fidelity, as per the study design., enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Application Plus Online Therapist Support Group, interventions name: Application Only Group, outcomesModule primaryOutcomes measure: PTSD Symptom Severity, secondaryOutcomes measure: Depression Anxiety and Stress Symptom Severity, secondaryOutcomes measure: Quality of Life Improvement, secondaryOutcomes measure: Feasibility: Attrition Rate, secondaryOutcomes measure: Feasibility: Recruitment Rate, secondaryOutcomes measure: Feasibility: Retention Rate, secondaryOutcomes measure: Feasibility: Adherence Rate to the Mobile Application, secondaryOutcomes measure: Feasibility: Consent Rate, secondaryOutcomes measure: Feasibility: Fidelity of Intervention Delivery, secondaryOutcomes measure: Acceptability: System Usability Scale (SUS) Score for Acceptability, secondaryOutcomes measure: Acceptability: Preferred and Least Preferred Module Components, secondaryOutcomes measure: Acceptability: Application Utilization Frequency, secondaryOutcomes measure: Acceptability: Likelihood to Recommend the Application, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288581, orgStudyIdInfo id: UDDS-Pedo-02-2024, briefTitle: U Shaped Toothbrush in Removing Plaque in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Damascus University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.Children accepted in the study will be randomly divided into two groups:The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH), conditionsModule conditions: Dental Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Traditional toothbrush group, interventions name: U shaped toothbrush group, outcomesModule primaryOutcomes measure: Changing in plaque index, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Damascus University, status: RECRUITING, city: Damascus, zip: 20872, country: Syrian Arab Republic, contacts name: Kamar Abdulrahman, MSc. student, role: CONTACT, phone: 00963957510093, email: [email protected], geoPoint lat: 33.5102, lon: 36.29128, hasResults: False |
protocolSection identificationModule nctId: NCT06288568, orgStudyIdInfo id: Shift2Health, briefTitle: Night Shift Work and Biomarkers of Obesity Risk in Hospital and Industry Workers, acronym: Shift2Health, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2028-05-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Vienna, class: OTHER, collaborators name: Medical University of Vienna, collaborators name: FH Joanneum Gesellschaft mbH, collaborators name: Wageningen University and Research, collaborators name: Wageningen University, collaborators name: University of Bremen, collaborators name: Verein zur Förderung des Technologietransfers an der Hochschule Bremerhaven e.V., collaborators name: UNIVERSYTET MEDYCZNY W LODZI, collaborators name: Københavns Universitet, collaborators name: Charite University, Berlin, Germany, collaborators name: Erasmus Medical Center, descriptionModule briefSummary: Shift work is a well-known risk factor for the development of overweight and obesity, which may lead to downstream effects such as increased risk of cardiometabolic diseases and cancer. However, the biological and behavioral mechanisms underlying the obesogenicity of night shift work are not well understood. Population-based mechanistic studies in real life shift workers are needed to address how night shift work impacts metabolic health.The investigators aim to characterize the behavioural, environmental, and biological mechanisms and pathways for the association of night shift work and obesity across Europe.The investigators will conduct a cross sectional study in 5 European countries (Austria, Denmark, Germany, Netherlands and Poland) and recruit 1000 rotating night shift workers and day workers (200/country) from the health sector and different industries. Night and day workers will be age-frequency (3 age groups), gender and (where possible) working tasks matched. Participants will complete online questionnaires and report their diet habits in a mobile app. Body composition, dietary behavior and sensory preferences will be tested. Biologic specimens (blood, urine, saliva, hair and feces) will be collected at the workplace on a day where participants are working on a day shift (or a day off). In a subsample (Austria and Netherlands) shift workers will provide biological samples (spot blood, urine and saliva) both on a day shift and on a night shift. Biomarkers including hormones, cellular immunity and inflammation, parameters linked to gut health and metabolism of fat and sugar, appetite, oxidative stress, metabolomics and microbiota will be measured. The investigators hypothesize that compared to day workers, night shift workers will experience disrupted levels of pre-obesity markers. Higher circadian disruption, sleep disruption and mistimed eating patterns workers will be associated with more disrupted biomarker profiles. Among rotating shift workers, night shift will be associated with acute disrupted melatonin production, metabolomic profiles and composition of oral microbiota compared to a day shift., conditionsModule conditions: Obesity, conditions: Shift-work Disorder, conditions: Circadian Rhythm Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: high-sensitive C-Reactive Protein (hs-CRP), secondaryOutcomes measure: The investigators will consider levels of hormones in plasma, secondaryOutcomes measure: The investigators will consider levels of hormones in plasma, secondaryOutcomes measure: The investigators will consider levels of parameters linked to gut health in serum and in feces, secondaryOutcomes measure: The investigators will consider levels of parameters linked to gut health in serum and in feces, secondaryOutcomes measure: The investigators will consider levels of parameters linked to gut health in serum and in feces, secondaryOutcomes measure: The investigators will consider levels of parameters linked to gut health in serum and in feces, secondaryOutcomes measure: The investigators will consider parameters of cellular immunity and inflammation in plasma, secondaryOutcomes measure: The investigators will consider parameters of cellular immunity and inflammation in plasma, secondaryOutcomes measure: The investigators will consider parameters of cellular immunity and inflammation in plasma, secondaryOutcomes measure: The investigators will consider parameters of metabolism of fat and sugar in plasma, secondaryOutcomes measure: The investigators will consider parameters of metabolism of fat and sugar in plasma, secondaryOutcomes measure: The investigators will consider parameters of metabolism of fat and sugar in plasma, secondaryOutcomes measure: The investigators will consider parameters of metabolism of fat and sugar in plasma, secondaryOutcomes measure: The investigators will consider parameters of metabolism of fat and sugar in plasma, secondaryOutcomes measure: The investigators will consider levels of appetite markers in plasma, secondaryOutcomes measure: The investigators will consider levels of appetite markers in plasma, secondaryOutcomes measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine, secondaryOutcomes measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine, secondaryOutcomes measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine, secondaryOutcomes measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine, secondaryOutcomes measure: The investigators will consider levels of oxidative stress in whole blood, serum, plasma and urine, secondaryOutcomes measure: The investigators will consider metabolomics analysis of plasma samples and dry blood spots (DBS), secondaryOutcomes measure: The investigators will consider microbiome analysis of feces samples and tongue swabs, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06288555, orgStudyIdInfo id: 020/2566, briefTitle: Validation of Ipswich Touch Test for Diabetic Peripheral Neuropathy Screening in Primary Care, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2024-01-23, completionDateStruct date: 2024-01-23, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Ponlawat Hanchana, MD, class: OTHER_GOV, descriptionModule briefSummary: The goal of this observational study is to assess the accuracy of screening for diabetic peripheral neuropathy by comparing the Ipswich touch test with the 10-g monofilament test in patients diagnosed with type 2 diabetes.The main question it aims to answer is:How does the accuracy of the Ipswich Touch Test for identifying peripheral neuropathy compare to the traditional 10-g monofilament test?Participants underwent both the Ipswich touch test and the 10-g monofilament test., conditionsModule conditions: Diabetic Foot, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 274, type: ACTUAL, armsInterventionsModule interventions name: Ipswich touch test, outcomesModule primaryOutcomes measure: The accuracy of the Ipswich touch test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ponlawat Hanchana, MD, city: Saraburi, zip: 18120, country: Thailand, geoPoint lat: 14.53333, lon: 100.91667, hasResults: False |
protocolSection identificationModule nctId: NCT06288542, orgStudyIdInfo id: MD-250-2022, briefTitle: Preoperative Dextrose Infusion and Postoperative Nausea and Vomiting, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This research aims to investigate the efficacy of preoperative intravenous infusion of dextrose 5% during fasting in lowering the incidence and severity of post-operative nausea and vomiting related to laparoscopic gynaecologic procedures, conditionsModule conditions: Effect of Dextrose on Postoperative Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 111, type: ESTIMATED, armsInterventionsModule interventions name: group d, interventions name: group R, outcomesModule primaryOutcomes measure: frequency of post-opertive nausea and vomiting in 24 hour, secondaryOutcomes measure: TOTAL AMOUNT OF ANTIEMETIC REQUIRED, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288529, orgStudyIdInfo id: 1, briefTitle: EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Health Sciences Balikesir Hospital Eduation and Research, class: OTHER_GOV, descriptionModule briefSummary: Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI., conditionsModule conditions: Chronic Kidney Diseases, conditions: Type2diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 975, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Development of post-contrast acute kidney injury, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Health Sciences Balikesir Education and Research Hospital, city: Balıkesir, zip: 10100, country: Turkey, geoPoint lat: 39.64917, lon: 27.88611, hasResults: False |
protocolSection identificationModule nctId: NCT06288516, orgStudyIdInfo id: 7484, briefTitle: BenRalizumab Effect on Airway Remodeling in Severe asTHma, acronym: BREATH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Aristotle University Of Thessaloniki, class: OTHER, collaborators name: Pulmonary Clinic, Aristotle University of Thessaloniki, Greece, collaborators name: Pulmonary Clinic, University of Ioannina, collaborators name: Pulmonary Clinic, Democritus University of Thrace, collaborators name: 2nd Pulmonary Clinic, Kapodistrian University of Athens, collaborators name: University Hospital of Crete, collaborators name: Pulmonary and Respiratory Failure Department, National and Kapodistrian University of Athens, collaborators name: University Hospital of Patras, descriptionModule briefSummary: Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice.Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment.Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis.Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?, conditionsModule conditions: Asthma; Eosinophilic, conditions: Airway Remodeling, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Benralizumab (30mg) administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Benralizumab 30 mg/ml, outcomesModule primaryOutcomes measure: Change in sub-basement membrane thickness, primaryOutcomes measure: Change in airway smooth muscle area, primaryOutcomes measure: Change in airway smooth muscle layer thickness, primaryOutcomes measure: Change in submucosal eosinophil number, primaryOutcomes measure: Change in epithelial integrity, primaryOutcomes measure: Change in collagen thickness, secondaryOutcomes measure: Change of cytokine and protein levels, secondaryOutcomes measure: Change in exacerbation rate, secondaryOutcomes measure: Change in blood eosinophil levels, secondaryOutcomes measure: dentification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital, status: RECRUITING, city: Thessaloniki, zip: 57010, country: Greece, contacts name: Kalliopi Domvri, Dr, role: CONTACT, phone: 00302313307258, email: [email protected], contacts name: Konstantinos Porpodis, Prof, role: CONTACT, phone: 00302313307179, email: [email protected], geoPoint lat: 40.64361, lon: 22.93086, hasResults: False |
protocolSection identificationModule nctId: NCT06288503, orgStudyIdInfo id: HRF2023, briefTitle: Hydrolysed Rice Formula Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Nutricia UK Ltd, class: INDUSTRY, descriptionModule briefSummary: This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety., conditionsModule conditions: Cow's Milk Protein Allergy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: Hydrolysed Rice Protein Formula, interventions name: Cow's Milk Based Extensively Hydrolysed Formula, outcomesModule primaryOutcomes measure: Growth, secondaryOutcomes measure: Gastrointestinal Tolerance, secondaryOutcomes measure: Stool frequency and consistency, secondaryOutcomes measure: Study Product Intake, secondaryOutcomes measure: Patient Orientated Scoring Atopic Dermatitis Symptoms (PO-SCORAD), secondaryOutcomes measure: Patient Reported Atopic Symptoms, secondaryOutcomes measure: Cow's Milk Related Symptom Score, secondaryOutcomes measure: Food Allergy Quality of Life-Parental Burden (FAQL-PB), secondaryOutcomes measure: Acceptability of the Study Formula, secondaryOutcomes measure: Nutrient Intake (Energy, Protein, Micronutrients), secondaryOutcomes measure: Dietetic Goal, secondaryOutcomes measure: Overall Safety, eligibilityModule sex: ALL, minimumAge: 0 Months, maximumAge: 13 Months, stdAges: CHILD, contactsLocationsModule locations facility: Gloucestershire Royal NHS Trust, status: RECRUITING, city: Gloucester, state: Gloucestershire, zip: GL1 3NN, country: United Kingdom, contacts name: Victoria Bittle, role: CONTACT, phone: 0300 422 5506, email: [email protected], geoPoint lat: 51.86568, lon: -2.2431, locations facility: Bristol Royal Hospital for Children, status: RECRUITING, city: Bristol, state: Somerset, zip: BS16 1TA, country: United Kingdom, contacts name: Sarah Trace, role: CONTACT, phone: 0117 3428802, email: [email protected], geoPoint lat: 51.45523, lon: -2.59665, hasResults: False |
protocolSection identificationModule nctId: NCT06288490, orgStudyIdInfo id: AMCS-009, briefTitle: A Single Arm Study Comparing ACC Supplement to CCS in Management of Hypoparathyroidism, acronym: AMCS009, statusModule overallStatus: TERMINATED, startDateStruct date: 2013-04, primaryCompletionDateStruct date: 2014-06, completionDateStruct date: 2014-06-25, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Amorphical Ltd., class: INDUSTRY, descriptionModule briefSummary: Primary objective:Phase I Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).Phase II To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL).Secondary objectives:Phase I* ACC dose selection - to confirm the conversion factor of ACC from CCS* To determine the effect of food on ACC absorptionPhase II* To test the hypothesis that treatment with smaller doses of elemental calcium from ACC compared to CCS will not cause an increase in hypercalciuria in patients with hypoparathyroidism* To test the hypothesis that smaller doses of elemental calcium from ACC can reduce the side effects related with high calcium consumption.Amorphical has a strong basis to believe that the ACC product is better absorbed compared to the commercially available CCS products and therefore, can maintain desirable target albumin corrected calcium values in serum (CA) with smaller doses of elemental calcium from ACC. As results, the burden of taking high doses of calcium supplementation along with the side effects of the standard therapy (gastrointestinal discomfort and hypercalciuria) will be reduced.Testing serum CA and urine calcium values in subjects with hypoparathyroidism may provide a straightforward method to test this hypothesis.The study is designed to be conducted with extra precaution in order to avoid disturbing the fragile balance between CA levels in serum and calcium levels urine. The crossover design of phase II of the study allows a more accurate and reliable comparison of results attributable to the specific treatment within the same individual. In addition, the subjects will continue consuming all their routine medication throughout the trial. The subjects in the control arm will consume their routine calcium supplement doses thus, will be treated with a standard of care., conditionsModule conditions: Hypoparathyroidism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Proof of concept: treatment with smaller doses of elemental calcium from ACC compared to CCS can maintain target serum calcium (corrected for albumin) values (7.0-10.0 mg/dL), primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: amorphous calcium carbonate, outcomesModule primaryOutcomes measure: Calcium (albumin-corrected) serum level - composite value based on multiple measurements, secondaryOutcomes measure: Urine calcium level - 24h urine collection, secondaryOutcomes measure: Phosphorous serum level - composite value based on multiple measurements, secondaryOutcomes measure: Urine calcium level - 24h urine collection, secondaryOutcomes measure: Urine calcium level - 24h urine collection, secondaryOutcomes measure: Assessment of symptoms and signs related with hypocalcemia - composite value based on multiple measurements, secondaryOutcomes measure: Urine creatinine level - 24h urine collection, secondaryOutcomes measure: Urine creatinine level - 24h urine collection, secondaryOutcomes measure: Urine creatinine level - 24h urine collection, secondaryOutcomes measure: Urine phosphorus level - 24h urine collection, secondaryOutcomes measure: Urine phosphorus level - 24h urine collection, secondaryOutcomes measure: Urine phosphorus level - 24h urine collection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rambam Health Care Campus, city: Haifa, zip: 31096, country: Israel, geoPoint lat: 32.81841, lon: 34.9885, hasResults: False |
protocolSection identificationModule nctId: NCT06288477, orgStudyIdInfo id: 2023-2, briefTitle: Clinical and Radiographic Evaluation of Vital Pulpotomy Techniques in Primary Molars Using of Premixed Bioactive Bioceramic MTA (Neo-putty) as a Novel Pulpotomy Medication Versus Formocresol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: October University for Modern Sciences and Arts, class: OTHER, descriptionModule briefSummary: Despite the benefit of formocresol, there are toxic effects allergic reactions and local soft and hard tissue necrosis have been reported when such formaldehyde compounds were used clinically, however, the adverse effect of the clinically used of this compound are not widely reported. It has been stated that it has a side effect on the permanent successor although it results as a successful technique for the treatment of the primary teeth, conditionsModule conditions: Vital, conditions: Pulpotomy, conditions: Techniques, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: A cotton pellet moistened with full-strength FC, interventions name: Neo-Putty, outcomesModule primaryOutcomes measure: Clinical success, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288464, orgStudyIdInfo id: 315656, secondaryIdInfos id: 22/WM/0222, type: OTHER, domain: Health Research Authority, briefTitle: Enteral Feeding of Fibre to Improve Microbiota, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-09, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Lancashire Teaching Hospitals NHS Foundation Trust, class: OTHER, collaborators name: Lancaster University, descriptionModule briefSummary: Following surgical removal of diseased bowel, patients often require a temporary redirection of bowel contents to a stoma, to allow healing prior to re-joining of the remaining bowel at a later date. Some patients may experience complications, either during or after reversal surgery, and this may be due to changes in the 'friendly' bacteria that live in our bowels. Previous research shows that the distal section of bowel that is non-functioning undergoes tissue-wasting and the 'friendly' bacteria that help our digestion die. Data shows that patients that have a reduction in their microflora are more likely to experience side effects. This study investigates a method of replenishing the microflora prior to surgery., conditionsModule conditions: Bowel Dysfunction, conditions: Colon Disease, conditions: Ileum--Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Cohort, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Soluble Fibre, outcomesModule primaryOutcomes measure: Concentration of Microbiota, primaryOutcomes measure: Concentration of Immune Cell Populations, secondaryOutcomes measure: Length of Stay, secondaryOutcomes measure: Rate of clinical complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lancashire Teaching Hospitals NHS, status: RECRUITING, city: Preston, state: Lancashire, zip: PR2 9HT, country: United Kingdom, contacts name: Kina Bennett, role: CONTACT, phone: (+44) 01772 522031, email: [email protected], contacts name: Research Access, role: CONTACT, email: [email protected], contacts name: Arnab Bhowmick, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.76282, lon: -2.70452, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-02-01, uploadDate: 2024-02-23T12:17, filename: Prot_000.pdf, size: 250752, hasResults: False |
protocolSection identificationModule nctId: NCT06288451, orgStudyIdInfo id: STUDY00018021, secondaryIdInfos id: 1K23DK136930-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1K23DK136930-01, briefTitle: DePTH: De-emphasize PTH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2027-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The De-emphasize Parathyroid Hormone (DePTH) Study is a 12-month pragmatic, randomized, parallel-group, active comparator, open-label, blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis. It tests the hypothesis that low fixed-dose oral calcitriol (intervention) will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism, bone turnover, and serum calcification propensity, compared with variably-dosed intravenous activated vitamin D titrated to PTH targets (usual care)., conditionsModule conditions: Kidney Failure, Chronic, conditions: Chronic Kidney Disease-Mineral and Bone Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Oral calcitriol with cinacalcet rescue, interventions name: IV activated vitamin D, outcomesModule primaryOutcomes measure: Change in fibroblast growth factor-23, secondaryOutcomes measure: Change in serum calcium, secondaryOutcomes measure: Change in serum phosphate, secondaryOutcomes measure: Change in serum bone-specific alkaline phosphatase, secondaryOutcomes measure: Change in serum parathyroid hormone, secondaryOutcomes measure: Change in T50 test of serum calcification propensity, otherOutcomes measure: Patient acceptability, otherOutcomes measure: Patient acceptability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, status: RECRUITING, city: Seattle, state: Washington, zip: 98104, country: United States, contacts name: Simon Hsu, MD, MS, role: CONTACT, phone: 206-540-5714, email: [email protected], contacts name: Ian H de Boer, MD, MS, role: PRINCIPAL_INVESTIGATOR, contacts name: Simon Hsu, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False |
protocolSection identificationModule nctId: NCT06288438, orgStudyIdInfo id: E5012-R, secondaryIdInfos id: 23-2306, type: OTHER, domain: COMIRB, briefTitle: Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-11-02, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: VA Office of Research and Development, class: FED, descriptionModule briefSummary: Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions., conditionsModule conditions: Multimorbidity, conditions: Physical Deconditioning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor will be blinded to group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Motivational Interviewing Techniques, interventions name: Physical Therapy Interventions, interventions name: Education, interventions name: Health Status Updates, interventions name: Physical Therapy Consult, outcomesModule primaryOutcomes measure: 2 Minute Step Test, secondaryOutcomes measure: Arm Curl Test, secondaryOutcomes measure: 30 Second Sit To Stand, secondaryOutcomes measure: Physical Activity, secondaryOutcomes measure: Exercise readiness to change, secondaryOutcomes measure: Self-efficacy for Exercise Scale, secondaryOutcomes measure: Self-efficacy of Managing Chronic Conditions, secondaryOutcomes measure: The Patient-Specific Functional Scale, secondaryOutcomes measure: Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a, secondaryOutcomes measure: Physical Activity and Social Support Scale, secondaryOutcomes measure: Geriatric Pain Measure, secondaryOutcomes measure: Pain Coping Inventory, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rocky Mountain Regional VA Medical Center, Aurora, CO, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Jennifer E Stevens-Lapsley, PhD, role: CONTACT, phone: 303-949-9304, email: [email protected], contacts name: Michelle R Rauzi, DPT, role: CONTACT, phone: (208) 630-4002, email: [email protected], contacts name: Jennifer E. Stevens-Lapsley, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False |
protocolSection identificationModule nctId: NCT06288425, orgStudyIdInfo id: SPACE-KIT, briefTitle: Spatial Transcriptomics in Kidney Transplantation, acronym: SPACE-KiT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2030-01-01, completionDateStruct date: 2035-01-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Western Sydney Local Health District, class: OTHER, descriptionModule briefSummary: The study is an investigator-led, prospective, longitudinal, observational cohort study.The central hypothesis for this study is that spatial data will reveal new insights to immune cell function and local interactions within the kidney tissue to better predict important clinical outcomes. Investigators aspire to establish a prospective, longitudinal cohort to improve the diagnosis and management of kidney transplant rejection using precision pathology.By utilising new spatial technologies, the investigators aim to:* Derive a spatially resolved transcriptomic signature of kidney transplant rejection subtypes* Derive accurate transcriptomic signatures aligned with key cell types within the transplant kidney* Develop refinements to histological kidney rejection diagnostic and scoring classification* Correlate of spatial and refined biopsy scoring features to clinically important outcomes, conditionsModule conditions: Transplant Complication, conditions: Kidney Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Non interventional, outcomesModule primaryOutcomes measure: Kidney biopsy features, primaryOutcomes measure: Kidney biopsy transcriptomic signature, primaryOutcomes measure: Kidney cell type composition, secondaryOutcomes measure: All cause graft loss, secondaryOutcomes measure: Death censored graft loss (DCGL), secondaryOutcomes measure: Treatment resistant rejection, secondaryOutcomes measure: Delayed graft function (DGF), secondaryOutcomes measure: Biopsy evidence of borderline rejection, secondaryOutcomes measure: Biopsy proven acute rejection, secondaryOutcomes measure: Chronic rejection, secondaryOutcomes measure: Interstitial fibrosis scores (IFTA), secondaryOutcomes measure: BK virus associated nephropathy, secondaryOutcomes measure: Kidney function, secondaryOutcomes measure: Albuminuria, secondaryOutcomes measure: Surrogate end-points, secondaryOutcomes measure: Donor to recipient mismatches, secondaryOutcomes measure: Proteinomic signature, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Westmead Hospital, city: Westmead, state: New South Wales, zip: 2145, country: Australia, geoPoint lat: -33.80383, lon: 150.98768, hasResults: False |
protocolSection identificationModule nctId: NCT06288412, orgStudyIdInfo id: NN1436-7615, secondaryIdInfos id: U1111-1285-1665, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2023-505012-38, type: OTHER, domain: European Medical Agency (EMA), briefTitle: A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-11-04, completionDateStruct date: 2024-11-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The study will investigate the safety of once weekly insulin icodec subcutaenously (s.c.) during and after exercise and prolonged fasting in patients with type 2 diabetes (T2D). Participants will first receive insulin decludec (Tresiba®, a long-acting insulin taken once daily) for atleast one week. Afterwards participants will receive insulin icodec that will be administered once weekly at the study site (for a minimum of 7 weeks and maximum of 14 weeks). Insulin icodec is a novel long-acting insulin analogue for once-weekly administration for the treatment of type 2 diabetes. The study will last for about 16-30 weeks. Participant must not participate if participant have suspected hypersensitivity reactions to the study products or cardiovascular diseases within the last 180 days. Female participant cannot take part if she is pregnant, breast-feeding or planning to become pregnant during the study period., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Insulin icodec, interventions name: Insulin degludec, outcomesModule primaryOutcomes measure: Time below range, glucose less than (<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter [mg/dL]) within 24 hours after start of exercise (TBR3.0mmol/L,exe), secondaryOutcomes measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 24 hours after start of exercise (TBR3.9mmol/L,exe), secondaryOutcomes measure: Time in range, glucose 3.9-10.0 mmol/L (70-180 mg/dL) within 24 hours after start of exercise (TIR3.9-10.0mmol/L,exe), secondaryOutcomes measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 24 hours after start of exercise (TAR10.0mmol/L,exe), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes during exercise (Hypoexe), secondaryOutcomes measure: Amount of carbohydrate intake during exercise (CHOexe), secondaryOutcomes measure: Amount of carbohydrate intake from end of standardised lunch meal until start of exercise (CHOpre-exe), secondaryOutcomes measure: Amount of carbohydrate intake after stop of exercise until start of standardised dinner meal (CHOpost-exe), secondaryOutcomes measure: Number of hypoglycaemic within 24 hours after start of exercise (Hypo24h,exe), secondaryOutcomes measure: Number of hypoglycaemic episodes for 24 hours in reference week (43 to 67 hours after dosing) (Hypo24h,ref), secondaryOutcomes measure: Time below range, glucose <3.0 mmol/L (54 mg/dL) within 18 hours after start of fasting (TBR3.0mmol/L,fast), secondaryOutcomes measure: Time below range, glucose <3.9 mmol/L (70 mg/dL) within 18 hours after start of fasting (TBR3.9mmol/L,fast), secondaryOutcomes measure: Time in range, glucose 3.9-10 mmol/L (70-180 mg/dL) within 18 hours after start of fasting (TIR3.9-10.0mmol/L,fast), secondaryOutcomes measure: Time above range, glucose >10 mmol/L (180 mg/dL) within 18 hours after start of fasting (TAR10.0mmol/L,fast), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes during fasting (Hypofast), secondaryOutcomes measure: Amount of carbohydrate administered intravenously during fasting (CHOfast), secondaryOutcomes measure: Number of hypoglycaemic episodes within 18 hours after start of fasting (Hypo18h,fast), secondaryOutcomes measure: Number of hypoglycaemic episodes for 18 hours in reference week (26 to 44 hours after dosing) (Hypo18h,ref), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, status: RECRUITING, city: Graz, zip: 8010, country: Austria, geoPoint lat: 47.06667, lon: 15.45, hasResults: False |
protocolSection identificationModule nctId: NCT06288399, orgStudyIdInfo id: DAS-7688, secondaryIdInfos id: U1111-1292-7248, type: OTHER, domain: World Health Organization (WHO), briefTitle: Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1322, type: ESTIMATED, armsInterventionsModule interventions name: No treatment given, outcomesModule primaryOutcomes measure: Proportion of Obesity Related Comorbidities (ORC, existing/newly diagnosed) among adult people with obesity (BMI above or equal to 30 kg/m2) over a period of 12 months across the Gulf region in primary and secondary hospitals as well as obesity clinics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Farwaniya Hospital, city: Farwaniya, zip: 85000, country: Kuwait, locations facility: Al-Adan Hospital, city: Hadiya, zip: 52700, country: Kuwait, locations facility: Al-Amiri Hospital, city: Kuwait City, zip: 13001, country: Kuwait, geoPoint lat: 29.36972, lon: 47.97833, locations facility: Novo Nordisk Investigational Site, city: Kuwait, zip: 12030, country: Kuwait, geoPoint lat: 29.36972, lon: 47.97833, locations facility: National Diabetes and Endocrine Center, city: Muscat, zip: 113, country: Oman, geoPoint lat: 23.58413, lon: 58.40778, locations facility: Samail Polyclinic, city: Samail, zip: 620, country: Oman, geoPoint lat: 23.3, lon: 57.98333, locations facility: Hamad General Hospital, city: Doha, zip: 122104, country: Qatar, geoPoint lat: 25.28545, lon: 51.53096, locations facility: PHCC, city: Doha, zip: 122104, country: Qatar, geoPoint lat: 25.28545, lon: 51.53096, hasResults: False |
protocolSection identificationModule nctId: NCT06288386, orgStudyIdInfo id: 2024-ATTACHMENTS, briefTitle: Influence of Different Nanohybrid Flowable Composite Resin on Shear Bond Strength and Dimensional Changes of Invisalign Attachments After 6 Months of Brushing, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The present study will be a single-center, split-mouth, randomized controlled clinical trial. Patients undergoing orthodontic treatment with Invisalign aligners will be enrolled after signing the informed consent. Two different flowable composite resins will be evaluated for the performing of attachments using a split-mouth design:* group A: Filtek Supreme Flow (3M Unitek, Monrovia, Calif)* group B: Grandioso Heavy Flow (VOCO GmbH, Cuxhaven Germany)Digital impressions with iTero intraoral scanner will be performed; digital impressions will be performed after 3 months (T1) and 6 months (T2) from the baseline.Digital scans will be used to assess any changes in shape and volume of the attachments per each different time frame. Each tooth will be separated from the others and superimpositions of the single tooth will be performed with ZEISS Inspect software.After attachments placement, the clinicians will be asked to answer, on a scale from 1 to 10, to this questionnaire's questions about the two different flowable composites; each question is repeated for each composite resin.Type of brushing (with manual or electric toothbrush) and hand of brushing will be recorded., conditionsModule conditions: Malocclusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Split-mouth design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: GrandioSO Heavy Flow, interventions name: Filtek Z350XT Flowable, outcomesModule primaryOutcomes measure: Changes in the volume of attachments, primaryOutcomes measure: Attachments failure rate, primaryOutcomes measure: Type of brushing, primaryOutcomes measure: Change in questionnaire's answers, primaryOutcomes measure: Hand of brushing, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False |
protocolSection identificationModule nctId: NCT06288373, orgStudyIdInfo id: NACI-CERV-003, briefTitle: Neoadjuvant Chemoimmunotherapy Versus Concurrent Chemoradiotherapy for LACC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2031-03-01, completionDateStruct date: 2031-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: Southwest Hospital, China, collaborators name: Women Hospital, School of Medicine, Zhejiang University, collaborators name: Anhui Provincial Cancer Hospital, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: Qilu Hospital of Shandong University, collaborators name: Beijing Friendship Hospital, collaborators name: Tianjin Medical University General Hospital, collaborators name: West China Second University Hospital, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: Xiangya Hospital of Central South University, collaborators name: Gansu Provincial Maternal and Child Health Care Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Shengjing Hospital, descriptionModule briefSummary: It is a prospective, open-label, randomized, controlled phase II/III clinical trial in which patients with PD-L1-positive FIGO stage IB3, IIA2 and IIB（tumors \>4 cm in diameter）will be enrolled and randomly divided into the neoadjuvant chemoimmunotherapy plus surgery group and the CCRT group., conditionsModule conditions: Cervical Cancer, conditions: Locally Advanced Cervical Cancer, conditions: Concurrent Chemoradiotherapy, conditions: Neoadjuvant Chemoimmunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 440, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab, interventions name: Cisplatin, interventions name: Nab paclitaxel, interventions name: Radical surgery, interventions name: external beam radiation therapy (EBRT) + brachytherapy, interventions name: Cisplatin, outcomesModule primaryOutcomes measure: Progression-free survival, PFS, primaryOutcomes measure: Objective Response Rate, ORR, secondaryOutcomes measure: Overall survival, OS, secondaryOutcomes measure: Proportion of patients undergoing radical surgery, secondaryOutcomes measure: Pathologic Complete Response, secondaryOutcomes measure: The surgical complication rate, secondaryOutcomes measure: Safety and toleraty, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Kezhen Li, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Jing Chen, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Kezhen Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Gang Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06288360, orgStudyIdInfo id: NACI-CERV-002, briefTitle: Neoadjuvant Immunochemotherapy in PD-L1-negative LACC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: Southwest Hospital, China, collaborators name: Women Hospital, School of Medicine, Zhejiang University, collaborators name: Anhui Provincial Cancer Hospital, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: Gansu Provincial Maternal and Child Health Care Hospital, collaborators name: Beijing Friendship Hospital, collaborators name: Tianjin Medical University General Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: West China Second University Hospital, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: Zhejiang Cancer Hospital, collaborators name: Shengjing Hospital, collaborators name: Qilu Hospital of Shandong University, descriptionModule briefSummary: This is a multicenter, prospective, single-arm, phase 2 clinical trial designed to evaluate the therapeutic efficacy of the NACI (neoadjuvant chemotherapy plus Camrelizumab) for PD-L1-negative locally advanced cervical cancer., conditionsModule conditions: Cervical Cancer, conditions: Locally Advanced Cervical Cancer, conditions: PD-L1 Negative, conditions: Neoadjuvant Chemoimmunotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab, interventions name: Paclitaxel-albumin, interventions name: Cisplatin, interventions name: radical surgery, outcomesModule primaryOutcomes measure: Pathologic complete response, secondaryOutcomes measure: Surgical Complications, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Positive surgical margin rate, secondaryOutcomes measure: event-free survival, secondaryOutcomes measure: overall survival, secondaryOutcomes measure: adverse event, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Jing Chen, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Kezhen Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Gang Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06288347, orgStudyIdInfo id: 216099, briefTitle: Study of the Efficacy of GGON: a Cognitive Training App for Orthorexia Nervosa., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-06-17, completionDateStruct date: 2024-06-17, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: The aim of the present study is to evaluate the efficacy of GGON to decrease the maladaptive beliefs associated with orthorexia nervosa (ON) in non-clinical adult population. Specifically, a randomized controlled trial with crossover assignment design and two groups (experimental and control) will be carried out in adults aged 18-65 years to assess the changes pre and post use the app. It's expected that after the use of the GGON app for 15 days are, at the primary level: decrease in the degree of ascription to dysfunctional beliefs associated with ON; and at the secondary level: decrease in orthorexia nervosa symptomatology, in eating symptomatology and in obsessive beliefs; increase in self-esteem; and no changes in drepessive symptomatology. These results are also expected to be maintained in subsequent follow-ups, at 15 days and a month after to finish the app in experimental group, and 15 days after to finish the app in control group., conditionsModule conditions: Orthorexia Nervosa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants were requested to complete web-based assessment, with questionnaires relating to maladaptive beliefs associated with ON, ortorexia, eating and depressive symptomatology, obsessive belifs and self-esteem at baseline (T1).The experimental group started using the app for 15 days, and later completed the following assessment (T2). The control group also completed the T2 in the same date but started to use the app after this second assessment.15 days and one month later, both groups completed T3 and T4., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: GGON mobile app., outcomesModule primaryOutcomes measure: Change in the degree of ascription to dysfunctional beliefs associated with Orthorexia Nervosa, secondaryOutcomes measure: Change in Orthorexia symptomatology, secondaryOutcomes measure: Change in eating symptomatology, secondaryOutcomes measure: Change in self-esteem., secondaryOutcomes measure: Change in emotional symptomatology, secondaryOutcomes measure: Change in obsessive beliefs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Valencia, city: Valencia, zip: 46010, country: Spain, geoPoint lat: 39.46975, lon: -0.37739, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-04-18, uploadDate: 2024-03-11T04:30, filename: ICF_000.pdf, size: 79708, hasResults: False |
protocolSection identificationModule nctId: NCT06288334, orgStudyIdInfo id: PUTH PD_V 1.2, briefTitle: Exploration of the Optimal Dosage of Cetirizine in the Treatment of Allergic Diseases in Chinese Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-08-06, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: To obtain the pharmacokinetics of cetirizine in Chinese children with allergic disease., conditionsModule conditions: Allergic Disease, conditions: Children, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: 1-3 Cetirizine Pharmacokinetic samples, outcomesModule primaryOutcomes measure: Plasma concentration, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Yafen Li, role: CONTACT, phone: 18222566785, email: [email protected], contacts name: Wei Zhou, role: PRINCIPAL_INVESTIGATOR, contacts name: Wei Liu, role: PRINCIPAL_INVESTIGATOR, contacts name: Dongyang Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06288321, orgStudyIdInfo id: UW22221, briefTitle: A Study Investigating Whether Low Dose Eyedrops for Pupil Dilation is as Effective and Safe as Standard Dose Eyedrops in Examination for Retinopathy of Prematurity., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-10, primaryCompletionDateStruct date: 2023-03-22, completionDateStruct date: 2023-03-22, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: A prospective, randomized controlled study was conducted from August, 2022 to March, 2023 in the neonatal intensive care unit in Queen Mary Hospital, Hong Kong. The aim of this study was to determine whether microdrops Mydrin-P demonstrates similar efficacy as standard Mydrin -P eyedrops applied to neonates undergoing retinopathy of prematurity (ROP) screening exams, also to ascertain the optimal time for eye examination after administration of mydriatics and assess whether the cardiovascular, respiratory and gastrointestinal adverse effects differ between microdrops and standard dose Mydrin-P.Preterm infants were randomized to receive either the standard Mydrin-P eyedrops or the mydriatic microdrops which contained around one-third of the standard Mydrin-P dosage. The primary outcome measured whether a successful ROP examination was conducted. Secondary outcomes included pupil diameters at baselines, 30 minutes, 60 minutes, 120 minutes after eyedrops instillation and at the time of ROP exam as well as adverse effects followed by the mydriatics administration.A total of 18 patients were enrolled in this study with total 46 episodes of ROP recorded. All episodes with microdrops instillation led to successful ROP exams. There was no statistically significant difference between standard eyedrops and microdrops in determining the success of ROP exam (p=0.233). Mean pupil diameter did not differ between the microdrops and standard eyedrops group. At the time of ROP exam, the mean pupil diameter was 5.47mm in the standard eyedrops group and 5.73mm in the microdrops group. The optimal time for ROP exam was 60 minutes to 120 minutes after first dose of mydriatic. Also there was no difference in the occurrence of systemic side effects when compared to standard Mydrin P drops.Hence the study concluded that microdrops have similar efficacy and safety profile compared to standard Mydrin-P eyedrops., conditionsModule conditions: Retinopathy of Prematurity, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Microdrop Mydrin-P, interventions name: Standard Mydrin-P, outcomesModule primaryOutcomes measure: Successfulness of a ROP exam, secondaryOutcomes measure: Pupil diameters, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Oxygen requirement, secondaryOutcomes measure: Episodes of vomiting, secondaryOutcomes measure: Volume of gastric residuals, secondaryOutcomes measure: Episodes of apnoea, secondaryOutcomes measure: Episodes of periorbital blanching, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Paediatrics and Adolescent Medicine, Queen Mary Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2022-07-14, uploadDate: 2024-02-18T04:50, filename: Prot_000.pdf, size: 94463, hasResults: False |
protocolSection identificationModule nctId: NCT06288308, orgStudyIdInfo id: FAR in lupus nephritis (LN), briefTitle: Fibrinogen to Albumin Ratio (FAR) as a Predictive Biomarker for Lupus Nephritis (LN), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN), conditionsModule conditions: Lupus Nephritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: fibronigin to albumin ratio, outcomesModule primaryOutcomes measure: Fibrinogen to Albumin ratio as a predictive biomarker for lupus nephritis (LN), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288295, orgStudyIdInfo id: Etude SCORDOM, briefTitle: Retrospective Study on Data Aiming to Establish a Prediction Score for Return Home at the Time of Admission to a Multidisciplinary Medical Department (SCORDOM, acronym: SCORDOM, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-02-28, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Elsan, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to define clinical, biological and socio-cultural criteria, from the very first days of hospitalization on the multidisciplinary medicine department, to guide the patient's discharge from hospital (return to home when discharged from hospital).The data collected will be those contained in the medical records of patients over 60 years of age who were admitted to the multidisciplinary medical department between October 2021 and February 2022 and between October 2022 and February 2023.This study also aims at developing and validating a predictive score of orientation at the end of hospitalisation.Participants are patients previously hospitalized. They will be informed about the study by post and will be able to object to the use of his or her data., conditionsModule conditions: Continuity of Patient Care, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters, secondaryOutcomes measure: Number of patients with a return to home after hospitalization and with similar clinical parameters, similar age category, similar pathology and similar biological parameters, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Privé Nancy Lorraine, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False |
protocolSection identificationModule nctId: NCT06288282, orgStudyIdInfo id: STUDY-23-01287, briefTitle: Behavioral and Cognitive Predictors of Persistent Pain and Opioid Misuse in Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-20, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2024-12-20, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: Chronic lower back pain (CLBP) affects approximately 20% of the global population. The study objective is to determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in patients with chronic pain. This is a prospective consented cross-sectional study characterizing behavioral and cognitive phenotypes using both patient-reported survey measures and cognitive testing. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and risk for opioid misuse (Primary outcomes: COMM scores, SOAPPR scores). Secondary outcomes is BPI measurement. A Certificate of Confidentiality will provide additional protections for participants., conditionsModule conditions: Chronic Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Screener and Opioid Assessment for patients with pain revised (SOAPPR), primaryOutcomes measure: Current Opioid misuse measure (COMM) surveys, secondaryOutcomes measure: Pain Intensity with Brief Pain inventory (BPI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Pain management centers, status: RECRUITING, city: New York, state: New York, zip: 10029, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06288269, orgStudyIdInfo id: PhrapokklaoHospital, briefTitle: Factors of Control Hypertension or Type 2 Diabetes on the Severity of Stroke and Survival Rates Within 1 Year in Trat, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Phrapokklao Hospital,Thailand, class: OTHER, descriptionModule briefSummary: The purpose of this study was to study factors for controlling hypertension or type 2 diabetes before stroke diagnosis on the severity level when a stroke occurs, NIHSS, and survival rate after having a stroke in 1 year in Trat Province The research hypothesis was patients with hypertension or type 2 diabetes who are well-controlled Will have a lower NIHSS score than the group whose disease is not well-controlled. and patients with hypertension or type 2 diabetes that is well controlled There will be a higher survival rate for patients diagnosed with cerebrovascular disease within 1 year than those whose disease cannot be controlled., conditionsModule conditions: Stroke, conditions: Hypertension, conditions: Type2diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 291, type: ACTUAL, armsInterventionsModule interventions name: Severity of Stroke and 1 year survival, outcomesModule primaryOutcomes measure: Stroke severity was assessed using the National Institute of Health Stroke Scale (Clinical Mild NIHSS = 0-4 and Clinical Moderate to severe NIHSS = 5-42), primaryOutcomes measure: 1 year survival death, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Trat Provincial Public Health Office, city: Trat, zip: 23000, country: Thailand, geoPoint lat: 12.24364, lon: 102.51514, hasResults: False |
protocolSection identificationModule nctId: NCT06288256, orgStudyIdInfo id: STUDY-22-01390, briefTitle: Neurocognitive and Genomic Predictors of Persistent Pain and Opioid Misuse After Spine Surgery, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Icahn School of Medicine at Mount Sinai, class: OTHER, descriptionModule briefSummary: Having spine surgery and recovery is a vulnerable period when opioid naive patients may transition into long-term use of opioids, and when previously opioid tolerant patients may be at risk to continue towards long-term opioid use and dependence. However, little is known about risk for developing opioid misuse, taking opioids differently than indicated or prescribed, and later OUD. This study addresses the question of whether behavior, cognitive features, and genomic markers can predict misuse of opioids, persistent pain and disability in individuals after spine surgery.To determine if impulsivity, inhibitory control, drug choice, and/or cognitive distortions predict opioid misuse and disability in spine surgery patients with differential gene expression.This is a prospective observational longitudinal study characterizing behavioral phenotypes in adults undergoing spine surgery using both patient-reported survey measures, cognitive testing and blood sampling. Outcome measures include correlations between impulsivity measures, opioid drug choice responses and cognitive distortion scores, and opioid misuse with spine related disability, and gene expression counts., conditionsModule conditions: Lumbar Spine Pathology, conditions: Elective Spine Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: Current Opioid Misuse Measure (COMM) Score, secondaryOutcomes measure: Numerical Rating Scale (NRS) Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Spine Center, city: New York, state: New York, zip: 10029, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06288243, orgStudyIdInfo id: Samatya, briefTitle: Functionality, Cognition And Swallowing Skills In Patients With AcuteSTROKE, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-01, primaryCompletionDateStruct date: 2019-05-28, completionDateStruct date: 2019-05-29, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: Aim: Studies in which the results of the screening test evaluating swallowing skills in acute stroke patients are evaluated together with other components that may affect swallowing function are limited. The aim of this study is to determine which factors are associated with swallowing abilities in patients with acute stroke, including lesion location, cognitive level, clinical features, risk factors for stroke, and level of functionality.Methods: The 97 acute stroke patients included in the study were grouped in terms of lesion type, affected side, and risk factors for stroke. Turkish MMASA (TR-MMASA) was used to evaluate the swallowing ability of the patients. Additionally, Standardized Mini Mental Test (SMMT) and Modified Rankin Scale (MRS) were applied to evaluate cognition level and functionality, respectively., conditionsModule conditions: Stroke, Acute, conditions: Swallowing Disorder, conditions: Cognitive Impairment, conditions: Stroke, conditions: Movement Disorders, conditions: Dysphagia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 97, type: ACTUAL, armsInterventionsModule interventions name: Clinician-observed assessment tests, outcomesModule primaryOutcomes measure: The Correlation Between Swallowing Skills and Cognitive Status, primaryOutcomes measure: The Correlation Between Swallowing Skills and Functionality, secondaryOutcomes measure: The relationship between stroke risk factors and swallowing skills, secondaryOutcomes measure: The relationship between demographic informations and swallowing skills, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 92 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06288230, orgStudyIdInfo id: LT01-101, briefTitle: An Open Label Study of Gene Therapy Product in Spinal Muscular Atrophy Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Lantu Biopharma, class: INDUSTRY, descriptionModule briefSummary: This is an interventional study to evaluate safety and efficacy of AAV-hSMN1 in spinal muscular atrophy patients., conditionsModule conditions: Spinal Muscular Atrophy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: vesemnogene lantuparvovec, outcomesModule primaryOutcomes measure: Numbers of participants with adverse events (AEs), serious adverse events (SAEs), secondaryOutcomes measure: Change from baseline in hours of daily ventilation support and motor function, secondaryOutcomes measure: Change from baseline in ambulatory function, secondaryOutcomes measure: Change from baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06288217, orgStudyIdInfo id: NS-CIP-001, briefTitle: Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: NeuraStasis, Inc, class: INDUSTRY, descriptionModule briefSummary: This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study., conditionsModule conditions: Stroke, Ischemic, conditions: Upper Extremity Paresis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation), interventions name: Upper Limb Rehabilitation, interventions name: Sham Stimulation, outcomesModule primaryOutcomes measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change, secondaryOutcomes measure: Action Research Arm Test (ARAT) Average Change, secondaryOutcomes measure: Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %, secondaryOutcomes measure: Proportion of subjects completing all pre-specified treatment doses, secondaryOutcomes measure: Subject Questionnaire on Device Usage, secondaryOutcomes measure: Therapist Questionnaire on Device Usage, secondaryOutcomes measure: Serious adverse device effects (SADE) rate at 24 hours post-therapy session, secondaryOutcomes measure: Stroke impact scale (SIS) Summative Score Average Change, secondaryOutcomes measure: Analysis of the number of stimulations per therapy session, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Texas Health Science Center at Houston, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Sean Savitz, MD, role: CONTACT, phone: 713-500-7083, email: [email protected], contacts name: Emily Stevens, OTR, role: CONTACT, phone: 713-500-7914, email: [email protected], geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06288204, orgStudyIdInfo id: Denise Mafra16, briefTitle: Green Propolis Extract and Royal Jelly in Hypertensive Patients and/or With Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Universidade Federal Fluminense, class: OTHER, collaborators name: Conselho Nacional de Desenvolvimento Científico e Tecnológico, collaborators name: Rio de Janeiro State Research Supporting Foundation (FAPERJ), collaborators name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., descriptionModule briefSummary: This work aims to evaluate the effects of the association of green propolis extract with royal jelly on inflammation and oxidative stress in participants with CKD and SAH, in a longitudinal, randomized, double-blind, placebo-controlled clinical trial that will be carried out for 2 months., conditionsModule conditions: Chronic Kidney Diseases, conditions: Hypertension, conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 153, type: ESTIMATED, armsInterventionsModule interventions name: Propolis + Royal Jelly, interventions name: Royal Jelly, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in inflammation, oxidative stress, primaryOutcomes measure: Change in intestinal microbiota, secondaryOutcomes measure: Change in senescence biomarkers, secondaryOutcomes measure: Change in uremic toxins, otherOutcomes measure: Change in adhesion molecules, otherOutcomes measure: Change in blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Denise Mafra, city: Rio de Janeiro, state: RJ, zip: 22260050, country: Brazil, contacts name: Denise Mafra, phd, role: CONTACT, phone: 21985683003, email: [email protected], geoPoint lat: -22.90278, lon: -43.2075, hasResults: False |
protocolSection identificationModule nctId: NCT06288191, orgStudyIdInfo id: MIA2023/490, secondaryIdInfos id: CA224-1065, type: OTHER, domain: Bristol-Myers Squibb, briefTitle: Neoadjuvant Nivolumab and Relatlimab in Cutaneous Squamous Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2036-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Melanoma Institute Australia, class: OTHER, collaborators name: Bristol-Myers Squibb, descriptionModule briefSummary: The goal of this study is to test neoadjuvant therapy with the dual inhibition of Programmed cell death protein 1 (PD-1) and lymphocyte activation gene 3 (LAG-3) immune checkpoint pathways in a cohort of treatment-naïve, resectable stage II to IV cutaneous squamous cell carcinoma on the pathological response rate (pCR) and recurrence-free survival., conditionsModule conditions: Cutaneous Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open label, single arm, single centre, clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Nivolumab 240 mg / Relatlimab 80 mg in a fixed dose combination, outcomesModule primaryOutcomes measure: Pathological complete response rate, secondaryOutcomes measure: Pathological near pathological response (near pCR), partial response (pPR) and pathological non-response (pNR) rate, secondaryOutcomes measure: Toxicity and tolerability of neoadjuvant immunotherapy and surgery, secondaryOutcomes measure: Objective response rate to neoadjuvant therapy, secondaryOutcomes measure: Metabolic response rate to neoadjuvant immunotherapy, secondaryOutcomes measure: Recurrence-free survival, secondaryOutcomes measure: Disease progression rate, secondaryOutcomes measure: Event-free survival rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Patient reported quality of life (QLQ-C30), secondaryOutcomes measure: Patient reported quality of life (EQ-5L-5D), secondaryOutcomes measure: Study treatment completion rate and the causes of any missed treatments, secondaryOutcomes measure: De-escalation of adjuvant radiotherapy., otherOutcomes measure: Identification of tissue and blood biomarkers of response / resistance, otherOutcomes measure: Profile of the gut microbiome from faecal samples and relationship to response and toxicities., otherOutcomes measure: The pathological response to RECIST, immune related response criteria and PERCIST response, otherOutcomes measure: Assessment of the response to neoadjuvant using the immune-related response criteria (irRC) and correlate the assessment with the RECIST 1.1 response at each timepoint, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288178, orgStudyIdInfo id: 2022/18, briefTitle: The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations, acronym: Obesity, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-19, primaryCompletionDateStruct date: 2023-01-20, completionDateStruct date: 2023-02-20, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels., conditionsModule conditions: Obesity, conditions: Glycemic Index, conditions: Blood Glucose, conditions: Bread, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 103, type: ACTUAL, armsInterventionsModule interventions name: Bread consumption, outcomesModule primaryOutcomes measure: One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption., secondaryOutcomes measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Avrasya University, city: Trabzon, zip: 61000, country: Turkey, geoPoint lat: 41.005, lon: 39.72694, hasResults: False |
protocolSection identificationModule nctId: NCT06288165, orgStudyIdInfo id: CopperHealthCentre2, briefTitle: Lower Silesia Sinus Reducer Registry, acronym: LSSRR, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-11, primaryCompletionDateStruct date: 2027-05-11, completionDateStruct date: 2027-05-11, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Regional Cardiology Center, The Copper Health Centre (MCZ),, class: OTHER, descriptionModule briefSummary: Lower Silesia Sinus Reducer Registry is a, single-center, single-arm registry including patients with chronic disabling refractory angina pectoris (Canadian Cardiovascular Society \[CCS\] classes 2-4) despite maximally tolerated anti-angina medical therapy who underwent Coronary Sinus Reducer implantation ., conditionsModule conditions: Safety Issues, conditions: Efficacy, Self, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Coronary Sinus Reducer Implantation, outcomesModule primaryOutcomes measure: The Clinical success - reduction of angina symptoms, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Change in potential aerobic capacity and endurance - The six minute walking test (6MWT), secondaryOutcomes measure: Reducing the severity of angina and it impact on quality of life, as shown by the Seattle Angina Questionnaire., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, The Copper Health Centre (MCZ), status: RECRUITING, city: Lubin, state: Lower Silesia, zip: 59-300, country: Poland, contacts name: Adrian Włodarczak, M.D; Ph.D.Assoc Prof., role: CONTACT, phone: +48768460300, email: [email protected], contacts name: Szymon Włodarczak, MD, role: CONTACT, phone: +4876 846 03 00, email: [email protected], geoPoint lat: 51.40089, lon: 16.20149, locations facility: Cardiac Department of Copper Health Center, status: RECRUITING, city: Lubin, state: Lower Silesia, zip: 59301, country: Poland, contacts name: Adrian Włodarczak, Prof, role: CONTACT, phone: 76 846 03 00, phoneExt: 0048, email: [email protected], contacts name: Szymon Włodarczak, MD, role: CONTACT, phone: 76 846 03 00, phoneExt: 0048, email: [email protected], contacts name: Piotr Rola, Ph D; MD, role: SUB_INVESTIGATOR, geoPoint lat: 51.40089, lon: 16.20149, hasResults: False |
protocolSection identificationModule nctId: NCT06288152, orgStudyIdInfo id: STS-Transplant, briefTitle: Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Alp Sener, class: OTHER, descriptionModule briefSummary: End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation.This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function., conditionsModule conditions: Renal Transplant, conditions: Kidney Transplant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Sodium Thiosulfate, outcomesModule primaryOutcomes measure: Effects of STS will be measured by: Delayed graft function, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288139, orgStudyIdInfo id: open fracture tibia, briefTitle: Management of Open Fracture Tibia in Teenagers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The aim of this study is to study the incidence of open tibial fractures in early teenagers and evaluate the management outcomes, conditionsModule conditions: Open tíbia Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number, secondaryOutcomes measure: To evaluate treatment outcomes, secondaryOutcomes measure: Soft tissue healing, secondaryOutcomes measure: Complication, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 19 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288126, orgStudyIdInfo id: MoMM-FET, briefTitle: Maternal and Fetal Metabolic Changes, acronym: MoMM-FET, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-08-01, primaryCompletionDateStruct date: 2020-10-09, completionDateStruct date: 2021-01-18, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliero, Universitaria Pisana, class: OTHER, descriptionModule briefSummary: The goal of this observational prospective project is to study the metabolic alterations during normal and complicated pregnancies, obtaining an early detection of metabolic changes, offering new insights into future prevention and treatment strategies for both mother and offspring.Primary objectives:* measurement of maternal blood adipokine levels, during the first trimester of pregnancy, in two groups of women (high and low risk), in order to identify early markers which, in conjunction with the medical history, can identify women at increased risk of developing GDM* ultrasound measurement of adipose tissue deposits at ectopic sites, comparing low- and high-risk women, and assessing the effect of pregnancy on these deposits.* Identification, by targeted ultrasound assessment, of fetuses at increased risk of macrosomia.Secondary objectives:* Evaluation of the prevalence of GDM and its complications in a population of low- and high-risk women.* Evaluation of neonatal complications in children born to low- and high-risk mothers (need for resuscitation, hypoglycaemia, hypocalcaemia, admission to neonatal intensive care unit).The participants will be recruited during first trimester ultrasound after signing the informed consent., conditionsModule conditions: Pregnancy Related, conditions: Maternal-Fetal Relations, conditions: Metabolism Disorder, Glucose, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 457, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Blood adipokine levels, primaryOutcomes measure: Abdominal Fat Thickness, primaryOutcomes measure: Fetal Adipose Tissue Deposits, secondaryOutcomes measure: Gestational diabetes prevalence, secondaryOutcomes measure: Obstetric complications and mode of delivery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Universitaria Pisana, city: Pisa, zip: 56126, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False |
protocolSection identificationModule nctId: NCT06288113, orgStudyIdInfo id: 23-001509, secondaryIdInfos id: NCI-2024-00310, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-001509, type: OTHER, domain: UCLA / Jonsson Comprehensive Cancer Center, briefTitle: Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-27, completionDateStruct date: 2027-01-27, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Jonsson Comprehensive Cancer Center, class: OTHER, collaborators name: Novartis Pharmaceuticals, descriptionModule briefSummary: This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer., conditionsModule conditions: Castration-Resistant Prostate Carcinoma, conditions: Stage IVB Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Gallium Ga 68 Gozetotide, interventions name: Lutetium Lu 177 Vipivotide Tetraxetan, interventions name: Positron Emission Tomography, interventions name: Questionnaire Administration, interventions name: Single Photon Emission Computed Tomography, outcomesModule primaryOutcomes measure: 12-month overall survival, secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Rate of prostate specific antigen (PSA) response, secondaryOutcomes measure: Biochemical progression-free survival (PFS), secondaryOutcomes measure: Overall Survival from start of first regimen, secondaryOutcomes measure: Overall survival from the end of the first regimen, secondaryOutcomes measure: Radiographic progression-free survival (rPFS), secondaryOutcomes measure: Bone Pain, secondaryOutcomes measure: Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT)., secondaryOutcomes measure: Changes in health-related quality of life_Brief Pain Inventory Short form, secondaryOutcomes measure: Changes in health-related quality of life_ Eastern Cooperative Oncology Group score, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA / Jonsson Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Ethan Lam, role: CONTACT, phone: 310-206-7372, email: [email protected], contacts name: Stephanie Lira, role: CONTACT, phone: 3102060596, email: [email protected], contacts name: Jeremie Calais, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False |
protocolSection identificationModule nctId: NCT06288100, orgStudyIdInfo id: OWHTOPTS, briefTitle: The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: High tibial osteotomy has been established as an efficient surgical intervention for young patients with uni-compartmental osteoarthritis of the knee. The principle of this surgery involves the realignment of the lower extremity to shift the load distribution from the medial compartment into the lateral compartment, thus leading to a decrease in symptoms related to medial compartment knee Osteoarthritis However, medial opening wedge high tibial osteotomy is also known to affect the posterior tibial slope angle, and it is reported that posterior tibial slope angle increases after medial opening wedge high tibial osteotomy ., conditionsModule conditions: Genu Varum, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: The Effect of Open Wedge High Tibial Osteotomy on the Posterior Tibial Slope In Skeletally Mature Patient, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohamed Abdelfattah Abbas, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06288087, orgStudyIdInfo id: 2023-20/672, briefTitle: Comparing Machine Guided VR Based Training With Educator Guided Training in Metaverse, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-03-29, completionDateStruct date: 2024-04-11, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: The main aim of this study is to compare the learning outcomes of machine guided VR based training for adult advanced life support with educator guided training in metaverse environment., conditionsModule conditions: Advanced Cardiac Life Support, conditions: Virtual Reality, conditions: Serious Game, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: the group trained with VR Based Training with Machine Guidance will be referred as MG group and the group trained with VR Based Training with Educators Guidance in Metaverse will be referred as EG group., whoMasked: PARTICIPANT, enrollmentInfo count: 62, type: ESTIMATED, armsInterventionsModule interventions name: VR Based Training with Machine Guidance (MG Group), interventions name: VR Based Training with Educator Guidance in Metaverse (EG Group), outcomesModule primaryOutcomes measure: Comparing Learning outcome of the Advanced Cardiac Life Support Training of the two interventions used in this study, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Acibadem University CASE (Center of Advanced Simulation and Education), status: RECRUITING, city: Istanbul, state: Non-US/Canada, zip: 34752, country: Turkey, contacts name: Dilek Kitapcioglu, Assist.Prof, role: CONTACT, phone: +905323636115, email: [email protected], contacts name: Mehmet Emin Aksoy, Assoc.Prof, role: CONTACT, phone: +905052685158, email: [email protected], contacts name: Dilek Kitapcioglu, Assist.Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Mehmet Emin Aksoy, Assoc.Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Arun Ekin Ozkan, M.Sc., role: SUB_INVESTIGATOR, contacts name: Tuba Usseli, M.Sc., role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Acibadem University CASE (Center of Advanced Simulation and Education), status: NOT_YET_RECRUITING, city: Istanbul, state: Non-US/Canada, zip: 34752, country: Turkey, contacts name: Mehmet Emin Aksoy, Assoc.Prof, role: CONTACT, phone: +902165004201, email: [email protected], contacts name: Dilek Kitapcioglu, Ph.D., role: CONTACT, phone: +2165004202, phoneExt: Aksoy, email: [email protected], contacts name: Dilek Kitapcioglu, MD, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Mehmet Emin Aksoy, MD, Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Arun Ekin Ozkan, M.Sc., role: SUB_INVESTIGATOR, contacts name: Tuba Usseli, M.S, role: SUB_INVESTIGATOR, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06288074, orgStudyIdInfo id: SF-2022-1-1061, briefTitle: Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Capital Medical University, class: OTHER, descriptionModule briefSummary: Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia., conditionsModule conditions: Severe Community-acquired Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Multi-omics tests, outcomesModule primaryOutcomes measure: Hospital mortality, secondaryOutcomes measure: Cause of death, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Length of ICU stay, secondaryOutcomes measure: Expense during hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Institute of Respiratory Medicine, status: RECRUITING, city: Beijing, state: Beijing, zip: 100027, country: China, contacts name: Zhaohui Tong, Dr, role: CONTACT, phone: +86 010 8523 1000, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06288061, orgStudyIdInfo id: Phrenic Nerve Neuromodulation, briefTitle: Effectiveness of Non-invasive Phrenic Nerve Neuromodulation in Subjects With Inflammatory Bowel Disease and Neck Pain., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-06-06, completionDateStruct date: 2025-07-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: Inflammatory bowel diseases (IBD) are chronic relapsing diseases that generate an autoimmune response against the bowel and its microbiota. Its prevalence is increasing worldwide. These include Ulcerative Colitis (UC) and Crohn's Disease(CD).The Phrenic nerve originates at the roots C3-C4-C5 carrying motor and sensory information. Directly or through connections it innervates the diaphragm, pleura, right atrium, pericardium, oesophagus, peritoneum, stomach, falciform and coronary ligaments of the liver, Glisson's capsule, hepatic and inferior vena cava, liver (parenchyma), gallbladder and the rest of the biliary tract, pancreas, small intestine and adrenal glands. It also has fibres of the autonomic nervous system.Studies show that there is a link between people suffering from IBD and hepatopancreato-biliary diseases. It can therefore generate referred pain to the C3-C4-C5 dermatomes.Based on the above, the main objective would be to analyse whether non-invasive neuromodulation of the Phrenic nerve reduces neck pain in people with IBD. Secondary objectives were to assess the impact of treatment on quality of life and to study the relationship between IBD and cervical pain.Hypothesis:Non-invasive Phrenic nerve neuromodulation in subjects suffering from inflammatory bowel disease and neck pain will improve their quality of live, disability and sensitisation, as well as neck pain and mobility., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Non-invasive Neuromodulation, interventions name: Cervico-dorsal Massage, outcomesModule primaryOutcomes measure: The Visual Analogue Scale (VAS), primaryOutcomes measure: Cervical mobility, primaryOutcomes measure: The Neck Disability Index (NDI), primaryOutcomes measure: The Pressure Pain Threshold (PPT), secondaryOutcomes measure: The Inflammatory Bowel Disease Questionnaire (IBDQ-32), secondaryOutcomes measure: The World Health Organization Quality of Life (WHOQOL-BREF), secondaryOutcomes measure: The Central Sensitization Inventory (CSI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Puerto Real, city: Puerto Real, state: Cádiz, zip: 11510, country: Spain, geoPoint lat: 36.52819, lon: -6.19011, hasResults: False |
protocolSection identificationModule nctId: NCT06288048, orgStudyIdInfo id: 23/107-EC X TFM 07/03/2023, briefTitle: Effect of Mirror Therapy on Post-Needling Pain Following Deep Dry Needling of Myofascial Trigger Point in Lateral Elbow Pain, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-03-07, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Canarias, class: OTHER, descriptionModule briefSummary: The goal of this randomized, controlled pilot trial is to investigate the immediate effects of incorporating Mirror Visual Feedback Therapy (MFT) on pain sensitivity and motor performance in individuals experiencing Post-needling pain associated with lateral elbow pain. The main questions it aims to answer are:* Does incorporating Mirror Visual Feedback Therapy reduce Post-needling pain intensity?* Does incorporating Mirror Visual Feedback Therapy improve pressure pain threshold?* Does incorporating Mirror Visual Feedback Therapy improve maximum grip strenght?Participants will be asked to undergo pre- and post-treatment evaluations, which include assessments of Post-needling pain intensity, pressure pain threshold, two-point discrimination threshold, and maximum hand grip strength.Participants in the Experimental Group will receive Deep Dry Needling in the m. Brachioradialis, Ischemic Compression, Cold Spray, Stretching, and Mirror Visual Feedback Therapy. Those in the Control Group will not receive Mirror Visual Feedback Therapy.Researchers will compare the Experimental Group to the Control Group to see if the incorporation of Mirror Visual Feedback Therapy results in a reduction in Post-needling pain intensity and improvement in pressure pain threshold., conditionsModule conditions: Lateral Elbow Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Allocation and data assessor were blinded., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 49, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching + MFT, interventions name: Deep Dry Needling (DDN), Ischemic Compression, Cold Spray with Stretching, outcomesModule primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Pain pressure threshold, primaryOutcomes measure: Two-point discrimination threshold, primaryOutcomes measure: Maximum hand grip strength, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad Europea de Canarias, city: La Orotava, state: Santa Cruz De Tenerife, zip: 38300, country: Spain, geoPoint lat: 28.39076, lon: -16.52309, hasResults: False |
protocolSection identificationModule nctId: NCT06288035, orgStudyIdInfo id: R.21.02.1191, briefTitle: Oral Dexamethasone for Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy., conditionsModule conditions: Postoperative Nausea and Vomiting, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone at night before surgery. The primary outcome will be the incidence of postoperative nausea and vomiting. 814 patients are intended to be recruited for this non-inferiority trial., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcome assessors will be blinded to the group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 814, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone Oral, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Postoperative nausea or vomiting (PONV), secondaryOutcomes measure: Rescue antiemetic, secondaryOutcomes measure: Early PONV, secondaryOutcomes measure: Late PONV, secondaryOutcomes measure: Visual Analogue Scale (VAS) at the time of discharge from PACU, secondaryOutcomes measure: VAS at the time of discharge from hospital, secondaryOutcomes measure: Postoperative fatigue, secondaryOutcomes measure: Postoperative quality of recovery, secondaryOutcomes measure: Post-Discharge Nausea and Vomiting (PDNV), otherOutcomes measure: Surgical Site Infection (at follow-up), otherOutcomes measure: Itching or burning sensation on dexamethasone injections, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mansoura University Faculty of Medicine, status: RECRUITING, city: Mansoura, state: Aldakahlia, zip: 35516, country: Egypt, contacts name: Moataz M Emara, MD, EDAIC, role: CONTACT, phone: 01064048848, email: [email protected], geoPoint lat: 31.03637, lon: 31.38069, hasResults: False |
protocolSection identificationModule nctId: NCT06288022, orgStudyIdInfo id: COA. MURA2023/947, briefTitle: Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL., conditionsModule conditions: Surgery-Complications, conditions: Nephrolithiasis Staghorn Calculus, conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial in 2 group1. total tubeless mini-PCNL2. tubeless mini-PCNL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: All eligible patients will be provided with an explanation of the research and invited to participate.Patient will participate or not depends on whether they not meet the surgical exclusion criteria. If they meet the criteria, they will not participate in the research. If they not meet the criteria, they will be randomly assigned to one of the groups.Patients will not be informed of the treatment intervention in advance, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: total tubeless mini-PCNL, interventions name: tubeless mini-PCNL, outcomesModule primaryOutcomes measure: incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL, secondaryOutcomes measure: The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ramathibodi Hospital, Mahidol University, city: Bangkok, state: Ratchathewi, zip: 10400, country: Thailand, contacts name: Thanakorn Sirajarus, role: CONTACT, phone: 086-599-3259, email: [email protected], contacts name: Chinnakhet Ketsuwan, role: CONTACT, phone: 086-345-6901, email: [email protected], geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06288009, orgStudyIdInfo id: 2135389, briefTitle: Outcomes of Running Locking Suture vs Standard Running Suture in Surgical Wounds, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: When patients have surgery on the head and face, stitches are the standard way to close the wound. Wounds always result in a scar, but doctors are always looking for ways to reduce scarring. Several studies have been done to test ways to close wounds that reduce scarring. The most commonly performed closure technique uses running sutures, where a single strand of suture is continued along the length of the wound with a series of uninterrupted stiches. However, alternative closure techniques exist such as the running locking suture, which can offer advantages such as improved tension and thus reduce post-operative complications with better aesthetic outcome. In this study, half the wound will be stitched with standard running sutures and the other half will be stitched with running locking sutures. This will allow us to see if the side with running locking sutures heals with less scarring., conditionsModule conditions: Scarring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Two blinded observers will record their scores independently using the POSAS instrument., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Running locking suture, interventions name: Standard running suture, outcomesModule primaryOutcomes measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS), secondaryOutcomes measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS), secondaryOutcomes measure: Width of Scar as measured using Trace-to-Tape Method, secondaryOutcomes measure: Complications or Adverse Events from Treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Davis - Dermatology Department, status: RECRUITING, city: Sacramento, state: California, zip: 95816, country: United States, contacts name: John Robb, BS, role: CONTACT, phone: 916-551-2636, email: [email protected], contacts name: Daniel Eisen, MD, role: CONTACT, phone: 916-551-2611, email: [email protected], contacts name: Daniel Eisen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Keemberly Kim, MD, role: SUB_INVESTIGATOR, contacts name: Samantha Daniel, MD, role: SUB_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False |
protocolSection identificationModule nctId: NCT06287996, orgStudyIdInfo id: 23MMHIS503e NA, briefTitle: Effects of Warm Water Footbath Intervention on Sleep Quality, Fatigue and Heart Rate Variability in Patients With Heart Failure, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Mackay Memorial Hospital, class: OTHER, descriptionModule briefSummary: This study adopted an experimental research design to explore the effects of a warm water foot bath program on fatigue, sleep, and heart rate variability in patients with heart failure. The subjects of the study were heart failure patients in the cardiology outpatient department. The patients were randomly assigned to the experimental group and the control group. The control group received routine care and wore an actigraph. The experimental group received 4 additional care in addition to routine care and wearing an actigraph. Weekly warm water foot bath, data collection includes subjective sleep quality and fatigue level, physiological measurements: sleep quality-sleep time and efficiency, and heart rate variability index., conditionsModule conditions: Footbath, conditions: Heart Failure, conditions: Sleep Quality, conditions: Fatigue, conditions: Heart Rate Variability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: footbath and actigraphy, interventions name: actigraphy, outcomesModule primaryOutcomes measure: sleep quality, secondaryOutcomes measure: fatigue, otherOutcomes measure: heart rate variability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mackay Memorial Hospital, city: Taipei, state: Zhongshan, zip: 104, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06287983, orgStudyIdInfo id: KayseriCHIMT001, briefTitle: Effect of Inspiratory Muscle Training on Respiratory Functions and Exercise Capacity, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, descriptionModule briefSummary: In this study, we aimed to evaluate the effect of Anti- tumor necrosis factor (TNF) treatment on pulmonary functions in patients with AS and to evaluate the pulmonary functions and exercise performance of patients by adding inspiratory muscle training to spinal mobility exercises in patients with AS using Anti-TNF. We also aimed to investigate the relationship between these parameters and disease activity, spinal mobility and quality of life., conditionsModule conditions: Ankylosing Spondylitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A total of 44 patients were randomly divided into 2 groups using the sealed envelope randomization method. The exercise program will be applied to both groups 3 sessions a week for 60 minutes for 6 weeks. Inspiratory muscle training will also be added to the intervention group. Patients included in the study; At weeks 0, 6, 12 and 24, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), BASFI (Bath Ankylosing Spondylitis Functional Index), ASQoL (The Ankylosing Spondylitis Quality of Life), Modified Borg Scale, Visual Analog scale (VAS) and maximum Dyspnea measurement during exercise, 6-minute walk test, chest expansion measurement and respiratory function test (spirometry) will be evaluated., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Inspiratory Muscle Trainer (IMT) (POWERbreathe Medic Classic), interventions name: The Sample Spondylitis Exercise Program, outcomesModule primaryOutcomes measure: Respiratory function test (Spirometry), secondaryOutcomes measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI):, secondaryOutcomes measure: Bath Ankylosing Spondylitis Functional Index (BASFI), secondaryOutcomes measure: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL), secondaryOutcomes measure: Modified Borg Scale, secondaryOutcomes measure: Measurement of dyspnea at maximum exercise with the Visual Analog Scale (VAS), secondaryOutcomes measure: 6-minute walk test (6MWT), secondaryOutcomes measure: Chest expansion measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital, status: RECRUITING, city: Kayseri, zip: 38080, country: Turkey, contacts name: Havva Talay Çalış, Prof, role: CONTACT, phone: +90352 315 77 00, phoneExt: 61244, email: [email protected], contacts name: Esra Yaprak Tas, MD, role: CONTACT, phone: +905062007571, email: [email protected], geoPoint lat: 38.73222, lon: 35.48528, hasResults: False |
protocolSection identificationModule nctId: NCT06287970, orgStudyIdInfo id: 2023-250-KY, briefTitle: TaVNS Improves the Symptoms of Patients With Moderate to Severe CP/CPPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-18, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Jiani Wu, class: OTHER, descriptionModule briefSummary: This trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This study is a prospective, randomized, controlled trial. A total of 68 patients with CP/CPPS will be recruited. After baseline assessment, the patients will be randomized into taVNS group (n = 34) and sham-taVNS group (n = 34). The intervention of two group will last for 4 weeks with a 8-week follow-up period after the treatment. The National Institutes of Health chronic Prostatitis Symptom Score index (NIH-CPSI), International Prostate Symptom Score Scale (IPSS), European quality of Life-5 Dimensions Questionnaire (EQ-5D), self-rating anxiety Scale (SAS) and self-rating depression scale (SDS) will be assessed. The adverse events during the whole study will be recorded detailedly., conditionsModule conditions: Chronic Prostatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous Auricular Vagus Nerve Stimulation, interventions name: Sham Transcutaneous Auricular Vagus Nerve Stimulation, outcomesModule primaryOutcomes measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 4, secondaryOutcomes measure: Change from baseline in National Institute of Health Chronic Prostatitis Symptom Index(NIH-CPSI) total score at week 8 and week 12, secondaryOutcomes measure: The changes from baseline of NIH-CPSI pain score, urinary score and quality of life score, respectively at week 4, 8 and 12, secondaryOutcomes measure: Proportion of responders at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in International Prostate Symptom Score (IPSS) score at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in EuroQol Five Dimensions Questionnaire (EQ-5D) at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in Self-rating Anxiety Scale (SAS) at week 4, 8 and 12, secondaryOutcomes measure: The change from baseline in the Self-rating Depression Scale (SDS) at week 4, 8 and 12, otherOutcomes measure: Evaluation of patient expectations, otherOutcomes measure: Blinding Evaluation, otherOutcomes measure: Incidence of Treatment-Emergent Adverse Events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Guang'anmen Hospita, China Academy of Chinese Medical Sciences, city: Beijing, state: Beijing, zip: 100053, country: China, contacts name: Jiani Wu, role: CONTACT, phone: +8613426116653, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06287957, orgStudyIdInfo id: IU-DHF-AG-01, briefTitle: Chitosan Brushes vs Air-Abrasive Devices on Peri-implant Mucositis Treatment: A Randomized Clinical, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: Bleeding on probing (0,1,2,3), plaque index (+,-) and pocket probing depth will be recorded for each visit. Before the procedure, the patient will be randomly assigned to one of four groups and records will be kept. In the frst visit of the patient, necessary actions will be taken according to the group to which the patient is assigned. The implant periphery of the patients assigned to the chitosan brush group will be debrided with a chitosan brush with circular movements. The implants of the patients assigned to the air abrasive device group will be cleaned in the same way with circular movements. The debrided area of both groups will be washed with sterile serum after the treatment. Patients will be called at the 2nd, 4th and 12th weeks and compared with the records kept., conditionsModule conditions: Peri-implant Mucositis, conditions: Peri-Implantitis, conditions: Bleeding on Probing, conditions: Periodontal Pocket, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are going to be 4 treatment groups. Group 1: Mini Implant Platform treated with Labrida Bioclean Group 2: Regular Implant Platform treated with Labrida Bioclean Group 3: Mini Implant Platform treated with Air-Flow Device Group 4: Regular Implant Platform treated with Air-Flow Device, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Labrida BioClean, interventions name: EMS Handy 3.0 Perio Premium, outcomesModule primaryOutcomes measure: Probing Depth, secondaryOutcomes measure: Bleeding on Probing, otherOutcomes measure: Plaque Index, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul University, status: RECRUITING, city: Istanbul, state: Fatih, zip: 34080, country: Turkey, contacts name: Alper Gultekin, Assistant Professor, role: CONTACT, phone: +90 5326757236, email: [email protected], contacts name: Kerem Bahceci, PhD Candidate, role: CONTACT, phone: +90 5317132633, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06287944, orgStudyIdInfo id: 23694, secondaryIdInfos id: NCI-2024-01131, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23694, type: OTHER, domain: City of Hope Medical Center, secondaryIdInfos id: P30CA033572, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA033572, briefTitle: 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-18, primaryCompletionDateStruct date: 2027-02-24, completionDateStruct date: 2027-02-24, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: City of Hope Medical Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS., conditionsModule conditions: Acute Lymphoblastic Leukemia, conditions: Acute Myeloid Leukemia, conditions: Myelodysplastic Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Actinium Ac 225-DOTA-Daratumumab, interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Daratumumab, interventions name: Echocardiography, interventions name: Fludarabine, interventions name: Hematopoietic Cell Transplantation, interventions name: Indium In 111-DOTA-Daratumumab, interventions name: Melphalan, interventions name: Multigated Acquisition Scan, interventions name: Radionuclide Imaging, interventions name: Single Photon Emission Computed Tomography, interventions name: Sirolimus, interventions name: Tacrolimus, interventions name: Total Marrow and Lymphoid Irradiation, outcomesModule primaryOutcomes measure: Incidence of adverse events (CTCAE), primaryOutcomes measure: Incidence of adverse events (Bearman), primaryOutcomes measure: Dose limiting toxicity (DLT), primaryOutcomes measure: Maximum tolerated dose/recommended phase II dose (MTD/RP2D), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Cumulative incidence of relapse/progression (CIR), secondaryOutcomes measure: Graft versus host disease and relapse free survival (GRFS), secondaryOutcomes measure: Complete remission (CR) proportion, secondaryOutcomes measure: Non-relapse mortality (NRM), secondaryOutcomes measure: Incidence of infection, secondaryOutcomes measure: Neutrophil recovery rate, secondaryOutcomes measure: Incidence of grade 2-4 and 3-4 acute graft-versus-host disease (GVHD), secondaryOutcomes measure: Incidence of chronic GVHD (cGVHD), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: City of Hope Medical Center, city: Duarte, state: California, zip: 91010, country: United States, contacts name: Jeffrey Y. Wong, role: CONTACT, phone: 626-218-2247, email: [email protected], contacts name: Jeffrey Y. Wong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.13945, lon: -117.97729, hasResults: False |
protocolSection identificationModule nctId: NCT06287931, orgStudyIdInfo id: sdllycyy001, briefTitle: Probiotics for Gallstones in Post-bariatric Surgery Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Shandong Linglong Yingcheng Hospital, class: NETWORK, descriptionModule briefSummary: Obesity is an increasing epidemic worldwide and has a significant impact on human health and socioeconomics. Multiple studies have shown that bariatric surgery increases the risk of postoperative gallbladder stones. Contributing factors to gallstone formation include gallbladder motility and bile supersaturation due to rapid weight loss and cholesterol mobilization. At present, the prevention and treatment of gallbladder stones in obese patients after bariatric surgery are still controversial. In recent years, the study of ursodeoxycholic acid in preventing gallbladder stone formation after bariatric surgery has become a research hotspot. At the same time, other studies have shown that taking probiotics or digestive enzymes may improve gastrointestinal symptoms and improve quality of life after bariatric surgery. Therefore, the purpose of this study was to determine the ability of probiotics to prevent gallstone formation after bariatric surgery and to evaluate the impact of oral probiotics on quality of life in patients after bariatric surgery., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Gallstone, conditions: Gallstone Attack, conditions: Gastrointestinal Quality of Life Index, conditions: Probiotics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Ursodoxycholic acid group, interventions name: Bifidobacterium group, outcomesModule primaryOutcomes measure: The incidence of gallstones in bariatric surgery patients, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shandong Linglong Yingcheng Hospital, status: RECRUITING, city: Yantai, state: Shandong, zip: 264000, country: China, contacts name: Xuan Qiu, MD, role: CONTACT, phone: 8618354280081, email: [email protected], contacts name: Ni Wang, MD, role: CONTACT, phone: 8618705353551, email: [email protected], geoPoint lat: 37.47649, lon: 121.44081, hasResults: False |
protocolSection identificationModule nctId: NCT06287918, orgStudyIdInfo id: 3HP-2827-101, briefTitle: A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: 3H (Suzhou) Pharmaceuticals Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II)., conditionsModule conditions: Solid Tumors With FGFR2 Alterations, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: 3HP-2827, outcomesModule primaryOutcomes measure: Dose Escalation Stage- incidence of adverse events (AEs), primaryOutcomes measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs), primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs, primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results, primaryOutcomes measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters, primaryOutcomes measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827, primaryOutcomes measure: Expansion stage -Objective response rate（ORR）, secondaryOutcomes measure: Plasma Concentration of 3HP-2827 and/or its major metabolites, secondaryOutcomes measure: Duration of Response (DOR) as assessed by RECIST v1.1, secondaryOutcomes measure: Progression-free survival (PFS) as assessed by RECIST v1.1, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Dose escalation stage - Objective Response Rate (ORR), secondaryOutcomes measure: Expansion Stage- incidence of adverse events (AEs), secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs, secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results, secondaryOutcomes measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Phoenix, state: Arizona, zip: 85054, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: The University of Texas MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06287905, orgStudyIdInfo id: Soh-Med-23-02-24, briefTitle: A Comparative Study of Using Scorpion Antivenom Versus Scorpion Antivenom and Prazosin, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Interventional study designed for the evaluation of characters and the outcome of scorpion sting patients will admit to Sohag University Hospitals in 2 randomized groups. The first group will receive scorpion antivenom only whether by the intravenous or the intramuscular route of administration. The second group will receive a combination of prazosin plus scorpion antivenom whether by the intravenous or the intramuscular route of administration. Both groups will receive proper first aid and supportive treatment, conditionsModule conditions: Morality, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: observational comparative, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Simple randomization, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Prazosin Oral Tablet, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: Morbidity, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Meray Medhat Shokry Zaghary, status: RECRUITING, city: Sohag, zip: 82515, country: Egypt, contacts name: Meray M Shokry Zaghary, role: CONTACT, phone: +201028911003, email: [email protected], contacts name: Mai M Abd El Kader, role: CONTACT, phone: +201028911003, email: [email protected], geoPoint lat: 26.55695, lon: 31.69478, hasResults: False |
protocolSection identificationModule nctId: NCT06287892, orgStudyIdInfo id: AI-ECG-HCM, briefTitle: Diagnosis of HCM With AI-ECG, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: The study aims to establish a diagnostic model of hypertrophic cardiomyopathy with artificial intelligence-enhanced electrocardiogram., conditionsModule conditions: Hypertrophic Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnosis of HCM with AI-ECG, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 180 Fenglin Road, status: RECRUITING, city: Shanghai, zip: 200032, country: China, contacts name: Yixiu Liang, MD, role: CONTACT, phone: +8664041990, phoneExt: 612844, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06287879, orgStudyIdInfo id: 20231121, briefTitle: Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Zhongnan Hospital, class: OTHER, descriptionModule briefSummary: Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia, conditionsModule conditions: Dry Eye, conditions: MGD-Meibomian Gland Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dry eye examination, outcomesModule primaryOutcomes measure: Lacrimal river height, primaryOutcomes measure: tear break-up time, primaryOutcomes measure: tear-film lipid layer thickness, primaryOutcomes measure: meibomian glands two-dimensional digital infrared images, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongnan Hospital of Wuhan University, status: RECRUITING, city: Wuhan, state: Hubei, zip: 430071, country: China, contacts name: Min Ke, Doctor, role: CONTACT, phone: +86-18672395959, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06287866, orgStudyIdInfo id: 2099470, briefTitle: Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. We are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, we numb and then shave off a thin piece of skin (usually from the groin area) and place it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method., conditionsModule conditions: Scarring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Two blinded observers will record their scores independently using the POSAS instrument., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Pinch Graft, outcomesModule primaryOutcomes measure: Time to re-epithelialization, secondaryOutcomes measure: Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS), secondaryOutcomes measure: Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Davis - Dermatology Department, status: RECRUITING, city: Sacramento, state: California, zip: 95816, country: United States, contacts name: John Robb, BS, role: CONTACT, phone: 916-551-2636, email: [email protected], contacts name: Daniel Eisen, MD, role: CONTACT, phone: 916-551-2611, email: [email protected], contacts name: Daniel Eisen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Keemberly Kim, MD, role: SUB_INVESTIGATOR, contacts name: Ilana Breen, MD, role: SUB_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False |
protocolSection identificationModule nctId: NCT06287853, orgStudyIdInfo id: EMBODY-004, briefTitle: Tapestry Rotator Cuff Repair PMCF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2028-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Zimmer Biomet, class: INDUSTRY, descriptionModule briefSummary: The study design is a prospective, multi-center, single-arm, non-randomized, and noncontrolled post market clinical follow-up study involving orthopedic surgeons skilled in arthroscopic rotator cuff repair as determined by the Sponsor., conditionsModule conditions: Rotator Cuff Tears, conditions: Rotator Cuff Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Tapestry Biointegrative Implant, outcomesModule primaryOutcomes measure: Re-tear rate after arthroscopic rotator cuff repair, secondaryOutcomes measure: The American Shoulder and Elbow Surgeons (ASES) Score, secondaryOutcomes measure: Constant-Murley Score (CMS), secondaryOutcomes measure: The Single Assessment Numeric Evaluation (SANE) Score, secondaryOutcomes measure: EQ-5D-5L (EuroQol), secondaryOutcomes measure: Return to Work/Activity, secondaryOutcomes measure: Patient Satisfaction, secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: MRI Sugaya Classification, secondaryOutcomes measure: MRI Goutallier Classification, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287840, orgStudyIdInfo id: 17-301, secondaryIdInfos id: 488294, type: OTHER_GRANT, domain: Canadian Institute for Health Research, briefTitle: Canadian Bone Strength Development Study, acronym: CanBSDS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: University of Saskatchewan, class: OTHER, collaborators name: University of Calgary, collaborators name: The Hospital for Sick Children, collaborators name: Children's Hospital of Eastern Ontario, descriptionModule briefSummary: The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are:1. Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength.2. Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development.3. Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D.Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years., conditionsModule conditions: Type-1 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 204, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Trabecular Thickness (μm), primaryOutcomes measure: Bone Strength (Failure load), secondaryOutcomes measure: Total, Cortical and Trabecular Bone Area (mm^2), secondaryOutcomes measure: Total, Cortical and Trabecular Bone Density (mg HA/cm^3), secondaryOutcomes measure: Cortical Thickness (μm), secondaryOutcomes measure: Cortical Porosity, secondaryOutcomes measure: Trabecular Bone Volume Fraction (%), secondaryOutcomes measure: Trabecular Bone Number (1/mm), secondaryOutcomes measure: Trabecular Bone Separation (μm), secondaryOutcomes measure: Total Body and Hip Bone Mineral Content (g), secondaryOutcomes measure: Total Body and Hip Areal Bone Mineral Density (g/cm^2), secondaryOutcomes measure: Age from Peak Height Velocity (years), secondaryOutcomes measure: Pubertal Development, secondaryOutcomes measure: Long Jump (m), secondaryOutcomes measure: Hand Grip (N), secondaryOutcomes measure: Bone Impacts, secondaryOutcomes measure: Physical Activity (minutes/day), secondaryOutcomes measure: Food Frequency Questionnaire, secondaryOutcomes measure: Health, secondaryOutcomes measure: Osteocalcin, secondaryOutcomes measure: Procollagen type I N-propeptide (P1NP-N), secondaryOutcomes measure: C-terminal telopepide (CTx), secondaryOutcomes measure: Sclerostin, secondaryOutcomes measure: Insulin growth factor-1, secondaryOutcomes measure: Alkaline phosphatase, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Saskatchewan, status: RECRUITING, city: Saskatoon, state: Saskatchewan, zip: S7N5B2, country: Canada, contacts name: Saija Kontulainen, PhD, role: CONTACT, phone: (306)966-1077, email: [email protected], geoPoint lat: 52.13238, lon: -106.66892, hasResults: False |
protocolSection identificationModule nctId: NCT06287827, orgStudyIdInfo id: 190224, briefTitle: Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: UNICEF - Venezuela, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to compare the effectiveness, safety, and efficiency of the simplified protocol, which includes the following three modifications: a) use of a single treatment product (RUTF), b) reduced dose, c) expanded cut-offs, with the standard protocol based on the 2023 World Health Organization (WHO) guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months, in outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela.The main question it aims to answer is:What is the effectiveness, safety, and efficiency of the simplified protocol, which includes these three modifications (use of a single treatment product (RUTF), reduced dose, expanded cut-offs) when compared to a standard protocol that is based on the 2023 WHO guidelines for the prevention and treatment of acute malnutrition in children aged 6 to 59 months in the outpatient care services of the states of Bolívar, Capital District, La Guaira, and Miranda of Venezuela? This prospective cohort, longitudinal study will be conducted in 4 states, treating children aged 6-59 months diagnosed with uncomplicated AM, defined as WHZ \<-2 or mid-upper-arm circumference (MUAC) \<125mm or bilateral edema. Children will be prospectively followed for 16 weeks or until their recovery.Researchers will compare the simplified protocol cohort with the standard protocol cohort to determine which one has the best effectiveness, safety, and efficiency indicators in the Venezuela context.The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment, and changes in anthropometry (weight, height, and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death, and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered., conditionsModule conditions: Acute Malnutrition in Childhood, conditions: Wasting, conditions: Child Malnutrition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Simplified protocol, interventions name: Standard protocol, outcomesModule primaryOutcomes measure: Recovery rate, primaryOutcomes measure: Weight gain, primaryOutcomes measure: Mid-Upper Arm Circumference (MUAC) gain, primaryOutcomes measure: Duration of the treatment, primaryOutcomes measure: Prevalence of child morbidity, primaryOutcomes measure: Number of RUTF delivered per child, primaryOutcomes measure: Cost per child, secondaryOutcomes measure: Prevalence of child stunting, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Bolivar State Centers, status: RECRUITING, city: Puerto Ordaz, state: Bolivar, zip: 8050, country: Venezuela, contacts name: Mary Lares, PhD, role: CONTACT, phone: +584166203588, email: [email protected], contacts name: Mary Lares, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 8.29829, lon: -62.72198, locations facility: Ditrict Capital centers, status: RECRUITING, city: Caracas, state: Capital District, zip: 1090, country: Venezuela, contacts name: Pablo Hernandez, MSc, role: CONTACT, phone: +584142561345, email: [email protected], contacts name: Pablo Hernandez, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 10.48801, lon: -66.87919, locations facility: Miranda State Centers, status: RECRUITING, city: Santa Lucia, state: Miranda, zip: 1214, country: Venezuela, contacts name: Pablo Hernandez, MSc, role: CONTACT, phone: +584142561345, email: [email protected], contacts name: Pablo Hernandez, MSc, role: PRINCIPAL_INVESTIGATOR, locations facility: La Guaira State Centers, status: RECRUITING, city: La Guaira, zip: 1160, country: Venezuela, contacts name: Claret Mata, MSc, role: CONTACT, phone: +584142052498, email: [email protected], contacts name: Claret Mata, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 10.59901, lon: -66.9346, hasResults: False |
protocolSection identificationModule nctId: NCT06287814, orgStudyIdInfo id: RECHMPL23_0299, briefTitle: French Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.FRENCH-MRD-CRC is the French study of the european GUIDE.MRD project., conditionsModule conditions: Colorectal Cancer, conditions: Stage III Colon Cancer, conditions: Minimal Residual Disease, conditions: Liquid Biopsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample/lliquid biopsy, outcomesModule primaryOutcomes measure: 3-year disease-free survival (DFS), secondaryOutcomes measure: Sensitivity (Se) of the ctDNA diagnostics, secondaryOutcomes measure: Specificity (Sp) of the ctDNA diagnostics, secondaryOutcomes measure: Positive predictive value of the ctDNA diagnostics, secondaryOutcomes measure: Negative predictive value of the ctDNA diagnostics, secondaryOutcomes measure: Area under the curve of the ctDNA diagnostics, secondaryOutcomes measure: Time to clinical recurrence, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Time to molecular recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287801, orgStudyIdInfo id: 2024P000271, briefTitle: Annual Wellness Visits vs GRACE-augmented Annual Wellness Visits For Older Adults With High Needs - Phase 1, acronym: SPIRE1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Brandeis University, collaborators name: Patient-Centered Outcomes Research Institute, collaborators name: Vanderbilt University Medical Center, collaborators name: Dartmouth-Hitchcock Medical Center, collaborators name: Indiana University, descriptionModule briefSummary: This study consists of three aims focused on examining the feasibility of adding the Geriatric Resources and Assessment for the Care of Elders (GRACE) model to structured Annual Wellness Visits (AWVs) to improve patient and caregiver outcomes and reduce hospitalizations in older adults with complex health needs. The objectives are to:1. Co-design a community-centric implementation strategy for the AWVs vs AWVs + GRACE -augmented care (AWV GRACE) study arms2. Develop a referral pathway and algorithm to optimize enrollment of eligible participants3. Conduct a pilot clinical trial to assess the feasibility of the AWV GRACE intervention., conditionsModule conditions: Healthy Aging, conditions: Health Care Utilization, conditions: Health-Related Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Feasibility of a clinical comparative effectiveness trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcomes assessor team will be blinded to the intervention assignments of participants. Due to the nature of the intervention, the participants, the investigator, and the care providers are unable to be blinded to the participant assignments., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Annual Wellness Visit, interventions name: Geriatric Resources and Assessment for the Care of Elders, outcomesModule primaryOutcomes measure: Hospitalizations, primaryOutcomes measure: Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CG-CAHPS) with Patient Centered Medical Home 1.0 supplement (PCMH CAHPS), primaryOutcomes measure: Net Promotor Score, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - Physical Health (PH) and Mental Health (MH), secondaryOutcomes measure: Caregiver Strain, secondaryOutcomes measure: Patient's out-of-pocket costs for up to 180 days after enrollment, secondaryOutcomes measure: Caregiver's hours spent caregiving., secondaryOutcomes measure: Pilot ACOs Staffing costs, otherOutcomes measure: Exploratory Geriatric Outcomes - Number of participants with new ICD-10 diagnosis codes, otherOutcomes measure: Exploratory Geriatric Outcomes- number of participants that complete advanced care planning documents, otherOutcomes measure: Exploratory Geriatric Outcomes - number of participants with inappropriate medications, otherOutcomes measure: Covariate - Demographics, otherOutcomes measure: Covariate - Medicare Entitlement Status, otherOutcomes measure: Covariate - Elixhauser comorbidity index, otherOutcomes measure: Covariate - Area Deprivation Index, otherOutcomes measure: Covariate - Loneliness, otherOutcomes measure: Exploratory - Hope, otherOutcomes measure: Covariate - Activities of daily living (ADL), otherOutcomes measure: Exploratory - ED visits, otherOutcomes measure: Exploratory - Observation visits, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287788, orgStudyIdInfo id: NFEC-2024-068, briefTitle: A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-10-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC., conditionsModule conditions: Radiation-induced Oropharyngeal Mucositis, conditions: Swallowing-induced Breakthrough Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, outcomesModule primaryOutcomes measure: The AUC of the predictive model, secondaryOutcomes measure: The accuracy, sensitivity, specificity, positive predictive value, negative predictive value and F1 score of the predictive model, secondaryOutcomes measure: The important predictors of severe oropharyngeal mucositis in the predictive model, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Jian Guan, Ph.D., role: CONTACT, phone: 86+13632102247, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, hasResults: False |
protocolSection identificationModule nctId: NCT06287775, orgStudyIdInfo id: NCI-2024-01398, secondaryIdInfos id: NCI-2024-01398, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 10629, type: OTHER, domain: JHU Sidney Kimmel Comprehensive Cancer Center LAO, secondaryIdInfos id: 10629, type: OTHER, domain: CTEP, secondaryIdInfos id: UM1CA186691, type: NIH, link: https://reporter.nih.gov/quickSearch/UM1CA186691, briefTitle: Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-24, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase I/II trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer., conditionsModule conditions: Extensive Stage Lung Small Cell Carcinoma, conditions: Stage IV Lung Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Atezolizumab, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Durvalumab, interventions name: Echocardiography, interventions name: Iadademstat, interventions name: Magnetic Resonance Imaging, interventions name: Multigated Acquisition Scan, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Incidence of adverse events, otherOutcomes measure: Detection of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) minimal residual disease, otherOutcomes measure: Impact of iadademstat on the correlation of immune checkpoint inhibitors (ICIs) and the presence of cachexia, otherOutcomes measure: Exposure response relationships of iadademstat in combination with ICIs, otherOutcomes measure: Changes to small cell lung cancer subtype, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287762, orgStudyIdInfo id: 10001737, secondaryIdInfos id: 001737-NR, briefTitle: A Natural History Study of RYR1-Related Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2031-04-30, completionDateStruct date: 2031-12-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Nursing Research (NINR), class: NIH, descriptionModule briefSummary: Background:Congenital myopathies (CM) are genetic disorders that can cause decreased muscle tone and muscle weakness. Most CMs in the United States are related to the ryanodine receptor 1 (RYR1) gene. Researchers need more natural history data to learn about these CMs in children and adults.Objective:To learn more about the signs, symptoms, and course of RYR1-related disorders.Eligibility:People aged 7 years and older with an RYR1-related disorder.Design:Ambulatory participants will come to the Clinical Center and non-ambulatory participants will visit via telehealth.Visits will be once a year for 3 or 5 years. Clinical Center visits will take 2 to 3 days.All participants will undergo tests including:Photos and videos. These will be taken to document the participant s condition.Blood and urine tests.Activity Tracker. Participants will wear a device to record their activity.Questionnaires. Participants will answer questions about their health, pain, fatigue, stress, quality of life, and other topics.Participants who visit the Clinical Center will also undergo:Tests of heart and lung function.Motor skills and strength tests. Participants will walk, climb stairs, kneel, crawl, stand up, and perform other movements to test their strength and abilities. They will squeeze and pinch a handheld device to test their grip.Imaging scans.Skin biopsy. Adult participants may opt to have a sample of skin taken (one time only).Eye exam, conditionsModule conditions: Ryanodine Receptor 1-Related Myopathy, conditions: Ryanodine Receptor 1 Related Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Adverse and disease-related events, primaryOutcomes measure: Medical data review, primaryOutcomes measure: Ophthalmology, primaryOutcomes measure: Patient-reported outcomes, primaryOutcomes measure: Pulmonary function, primaryOutcomes measure: Motor function and performance, secondaryOutcomes measure: Characterize phenotype and disease course over an extended (2-year) period (total 5 years).Collect exploratory biomarker data., eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: Irene Chrismer, role: CONTACT, phone: 240-591-8884, email: [email protected], contacts name: NIH Clinical Center Office of Patient Recruitment (OPR), role: CONTACT, phone: (800) 411-1222, phoneExt: TTY dial 711, email: [email protected], geoPoint lat: 38.98067, lon: -77.10026, hasResults: False |
protocolSection identificationModule nctId: NCT06287749, orgStudyIdInfo id: RECHMPL23_0298, briefTitle: French Assessment of MRD by Liquid Biopsies in PDAC Patients (FRENCH.MRD.PDAC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-10-31, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: The overall objective of this GUIDE.MRD consortium is to confirm that ctDNA detected after curative intended treatment for PDAC is a marker of residual disease and for risk-of-recurrence, and applicable in clinical practice.Primary objective To confirm that ctDNA analyses performed after PDAC treatment can identify patients with a high risk-of-recurrence.Specifically, the investigators want to determine the association between disease-free survival (DFS) and ctDNA detection status after1. curative-intended surgery and2. adjuvant chemotherapy.FRENCH.MRD.PDAC is the French study of the european GUIDE.MRD project, conditionsModule conditions: Pancreatic Cancer Resectable, conditions: Pancreatic Ductal Adenocarcinoma, conditions: Minimal Residual Disease, conditions: Liquid Biopsy, conditions: ctDNA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample/Liquid Biopsy, outcomesModule primaryOutcomes measure: 3-year Disease-free survival (DFS), secondaryOutcomes measure: Sensitivity (Se) of the ctDNA diagnostics, secondaryOutcomes measure: Specificity (Sp) of the ctDNA diagnostics, secondaryOutcomes measure: Positive predictive value of the ctDNA diagnostics, secondaryOutcomes measure: Negative predictive value of the ctDNA diagnostics, secondaryOutcomes measure: Are Under the Curve of the ctDNA diagnostics, secondaryOutcomes measure: Time to clinical recurrence, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Time to molecular recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287736, orgStudyIdInfo id: 2023H0386, briefTitle: Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, collaborators name: Neuright, Inc., descriptionModule briefSummary: This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers., conditionsModule conditions: Diabetic Peripheral Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Spinal Cord Stimulator Implantation (SCS), outcomesModule primaryOutcomes measure: Change in Pain level, primaryOutcomes measure: Change in Diabetic Peripheral Neuropathy (DPN) Pain using the Neuropathic pain diagnostic questionnaire (DN4), primaryOutcomes measure: Change in PROMIS quality of life in relation to pain level, secondaryOutcomes measure: change in neuropathic symptoms using Michigan Neuropathy Screening instrument, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University Wexner Medical Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Uchechi Okafor, role: CONTACT, phone: 614-366-3439, email: [email protected], contacts name: Brian Dalm, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Kristy Townsend, PhD, role: SUB_INVESTIGATOR, contacts name: Magdalena Blaszkiewicz, PhD, role: SUB_INVESTIGATOR, contacts name: Miriam Freimer, MD, role: SUB_INVESTIGATOR, contacts name: Bakri Elsheikh, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False |
protocolSection identificationModule nctId: NCT06287723, orgStudyIdInfo id: RECHMPL23_0297, briefTitle: French Assessment of MRD by Liquid Biopsies in Colorectal With Liver Metastasis Patients (FRENCH.MRD.CRLM), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2028-10-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough.There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points.The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient.FRENCH.MRD.CRLM is the French study and part of the european GUIDE.MRD project., conditionsModule conditions: Colorectal Cancer, conditions: Liver Metastases, conditions: Stage IV Colorectal Cancer, conditions: Minimal Residual Disease, conditions: Liquid Biopsy, conditions: ctDNA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Blood sample/Liquid biopsy, outcomesModule primaryOutcomes measure: 3-year disease free survival, secondaryOutcomes measure: Sensitivity (Se) of the ctDNA diagnostics, secondaryOutcomes measure: Specificity (Sp) of the ctDNA diagnostics, secondaryOutcomes measure: Positive predictive value of the ctDNA diagnostics, secondaryOutcomes measure: Negative predictive value of the ctDNA diagnostics, secondaryOutcomes measure: Area under the curve of the ctDNA diagnostics, secondaryOutcomes measure: Time to clinical recurrence, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Time to molecular recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287710, orgStudyIdInfo id: CHUBX 2023/32, briefTitle: Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA, acronym: FRENCH-PREMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2024-11-17, completionDateStruct date: 2025-04-17, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bordeaux, class: OTHER, descriptionModule briefSummary: In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion)., conditionsModule conditions: Premature Baby 26 to 32 Weeks, conditions: Premature Baby 33 to 36 Weeks, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment)., outcomesModule primaryOutcomes measure: Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness,, secondaryOutcomes measure: Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness, eligibilityModule sex: ALL, minimumAge: 1 Minute, maximumAge: 5 Months, stdAges: CHILD, contactsLocationsModule locations facility: Bordeaux Hospital University, status: RECRUITING, city: Bordeaux, zip: 33076, country: France, contacts name: Sophie CRAMAREGEAS, MD, role: CONTACT, phone: 0557821269, contacts name: [email protected], role: CONTACT, geoPoint lat: 44.84044, lon: -0.5805, hasResults: False |
protocolSection identificationModule nctId: NCT06287697, orgStudyIdInfo id: LOA/RAP/2019/20, briefTitle: Energy Expenditure and Body Composition of Infants and Young Children (6-24 Months Old) in Asia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-01-21, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: International Atomic Energy Agency, collaborators name: National Institute of Nutrition, Vietnam, collaborators name: Faculty of Medicine, University of Ruhuna, Sri Lanka, collaborators name: Pakistan Institute of Nuclear Science and Technology (PINSTECH), collaborators name: Food and Nutrition Research Institute, Philippines, collaborators name: FAO, descriptionModule briefSummary: This project is a collaboration between International Atomic Energy Agency (IAEA), FAO Regional Office for Asia and The Pacific, and Mahidol University, Thailand to carry out the study on doubly-labeled water for assessment of total energy expenditure and body composition among infants and young children aged 6-23 months old. Thailand conducted a longitudinal study with participation from 4 other countries, namely, Pakistan, Philippines, Sri Lanka and Vietnam, in undertaking the same assessments in a cross-sectional design., conditionsModule conditions: Energy Expenditure, conditions: Body Composition, conditions: Infants and Young Children, conditions: Infant and Young Child Feeding, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 391, type: ACTUAL, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Total Energy Expenditure, primaryOutcomes measure: Body composition, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Length, secondaryOutcomes measure: Head circumference, secondaryOutcomes measure: Mid-upper arm circumference, secondaryOutcomes measure: Triceps skinfold thickness, secondaryOutcomes measure: Subscapular skinfold thickness, secondaryOutcomes measure: Infant and Young Child Feeding (IYCF), secondaryOutcomes measure: Dietary intake, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 24 Months, stdAges: CHILD, contactsLocationsModule locations facility: Institute of Nutrition, Mahidol University, city: Salaya, state: Nakhon Pathom, zip: 73170, country: Thailand, geoPoint lat: 13.802, lon: 100.32111, hasResults: False |
protocolSection identificationModule nctId: NCT06287684, orgStudyIdInfo id: ESICM-22, briefTitle: Molecular Endotype-Specific Dynamics of Lung Endothelial Barrier Integrity in Sepsis, acronym: MENDSEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-13, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Mater Dei Hospital, Malta, class: OTHER, collaborators name: European Society of Intensive Care Medicine, collaborators name: University of Malta, descriptionModule briefSummary: Sepsis is a complex syndrome that causes lethal organ dysfunction due to an abnormal host response to infection. No drug specifically targeting sepsis has been approved. The heterogeneity in sepsis pathophysiology hinders the identification of patients who would benefit, or be harmed, from specific therapeutic interventions. Recent clinical genomics studies have shown that sepsis patients can be stratified as molecular endotypes, or subclasses, with important clinical implications. Classifying sepsis patients as molecular endotypes revealed that a poor prognosis endotype was characterized by immunosuppression and septic shock. Against this backdrop, the study hypothesis is that a poor prognosis for sepsis is defined by a molecular endotype reflecting impaired innate immune and endothelial barrier integrity in the primary anatomical site of infection., conditionsModule conditions: Sepsis, conditions: Septic Shock, conditions: Pneumonia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Blood transcriptomics and BAL protein profiling, outcomesModule primaryOutcomes measure: Patient stratification as transcriptomic endotypes, primaryOutcomes measure: Lung endothelial barrier integrity, secondaryOutcomes measure: Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mater Dei hospital, Intensive Care Unit, status: RECRUITING, city: Imsida, zip: MSD2080, country: Malta, contacts name: Carmel Abela, role: CONTACT, phone: +35625450000, email: [email protected], geoPoint lat: 35.8925, lon: 14.48278, hasResults: False |
protocolSection identificationModule nctId: NCT06287671, orgStudyIdInfo id: COCO, briefTitle: Colorectal Omics and ofCS Proteoglycans, acronym: COCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2032-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Claus Anders Bertelsen, PhD, MD, class: OTHER, collaborators name: Viborg Regional Hospital, descriptionModule briefSummary: This observational study aims to test proteomics, metabolomics and proteoglycans as predictors of postoperative complications after colorectal surgery and as biomarkers of colorectal cancer.The main questions to answer are:* can these biomarkers predict anastomotic leakages* can these biomarkers predict recurrence after colorectal cancer* can these biomarkers be used as diagnostic tests for colorectal cancer* can these biomarkers be identified in the tumorParticipants will undergo elective colorectal resection or stoma closure., conditionsModule conditions: Colorectal Cancer, conditions: Diverticulitis, Colonic, conditions: Inflammatory Bowel Diseases, conditions: Stoma Colostomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Colorectal resection or stoma closure, outcomesModule primaryOutcomes measure: Rate of anastomotic leakage diagnosed by CT-scan or reoperation, primaryOutcomes measure: Rate of major postoperative complications, primaryOutcomes measure: Short-term mortality, primaryOutcomes measure: Recurrence after colorectal cancer, primaryOutcomes measure: Diagnostic value of omics and other biomarkers detecting colorectal cancer, primaryOutcomes measure: Correlation between biomarker in plasma and tissue, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nordsjaellands Hospital, city: Hillerød, zip: 3400, country: Denmark, contacts name: Nanna B Hupfeld, MD, role: CONTACT, phone: +4548292793, email: [email protected], contacts name: Claus A Bertelsen, PhD, role: CONTACT, phone: +4548295972, email: [email protected], geoPoint lat: 55.92791, lon: 12.30081, locations facility: Regionshospitalet Viborg, city: Viborg, zip: 8800, country: Denmark, contacts name: Uffe S Løwe, PhD, role: CONTACT, geoPoint lat: 56.45319, lon: 9.40201, hasResults: False |
protocolSection identificationModule nctId: NCT06287658, orgStudyIdInfo id: E-57428665-050.04-240046, briefTitle: The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Ondokuz Mayıs University, class: OTHER, descriptionModule briefSummary: This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement., conditionsModule conditions: Urinary Incontinence, conditions: Menopause, conditions: Wolman Disease, conditions: Quality of Life, conditions: Psychological Well-Being, 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: Training on Kegel exercise and Ba Duan Jin applications online, interventions name: training on Kegel exercises and Ba Duan Jin applications after the research is completed, outcomesModule primaryOutcomes measure: Psychological Well-Being Scale, primaryOutcomes measure: Incontinence Quality of Life Scale, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tuba Yilmaz Bulut, status: RECRUITING, city: Kocaeli, country: Turkey, contacts name: TUBA YILMAZ BULUT, Dr., role: CONTACT, phone: 05343435109, email: [email protected], geoPoint lat: 39.62497, lon: 27.51145, hasResults: False |
protocolSection identificationModule nctId: NCT06287645, orgStudyIdInfo id: Retinal Images Dataset, briefTitle: Color Fundus Photograph With Experts Labelling, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-12, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Pakistan Council of Scientific and Industrial Research, class: OTHER, collaborators name: Al-Ibrahim Eye Hospital, descriptionModule briefSummary: This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care., conditionsModule conditions: Retinal Disease, conditions: Diabetic Retinopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50000, type: ESTIMATED, armsInterventionsModule interventions name: Color Fundus Photography/Non-Mydriatic Opthalmic Cameras, outcomesModule primaryOutcomes measure: Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale, primaryOutcomes measure: Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale, primaryOutcomes measure: Finding inter-rater agreement among the graders, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Al Ibrahim Eye Hospital, status: RECRUITING, city: Karachi, country: Pakistan, contacts name: Ghulam Mustafa, role: CONTACT, email: [email protected], geoPoint lat: 24.8608, lon: 67.0104, hasResults: False |
protocolSection identificationModule nctId: NCT06287632, orgStudyIdInfo id: 2024P000451, briefTitle: CPAP in Patients With Severe Obesity After Anesthesia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are:1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia?2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia?Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes.* Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure* Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present)., conditionsModule conditions: Obesity, Abdominal, conditions: Anesthesia Morbidity, conditions: Apnea, Obstructive Sleep, conditions: Atelectases, Postoperative Pulmonary, conditions: Ventilator Lung, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Recruitment/ITP-CPAP (Intervention A), interventions name: Standard CPAP (Intervention B), interventions name: Atmospheric Pressure, outcomesModule primaryOutcomes measure: End expiratory lung impedance, secondaryOutcomes measure: Regional lung ventilation, secondaryOutcomes measure: Right ventricular function, secondaryOutcomes measure: Mean pulmonary artery pressure, secondaryOutcomes measure: Inspiratory effort, secondaryOutcomes measure: Abdominal muscle thickness, secondaryOutcomes measure: Respiratory rate, secondaryOutcomes measure: Oxygen saturation, secondaryOutcomes measure: Systemic blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287619, orgStudyIdInfo id: 22-5685, briefTitle: Post-operative Intravenous Iron to Treat Iron-deficiency Anemia in Patients Undergoing Cardiac Surgery, acronym: POAM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Queen's University, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: Heart and Stroke Foundation of Canada, descriptionModule briefSummary: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo., conditionsModule conditions: Chronic Iron Deficiency Anaemia, conditions: Cardiac Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: This is a blinded study, with patients randomized to receive ferric derisomaltose (Monoferric) or placebo. Given that the products have different physical appearances, an unblinded research pharmacist will prepare the IMP then blind the appearance of the IMP for both the intervention group and control group by covering the IV bag and tubing with opaque plastic. All other clinicians, research coordinators, outcome assessors, and patients will remain blinded by using a generic product label in the patient chart and/or the electronic product name (i.e., POAM study drug dose 1 and dose 2, rather than specifying type of product used)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Monoferric Injectable Product, interventions name: 0.9% sodium chloride solution, outcomesModule primaryOutcomes measure: Feasibility Outcome 1: Percentage of major protocol deviations, primaryOutcomes measure: Feasibility Outcome 2: Adequate patient enrollment, primaryOutcomes measure: Feasibility Outcome 3: Percentage of patients lost to follow-up at 90 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kingston Health Sciences Centre, city: Kingston, state: Ontario, zip: K7L 3N6, country: Canada, geoPoint lat: 44.22976, lon: -76.48101, locations facility: Sunnybrook Health Sciences Centre, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Toronto General Hospital - University Health Network, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False |
protocolSection identificationModule nctId: NCT06287606, orgStudyIdInfo id: CTP0302, briefTitle: A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-08-29, primaryCompletionDateStruct date: 2024-01-17, completionDateStruct date: 2024-05-14, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Taejoon Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy, conditionsModule conditions: Bowel Preparation, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 161, type: ACTUAL, armsInterventionsModule interventions name: CTP0302-A, interventions name: CTP0302-B, interventions name: Conventional OST, outcomesModule primaryOutcomes measure: Ratio of subjects With successful Bowel Cleansing, secondaryOutcomes measure: Each segments ratio of subject with successful Bowel Cleansing, otherOutcomes measure: Comparison of Acute gastropathy probability score, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taejoon Pharmaceutical Co., Ltd., city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06287593, orgStudyIdInfo id: NeoLiq, briefTitle: The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients., conditionsModule conditions: EGF-R Positive Non-Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: ctDNA monitoring, outcomesModule primaryOutcomes measure: the rate of major pathological response (MPR), secondaryOutcomes measure: the rate of pathological complete response (pCR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287580, orgStudyIdInfo id: STU-2024-0140, briefTitle: Effects of Antihypertensive Drug Treatment on Brain Blood Flow, Cognition, and Regulation of Nervous System in Older Adults With Hypertension., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, descriptionModule briefSummary: High blood pressure (BP) is a public health problem worldwide. Nearly three-quarters of older adults (age \~60 years) in the United States have high BP. High BP links to many health problems, like stroke. Drug treatments are typically used in clinics to reduce high BP and the risk of associated health problems. However, these drug treatments may not always benefit brain health. For example, drug treatment may reduce brain blood flow, which may reduce cognitive function in older adults with high BP. Alternatively, reduced brain blood flow may cause high BP due to increased nervous system activity (the so-called "fight or flight response"). Thus, monitoring brain blood flow may help to manage high BP during drug treatment.It is unknown if brain blood flow and its control will be altered by drug treatment in older high BP patients. Therefore, study team will recruit older adults with high BP, who receive either drug treatment or a placebo for 2 weeks and will assess brain blood flow, cognitive function, and nervous system control before and after treatment.Results from this study will provide novel and clinically relevant information on the impact of drug treatment for high BP on brain health. Investigators expect these results will suggest that it is crucial to measure brain blood flow, which may be a therapeutic new target for BP control and brain health., conditionsModule conditions: Essential Hypertension, conditions: Older Adults, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: chlorthalidone 25 mg, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Muscle sympathetic nerve activity (MSNA) from baseline at 2 weeks post intervention, primaryOutcomes measure: Change in cognitive performance from baseline at 2 weeks post intervention via Stroop Color and Word Test, primaryOutcomes measure: Change in cognitive performance from baseline at 2 weeks post intervention via NIH Toolbox Cognitive Battery, primaryOutcomes measure: Change in Cerebral blood flow from baseline at 2 weeks post intervention, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Exercise and Environmental Medicine, city: Dallas, state: Texas, zip: 75231, country: United States, contacts name: Takuro Washio, Ph.D., role: CONTACT, phone: 214-345-4852, email: [email protected], geoPoint lat: 32.78306, lon: -96.80667, hasResults: False |
protocolSection identificationModule nctId: NCT06287567, orgStudyIdInfo id: IIT2023078-EC-1, briefTitle: Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: This exploratory study is to investigate the efficacy, safety and tolerability of Lusutrombopag in the treatment of primary immune thrombocytopenia in Chinese patients who have failed first-line therapy, conditionsModule conditions: Idiopathic Thrombocytopenic Purpura, conditions: Immune Thrombocytopenia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: Lusutrombopag Oral Tablet, outcomesModule primaryOutcomes measure: Percentage of Participants with a Platelet Response after 4 Weeks (Day 29), secondaryOutcomes measure: Percentage of Participants with a Platelet Response after 12 Weeks (Day 85), secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Count of ≥100x10^9/L in the Core Study, secondaryOutcomes measure: Change in Platelet Count, secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥50x10^9 /L during the Treatment, secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Count of≥100x10^9 /L during the treatment, secondaryOutcomes measure: Time to first Achieve a Platelet Count of ≥ 50x10^9/L, secondaryOutcomes measure: Time to first Achieve a Platelet Count of ≥100x10^9 /L, secondaryOutcomes measure: Percentage of Participants Who at least once Achieved a Platelet Coun platelet count≥30×10^9/L, a≥2-fold increase from baseline within week 1-4 and week 5-12，respectively., secondaryOutcomes measure: Durable Platelet Response (platelet count ≥50×10^9/L in ≥75% of weeks) Rate, secondaryOutcomes measure: Cumulated Number of Weeks of Response（≥50x10^9/L）, secondaryOutcomes measure: Percentage of Participants with a Reduction in the use of Concomitant ITP Medications from Baseline, secondaryOutcomes measure: The Incidence and Rating of Bleeding Events During the Study, secondaryOutcomes measure: Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study, secondaryOutcomes measure: Number of Participants With Adverse Events (AEs), secondaryOutcomes measure: Change in Health-related Quality of Life Assessed by FACIT-F Scale from Baseline to Week 16, secondaryOutcomes measure: Change in Health-related Quality of Life Assessed by ITP-PAG Scale from Baseline to Week 16, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Hematology & Blood Diseases Hospital, city: Tianjin, state: Tianjin, zip: 300020, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06287554, orgStudyIdInfo id: 404/2024, briefTitle: Effect of Early Implementation of Prone Positioning, acronym: prone, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-03-04, primaryCompletionDateStruct date: 2022-04-20, completionDateStruct date: 2022-04-20, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Zulekha Hospitals, class: OTHER, collaborators name: Al-Azhar University, descriptionModule briefSummary: Background and objective: The ramifications of early lung protective measures and prone positioning on the ICU length of stay rates of participants admitted to the ICU with acute respiratory distress syndrome amid the COVID-19 pandemic constitute a pivotal examination. The study aims to identify the effect of early prone positioning on the length of stay, discharge rate, and number of tracheostomized patients in the ICU., conditionsModule conditions: Severe Acute Respiratory Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: PRONE POSITION, outcomesModule primaryOutcomes measure: Number of discharged patients, secondaryOutcomes measure: The total length of stay, secondaryOutcomes measure: ICU length of stay, secondaryOutcomes measure: Patients who underwent tracheostomy procedures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Al-Azhar faculty of medicine, city: Cairo, zip: 12546, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06287541, orgStudyIdInfo id: 2023-SR-486, briefTitle: The Necessity of a Second Transurethral Resection in High-risk Non-muscle-invasive Bladder Cancer Patients With Negative Urine Biomarker After Initial Transurethral Resection, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy of using a urine biomarker test to guide the decision-making process regarding the necessity of reTURBT in NMIBC patients. The main question aims to answer whether patients with negative urine biomarker tests can safely avoid reTURBT without compromising recurrence-free survival. Participants who have completed the initial TURBT and tested negative for the urine biomarker will be enrolled in the study. They will then be randomized 1:2 into two groups:Group A: Participants will not receive reTURBT and Group B: Participants will undergo reTURBT. Researchers will compare the RFS rates between Group A (no reTURBT) and Group B (reTURBT) to determine if the urine biomarker test can safely spare patients from unnecessary reTURBT., conditionsModule conditions: Non Muscle Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants who meet the inclusion criteria are randomized 1:2 into two parallel groups. Group A: Participants assigned to this group will not undergo reTURBT. They will receive standard follow-up care as per institutional guidelines.Group B: Participants assigned to this group will undergo reTURBT as part of their treatment protocol. Following reTURBT, they will also receive standard follow-up care. Outcome measures of recurrence rate and RFS would be compared between the two groups to determine the effectiveness and safety of the urine genetic test-guided approach compared to standard care with reTURBT.Throughout the study period, both groups are followed up simultaneously, allowing for parallel comparisons of outcomes., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 428, type: ESTIMATED, armsInterventionsModule interventions name: Urine biomarker -Guided without reTURBT, outcomesModule primaryOutcomes measure: 2-year RFS rate, secondaryOutcomes measure: RFS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Qiang Lv, Ph.D, role: CONTACT, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, hasResults: False |
protocolSection identificationModule nctId: NCT06287528, orgStudyIdInfo id: 23-307, briefTitle: A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2028-02-23, completionDateStruct date: 2028-02-23, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Memorial Sloan Kettering Cancer Center, class: OTHER, descriptionModule briefSummary: Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks., conditionsModule conditions: Philadelphia-Negative ALL, conditions: Philadelphia-Positive ALL, conditions: Relapsed ALL, Adult, conditions: Refractory Acute Lymphoblastic Leukemia, conditions: Refractory Acute Lymphoblastic Leukemia (ALL), conditions: Refractory Acute Lymphoid Leukemia in Relapse, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: 19-28z/IL-18 CAR T cells, outcomesModule primaryOutcomes measure: Toxicity as determined by CTCAE, version 5.0, eligibilityModule sex: ALL, minimumAge: 17 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), status: RECRUITING, city: Basking Ridge, state: New Jersey, zip: 07920, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 40.70621, lon: -74.54932, locations facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities), status: RECRUITING, city: Middletown, state: New Jersey, zip: 07748, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 40.39652, lon: -74.09211, locations facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities), status: RECRUITING, city: Montvale, state: New Jersey, zip: 07645, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 41.04676, lon: -74.02292, locations facility: Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities), status: RECRUITING, city: Commack, state: New York, zip: 11725, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 40.84288, lon: -73.29289, locations facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities), status: RECRUITING, city: Harrison, state: New York, zip: 10604, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 40.96899, lon: -73.71263, locations facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities), status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities), status: RECRUITING, city: Uniondale, state: New York, zip: 11553, country: United States, contacts name: Jae Park, MD, role: CONTACT, phone: 646-608-3743, geoPoint lat: 40.70038, lon: -73.59291, hasResults: False |
protocolSection identificationModule nctId: NCT06287515, orgStudyIdInfo id: 2023-0940, secondaryIdInfos id: NCI-2024-01986, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Hypophysectomy by Stereotactic Radiosurgery for Cancer-Related Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2027-07-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn if hypophysectomy (treatment of the pituitary gland) using a type of radiation treatment called stereotactic radiosurgery (SRS) can help to relieve cancer-related pain., conditionsModule conditions: Hypophysectomy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic Radiosurgery, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Chenyang Wang, MD, role: CONTACT, phone: 832-710-1570, email: [email protected], contacts name: Chenyang Wang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False |
protocolSection identificationModule nctId: NCT06287502, orgStudyIdInfo id: KHRehab_LeungHC_2, briefTitle: Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-09, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Kowloon Hospital, Hong Kong, class: OTHER, descriptionModule briefSummary: This is a prospective parallel group, double-blinded randomized controlled trial. Subjects are randomized into two groups - the intervention group and waitlist control group. Subjects received resistance, aerobic, flexibility and balance exercise training; and nutritional supplement containing β-hydroxy β-methylbutyrate (HMB). The intervention group would first receive the intervention during the 12-week study period. Meanwhile, the waitlist control group would receive 12 weeks of conventional care. After the study period, they would receive the same intervention., conditionsModule conditions: Sarcopenia, conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: β-hydroxy β-methylbutyrate (HMB), interventions name: Resistance, aerobic, flexibility and balance exercise training, outcomesModule primaryOutcomes measure: Grip strength, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Appendicular skeletal muscle mass index, secondaryOutcomes measure: 6-metre walk test, secondaryOutcomes measure: 5-time chair stand test, secondaryOutcomes measure: Short Physical Performance Battery (SPPB), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kowloon Hospital, city: Kowloon, country: Hong Kong, geoPoint lat: 22.31667, lon: 114.18333, hasResults: False |
protocolSection identificationModule nctId: NCT06287489, orgStudyIdInfo id: No.:2023-08-010ACF, briefTitle: Effects of Mediterranean Diet on Subjective Cognitive Decline, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-26, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Chih-Ping Chung, class: OTHER_GOV, collaborators name: National Yang Ming Chiao Tung University, descriptionModule briefSummary: Research Questions:1. Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?2. What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?Research Objective:Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms., conditionsModule conditions: Subjective Cognitive Decline, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Mediterranean diet phase X regular diet phase, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mediterranean diet, interventions name: Regular diet, outcomesModule primaryOutcomes measure: Cognitive functional change, primaryOutcomes measure: Physical function 1 - gait speed change, primaryOutcomes measure: Physical function 2 - handgrip strength change, primaryOutcomes measure: Physical function 3 - stand from chair speed change, primaryOutcomes measure: Brain MRI structural change - total and regional voxel-based brain parenchymal features change, primaryOutcomes measure: Brain MRI functional change - total and regional voxel-based brain functional features change, primaryOutcomes measure: Brain MRI neurovascular lesion change - small vessel disease markers, primaryOutcomes measure: Brain MRI neurovascular structural change - microvascular density, secondaryOutcomes measure: AD circulatory biomarkers, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei Veterans General Hospital, status: RECRUITING, city: Taipei, zip: 11217, country: Taiwan, contacts name: Chih-Ping Chung, MD PhD, role: CONTACT, phone: +886-2-918155976, email: [email protected], geoPoint lat: 25.04776, lon: 121.53185, hasResults: False |
protocolSection identificationModule nctId: NCT06287476, orgStudyIdInfo id: H-23043870, briefTitle: Alveolar-capillary Reserve After Exercise in Chronic Obstructive Pulmonary Disease (COPD) (COP-DTPA), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: It is unknown whether individuals with COPD exhibit abnormal alveolar-capillary breaching during exercise, and whether this contributes to exertional dyspnoea. The aim of this study is to investigate whether individuals with COPD exhibit an abnormal increase in alveolar-capillary breaching during exertion, as indicated by an increase alveolar-capillary permeability with a concomitantly exacerbated increase in lung tissue mass., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Acute exercise bout on visit 2 and 3, outcomesModule primaryOutcomes measure: Rest-to-exercise pulmonary DTPA clearance change after exercise in COPD vs. controls, secondaryOutcomes measure: Pulmonary DTPA clearance at rest in COPD vs. controls, secondaryOutcomes measure: Pulmonary DTPA clearance after exercise in COPD vs. controls, secondaryOutcomes measure: Rest-to-exercise change in lung tissue mass in COPD vs. controls, otherOutcomes measure: Lung tissue mass at rest in COPD vs. controls, otherOutcomes measure: Lung tissue mass after exercise in COPD vs. controls, otherOutcomes measure: Rest-to-exercise pulmonary DTPA clearance and lung tissue mass change according to GOLD, otherOutcomes measure: Supine pulmonary capillary blood volume after exercise in COPD vs. controls, otherOutcomes measure: Supine cardiac output after exercise in COPD vs. controls, otherOutcomes measure: Supine pulmonary capillary blood volume at rest in COPD vs. controls, otherOutcomes measure: Supine cardiac output at rest in COPD vs. controls, otherOutcomes measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) after exercise in COPD vs. controls, otherOutcomes measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) after exercise in COPD vs. controls, otherOutcomes measure: Supine alveolar-capillary membrane diffusing capacity (DM) after exercise in COPD vs. controls, otherOutcomes measure: Supine pulmonary diffusing capacity to nitric oxide (DLNO) at rest in COPD vs. controls, otherOutcomes measure: Supine haemoglobin-corrected pulmonary diffusing capacity to carbon monoxide (DLCOc) at rest in COPD vs. controls, otherOutcomes measure: Supine alveolar-capillary membrane diffusing capacity (DM) at rest in COPD vs. controls, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center For Physical Activity Research, Rigshospitalet, city: Copenhagen, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06287463, orgStudyIdInfo id: DCC-3084-01-001, briefTitle: Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Deciphera Pharmaceuticals LLC, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, Phase 1/2 clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)., conditionsModule conditions: Advanced Solid Tumor, conditions: RAF Mutation, conditions: RAS Mutation, conditions: NF1 Mutation, conditions: Non-Small Cell Lung Cancer, conditions: Pancreatic Ductal Adenocarcinoma, conditions: Melanoma, conditions: BRAF Gene Mutation, conditions: CRAF Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: DCC-3084, outcomesModule primaryOutcomes measure: Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1), primaryOutcomes measure: Objective Response Rate (ORR) (ModA Part 2), secondaryOutcomes measure: ORR (ModA Part 1), secondaryOutcomes measure: Progression-Free Survival (PFS) (ModA Part 1 and 2), secondaryOutcomes measure: Overall Survival (OS) (ModA Part 1 and 2), secondaryOutcomes measure: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Ildefonso Ismael Rodriguez Rivera, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: NEXT Oncology Virginia, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Alexander Spira, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False |
protocolSection identificationModule nctId: NCT06287450, orgStudyIdInfo id: IN006001, briefTitle: A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Shenzhen Shenxin Biotechnology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults., conditionsModule conditions: Respiratory Syncytial Virus Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, 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: Bivalent RSV Vaccine (IN006), interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination, primaryOutcomes measure: Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination, primaryOutcomes measure: Percentage of Participants With Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination, primaryOutcomes measure: Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination, secondaryOutcomes measure: Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay), secondaryOutcomes measure: Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay), secondaryOutcomes measure: Vaccine Response Rate for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay), secondaryOutcomes measure: GMC for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]), secondaryOutcomes measure: GMFR for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]), secondaryOutcomes measure: Vaccine Response Rate for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA]), secondaryOutcomes measure: Frequency of Pre-F Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay), secondaryOutcomes measure: Frequency of Pre-F Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay), secondaryOutcomes measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination, secondaryOutcomes measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Unsolicited AEs Through 28 Days After Revaccination, secondaryOutcomes measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any MAAEs Through 6 Months After Revaccination, secondaryOutcomes measure: Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any SAEs, AESIs, and AEs Leading to Study Discontinuation Through 6 Months After Revaccination, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287437, orgStudyIdInfo id: B2023-335R, briefTitle: HRS9531 Controls Weight Regain in Obese Subjects, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients, conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: HRS9531, interventions name: HRS9531 placebo, outcomesModule primaryOutcomes measure: Percent Change in Body Weight from 24 weeks, secondaryOutcomes measure: Energy intake change from 24 weeks, secondaryOutcomes measure: Energy expenditure change from 24 weeks, secondaryOutcomes measure: Metabolic adaptation from 24 weeks, secondaryOutcomes measure: Systolic blood pressure and diastolic blood pressure change from 24 weeks, secondaryOutcomes measure: Body fat rate change from 24 weeks, secondaryOutcomes measure: Serum total cholesterol change from 24 weeks, secondaryOutcomes measure: Triglyceride change from 24 weeks, secondaryOutcomes measure: Nonestesterified fatty acid change from 24 weeks, secondaryOutcomes measure: Energy intake at baseline, secondaryOutcomes measure: Energy expenditure at baseline, secondaryOutcomes measure: Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale), secondaryOutcomes measure: Percent Change in Body Weight at 24 weeks, secondaryOutcomes measure: Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale), secondaryOutcomes measure: Energy expenditure at 24 weeks, secondaryOutcomes measure: Energy intake at 24 weeks, otherOutcomes measure: Change of body weight at 24 weeksl from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Xiaoying Li, city: Shanghai, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06287424, orgStudyIdInfo id: HMO-2O-0536, briefTitle: The Efficacy Of AGE On Periodontitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-04-04, primaryCompletionDateStruct date: 2022-09-30, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, collaborators name: Wakunaga Pharmaceutical Co., Ltd., descriptionModule briefSummary: The objective of this study is to assess the long-term efficacy of "AGE among on deep periodontal pockets by different doses of "AGE" for a period of 18 months., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 4 Regimen parralel groups, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Eligible subjects will be stratified based on Screening mean PPD (above or below 2mm), mean GBI (above or below 0.44), mean age (above or below 45 years old), gender (male or female) and tobacco use (yes or no). Within strata, subjects will be randomly assigned to one of the treatment groups using an encoded program. This assignment process and the distribution of test products will be conducted in a protected area that will ensure blinding of the examiner to the identity of the test products., whoMasked: PARTICIPANT, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule interventions name: Aged Garlic Extract, interventions name: Placebo, outcomesModule primaryOutcomes measure: Gingival Bleeding Index (GBI), primaryOutcomes measure: Probing Pocket Depth (PPD), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hebrew University, city: Jerusalem, zip: 9112102, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False |
protocolSection identificationModule nctId: NCT06287411, orgStudyIdInfo id: 202436, briefTitle: Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Xiao Chen, class: OTHER, descriptionModule briefSummary: This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards., conditionsModule conditions: Hepatic Malignancies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: FAPI PET/MR combined with gadoxetate disodium, outcomesModule primaryOutcomes measure: Diagnostic performance, secondaryOutcomes measure: Quantitative parameters of PET/MR, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Xiao Chen, Ph.D, role: CONTACT, phone: 15922970174, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, hasResults: False |
protocolSection identificationModule nctId: NCT06287398, orgStudyIdInfo id: NHL38, briefTitle: Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2031-11, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Australasian Leukaemia and Lymphoma Group, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R/R) large B-cell lymphoma who achieve a complete remission prior to planned transplant?* Is consolidation epcoritamab after ASCT deliverable and safe?* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.Participants will undergo three phases in this trial:1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT., conditionsModule conditions: DLBCL - Diffuse Large B Cell Lymphoma, conditions: High-grade B-cell Lymphoma, conditions: High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, conditions: DLBCL, Nos Genetic Subtypes, conditions: High Grade B-Cell Lymphoma, Not Otherwise Specified, conditions: Follicular Large Cell Lymphoma, Relapsed, conditions: Follicular Large Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: Epcoritamab, outcomesModule primaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Evaluate safety and tolerability of combination Epcoritamab with salvage-ASCT, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06287385, orgStudyIdInfo id: NELN202212A, briefTitle: An Exploratory RWE Study Exploring Effects of a Goat Milk Based Young Child Formula on Health Benefits, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Danone Nutricia, class: INDUSTRY, descriptionModule briefSummary: This is an exploratory real-world study designed to gain insight into the role of the product in terms of health benefits in toddlers, with the potential to generate hypotheses on key and other exploratory objectives., conditionsModule conditions: Healthy Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Goat-milk Based Formula, outcomesModule primaryOutcomes measure: Stool characteristics, secondaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Quality of life of subjects, secondaryOutcomes measure: Lifestyle-related immune indicators, otherOutcomes measure: Safety parameters, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 2 Years, stdAges: CHILD, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06287372, orgStudyIdInfo id: 3261, briefTitle: Comparison of Changes in Intra-myocardial Amino Acids During Use of Calafiore and Modified Del Nido Cardioplegia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-04, primaryCompletionDateStruct date: 2023-07-04, completionDateStruct date: 2023-07-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Damascus University, class: OTHER, descriptionModule briefSummary: The aim of the present study was to investigate intra-operative changes in markers of myocardial injury and myocardial intracellular amino acids during ischemia and reperfusion, comparing two methods of myocardial protection; Calafiore intermittent antegrade warm blood cardioplegia or modified del Nido intermittent antegrade cold blood cardioplegia in routine coronary artery bypass grafting procedures., conditionsModule conditions: Myocardial Injury, conditions: Cardiac Surgery, conditions: Myocardial Protection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Cardioplegic solution, outcomesModule primaryOutcomes measure: Changes in markers of myocardial injury, secondaryOutcomes measure: Changes in myocardial amino acid concentrations, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damascus University Cardiac Surgery Hospital, city: Damascus, country: Syrian Arab Republic, geoPoint lat: 33.5102, lon: 36.29128, hasResults: False |
protocolSection identificationModule nctId: NCT06287359, orgStudyIdInfo id: Local/2024/MP-01, briefTitle: Experience of Parents/Carers of Children With Severe Motor Disabilities Suffering From Spinal Pain?, acronym: Vé-Quo-Pa-H-R, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: Parents of disabled children suffer from back pain more frequently than the general population. At present, the literature does not identify any specific factors responsible for this suffering.For patients suffering from chronic back pain, there are specific treatment programmes in the Physical Medicine and Rehabilitation Department, with a focus on pain management.The investigators would like to develop specific programmes for parents/carers of children/adolescents with severe motor disabilities.To achieve this, it is important to gain a better understanding of the factors that contribute to the onset of pain.With this in mind, the investigators are conducting a qualitative study to gain a better understanding of the day-to-day lives of these parents., conditionsModule conditions: Low Back Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: individual interviews, outcomesModule primaryOutcomes measure: Individual interviews, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06287346, orgStudyIdInfo id: 240101, briefTitle: 5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece., acronym: 240101, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2029-01-01, completionDateStruct date: 2030-01-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: CeraRoot SL, class: INDUSTRY, descriptionModule briefSummary: The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question\[s\] it aims to answer are:* Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?* What are the complications associated to the procedure and differences between the two groups., conditionsModule conditions: Edentulism, conditions: Tooth Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 652, type: ESTIMATED, armsInterventionsModule interventions name: dental implant, outcomesModule primaryOutcomes measure: Survival rate, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Family Holistic Dentistry, status: RECRUITING, city: Boulder, state: Colorado, zip: 80303, country: United States, contacts name: CARMEN BURKE, DDS, role: CONTACT, phone: 303-219-0499, email: [email protected], contacts name: CARMEN BURKE, DDS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.01499, lon: -105.27055, locations facility: CeraRoot CLINIC, status: RECRUITING, city: Les Franqueses del Vallès, state: Barcelona, zip: 08520, country: Spain, contacts name: JOSEP OLIVA-OCHOA, DDS MSC, role: CONTACT, phone: 800-485-1613, email: [email protected], contacts name: Ekaterina Treatment coordinator, role: CONTACT, phone: +34 935 950 247, email: [email protected], contacts name: JOSEP OLIVA-OCHOA, DDS MSC, role: PRINCIPAL_INVESTIGATOR, contacts name: XAVIER OLIVA-OCHOA, DDS MSC, role: SUB_INVESTIGATOR, contacts name: CARLA OLIVA-PORTA, STUDENT, role: SUB_INVESTIGATOR, contacts name: ARNAU OLIVA-PORTA, STUDENT, role: SUB_INVESTIGATOR, geoPoint lat: 41.61929, lon: 2.29829, hasResults: False |
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