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SECONDARY OBJECTIVES: The use of Rescue medication, proportion of patients who required hospitalization, worsening of heart failure or pulmonary oedema, side effect of medication ( dizziness, headaches, gastrointestinal symptoms)
PATEINT POPULATION: Adults (18 and older) presenting to the emergency department at Sultan Qaboos University Hospital with symptomatic atrial fibrillation or atrial flutter with rapid ventricular response requiring treatment.
INTERVENTION: A single oral dose of 5 mg Bisoprolol (maximum dose of 5 mg) or a single intravenous dose of Diltiazem at 0.25 mg/kg (to a maximum dose of 30 mg).
CLINICAL MEASURMENT: Heart rate recorded every 15 minutes up to the 90-minute mark, with a 12-lead ECG performed every 30 minutes.
OUTCOME: For therapy to be considered effective, patients must achieve a ventricular rate ≤110/min or experience a drop-in ventricular rate of at least 20% at 60 minutes. conditions: Atrial Fibrillation With Rapid Ventricular Response conditions: Atrial Flutter With Rapid Ventricular Response studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * Study Design: Double-blind, randomized controlled trial.
* Participants: Patients with atrial fibrillation/flutter and rapid ventricular rate.
* Treatment Arms: Oral Bisoprolol vs. Intravenous Diltiazem.
* Randomization: Subjects randomly assigned to either treatment group.
* Primary Endpoint: Reduction of heart rate to a target level within a specific timeframe.
* Secondary Outcomes: Adverse effects, hospital admission rates, additional rate control needs.
* Objective: Compare effectiveness and safety of oral Bisoprolol to intravenous Diltiazem.
* Monitoring: Continuous observation of vital signs and electrocardiograms for safety. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: While the treating physician, nurse, and the patient will not be blinded to the treatment, the investigator collecting data and the statistician analysing it will remain blinded to treatment allocations. This ensures unbiased data collection and analysis. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Oral Bisoprolol name: Intravenous Diltiazem measure: Efficacy Outcome Evaluated by Achieving the Target Heart Rate Reduction measure: Safety Outcome Evaluated by the Presence of serious adverse event measure: The use of Rescue medication measure: Proportion of patients who required hospitalization measure: ED revisit measure: Number of Participants Experiencing Treatment-Related Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sultan Qaboos University Hospital city: Muscat state: Al-khod zip: 38 country: Oman name: Fatin k Al omairi, MD role: CONTACT phone: 71308058 phoneExt: +968 email: r2220@resident.omsb.org name: Awatif Al-Alalawi, MD role: PRINCIPAL_INVESTIGATOR name: Usama Alkhalasi, MD role: SUB_INVESTIGATOR name: Mohamed Al Rawahi, MD role: SUB_INVESTIGATOR name: Adil Al Riyami, MD role: SUB_INVESTIGATOR name: Said Al Hadhrami, MD role: SUB_INVESTIGATOR name: Hatim Al Lawati, MD role: SUB_INVESTIGATOR lat: 23.58413 lon: 58.40778 hasResults: False
<|newrecord|> nctId: NCT06276114 id: 07 briefTitle: IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON) acronym: DRAGON overallStatus: COMPLETED date: 2020-08-01 date: 2023-10-31 date: 2023-10-31 date: 2024-02-23 date: 2024-02-23 name: Medical University of Silesia class: OTHER briefSummary: The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers.
The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint. conditions: Coronary Artery Calcification conditions: Intravascular Lithotripsy conditions: Excimer Laser-coronary Atherectomy conditions: Stent Restenosis conditions: Stent Occlusion studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 121 type: ACTUAL name: Stent Underexpansion measure: The primary efficacy endpoint was device success measure: Device-oriented composite endpoint (DOCE) sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Unit of Structural Interventional Cardiology, Department of Clinical and Experimental Medicine, Careggi University Hospital city: Florence country: Italy lat: 43.77925 lon: 11.24626 facility: Fabrizio D'Ascenzo city: Turin country: Italy lat: 45.07049 lon: 7.68682 facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital city: Białystok country: Poland lat: 53.13333 lon: 23.16433 facility: First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland city: Gdańsk country: Poland lat: 54.35205 lon: 18.64637 facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland city: Katowice zip: 40-635 country: Poland lat: 50.25841 lon: 19.02754 facility: Jacek Legutko city: Kraków country: Poland lat: 50.06143 lon: 19.93658 facility: Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland city: Kraków country: Poland lat: 50.06143 lon: 19.93658 facility: 1st Military Hospital in Lublin, Lublin, Poland city: Lubin country: Poland lat: 51.40089 lon: 16.20149 facility: Department of Cardiology, Copper Health Centre (MCZ) city: Lubin country: Poland lat: 51.40089 lon: 16.20149 facility: Clinical Department of Interventional Cardiology, Medical University of Lublin city: Lublin country: Poland lat: 51.25 lon: 22.56667 facility: Department of Cardiology, University Hospital, Institute of Medical Sciences city: Opole country: Poland lat: 50.67211 lon: 17.92533 facility: Department of Cardiology, Poznan University of Medical Sciences city: Poznań country: Poland lat: 52.40692 lon: 16.92993 facility: Department of Cardiology, The Ministry of Internal Affairs and Administration Hospital, Rzeszow city: Rzeszów country: Poland lat: 50.04132 lon: 21.99901 facility: 1st Department of Cardiology, Medical University of Warsaw city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Cardiology and Internal Diseases, Military Institute of Medicine city: Warsaw country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Interventional Cardiology and Angiology, National Institute of Cardiology, Warsaw, Poland city: Warszawa country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration city: Warszawa country: Poland lat: 52.22977 lon: 21.01178 facility: Department of Invasive Cardiology, Wejherowo city: Wejherowo country: Poland lat: 54.60568 lon: 18.23559 facility: Centre for Heart Disease, University Hospital Wroclaw Department of Heart Disease, Wroclaw Medical University city: Wrocław country: Poland lat: 51.1 lon: 17.03333 facility: Third Department of Cardiology, Medical University of Katowice city: Zabrze country: Poland lat: 50.32492 lon: 18.78576 hasResults: False
<|newrecord|> nctId: NCT06276101 id: NEWISH-HPV-101 briefTitle: NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL overallStatus: RECRUITING date: 2024-01-25 date: 2024-12-30 date: 2025-07-30 date: 2024-02-23 date: 2024-02-23 name: Newish Technology (Beijing) Co., Ltd. class: INDUSTRY briefSummary: This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL. conditions: High-grade Squamous Intraepithelial Lesion (HSIL) studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: NWRD08 administered by electroporation measure: Safety measure: Dose-limiting toxicity (DLT) measure: Immunogenicity measure: Histopathology outcome and HPV Viral clearance measure: The recommended phase II dose (RP2D) sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Peking Union Medical College Hospital status: RECRUITING city: Beijing state: Beijing zip: 100730 country: China name: Fang Jiang, M.D. role: CONTACT phone: 86-010-69155635 email: 13671170943@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06276088 id: NFEC-2024-067 briefTitle: Plasma and Tissue SAA1 Levels in Cancer Patients to Predict Hyperprogression of Immunotherapy overallStatus: RECRUITING date: 2024-02-18 date: 2025-12-31 date: 2026-10-31 date: 2024-02-23 date: 2024-03-15 name: Nanfang Hospital, Southern Medical University class: OTHER briefSummary: Immune checkpoint inhibitors have ushered in a new era of cancer treatment, bringing significant survival benefits to patients. However, some patients have accelerated tumor growth in the early stage of immunotherapy, called hyperprogression. The quality of life of patients with hyperprogression is seriously reduced, and there is no effective treatment at present, and the prognosis is extremely poor. Therefore, early identification of high-risk groups of hyperprogression is the key to prevent hyperprogression. However, there are no effective biomarkers to predict hyperprogression. By sequencing, proteomics and metabolomics analysis of clinical tissue and blood samples, we found that the level of SAA1 was significantly increased in patients with hyperprogression, and SAA1 was an effective marker for predicting hyperprogression in pan-cancer. We planned to conduct a multicenter, prospective cohort study to verify the reliability of SAA1 as a marker for predicting hyperprogression of immunotherapy in pan-cancer patients. conditions: Immunotherapy conditions: Hyperprogression conditions: Biomarker studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 374 type: ESTIMATED measure: Incidence of hyperprogression measure: Event-free survival measure: Progression-free survival measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang hospital, Southern medical university status: RECRUITING city: Guangzhou state: Guangdong zip: 510515 country: China name: Jian Guan, M.D. role: CONTACT phone: 86+13632102247 email: guanjian5461@163.com name: Jian Guan, M.D. role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Fujian Provinical Hospital status: NOT_YET_RECRUITING city: Fuzhou country: China name: Yongmei Dai role: CONTACT lat: 26.06139 lon: 119.30611 facility: Huizhou Central People's Hospital status: NOT_YET_RECRUITING city: Huizhou country: China name: Yunming Tian role: CONTACT lat: 23.11147 lon: 114.41523 facility: Jieyang people's hospital status: NOT_YET_RECRUITING city: Jieyang country: China name: Peibao Lai role: CONTACT lat: 23.5418 lon: 116.36581 facility: Meizhou People's Hospital, Meizhou Academy of Medical Sciences Meizhou status: NOT_YET_RECRUITING city: Meizhou country: China name: Jianda Sun role: CONTACT lat: 24.2886 lon: 116.11767 hasResults: False
<|newrecord|> nctId: NCT06276075 id: 10/KRN/2020 briefTitle: The Impact of Erigo®Pro Therapy and Motor Imagery on the Balance of Stroke Patients. overallStatus: COMPLETED date: 2022-12-15 date: 2023-05-10 date: 2023-09-10 date: 2024-02-23 date: 2024-02-23 name: Anna Olczak class: OTHER briefSummary: The aim of the study is to examine the impact of motor imagery, Erigo®Pro tilt table intervention, and classic rehabilitation on the balance of people after a stroke. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 66 type: ACTUAL name: Conventional rehabilitation, the Erigo®Pro table, motor imagery measure: Trunk Control Test measure: Berg Balance Scale measure: RiabloTM device measure: RiabloTM device measure: Luna EMG measure: Luna EMG sex: ALL minimumAge: 38 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Military Institute of Medicine city: Warsaw state: Masovian District zip: 04-141 country: Poland lat: 52.22977 lon: 21.01178 hasResults: False
<|newrecord|> nctId: NCT06276062 id: Titanium nail usage briefTitle: Uses of Titanium Nail in Pediatric Fractures overallStatus: RECRUITING date: 2023-09-01 date: 2024-09 date: 2024-10 date: 2024-02-23 date: 2024-02-28 name: Sohag University class: OTHER briefSummary: The aim of this study is to investigate the short term functional and radiological outcomes of using double short titanium elastic nails as treatment of pediatric distal radius fractures. conditions: Trauma Injury of Upper Extremity Forearm Multiple conditions: Fracture of Distal End of Radius studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Distal radius fracture fixation in pediatrics. measure: Comparison between usage of titanium nail and old methods sex: ALL minimumAge: 4 Years maximumAge: 16 Years stdAges: CHILD facility: Sohag university status: RECRUITING city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
<|newrecord|> nctId: NCT06276049 id: DGETRRP2023-54 briefTitle: ChatGPT Helping Advance Training for Medical Students: A Study on Self-Directed Learning Enhancement acronym: CHAT-MS overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-25 date: 2024-01-06 date: 2024-03-02 date: 2024-02-23 date: 2024-02-23 name: Wang Shalong class: OTHER name: Central South University briefSummary: The goal of this clinical trial is to evaluate the effect of LearnGuide, a custom GPT developed with ChatGPT for supporting self-directed learning (SDL) in medical students. The main questions it aims to answer are:
How does LearnGuide influence SDL skills among medical students? Can LearnGuide improve critical thinking and learning flow as measured by Cornell Critical Thinking Test (CCTT) Level Z score and Global Flow Score (GFS)?
Participants will:
Undergo a two-hour introduction to LearnGuide. Engage in 12 weeks of SDL task-based training with LearnGuide\&amp;#39;s support.
If there is a comparison group: Researchers will compare the group utilizing LearnGuide for SDL and the group without this tool to see if there is a significant difference in SDL skills, critical thinking, and learning flow experiences. conditions: Self-Directed Learning conditions: Artificial Intelligence conditions: Medical Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 103 type: ACTUAL name: custom GPT supported self-directed learning measure: Self-Directed Learning Scale measure: Cornell Critical Thinking Test (CCTT) Level Z measure: Flow Short Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Geriatirc Surgery city: Changsha state: Hunan zip: 410011 country: China lat: 28.19874 lon: 112.97087 hasResults: False
<|newrecord|> nctId: NCT06276036 id: CAPID briefTitle: Autoimmune Cytopenias as a Sign of Primary Immunodeficiency. overallStatus: ACTIVE_NOT_RECRUITING date: 2019-07-23 date: 2024-12-01 date: 2025-06-01 date: 2024-02-23 date: 2024-03-29 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies conditions: Cytopenia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 53 type: ACTUAL name: Identification of specific markers measure: Identification of specific markers sex: ALL minimumAge: 1 Year maximumAge: 17 Years stdAges: CHILD facility: University of South Florida city: Tampa state: Florida zip: 33620 country: United States lat: 27.94752 lon: -82.45843 facility: Ghent University Hospital city: Ghent country: Belgium lat: 51.05 lon: 3.71667 facility: Clinica Pediatrica - Università di Catania city: Catania country: Italy lat: 37.49223 lon: 15.07041 facility: Meyer Children's Hospital IRCCS city: Florence country: Italy lat: 43.77925 lon: 11.24626 facility: IRCCS Istituto Giannina Gaslini city: Genova country: Italy lat: 44.40478 lon: 8.94438 facility: Azienda Ospedaliero Universitaria Pisana city: Pisa country: Italy lat: 43.70853 lon: 10.4036 hasResults: False
<|newrecord|> nctId: NCT06276023 id: 2023P003638 id: 1R01AG078204-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AG078204-01 briefTitle: Supporting Our Caregivers In ADRD Learning (SOCIAL) acronym: SOCIAL overallStatus: RECRUITING date: 2024-03-22 date: 2025-03-15 date: 2025-04-01 date: 2024-02-23 date: 2024-03-25 name: Massachusetts General Hospital class: OTHER name: National Institute on Aging (NIA) name: University of California, San Francisco briefSummary: Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks.
The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial.
Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention. conditions: Alzheimer's Disease and Related Dementias conditions: Quality of Life conditions: Caregiver Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: MASC is an intervention that includes evidence-based skills of: 1) mindfulness; 2) compassion toward others and self; 3) behavioral management skills. MASC comprises 6 sessions delivered in a group format over secure live video with Zoom. Each session includes psychoeducation on program skills, skill practice, strategies to incorporate the skill into the caregiver experience, and strategies for sustained practice. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 80 type: ESTIMATED name: Mindful and Self-Compassionate Care Program (MASC) name: Health Education Program (HEP) measure: Feasibility of Recruitment measure: Feasibility of Randomization measure: Feasibility of Assessment Measures measure: Feasibility of Quantitative Measures measure: Adherence to treatment measure: Patient's Global Impression of Change (PGIC) measure: Perceptions of Questionnaire Battery measure: Adherence to Home Practice measure: Perceptions of Email and Text Reminders measure: Credibility and Expectancy measure: Modified Perception of Global Improvement measure: Satisfaction with the Intervention measure: Therapist Fidelity measure: Symptoms of Depression measure: Mindfulness measure: Perceived Stress Scale measure: Symptoms of Anxiety measure: The Self-Compassion Scale measure: Compassion measure: Caregiver self-efficacy measure: Loneliness measure: Social Support measure: Well-being measure: Distress Due to Patient Challenges Behaviors measure: Dyadic Relationship Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114-2524 country: United States name: Michelle StPaul, MS role: CONTACT email: mstpaul2@mgh.harvard.edu lat: 42.35843 lon: -71.05977 hasResults: False
<|newrecord|> nctId: NCT06276010 id: 2023-102 briefTitle: Use of Nafamostat Mesilate for Anticoagulation in Patients With ECMO overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-12-31 date: 2024-02-23 date: 2024-02-26 name: Xiaotong Hou class: OTHER briefSummary: The purpose of this study is to evaluate the effectiveness and safety of nafamostat mesilate compared with unfractionated heparin for anticoagulation in patients with ECMO after cardiac surgery. conditions: Extracorporeal Membrane Oxygenation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 80 type: ESTIMATED name: nafamostat mesilate name: unfractionated heparin group measure: Incidence of thrombotic complications measure: Incidence of severe bleeding complications measure: Infusion volume of blood products measure: ACT qualified rate measure: Hospitalization mortality measure: The incidence of oxygenator dysfunction measure: Heparin-induced thrombocytopenia measure: Time to reach the target anticoagulant level for the first time sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06275997 id: GAIN briefTitle: GAIN Project: Gastric Cancer and Artificial Intelligence acronym: GAIN overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-03 date: 2028-03 date: 2024-02-23 date: 2024-02-23 name: Istituto Clinico Humanitas class: OTHER briefSummary: Our GAIN project comprises four core work packages (WPs): WP1. Nation-level randomized controlled trial; WP2. Development of an innovative AI tool; WP3. Novel microsimulation modelling; WP4. Patient inclusion.
The nation-level multi-center tandem randomized controlled trial (WP1) will contribute to a better understanding of how the real-time AI algorithm can reduce miss rate of early gastric cancer and dysplasia during gastroscopy. Moreover, the innovation project will contribute to development of a novel AI tool (WP2) that can stratify the risk of gastric cancer by identifying in vivo precancerous conditions. Furthermore, a microsimulation modelling will allow us to predict how the use of AI can prevent gastric cancer and affect cost and patients' burdens. The assessment of the balance between benefits and harms is quite crucial especially for this type of medical device because the value of innovative tools is sometimes overestimated due to stakeholders' enthusiasm (WP3). Finally, we will take care of patients' perspective throughout the study project by including patient organization in both WP1, 2, and 3 (WP4). conditions: Gastric Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel/Crossover Study Model; Patients will be randomized 1:1:1:1 primaryPurpose: PREVENTION masking: NONE count: 6600 type: ESTIMATED name: Integration of Artificial Intelligence (AI) assistance to screening gastroscopy measure: Miss rate reduction measure: Change number of Detections measure: patient satisfaction sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06275984 id: PI23/00288 id: 4R23/440 type: OTHER domain: IDIAP Jordi Gol briefTitle: Effectiveness of Online Training in Cardiopulmonary Resuscitation Maneuvers for a Network of Volunteers. acronym: EFORCP overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-12 date: 2024-02-23 date: 2024-04-15 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER name: Hospital Universitari Joan XXIII de Tarragona. briefSummary: Background: Cardiorespiratory arrest (CPA) occurs when there is a cessation of cardiac mechanical activity, typically diagnosed by the absence of consciousness, pulse, and breathing. Actions taken in response to CPA include recognizing the condition and promptly notifying emergency medical services, initiating Cardiopulmonary Resuscitation (CPR) maneuvers, and employing an Automated External Defibrillator (AED). Survival rates are directly influenced by the time elapsed between CPA onset and the initiation of CPR maneuvers, as well as the quality of these interventions
Hypotheses: Online education in CPR maneuvers is an effective and efficient tool for training individuals from the general population on how to respond to cardiac arrests
Objectives: The primary aim of this study is to assess the efficacy of online CPR and AED training within the general population of the province of Tarragona. Specific objectives include: 1) evaluating participants' theoretical and practical CPR skills in the short and medium term following online training, and 2) exploring the experiences of individuals who have completed the online training and simulation sessions using qualitative methodology.
Methodology:This study will unfold in several phases: 1) Online CPR-AED training and assessment of theoretical knowledge acquisition; 2) Evaluation of acquired practical CPR skills (know-how) within a simulation environment, conducted on a subset of the population completing phase 1;3)Analysis of the experiences of a subset of individuals who have participated in the preceding two phases, employing qualitative methodology
Variables and determinations:The primary response variable for phase 1 will be the difference in scores obtained from the online questionnaire between the final (post-training) and initial (pre-training) assessments.
In phase 2, the main variable will be the pass/fail categorization of scores in the simulation. This evaluation will be conducted by two members of the Advanced Clinical Simulation Unit at Joan XXII Hospital using a predefined checklist. Throughout the various phases of the study, socio-demographic data and course performance data will be taken into account
Expected results: The research team for this study aims to ascertain the efficacy and effectiveness of online CPR-AED training within the general population. Furthermore, the study aims to provide evidence regarding the optimal duration and frequency for repeating such training.
Applicability and Relevance: This proposal advocates for a significant and innovative project, given the dearth of literature on this topic. While there are existing indications and studies on CPR-AED training among specific populations such as students and healthcare professionals, the presented proposal seeks to broaden the scope of training to encompass the general population. conditions: Cardiorespiratory Arrest conditions: Cardiopulmonary Arrest With Successful Resuscitation studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 156 type: ESTIMATED name: online CPR-AED training measure: Difference between pre and post training scores in ad hoc designed scale measure: Percentage of participants that reach or exceed 10 out of 12 on the checklist measure: Odds ratios (with 95% CI) for adjustment variables measure: Scores on the standard satisfaction questionnaire commonly used by the Catalan Health Institute to evaluate training activities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IDIAP Jordi Gol city: Barcelona zip: 08007 country: Spain name: Ester Granado_Font, PhD role: CONTACT phone: 977778715 phoneExt: 405 email: egranado.tgn.ics@gencat.cat name: Ester Granado-Font, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<|newrecord|> nctId: NCT06275971 id: KBSMC 2022-07-006 briefTitle: Effectiveness of Continuous Glucose Monitoring System Among Cardiac Surgery Patients overallStatus: RECRUITING date: 2022-11-24 date: 2024-06-30 date: 2024-08-31 date: 2024-02-23 date: 2024-02-23 name: Kangbuk Samsung Hospital class: OTHER name: DexCom, Inc. briefSummary: The aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when Continuous Glucose Monitoring (CGM) is utilized, as compared to traditional methods of arterial/venous blood sampling and Point-of-Care Testing (POCT) for glucose monitoring. conditions: Cardiac Disease conditions: PreDiabetes conditions: Diabetes Mellitus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Treatment group: glycemic control using CGM Control group: glycemic control using arterial/venous blood sampling and POCT glucose primaryPurpose: TREATMENT masking: NONE count: 68 type: ESTIMATED name: Dexcom G6 name: SMBG or venous/arterial blood glucose measure: Time within the target range of 100-180 mg/dL measure: Time within the target range of 100-140 mg/dL measure: Time within the target range of 70-180 mg/dL measure: Time to reach <70 mg/dL measure: Time to reach <54 mg/dL measure: Time to reach >180 mg/dL measure: Time to reach >250 mg/dL measure: Standard Deviation (SD) measure: Coefficient of variation (CV) measure: Mean glucose measure: Glucose management indicator (GMI) measure: Number of days of ICU hospitalization measure: Number of days hospitalized after surgery measure: Number of participants with pneumonia occurrence after surgery measure: Number of participants with wound infection occurrence after surgery measure: Number of participants who underwent CRRT implementation after surgery measure: Number of participants with Atrial fibrillation occurrence after surgery measure: Number of participants with symptomatic CVA (ischemic and hemorrhagic) occurrence after surgery measure: Changes in concentration of serum CRP level after surgery measure: Mortality within 30 days of surgery sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kangbuk Samsung Hospital status: RECRUITING city: Seoul zip: 03181 country: Korea, Republic of name: Sun Joon Moon, MD role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06275958 id: 2023-506115-17 id: 2023-506115-17 type: EUDRACT_NUMBER briefTitle: DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer acronym: DOSAGE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-12 date: 2024-02-23 date: 2024-02-23 name: Leiden University Medical Center class: OTHER name: Dutch Colorectal Cancer Group name: Stichting Darmkanker briefSummary: The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.
Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness. conditions: Older Patients conditions: Colorectal Cancer conditions: Metastatic Cancer conditions: Candidates for Palliative Chemotherapy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A phase III, open-label, non-inferiority, randomized controlled clinical trial comparing dose-reduced chemotherapy versus standard dose chemotherapy in older adults with metastasized colorectal cancer primaryPurpose: TREATMENT masking: NONE count: 587 type: ESTIMATED name: Doublet Chemotherapy, Standard Dose (100%) name: Doublet Chemotherapy, Dose-reduced (75%) name: Monotherapy, Standard Dose (100%) name: Monotherapy, Dose-reduced (75%) measure: Progression-Free Survival measure: Quality of Life Questionnaire measure: Quality of Life Questionnaire measure: Physical functioning Questionnaire measure: Physical functioning Questionnaire measure: Grade 3-5 chemotherapy-related toxicity measure: Overall Survival measure: Number of completed treatment cycles measure: Dose reductions during treatment measure: Dose delay during treatment measure: Unplanned hospitalizations measure: Cumulative received dosage measure: Cost-effectiveness sex: ALL minimumAge: 70 Years stdAges: OLDER_ADULT facility: Jeroen Bosch Ziekenhuis city: 's-Hertogenbosch country: Netherlands lat: 51.69917 lon: 5.30417 facility: Noordwest Ziekenhuisgroep city: Alkmaar country: Netherlands lat: 52.63167 lon: 4.74861 facility: Ziekenhuis Amstelland city: Amstelveen country: Netherlands lat: 52.30083 lon: 4.86389 facility: Amsterdam UMC city: Amsterdam country: Netherlands lat: 52.37403 lon: 4.88969 facility: Rijnstate city: Arnhem country: Netherlands lat: 51.98 lon: 5.91111 facility: Wilhelmina Ziekenhuis city: Assen country: Netherlands lat: 52.99667 lon: 6.5625 facility: Rode Kruis Ziekenhuis city: Beverwijk country: Netherlands lat: 52.48333 lon: 4.65694 facility: Haaglanden Medisch Centrum city: Den Haag country: Netherlands lat: 52.07667 lon: 4.29861 facility: Hagaziekenhuis city: Den Haag country: Netherlands lat: 52.07667 lon: 4.29861 facility: Slingeland Ziekenhuis city: Doetinchem country: Netherlands lat: 51.965 lon: 6.28889 facility: Ziekenhuis Gelderse Vallei city: Ede country: Netherlands lat: 52.03333 lon: 5.65833 facility: Catharina Ziekenhuis city: Eindhoven country: Netherlands lat: 51.44083 lon: 5.47778 facility: Treant city: Emmen country: Netherlands lat: 52.77917 lon: 6.90694 facility: Admiraal de Ruyter Ziekenhuis city: Goes country: Netherlands lat: 51.50417 lon: 3.88889 facility: Beatrixziekenhuis city: Gorinchem country: Netherlands lat: 51.83652 lon: 4.97243 facility: Groene Hart Ziekenhuis city: Gouda country: Netherlands lat: 52.01667 lon: 4.70833 facility: Saxenburgh city: Hardenberg country: Netherlands lat: 52.57583 lon: 6.61944 facility: St. Jansdal Ziekenhuis city: Harderwijk country: Netherlands lat: 52.34167 lon: 5.62083 facility: Elkerliek Ziekenhuis city: Helmond country: Netherlands lat: 51.48167 lon: 5.66111 facility: Tergooi MC city: Hilversum country: Netherlands lat: 52.22333 lon: 5.17639 facility: Medisch Centrum Leeuwarden city: Leeuwarden country: Netherlands lat: 53.20139 lon: 5.80859 facility: Leiden University Medical Center city: Leiden country: Netherlands lat: 52.15833 lon: 4.49306 facility: Alrijne Ziekenhuis city: Leiderdorp country: Netherlands lat: 52.15833 lon: 4.52917 facility: Canisius Wilhelmina Ziekenhuis city: Nijmegen country: Netherlands lat: 51.8425 lon: 5.85278 facility: Laurentius Ziekenhuis city: Roermond country: Netherlands lat: 51.19417 lon: 5.9875 facility: Bravis ziekenhuis city: Roosendaal country: Netherlands lat: 51.53083 lon: 4.46528 facility: Ikazia Ziekenhuis city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 facility: Maasstad Ziekenhuis city: Rotterdam country: Netherlands lat: 51.9225 lon: 4.47917 facility: Ommelander Ziekenhuis city: Scheemda country: Netherlands lat: 53.17333 lon: 6.97222 facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen city: Terneuzen country: Netherlands lat: 51.33583 lon: 3.82778 facility: Bernhoven city: Uden country: Netherlands lat: 51.66083 lon: 5.61944 facility: Diakonessenhuis city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 facility: St Antonius city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 facility: VieCuri Medisch Centrum city: Venlo country: Netherlands lat: 51.37 lon: 6.16806 facility: Streekziekenhuis Koninging Beatrix city: Winterswijk country: Netherlands lat: 51.9725 lon: 6.71944 facility: Zaans Medisch Centrum city: Zaandam country: Netherlands lat: 52.43854 lon: 4.82643 hasResults: False
<|newrecord|> nctId: NCT06275945 id: 1010073 briefTitle: Feasibility Study of A VoRo UrologIc ScaffolD (ARID) acronym: ARID overallStatus: RECRUITING date: 2023-04-03 date: 2026-07-30 date: 2026-10-30 date: 2024-02-23 date: 2024-02-23 name: Levee Medical, Inc. class: INDUSTRY name: RQMplus briefSummary: The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.
The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years. conditions: Stress Urinary Incontinence conditions: Radical Prostatectomy studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, non-randomized first-in-man study primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Voro Urologic Scaffold measure: The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. measure: The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. measure: The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups. sex: MALE minimumAge: 45 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Hospital status: RECRUITING city: Panama City state: Punta Pacifica country: Panama name: Natalia Vega role: CONTACT email: nvega@candmresearch.org name: Margelis Munoz role: CONTACT phone: 507-6499-9304 email: mmunoz@candmresearch.org name: Gustavo Espino, MD role: PRINCIPAL_INVESTIGATOR lat: 8.9936 lon: -79.51973 hasResults: False
<|newrecord|> nctId: NCT06275932 id: TermoNeo/2023 briefTitle: Management of Healthy Newborn's Body Temperature at Birth overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-05-31 date: 2024-02-23 date: 2024-02-23 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: At birth, the newborn begins a process of adaptation to extrauterine life. One of the phases of this stabilization process is the maintenance of body temperature; indeed, the newborn passes from a warm environment (mother's womb) of around 37°C to an environment with a temperature lower (delivery room) and, therefore, must implement a series of physiological processes to be able to maintain body temperature constant and within ideal ranges through a balance between production and heat loss.
Hypothermia at birth could cause risks or comorbidities such as an increased risk of infant mortality, hypoglycemia, sepsis, metabolic acidosis, respiratory distress syndrome (RDS) and intraventricular hemorrhage (IVH).
One of the factors that affects heat loss in the delivery room is the relationship between surface area, volume and body mass of the newborn. The decrease in body temperature is directly related to gestational age and weight at birth; indeed, this problem is much more present in premature and/or low weight newborns at birth. Even if a full-term newborn has a more developed thermoregulation center than a preterm newborn, this does not mean that this type of newborns is not at risk heat dispersion.
To date, the strategies that are implemented for the physiological newborn are documented in the literature are, in addition to the heat chain described by the World Health Organization (WHO), the implementation of skin-to-skin contact (skin to skin) mother-newborn.
Some studies demonstrating the beneficial effect of this procedure on maintenance of the newborn's body temperature.
The aim of this study is to evaluate two healthcare interventions to prevent heat loss of healthy newborns at birth. conditions: Newborn, Infant conditions: Body Temperature conditions: Delivery Room studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 776 type: ESTIMATED name: Interventional group name: Standard of care group measure: Newborn's body temperature at the end of skin-to-skin contact measure: Newborns' proportion with a body temperature < 36.5°C when arriving at the nursery measure: Newborns' proportion with temperature below 36.0°C at the end of skin-to-skin contact and at arrival in the nursery measure: Newborns' proportion with moderate hypothermia (temperature 36.0 - 36.4°C) at the end of skin-to-skin contact and at arrival in the nursery measure: Newborns' proportion with hyperthermia (temperature > 37.5°C) at the end of skin-to-skin contact and at arrival in the nursery measure: Newborns' average temperature one hour after arriving at the nursery measure: Duration of nursery stay measure: Duration of skin-to-skin contact measure: Newborns' proportion exclusively breastfed at discharge measure: Type of breastfeeding at discharge measure: Newborns' proportion with hypoglycemia during hospitalization measure: Newborns' proportion affected by respiratory distress syndrome measure: Newborns' proportion transferred to the Neonatal Intensive Care Unit (NICU) measure: Newborns' weight loss at discharge measure: Mortality before discharge from hospital sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy name: Gabriele Sorrentino, pedRN role: CONTACT phone: +393496060149 email: gabriele.sorrentino@policlinico.mi.it name: Gabriele Sorrentino, pedRN role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06275919 id: IOV-BT-1-2023 MIRAGE briefTitle: Regorafenib for Recurrent Grade 2 and 3 Meningioma (MIRAGE Trial) acronym: MIRAGE overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-12 date: 2027-03 date: 2024-02-23 date: 2024-03-15 name: Istituto Oncologico Veneto IRCCS class: OTHER name: Bayer briefSummary: The focus of this study will be to investigate whether Regorafenib demonstrates antitumor activity against recurrent grade II or III meningiomas.
Small trials and case series suggest clinical relevant activity of several VEGF inhibitors such as sunitinib, bevacizumab and valatinib reporting a 6m-PFS rate of 42-64%. Indeed, VEGF and VEGF receptors (VEGFR) are regularly overexpressed in meningiomas and can correlate with outcome.
Regorafenib inhibits angiogenic receptor tyrosine kinases (RTKs) and is highly selective for VEGFR1/2/3; moreover Regorafenib inhibits PDGFRB, FGFR1 and oncogenic intracellular signalling cascades involving c-RAF/RAF1 and BRAF highly expressed in meningiomas.
Noteworthy, Regorafenib showed antitumor activity in vitro and in vivo in a recent study; indeed, Regorafenib showed significant inhibition of meningioma cell motility and invasion and in vivo, mice with orthotopic meningioma xenografts showed a reduced volume of signal enhancement in MRI following Regorafenib therapy; this translated in a significantly increased overall survival time (p\<0.05) for Regorafenib treated mice.
Moreover, Regorafenib showed good efficacy in different cancer types, such as colorectal cancer, GIST, hepatocellular carcinoma and glioblastoma (REGOMA trial) , maintainingmaintaining a good quality of life. conditions: Meningioma, Malignant studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Regorafenib 40 MG Oral Tablet name: Local Standard of Care measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Objective response rate (ORR) measure: Patient Reported Outcomes (PROs) measure: Patient Reported Outcomes (PROs) measure: Toxicity during treatment measure: Disease control rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRST Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" city: Meldola state: Forlì-Cesena country: Italy name: Lorena Gurrieri, MD role: CONTACT email: lorena.gurrieri@irst.emr.it name: Lorena Gurrieri, MD role: PRINCIPAL_INVESTIGATOR lat: 44.12775 lon: 12.0626 facility: Humanitas Cancer Center city: Rozzano state: Milano country: Italy name: Matteo Simonelli, MD role: CONTACT email: matteo.simonelli@hunimed.eu name: Matteo Simonelli, MD role: PRINCIPAL_INVESTIGATOR lat: 45.38193 lon: 9.1559 facility: Ospedale San Paolo city: Bari country: Italy name: Valeria Internò, MD role: CONTACT email: valeria.interno@libero.it name: Valeria Internò, MD role: PRINCIPAL_INVESTIGATOR lat: 41.11148 lon: 16.8554 facility: Ospedale Bellaria - AUSL Bologna city: Bologna country: Italy name: Enrico Franceschi, MD role: CONTACT email: e.franceschi@isnb.it name: Enrico Franceschi, MD role: PRINCIPAL_INVESTIGATOR lat: 44.49381 lon: 11.33875 facility: Azienda Ospedaliero Universitaria Careggi city: Firenze country: Italy name: Isacco Desideri, MD role: CONTACT email: isacco.desideri@unifi.it name: Isacco Desideri, MD role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: Policlinico San Martino city: Genova country: Italy name: Elisa Bennicelli, MD role: CONTACT email: elisa.bennicelli@hsanmartino.it name: Elisa Bennicelli, MD role: PRINCIPAL_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Spedali Riuniti city: Livorno country: Italy name: Anna Luisa Di Stefano, MD role: CONTACT email: annaluisa.distefano@uslnordovest.toscana.it name: Anna Luisa Di Stefano, MD role: PRINCIPAL_INVESTIGATOR lat: 43.54427 lon: 10.32615 facility: Azienda Ospedaliero Universitaria G. Martino city: Messina country: Italy name: Nicola Silvestris, MD role: CONTACT email: n.silvestris@unime.it name: Nicola Silvestris, MD role: PRINCIPAL_INVESTIGATOR lat: 38.19394 lon: 15.55256 facility: Fondazione IRCCS Istituto Neurologico Carlo Besta city: Milano country: Italy name: Paola Gaviani, MD role: CONTACT email: paola.gaviani@istituto-besta.it name: Paola Gaviani, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: IRCCS Ospedale San Raffaele city: Milano country: Italy name: Giulia Berzero, MD role: CONTACT email: berzero.giulia@hsr.it name: Giulia Berzero, MD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Ospedale del Mare city: Napoli country: Italy name: Bruno Daniele, MD role: CONTACT email: b.daniele@libero.it name: Bruno Daniele, MD role: PRINCIPAL_INVESTIGATOR lat: 40.85216 lon: 14.26811 facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS city: Roma country: Italy name: Silvia Chiesa, MD role: CONTACT email: silvia.chiesa@policlinicogemelli.it name: Silvia Chiesa, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: IRCCS Istituto Tumori Regina Elena city: Roma country: Italy name: Veronica Villani, MD role: CONTACT email: veronica.villani@ifo.it name: Veronica Villani, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Policlinico Umberto I - Università Sapienza Roma city: Roma country: Italy name: Giuseppe Minniti, MD role: CONTACT email: giuseppe.minniti@uniroma1.it name: Giuseppe Minniti, MD role: PRINCIPAL_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: A.O.U. Città della Salute e della Scienza di Torino city: Torino country: Italy name: Roberta Rudà, MD role: CONTACT email: roberta.ruda@unito.it name: Roberta Rudà, MD role: PRINCIPAL_INVESTIGATOR lat: 45.07049 lon: 7.68682 hasResults: False
<|newrecord|> nctId: NCT06275906 id: NAFLD-POS5 briefTitle: Influence of a Mediterranean Diet Combined With a Physical Activity Intervention, on NAFLD and Inflammation Parameters. acronym: NAFLD-POS5 overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2025-04-08 date: 2026-04-08 date: 2024-02-23 date: 2024-02-23 name: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis class: OTHER name: Russo Francesco name: Cozzolongo Raffaele name: Shahini Endrit name: Zappimbulso Marianna name: Giannuzzi Vito name: De Nucci Sara name: Rinaldi Roberta name: Sila Annamaria name: Tatoli Rossella name: Cerabino Nicole name: Donghia Rossella name: Franco Isabella name: Bianco Antonella name: Curci Ritanna name: Bagnato Claudia Beatrice name: Sciarra Sabrina name: Prospero Laura name: Serino Grazia name: Scalavino Viviana name: Piccinno Emanuele name: Pesole Pasqua Letizia name: Coletta Sergio name: Stabile Dolores name: Riezzo Giuseppe name: Ancona Anna name: D'Attoma Benedetta name: Ignazzi Antonia briefSummary: The study in question is an interventional study with nutritional intervention.
The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:
* specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
* circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
* intestinal barrier;
* body composition;
* intestinal microbiota;
* symptoms of IBS (irritable bowel syndrome) in patients with NAFLD. conditions: NAFLD conditions: Obesity conditions: IBS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study evaluates the effects of two different Mediterranean Diet models, based on different percentages of macronutrients, on NAFLD and Metabolic Risk.
The Mediterranean Diet is associated with a program of moderate intensity aerobic physical exercise (walking) carried out 3 times a week for 3 months. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Mediterranean diet and moderate intensity physical exercise (outdoor walking). measure: The effect of intervention on CAP value measure: The effect of intervention on FLI value measure: The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk measure: The effect of the intervention on the integrity of the intestinal barrier measure: The effect of the intervention on the Gastrointestinal Symptoms measure: The effect of the intervention on the Body Composition sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Irccs Saverio de Bellis city: Castellana Grotte state: Bari zip: 70013 country: Italy lat: 40.88643 lon: 17.16549 hasResults: False
<|newrecord|> nctId: NCT06275893 id: ACM01 briefTitle: IC14 (Atibuclimab) in Arrhythmogenic Cardiomyopathy overallStatus: RECRUITING date: 2024-03-29 date: 2025-02-01 date: 2025-08-01 date: 2024-02-23 date: 2024-04-02 name: Implicit Bioscience class: INDUSTRY briefSummary: The goal of this clinical trial is to test IC14 (atibuclimab) in patients with arrhythmogenic cardiomyopathy (ACM) and who have an implantable cardoverter/defibrillator in place. ACM is also called arrhythmogenic right ventricular dysplasia (ARV) or arrhythmogenic right ventricular cardiomyopathy (ARVC). The main questions the study aims to answer are the effect of treatment on blood markers of inflammation, safety, and pharmacokinetics. There will also be measurements of myocardial imaging of C-C chemokine receptor type 2 (CCR2+) immune cells (optional), monitoring of cardiac arrhythmias using the patient's pre-existing intracardiac cardioverter/defibrillator (ICD) and a Holter monitor, electrocardiogram (ECG), echocardiogram (ECHO), and blood tests. Results will be compared to baseline; there is no inactive placebo treatment group.
Participants will be asked to undergo screening and baseline testing, then receive 4 intravenous infusions with blood measurements before and after the infusion (including 24, 48, and 72 hours and 7, 14, and 28 days). Participants will be offered specialized scanning of the heart muscle, and will be asked to provide recordings from their ICD, undergo Holter monitoring twice, and have electrocardiograms (ECG), echocardiograms (ECHO) and blood tests. conditions: Arrhythmogenic Right Ventricular Dysplasia conditions: Arrhythmogenic Left Ventricular Cardiomyopathy conditions: Arrhythmogenic Right Ventricular Cardiomyopathy 1 conditions: Arrhythmogenic Cardiomyopathy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label treatment with IC14. Participant outcomes will be compared to baseline. Pharmacokinetics will be measured. primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: IC14 measure: Safety: Treatment-emergent adverse events and serious adverse events measure: Safety: Incidence of anti-drug antibodies measure: Inflammatory biomarker C-reactive protein measure: CCR2+ Myocardial Imaging (optional) measure: Ventricular tachycardia measure: Ventricular premature contractions measure: Sustained and non-sustained ventricular tachycardia measure: Treated ventricular tachycardia measure: Atrial premature contractions measure: New York Heart Association (NYHA) Functional Class measure: Implantable cardioverter/defibrillator (ICD) discharges measure: Quality-of-Life Score determined by the Kansas City Cardiomyopathy Questionnaire measure: Disease biomarker Troponin I measure: Disease biomarker N-terminal B-type natriuretic peptide (NT-pro-BNP) measure: Inflammatory biomarker interleukin (IL)1-beta measure: Pharmacokinetics: Serum IC14 concentration versus time curve measure: Pharmacokinetics: Peak serum IC14 concentration measure: Pharmacokinetics: Half life measure: Pharmacodynamics: Receptor Occupancy measure: Pharmacodynamics: Effective Concentration 95% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Philip S. Cuculich, MD role: PRINCIPAL_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False
<|newrecord|> nctId: NCT06275880 id: F-2023-3201-066 briefTitle: Intraarticular Collagen in Patients With Gonarthrosis overallStatus: COMPLETED date: 2023-04-01 date: 2023-07-30 date: 2024-01-10 date: 2024-02-23 date: 2024-02-23 name: Instituto Mexicano del Seguro Social class: OTHER_GOV briefSummary: The objective of this clinical trial is to verify the effectiveness of polyvinyl pyrrolidone collagen in all patients with symptomatic gonarthrosis grades II-IV in patients over 40 years of age. The main objectives that this study aims to answer are the following: