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<|newrecord|> nctId: NCT06279845 id: 2023YFC2308802-02 briefTitle: A Clinical Cohort Study on the Pathogen Spectrum of Hepatic Virus-caused Cirrhosis Complicated With Infection overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2026-11 date: 2026-11 date: 2024-02-28 date: 2024-03-04 name: Zhejiang University class: OTHER name: Beijing Ditan Hospital name: Beijing YouAn Hospital name: Huashan Hospital name: Qilu Hospital of Shandong University briefSummary: The goal of this observational study is to expound the population and characteristics of pathogenic microorganisms with co-infection, draw the pedigree of pathogenic microorganisms, and evaluate its influence on disease outcome in patients with hepatic virus-caused cirrhosis. The main questions it aims to answer are:
* Describe the populations and characteristics of pathogenic microorganisms responsible for co-infections in patients with hepatic virus-caused cirrhosis.
* Map the spectrum of pathogenic microorganisms, and evaluate their impact on disease regression. conditions: Liver Cirrhosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Secondary infection in patients at 4 weeks measure: quick SEPSIS RELATED ORGAN FAILURE ASSESSMENT(qSOFA) at 4 weeks measure: Survival rate sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279832 id: 3994 briefTitle: Radiomics and Radiogenomics Models to Predict Molecular Integrated Risk Classes and Prognostic Factors in Endometrial Cancer. acronym: Romantic overallStatus: RECRUITING date: 2023-11-01 date: 2024-10-31 date: 2025-10-31 date: 2024-02-28 date: 2024-02-28 name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS class: OTHER briefSummary: The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases).
These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines. conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: As far as the sample size concerns, the number of images required for the analysis are a figure of at least 100 positive cases (15). We considered as positive patients with a favorable prognostic profile according to PORTEC-4a and also low and intermediate risk class according to ESGO/ESTRO/ESP 2020 recommendations.Therefore, we estimate to enroll at least 1000 patients in order to reach the 100 positive cases. primaryPurpose: DIAGNOSTIC masking: NONE count: 1000 type: ESTIMATED name: trascriptomic profiling measure: Predictive value of the model measure: Validity of the model sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Agostino Gemelli IRCSS status: RECRUITING city: Rome state: Lazio zip: 00118 country: Italy name: francesco fanfani role: CONTACT phone: 0630151 email: francesco.fanfani@policlinicogemelli.it lat: 41.89193 lon: 12.51133 hasResults: False
<|newrecord|> nctId: NCT06279819 id: 2024-008 briefTitle: Effectiveness of Gut Microbiota-targeted Dietary Intervention Among HIV-infected Patients overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: Fudan University class: OTHER briefSummary: The goal of this clinical trial is to conduct a dietary intervention targeting HIV-specific gut microbiota alterations for primary ASCVD prevention and evaluate its effectiveness in preventing borderline ASCVD risk among HIV-infected patients. The main questions it aims to answer are:
* Explore the pivotal role of the gut-heart axis in the causal relationship between HIV infection and atherosclerotic cardiovascular disease.
* Develop a targeted dietary intervention focusing on gut microbiota to prevent the borderline risk of atherosclerotic cardiovascular disease in HIV-infected patients.
* Evaluate the effectiveness of the gut microbiota-targeted dietary intervention in reducing atherosclerotic cardiovascular disease risk among HIV-infected patients, altering gut microbiota composition, improving risk factors of atherosclerotic cardiovascular disease, and alleviating prodromal symptoms associated with atherosclerotic cardiovascular disease.
Participants in the intervention group will receive the gut microbiota-targeted dietary intervention thrice weekly for 3 months, accompanied by bi-weekly health education videos for the same duration. Meanwhile, the control group will continue routine follow-up and health education practices. The intervention will span three months, followed by a three-month follow-up period. Data collection will occur at baseline, 3 months, and 6 months. conditions: Hiv conditions: Cardiovascular Diseases conditions: Diet, Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: gut microbiota-targeted dietary intervention measure: ASCVD risk estimated by the PCE measure: The composition of gut microbiota measure: fasting blood lipids measure: blood pressure measure: BMI measure: ASCVD symptoms sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fudan University city: Shanghai state: Shanghai zip: 200032 country: China name: Junwen Yu role: CONTACT phone: 13320178333 email: 13320178333@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06279806 id: SerapAlkas briefTitle: The Effect of Mobile Health Application on Posttraumatic Growth in Women Diagnosed With Breast Cancer overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2024-06-30 date: 2024-10-30 date: 2024-02-28 date: 2024-02-28 name: Gazi University class: OTHER briefSummary: Breast cancer is the type of cancer that significantly affects women's health and causes the most mortal in women. Despite the high incidence of breast cancer, women living after breast cancer are increasing due to advances in early diagnosis and effective treatment options. Treatments are aimed at prolonging survival from breast cancer and enabling patients to live better. Women repeatedly experience many vital crises such as the diagnosis of cancer, the difficulties of the treatment process and the fear of recurrence in the post-treatment period. In the face of these crises, post-traumatic growth occurs when the individual's efforts to cope are transformed into positive psychological experiences. Positive experiences lead to improvement in women's life, while negative experiences make it difficult to cope and adapt. In order for post-traumatic growth to take place, women should be supported to cope with these negative emotions. The care given to patients during cancer treatment should be such as to support the change process that will help individuals adapt to the new lifestyle.This information and supportive care content should include the topics that women will need in the long term after the treatment, in addition to the diagnosis and treatment process. Generally, the education and counseling given to the patient at the last treatment appointment may be limited. Due to the long period from the last treatment appointment to the control appointment, patients cannot interact with healthcare professionals for a long time. Long-term side effects and needs of people may differ after breast cancer treatment. For this reason, the need for information and consultancy services of healthcare professionals continues in this process as well.Today, the use of remotely accessible mechanisms in the treatment of breast cancer and in the follow-up of women after treatment is increasing. It is thought that the mobile application to be developed within the scope of the project will increase the quality and efficiency of health services with an R\&D and innovative approach and make these services accessible to everyone through digital technologies. In addition, our study will set an example for nursing care to be presented in one of the priority areas of health, such as cancer, through digital technologies. In our study, it is aimed to evaluate the effect of mobile health application based on Mezirow's Transformational Learning Theory on post-traumatic development in women with breast cancer. The research is a single center, parallel group, stratified block randomized controlled experimental study. It is planned to be conducted with 56 (intervention: 28, control: 28) women at Gazi University Health Research and Practice Center. The training content to be included in the mobile application has been determined by considering the results of the studies in the literature and the recommendations of international guides to determine the problems experienced by women with breast cancer during the post-treatment period. After receiving expert opinions on the subject content, the development process of the mobile application will be started. In the implementation phase of the study, the women in the intervention group will start using the mobile application 1 week after completing the active treatment chemotherapy and radiotherapy) process.The implementation of the study will last 8 weeks. At the end of eight weeks, data collection tools will be applied to the women. The final tests will be repeated 4 weeks after the end of the application. Starting from this period, women in the control group who want to use the application will also be included in the mobile application system. After completing the data collection tools, the analysis and reporting part will be started. Statistical analyzes will be made using SPSS Package Program (IBM SPSS Statistics 27). Student t test, Pearson Chi-square test, Independent Sample t test, Mann Whitney U test, One-Way Analysis of Variance or Friedman test will be used in the analyses. conditions: Posttraumatic Growth conditions: Grief studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In order to ensure similarity between the groups, stratified block randomization will be used to assign the women in the sample group to the experimental and control groups. In this method, after stratification according to risk factors, block randomization is performed within each stratum. Since the type of treatment applied in breast cancer and marital status will significantly affect posttraumatic development, stratification was made in terms of these parameters. Stratum 1 in terms of treatment type: Mastectomy, 2nd stratum: Breast conserving surgery or reconstructive surgery during mastectomy; Stratum 1 in terms of partner presence: Has a partner, Stratum 2: No partner. In order to determine which stratum group the women who were found to meet the research criteria and who agreed to participate in the study were in, blocks will be formed with a combination of 4 and the assignment list will be determined through the www.randomizer.org website. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: The data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS program. The data will also be analyzed by an independent statistician. whoMasked: OUTCOMES_ASSESSOR count: 56 type: ESTIMATED name: Mobile health application use name: Information of the breast cancer survivor period booklet measure: Women's progression through the stages of grief measure: Women's increased level of posttraumatic development sex: FEMALE stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279793 id: MODIFYCSX briefTitle: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients. acronym: MODIFYCSX overallStatus: RECRUITING date: 2024-02-15 date: 2024-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-02-28 name: GCP-Service International West GmbH class: INDUSTRY name: Charite University, Berlin, Germany name: Wuerzburg University Hospital briefSummary: The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.
In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care. conditions: Cardiac Surgery conditions: High Risk Patients conditions: Intensive Care Unit conditions: Cardiopulmonary Bypass conditions: Valve Surgeries studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous FO- based lipid emulsion (Omegaven®), or placebo. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Researchers and clinical staff will be blinded to study intervention allocation. Unblinded delegate at each site will be able to prepare and dispense the investigational drug or placebo. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Long-chain n-3 fatty acids name: Intravenous 0.9% Sodium Chloride measure: Atrial fibrillation measure: Weaning from cardiopulmonary bypass (CPB) measure: Time to discharge alive measure: Persistent Organ Dysfunction + Death measure: Days alive and out of hospital measure: Hospital length of stay measure: ICU length of stay measure: Simplified Acute Physiology Score measure: Therapeutic Intervention Scoring System measure: ICU and Hospital Readmission rates measure: Delta Sequential Organ Failure Assessment Score (SOFA) Score measure: Mechanical ventilation measure: Stroke measure: Acute Kidney Injury measure: Infections rate measure: Clinical frailty scale measure: Development of delirium measure: Survival status measure: Physical activity assessment measure: Quality of Life (SF-36) measure: Adverse Events measure: Postoperative bleeding measure: Optional-Ultrasound measurement measure: Optional-Functional Status Score for Intensive Care Unit measure: Optional-Short Physical Performance Battery test measure: Optional-Hand grip dynamometer measure: Optional-Hand held dynamometer measure: Optional-Manual Muscle Testing measure: Optional-Left ventricular ejection function measure: Optional-Markers of inflammation measure: Optional-Hemodynamics measure: Sub-study sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RWTH Aachen University status: NOT_YET_RECRUITING city: Aachen country: Germany name: Moritz Immohr, M.D role: CONTACT email: mimmohr@ukaachen.de name: Aileen Hill, M.D role: CONTACT email: ahill@ukaachen.de lat: 50.77664 lon: 6.08342 facility: Charité Universitätsmedizin Berlin status: NOT_YET_RECRUITING city: Berlin country: Germany name: Sascha Ott, M.D role: CONTACT email: sascha.ott@dhzc-charite.de name: Maren Kleine-Brüggeney, M.D role: CONTACT email: maren.kleine-brueggeney@dhzc-charite.de lat: 52.52437 lon: 13.41053 facility: University of Bonn status: NOT_YET_RECRUITING city: Bonn country: Germany name: Markus Velten, M.D role: CONTACT email: markus.velten@ukbonn.de name: Maria Wittmann, M.D role: CONTACT email: Maria.Wittmann@ukbonn.de lat: 50.73438 lon: 7.09549 facility: Universität Göttingen status: NOT_YET_RECRUITING city: Göttingen country: Germany name: Reiner Wäschle, M.D role: CONTACT email: Reiner.Waeschle@med.uni-goettingen.de name: Anselm Bräuer, M.D. role: CONTACT email: abraeue@gwdg.de lat: 51.53443 lon: 9.93228 facility: University Medical Center Schleswig-Holstein status: NOT_YET_RECRUITING city: Kiel country: Germany name: Elke Gunnar, M.D role: CONTACT email: Gunnar.Elke@uksh.de name: Matthias Lindner, M.D role: CONTACT email: Matthias.Lindner@uksh.de lat: 54.32133 lon: 10.13489 facility: University of Muenster status: RECRUITING city: Münster country: Germany name: Alexander Zarbock, M.D role: CONTACT email: zarbock@uni-muenster.de name: Carola Wempe, M.D role: CONTACT email: Carola.Wempe@ukmuenster.de lat: 51.96236 lon: 7.62571 hasResults: False
<|newrecord|> nctId: NCT06279780 id: PI18/00932 briefTitle: Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity overallStatus: ACTIVE_NOT_RECRUITING date: 2019-01-01 date: 2023-12-31 date: 2024-08-31 date: 2024-02-28 date: 2024-02-28 name: Celia Bañuls class: OTHER name: Instituto de Salud Carlos III briefSummary: It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\], markers of inflammation \[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers. conditions: Obesity Adult Onset studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 109 type: ACTUAL name: very low-calorie diet measure: Analyze the changes in the diversity of the intestinal microbiota after dietetic intervention. measure: Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present metabolically healthy obesity (MHO) or metabolically unhealthy obesity (MUHO). measure: Evaluate significant changes in body fat mass percentage after the dietetic intervention. measure: Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietetic intervention. measure: Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention. measure: Assess significant changes in plasmatic homocysteine as an inflammatory parameter after the dietetic intervention. measure: Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention. measure: Evaluate significant changes in interleukin 6 (IL-6) levels as a pro-inflammatory molecule after the dietetic intervention. measure: Evaluate significant changes in tumor necrosis factor alpha (TNF-alpha) levels as a pro-inflammatory molecule after the dietetic intervention. measure: Assess significant changes in superoxide dismutase (SOD) levels after the dietetic intervention. measure: Analyze the significant differences between metabolomic profile before and after the dietetic intervention. measure: Evaluate if there is a significant reduction after the dietetic intervention in total ROS levels. measure: Assess if there is a significant reduction after the dietetic intervention in glutathione levels. measure: Analyze if there is a significant change after the dietetic intervention in total free radicals and superoxide levels. measure: Analyze if there is a significant reduction after the dietetic intervention in mitochondrial ROS production. measure: Evaluate if there is a significant improvement after the dietetic intervention in mitochondrial membrane potential. measure: Analyze the proportion of subjects achieving at least 10% reduction in weight compared with baseline. sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: FISABIO city: Valencia zip: 46020 country: Spain lat: 39.46975 lon: -0.37739 hasResults: False
<|newrecord|> nctId: NCT06279767 id: 2022-SR-557 briefTitle: Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma overallStatus: RECRUITING date: 2022-07-01 date: 2025-07-01 date: 2025-07-31 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: Glioblastoma, the most prevalent malignant tumor in the central nervous system, is characterized by high invasiveness and a propensity to recur, contributing to a relatively elevated mortality rate. Patients diagnosed with high-grade glioblastomas typically experience a median survival period of less than 14 months. Presently, the standard treatment for glioblastoma involves surgical resection combined with postoperative radiotherapy and chemotherapy, with postoperative chemotherapy playing a pivotal role in enhancing patient prognosis. Temozolomide (TMZ), a cutting-edge oral alkylating agent known for its advantageous properties, including easy traversal of the blood-brain barrier, induces DNA alkylation in tumor cells, fostering apoptosis. Currently, it serves as a frontline medication for postoperative chemotherapy in glioblastoma. However, clinical resistance to TMZ chemotherapy significantly hampers its efficacy in later stages. We have recently discovered and validated that 5-aminoimidazole-4-carboxamide (AICA), derived from TMZ, can transform into 5-aminoimidazole-4-carboxamide ribonucleotide-5-phosphate (AICAR) in GBM cells. Hypoxanthine phosphoribosyltransferase 1 (HPRT1) has been identified as the catalyst for the AICA reaction, generating AICAR. AICAR acts as an endogenous activator of AMP-activated protein kinase (AMPK), fostering chemoresistance in glioblastoma through the activation of the AMPK signaling pathway. 6-mercaptopurine (6-MP) competes effectively to inhibit HPRT1 activity, thereby impeding TMZ-induced AMPK activation and significantly heightening glioblastoma cell sensitivity to TMZ. In this project, we propose an innovative strategy involving the combination of 6-MP with TMZ for the treatment of glioblastoma. conditions: Glioblastoma conditions: Cancer conditions: Temozolomide studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 27 type: ESTIMATED name: 6-mercaptopurine measure: PFS measure: OS measure: Safety evaluation sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Neurosurgery of The First Affiliated Hospital of Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210029 country: China name: Yongping You, PhD role: CONTACT phone: 13770694258 email: YYPL3@sohu.com lat: 32.06167 lon: 118.77778 hasResults: False
<|newrecord|> nctId: NCT06279754 id: ZLXGBXKYXM-031-01 briefTitle: Recombinant Human Endostatin Combined With Envafolimab and Synchronal Radiochemotherapy overallStatus: NOT_YET_RECRUITING date: 2024-02-18 date: 2024-06-18 date: 2025-12-18 date: 2024-02-28 date: 2024-02-28 name: The First Affiliated Hospital of Xinxiang Medical College class: OTHER briefSummary: This study is a prospective, single arm, single center open clinical study aimed at evaluating the efficacy and safety of recombinant human endostatin and envafolimab combined with synchronal radiochemotherapy in patients with locally advanced squamous non-small cell lung cancer who cannot undergo surgery in stage III. conditions: Locally Advanced Squamous Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Recombinant Human Endostatin Injection measure: objective response rate measure: Overall survival measure: Progression-free survival sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279741 id: EVENEW id: 2022-500293-34 type: EUDRACT_NUMBER id: U1111-1291-0283 type: OTHER domain: Universal Trial Number briefTitle: Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants acronym: EVENEW overallStatus: RECRUITING date: 2023-12-28 date: 2027-01-31 date: 2029-12-31 date: 2024-02-28 date: 2024-02-28 name: EXO Biologics S.A. class: INDUSTRY briefSummary: The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution).
Infants will be followed up to 2 years of corrected age (end of study). conditions: Bronchopulmonary Dysplasia studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase 1 is an open-labelled, dose-escalated, and single-arm of EXOB-001. Phase 2 is a randomised, double-blind, placebo-controlled, and dose-finding of EXOB-001. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Phase 1 is an open-label, dose-escalation and single-arm study. In phase 2, Investigators will remain blinded to each subject's assigned treatment throughout the study. The Sponsor will put in place procedures to maintain this blind. Indeed, to ensure the blinding of the groups, the preparation and administration of the test product will be organized by different teams. In the event of a Quality Assurance audit, the auditor(s) will be allowed access to unblinded study treatment records at the site(s) to verify that randomisation/dispensing has been done accurately. Blinding will be broken by the Investigator for emergency purposes only, where knowledge of the blinded treatment could influence further subject care. In addition, subjects will be unblinded for safety reports, as per regulatory requirements. Study blind will be broken after the database lock. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 265 type: ESTIMATED name: Endotracheopulmonary Instillation, Suspension measure: Number of subjects with treatment-emergent adverse events (phase 1) measure: Number of subjects with BPD grade II-III incidence rate per groups (phase 2). measure: Assessment of medium-term safety of EXOB-001 (phase 1/2) measure: Number of subjects with dose-limiting toxicity (DLT) (phase 1) measure: Number of subjects needing for oxygen and ventilation for BPD incidence (phase 1/2) measure: Assessment of immune markers (phase 2) measure: Assessment of BPD incidence and severity (phase 1/2) measure: Safety evaluation (phase 1/2) measure: Assessment of lung ultrasound score (phase 1/2) measure: Number of subjects with complications of prematurity (phase 1/2) measure: Assessment of the respiratory morbidity (phase 1/2) measure: Assessment of neurodevelopment (phase 1/2) sex: ALL maximumAge: 10 Days stdAges: CHILD facility: Cliniques Universitaires Saint-Luc (UCLouvain) status: NOT_YET_RECRUITING city: Brussels zip: 1200 country: Belgium name: Olivier Danhaive, M.D. role: CONTACT phone: +32 2 764 79 00 email: olivier.danhaive@saintluc.uclouvain.be name: Olivier Danhaive, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: ISPPC CHU Charleroi status: NOT_YET_RECRUITING city: Charleroi zip: 6000 country: Belgium name: Serge Vanden Eijnden, M.D. role: CONTACT phone: +32 7 192 12 43 email: serge.vandeneijnden@chu-charleroi.be name: Serge Vanden Eijnden, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.41136 lon: 4.44448 facility: Clinique CHC Montlégia status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium name: Pierre Maton, M.D. role: CONTACT phone: +32 4 355 56 17 email: pierre.maton@chc.be name: Pierre Maton, M.D. role: PRINCIPAL_INVESTIGATOR lat: 50.63373 lon: 5.56749 facility: AOU Careggi status: NOT_YET_RECRUITING city: Florence country: Italy name: Carlo Dani, M.D. role: CONTACT phone: +39 055 7948421 email: carlo.dani@unifi.it name: Carlo Dani, M.D. role: PRINCIPAL_INVESTIGATOR lat: 43.77925 lon: 11.24626 facility: IRCCS Instituto Giannina Gaslini status: NOT_YET_RECRUITING city: Genova country: Italy name: Giorgia Brigati, M.D. role: CONTACT phone: +39 010 56362218 email: giorgiabrigati@gaslini.org name: Giorgia Brigati, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico status: NOT_YET_RECRUITING city: Milan country: Italy name: Anna Lavizzari, M.D. role: CONTACT email: anna.lavizzari@policlinico.mi.it role: CONTACT phone: +39 025 5032907 name: Anna Lavizzari, M.D. role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: AOU Policlinico di Modena status: NOT_YET_RECRUITING city: Modena country: Italy name: Alberto Berardi, M.D. role: CONTACT phone: +39 333 1053301 email: alberto.berardi@unimore.it name: Alberto Berardi, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.64783 lon: 10.92539 facility: Unità di Fase I della UOC Terapia Intensiva e Patologia Neonatale, Assistenza Neonatale (TINI) dell'Azienda Ospedale Università di Padova status: RECRUITING city: Padua zip: 35128 country: Italy name: Eugenio Baraldi, Prof role: CONTACT phone: +39 049 8213578 email: eugenio.baraldi@unipd.it name: Eugenio Baraldi, Prof role: PRINCIPAL_INVESTIGATOR lat: 45.40797 lon: 11.88586 hasResults: False
<|newrecord|> nctId: NCT06279728 id: DS1062-0003-EAP-MA briefTitle: Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients overallStatus: AVAILABLE date: 2024-02-28 date: 2024-04-08 name: Daiichi Sankyo class: INDUSTRY name: AstraZeneca briefSummary: The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial. conditions: Advanced Non-Small Cell Lung Cancer conditions: Metastatic Non Small Cell Lung Cancer studyType: EXPANDED_ACCESS name: Datopotamab deruxtecan sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen's Medical Center status: AVAILABLE city: Honolulu state: Hawaii zip: 96813 country: United States name: Principal Investigator role: CONTACT lat: 21.30694 lon: -157.85833 hasResults: False
<|newrecord|> nctId: NCT06279715 id: 3437 briefTitle: DFI and Aneuploidies overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-19 date: 2024-12-31 date: 2025-02-01 date: 2024-02-28 date: 2024-02-28 name: Clinique Ovo class: INDUSTRY briefSummary: IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.
Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes. conditions: Embryo Disorder studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 800 type: ESTIMATED name: Preimplantation Genetic Testing for Aneuploidy measure: DFI association and aneuploidy sex: ALL minimumAge: 18 Years maximumAge: 43 Years stdAges: ADULT facility: Clinique ovo city: Montreal state: Quebec zip: H4P 2S4 country: Canada lat: 45.50884 lon: -73.58781 hasResults: False
<|newrecord|> nctId: NCT06279702 id: OCalisir briefTitle: Serious Game Simulation and Comics in School Students overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-19 date: 2025-07-19 date: 2025-07-19 date: 2024-02-28 date: 2024-02-28 name: TC Erciyes University class: OTHER briefSummary: The aim of the study is to determine the effect of first aid training for injuries given to secondary school students through serious game simulation and comic books on knowledge, skills and motivation.
Hypotheses:
H1: First aid training given through simulation applications affects the level of knowledge.
H2: First aid training given through simulation applications affects the skill level.
H3: First aid training given with simulation application affects motivation.
H4: First aid training given with comics affects the level of knowledge.
H5: First aid training given with comic books affects the skill level.
H6: First aid training given with comics affects motivation.
METHOD: The research will be conducted as a randomized controlled experimental study with a pre-test-post-test design with children studying in the 5th and 6th grades of schools in the central district of Aksaray. One group will be given first aid training for injuries prepared with serious games, the other group will be given first aid training for injuries prepared with comic books. No intervention will be made to the control group. Serious game scenario software prepared based on the literature will be integrated into the computer. Appropriate statistics will be made after the research by applying the prepared data collection tools. With this research, the gap in the literature will be filled, children's first aid knowledge and skills in injuries will be increased, and school health nurses will be provided with up-to-date teaching material. conditions: First Aid studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: serious game and comics primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 54 type: ACTUAL name: SERIOUS GAME name: COMICS measure: Motivation Scale for Teaching Materials measure: Student Knowledge Level Evaluation Form for First Aid Application in Injuries measure: Student Skill Level Evaluation Form for First Aid Application in Injuries sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Özlem Çalışır city: Aksaray state: Center zip: 68200 country: Turkey lat: 38.37255 lon: 34.02537 hasResults: False
<|newrecord|> nctId: NCT06279689 id: CJTCDZ2301 briefTitle: Echography Study_Anthropometric Measurements overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-02-28 name: Crossject class: INDUSTRY briefSummary: This is a multi-center, exploratory, estimation study in both adult and pediatric populations. There is no investigational product injection during this study The exploratory objective of this study is to evaluate the anatomical characteristics of both anterolateral thighs in healthy adult and healthy pediatric populations (2 to 17 years old) by ultrasound scan before and while applying a force similar to the ZENEO® triggering force.
In the healthy adult population, anatomical characteristics of one shoulder (deltoid) and one upper arm (biceps and triceps) will also be evaluated by ultrasound scan before and while applying a force similar to ZENEO® triggering force.
Only ultrasound procedures will be performed using an investigational ultrasound system. All subjects will be asked to undergo 1 on site visit (Study Visit) during which the eligibility assessment and the ultrasound scans will be performed. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 90 type: ESTIMATED name: Ultrasound scans measure: STBD : Skin To Bone Distance measure: STMD: Skin To Muscle Distance measure: Thickness of skin layers (dermis, hypodermis) measure: Thickness of muscle layers measure: Circumferences measurements (thigh, upper arm, waist, hip) sex: ALL minimumAge: 2 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279676 id: SaFeGreff briefTitle: Improvement of Women's Health After Allogeneic Stem Cell Transplantation acronym: SaFeGreff overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2028-07 date: 2028-12 date: 2024-02-28 date: 2024-02-28 name: Ciusss de L'Est de l'Île de Montréal class: OTHER name: Centre hospitalier de l'Université de Montréal (CHUM) briefSummary: The aim of this prospective research project is to better understand vulvovaginal cGVHD to improve care of allografted women. The expected outcomes include better knowledge of the incidence and manifestations of vulvovaginal cGVHD, risk factors, response to treatments and impact on sexual health of allotransplanted female patients. The knowledge acquired will allow transplant clinicians to make more precise recommendations for gynecological management of future allografted women. conditions: GVHD, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Define the incidence and describe clinical presentation of vulvovaginal cGVHD after allogeneic stem cell transplants reflecting modern transplant practice. measure: Evaluate genital cGVHD treatment response measure: Evaluate the frequency of premature ovarian failure measure: Measure the incidence and prevalence of HPV infection measure: Evaluate the quality of life (QoL) of allografted women measure: Evaluate intimacy within relationships of allografted women measure: Evaluate sexual function of allografted women measure: Evaluate sexual distress of allografted women sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279663 id: NSTE-ACS Multivessel Trial briefTitle: Management Tactics for Patients High Risk With Acute Coronary Syndrome Without ST Segment Elevation and Multivessel Coronary Artery Disease acronym: NSTE-ACSMT overallStatus: RECRUITING date: 2024-02-29 date: 2028-12-31 date: 2029-12-31 date: 2024-02-28 date: 2024-03-13 name: Federal State Budgetary Institution National Medical Research Center named after academician E.N. Me class: OTHER_GOV name: Kemerovo Cardiology Center, Tarasov Roman Sergeevich name: Tomsk National Research Medical Center of the Russian Academy of Sciences, Ryabov Vyacheslav Valeryevich briefSummary: The study will include patients with acute coronary syndrome without ST segment elevation and multivessel CA lesion, who are subject to surgical treatment according to KG data (Syntax Score 23 - 32 points with significant damage to the anterior descending artery and/or trunk of the left coronary artery). The patient should be suitable for both CABG and PCI (confirmed by an X-ray surgeon and a cardiac surgeon). An X-ray surgeon and a cardiac surgeon, within the framework of planning the volume of revascularization, strives for the fullest feasible volume. Complete myocardial revascularization (that is, the desire for the absence of hemodynamically significant coronary arteries after revascularization, with a diameter of \> 2.5 mm, that is, residual coronary artery stenosis of no more than 60%). Thus, patients will be randomized into groups in a ratio of 1:1. Each group will need to include 230 patients (a total of 460). In the main group, revascularization will be performed by PCI, in the control group by CABG. conditions: Coronary Syndrome, Acute, Non-ST Elevation, High Risk Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 460 type: ESTIMATED name: Revascularization measure: Death from any cause measure: Combined endpoint (death from cardiovascular causes, MI, Stroke, repeated unplanned myocardial revascularization) measure: target LDL level measure: Myocardial infarction measure: Stroke measure: Repeated unplanned myocardial revascularization measure: Duration of the hospital period measure: Intra/perioperative complications measure: Significant hemorrhagic complications (grade 3 or more on the BARC scale) measure: Questionnaire sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anton status: RECRUITING city: Novosibirsk state: Novosibirsk Obl zip: 630055 country: Russian Federation name: Anton Obedinskiy, 1 role: CONTACT phone: +73833476099 phoneExt: 1 email: a_obedinskij@meshalkin.ru lat: 55.0415 lon: 82.9346 facility: Anton status: RECRUITING city: Novosibirsk state: Rechkunovskaya Str. zip: 630055 country: Russian Federation name: Anton Obedinskiy role: CONTACT phone: 89139322885 email: a_obedinskij@meshalkin.ru lat: 55.0415 lon: 82.9346 hasResults: False
<|newrecord|> nctId: NCT06279650 id: 2022-2741 briefTitle: Self-hypnosis Training for Chronic Pain Management overallStatus: RECRUITING date: 2024-02-01 date: 2024-06 date: 2024-12 date: 2024-02-28 date: 2024-02-28 name: Ciusss de L'Est de l'Île de Montréal class: OTHER briefSummary: Title: Self-hypnosis training in chronic pain management: A pilot study Our primary objective concerns the effect of hypnosis intervention on change in 24h pain between T0 (pre-intervention) and T4 (3-month follow-up). The secondary objectives concern the effects of the intervention on (i) change in 24h pain between T0 and T5 (6-month follow-up), (ii) changes from T0 in measures of the functional impact of pain, (iii) changes from T0 in anxiety-depression scores and (iv) changes from T0 in quality of life.
The study design is a Randomized efficacy pilot study. The study focuses on patients practicing self-hypnosis within HMR groups. The study population is pain clinic patients. The sample size is 60 pain clinic patients. Study duration: February 2024 - December 2024. Center responsible for the study: Centre de Recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) - CEMTL, Montreal, Quebec, Canada.
Adverse events: none expected. conditions: Hypnosis, Chronic Pain Management studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Self-hypnosis name: Psycho-education and cognitive Bahavioral therapy (CBT) measure: Time 1 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 1 : Questionnaire Brief Pain Inventory (BPI) measure: Time 1 : Hospital anxiety and depression scale (HADS) measure: Time 1 : SF-36 (36-Item Short Form Survey) measure: Time 1 : Questionnaire socio-demographic and clinical measure: Time 2 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 2 : Questionnaire Brief Pain Inventory (BPI) measure: Time 2 : Hospital anxiety and depression scale (HADS) measure: Time 2 : SF-36 (36-Item Short Form Survey) measure: Time 3 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 3 : Questionnaire Brief Pain Inventory (BPI) measure: Time 3 : Hospital anxiety and depression scale (HADS) measure: Time 3 : SF-36 (36-Item Short Form Survey) measure: Time 4 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 4 : Questionnaire Brief Pain Inventory (BPI) measure: Time 4 : Hospital anxiety and depression scale (HADS) measure: Time 4 : SF-36 (36-Item Short Form Survey) measure: Time 5 : Numerical Rating Scale (NRS) from 0 to 10 measure: Time 5 : Questionnaire Brief Pain Inventory (BPI) measure: Time 5 : Hospital anxiety and depression scale (HADS) measure: Time 5 : SF-36 (36-Item Short Form Survey) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 5415 Bd de l'Assomption status: RECRUITING city: Montréal state: Quebec zip: H1T 2M4 country: Canada name: David Ogez role: CONTACT email: david.ogez@umontreal.ca lat: 45.50884 lon: -73.58781 hasResults: False
<|newrecord|> nctId: NCT06279637 id: PRO00046457 briefTitle: Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-04 date: 2026-07 date: 2026-07 date: 2024-02-28 date: 2024-02-28 name: Medical College of Wisconsin class: OTHER briefSummary: This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.
The aims of the study are:
Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).
Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.
Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Joint Home-DM-BAT Intervention name: Usual Care measure: Glycemic Control (Hemoglobin A1C [HbA1C]) sex: ALL minimumAge: 50 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279624 id: NRCT9-4 briefTitle: Effectiveness of the PCV13 in Older Thai Adults overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-03 date: 2025-06 date: 2024-02-28 date: 2024-02-29 name: Mahidol University class: OTHER name: National Research Council of Thailand briefSummary: This is the matched 1:2 case-control study, prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia (CAP), accordingly from November 2023 through October 2024. The investigators define a CASE as a person aged ≥60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. While a CONTROL is defined as a person aged ≥60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge.
The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal CAP in Thai adults aged ≥ 60 years with or without any medical conditions.
The main questions it aims to answer is:
• What are the effectiveness of PCV13 for preventing all typed, vaccine typed, or non-vaccine typed of pneumococcal CAP among Thai older adults?
The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023. The investigators define case and control the same as prospective method, but all data were retrieved from archive database.
-The investigators select a 1:2 matched control with criteria as follows; 10-year-interval of age, ward (the same patient care such as out or in-patient, or admitted in the same level ward).
Participants will be
* collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition.
* explored their vaccine status by either vaccine book checking or hospital database.
Researcher will compare the effectiveness of PCV13 to prevent all typed, vaccine typed and non-vaccine typed pneumococcal pneumonia. conditions: Community-acquired Pneumonia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 840 type: ESTIMATED measure: Vaccine effectiveness of PCV13 on all types of pneumococcal CAP measure: Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06279611 id: LY007C1101 briefTitle: An Evaluation of LY007 Cell Injection for r/r B-NHL acronym: r/r B-NHL overallStatus: RECRUITING date: 2021-12-25 date: 2024-08-31 date: 2026-05-31 date: 2024-02-28 date: 2024-02-28 name: Shanghai Longyao Biotechnology Inc., Ltd. class: OTHER name: The First Affiliated Hospital with Nanjing Medical University name: Ruijin Hospital briefSummary: An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research conditions: B-NHL studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: LY007 measure: Maximum tolerated dose or clinically recommended dose measure: Dose limiting toxicity measure: Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern measure: PK aspect measure: PK aspect measure: PD aspect measure: therapeutic effect measure: Anti LY007 antibody measure: The titer of human anti mouse antibody measure: Exploratory study endpoint sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ruijin hospital status: RECRUITING city: Shanghai state: Shanghai country: China name: zhao weili, MD role: CONTACT phone: 13512112076 phoneExt: 610707 email: zwl_trial@163.com name: yan zixun, MD role: CONTACT phone: +8613482056727 phoneExt: 610707 email: yanzixun125@163.com lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06279598 id: UniversityGroningen briefTitle: PT-STRESS Study: Predicting Treatment Success and Dealing With Non-response in the Treatment of PTSD acronym: PT-STRESS overallStatus: RECRUITING date: 2024-01-01 date: 2031-05-20 date: 2032-08-31 date: 2024-02-28 date: 2024-02-28 name: University of Groningen class: OTHER name: Dimence briefSummary: The aim of this study is to increase understanding of the effectiveness and efficiency of psychological treatment for adult patients with posttraumatic stress disorder -PTSD- and to make it more personalized.
Key questions:
1. Which predictors of treatment success influence treatment outcome of patients with PTSD who receive the three psychotherapeutic treatments investigated in this study?
2. Which specific moderators can be identified with regard to the different psychotherapies (Eye Movement Desensitization and Reprocessing -EMDR-; Prolonged Exposure -PE-; and Interpersonal Psychotherapy -IPT- in the second phase)?
3. In patients with PTSD, does offering another proven effective form of trauma-focused psychotherapy (PE after EMDR, or EMDR after PE) improve symptoms following insufficient response to a first trauma-focused treatment?
4. Is switching from a trauma-focused therapy to a non-trauma-focused treatment (IPT) a more effective strategy for dealing with non-response to a first proven effective psychotherapeutic treatment compared to switching to another trauma-focused therapy?
5. Are there differences in treatment tolerance and differences in dropout rates between PE, EMDR and IPT?
Secondary goals:
* Investigating the extent to which therapist allegiance to a specific therapy method affects outcomes;
* Investigating whether the quality of therapy implementation or the treatment integrity ('adherence/ competence') affects treatment outcomes;
* Investigating how much the quality of the therapeutic alliance influences outcomes.