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<|newrecord|> nctId: NCT06361836 id: SBT777101-02 briefTitle: Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa overallStatus: RECRUITING date: 2024-05 date: 2026-06 date: 2026-06 date: 2024-04-12 date: 2024-04-12 name: Sonoma Biotherapeutics, Inc. class: INDUSTRY briefSummary: This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown. conditions: Hidradenitis Suppurativa studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Sequential escalating dose cohorts primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: SBT777101 measure: Incidence, nature, and severity of adverse events [Safety and Tolerability] measure: Incidence and nature of Dose Limiting Toxicities [DLTs] sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States name: Oliva Gabriel role: CONTACT phone: 617-525-8250 email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06361823 id: IIH-Semaglutide briefTitle: Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2025-01-01 date: 2024-04-12 date: 2024-04-12 name: Capital Medical University class: OTHER briefSummary: This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension. conditions: Idiopathic Intracranial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner. primaryPurpose: TREATMENT masking: NONE count: 74 type: ESTIMATED name: Semaglutide name: Low calorie diet measure: Intracranial pressure measure: Adverse reactions measure: Headache severity measure: Degree of papilledema measure: Perimetric mean deviation measure: Optic nerve sheath diameter measure: Body mass index sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361810 id: IRB00430008 briefTitle: PSMA Therapy and Immunotherapy in Kidney Cancer overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2030-07 date: 2031-07 date: 2024-04-12 date: 2024-04-12 name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins class: OTHER name: Merck Sharp & Dohme LLC name: Lantheus Medical Imaging briefSummary: This is a multi-center, single arm open label phase 1b/2 study of pembrolizumab in combination with 177Lu-PNT2002 (also known as 177Lu-PSMA I\&T) radiopharmaceutical therapy in patients with metastatic clear cell renal cell carcinoma (RCC) who have progressed after prior treatment with anti-programmed cell death protein 1 (PD1) or PD-L1 immune-checkpoint inhibitors (ICIs). The study comprises 2 phases: an open-label Phase 1b dose escalation portion followed by a Phase 2 dose expansion portion. Investigators hypothesize that pembrolizumab in combination with 177Lu-PNT2002 in in patients with metastatic clear cell RCC at a biologically active dose will result in tolerable safety profile and it will lead to improved radiological objective responses in patients who have progressed after prior treatment with standard anti-PD1 or anti- Programmed Cell Death Ligand 1 (PDL1) immune-checkpoint inhibitor containing regimen when compared to historic controls. Patients in both phases will have prostate-specific membrane antigen (PSMA), positron emission tomography (PET) imaging with the radiotracer (F-18)-DCFPyl, to help detect any spread of the cancer. conditions: Metastatic Renal Cell Carcinoma conditions: Metastatic Clear Cell Renal Cell Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: Pembrolizumab name: 177Lu-PNT2002 name: (F-18)-DCFPyL measure: Safety assessed by the incidence of dose limiting toxicities. measure: Objective response rate by RECIST 1.1 criteria measure: Progression free survival measure: Safety as assessed by number of participants experiencing adverse events measure: Disease control rates measure: Duration of response to study therapy measure: Overall survival rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361797 id: IRB00415412 briefTitle: Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2027-10 date: 2024-04-12 date: 2024-04-12 name: Johns Hopkins University class: OTHER name: ON Foundation briefSummary: Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair. conditions: Rotator Cuff Tears studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is designed as a parallel group 1:1:1 randomized controlled trial. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patients and research assistants collecting data will be unaware of assigned treatment until study completion. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Rotator cuff repair augmented with whole bone marrow name: Rotator cuff repair augmented with concentrated bone marrow measure: Number of Rotator cuff re-tears as assessed by magnetic resonance imaging measure: American Shoulder and Elbow Surgeons Score measure: Visual Analogue Pain Score measure: Subjective Shoulder Value score measure: Comprehensive Shoulder Assessment measure: Revision surgery rate measure: Rate of oral and/or intra-articular corticosteroid required sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Howard County General Hospital city: Columbia state: Maryland zip: 21230 country: United States name: Study Director role: CONTACT name: Principal Investigator role: CONTACT lat: 39.24038 lon: -76.83942 facility: Johns Hopkins Medicine - Green Spring Station city: Lutherville state: Maryland zip: 21093 country: United States name: Matthew J Best, MD role: CONTACT phone: 443-997-2663 email: [email protected] name: Uma Srikumaran, MD, MBA, MPH role: CONTACT phone: 410-546-1550 email: [email protected] lat: 39.42122 lon: -76.62608 hasResults: False
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<|newrecord|> nctId: NCT06361784 id: INT216-23 id: MFAG27480 type: OTHER_GRANT domain: AIRC Foundation for Cancer Research in Italy briefTitle: Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters. (LOCATION MATTERS) acronym: LM overallStatus: RECRUITING date: 2024-03-29 date: 2029-03-29 date: 2029-03-29 date: 2024-04-12 date: 2024-04-15 name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano class: OTHER name: Politecnico di Milano briefSummary: The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung. conditions: Locally Advanced Lung Non-Small Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy measure: Major adverse cardiac events post-RT measure: Increase in cardiac calcification after RT measure: Longitudinal variation of cardiopulmonary functional parameters measure: Texture variation in the heart substructures sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Istituto Nazionale dei Tumori status: RECRUITING city: Milan zip: 20133 country: Italy name: Alessandro Cicchetti, PhD role: CONTACT phone: 0223903858 email: [email protected] name: Chiara Casati role: CONTACT email: [email protected] name: Alessandro Cicchetti, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06361771 id: 29BRC24.0079 - PRICELESS briefTitle: Evaluation of Invisible Preparation Behaviors of Middle and High School Students in Sports Facilities (PRICELESS) acronym: PRICELESS overallStatus: RECRUITING date: 2024-01-08 date: 2024-12-20 date: 2024-12-20 date: 2024-04-12 date: 2024-04-18 name: University Hospital, Brest class: OTHER briefSummary: The investigators define the Invisible Preparation (IP) as the set of health behaviors that young athletes implement, on their own, to optimize their health and performances. This includes sleep, nutrition and hydration, physical well-being (injuries prevention) and mental well-being. If some studies have reported a lack of compliance in young athletes regarding sleep and hydration recommendations, the literature is poor in this field.
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The CMS (Brest Metropolitan Area Sports Medicine Centre, France) aims at preserving the health of young athletes. Prior to their medical examination, the patients will be asked, all along the year 2024, to fill out a form that question them about their health behaviors in the four areas of the IP.
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Under the direction of the Brest University Hospital, PRICELESS (Invisible Preparation of Middle and High School Students in Sports Institutions) study will try, based on their answers, to estimate the proportion of young athletes who declare adopting the health behaviors recommended in the IP. conditions: Sports Injury conditions: Prevention conditions: Training conditions: Hydration conditions: Nutrition conditions: Sleep conditions: Mental Health conditions: Physical Well-Being studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED measure: The proportion of teenagers who declare adopting the health behaviors recommended in the four areas of the Invisible Preparation. measure: The proportion of girls who declare adopting these behaviors, compared to the proportion in boys. measure: The proportion of Middle School students who declare adopting these behaviors, compared to the proportion in High School students. measure: The proportion of young athletes practicing an intensive sporting activity (10 hours or more per week), compared to the proportion in young athletes practicing a non-intensive sporting activity (less than 10 hours per week). measure: The proportion of young athletes with disabilities who declare adopting these behaviors, compared to the proportion in young athletes without disabilities. sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Chu Brest status: RECRUITING city: Brest zip: 29609 country: France name: Marie-Agnès GIROUX-METGES, PhD role: CONTACT phone: 0298347366 phoneExt: +33 email: [email protected] name: Florent GUIMARD, Resident role: CONTACT phone: 02 98 33 53 40 phoneExt: +33 email: [email protected] lat: 48.3903 lon: -4.48628 hasResults: False
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<|newrecord|> nctId: NCT06361758 id: B2023-326(2) briefTitle: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-05-31 date: 2027-05-31 date: 2024-04-12 date: 2024-04-16 name: Shanghai Zhongshan Hospital class: OTHER name: Sun Yat-sen University name: Eastern Hepatobiliary Surgery Hospital briefSummary: This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Cadonilimab+Lenvatinib measure: Objective Response Rate (ORR) per RECIST v1.1 measure: Objective Response Rate (ORR) per mRECIST measure: Disease control Rate (DCR) measure: Duration of response (DoR) measure: Progression-Free-Survival (PFS) measure: Overall survival Overall survival (OS) measure: Incidence of Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhongshan Hospital, Fudan University city: Shanghai state: Shanghai zip: 200032 country: China lat: 31.22222 lon: 121.45806 facility: Sun Yat-sen University Cancer Center) city: Guangzhou country: China name: Li Xu role: CONTACT name: Li Xu role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Eastern Hepatobiliary Surgery Hospital city: Shanghai country: China name: Kui Wang role: CONTACT name: Jun Xue role: CONTACT name: Kui Wang role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06361745 id: PG-005-6 briefTitle: Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases overallStatus: RECRUITING date: 2024-04-02 date: 2024-12-01 date: 2025-03-01 date: 2024-04-12 date: 2024-04-15 name: PersonGen BioTherapeutics (Suzhou) Co., Ltd. class: INDUSTRY briefSummary: Main purpose:
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To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
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Secondary purpose:
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To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
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To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID.
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To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects.
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To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects. conditions: Systemic Lupus Erythematosus conditions: Idiopathic Inflammatory Myopathies conditions: Systemic Sclerosis conditions: IgG4 Related Disease conditions: Primary Sjögren Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: UTAA09 injection primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: T cell injection targeting CD19 chimeric antigen receptor measure: AE measure: Cmax measure: CD19-positive cells measure: Disease remission/response/improvement rates measure: anti-CAR antibody sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PersonGen.Anke Cellular Therapeutice Co., Ltd status: RECRUITING city: Hefei country: China name: Huimin Meng, Doctor role: CONTACT phone: +86-18015580390 email: [email protected] lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06361732 id: ILBS-liver Transplant-03 briefTitle: Prevalence of CYP3A5 Polymorphisms in the Donors and ABCB1 Polymorphisms in the Recipients Undergoing Pediatric Liver Transplant and Their Influence on Tacrolimus Levels and Graft Function. overallStatus: RECRUITING date: 2022-12-17 date: 2024-10-30 date: 2024-10-30 date: 2024-04-12 date: 2024-04-12 name: Institute of Liver and Biliary Sciences, India class: OTHER briefSummary: It is known that Immunosuppression post-Liver transplant is central to achieving optimal outcomes in liver transplant recipients. It is required to maintain an adequate balance between reducing rejection and toxicities. Mainstay drugs for maintenance therapy are Calcinuerin inhibitors - Tacrolimus versus cyclosporine. Tacrolimus is preferred, as it has less rejection and better graft survival. However, there is risk of renal and metabolic toxicities. Tacrolimus is bound mainly to alpha1-acid-glycoprotein (encoded by the ABCB1gene) expressed on various epithelial and endothelial cells and lymphocytes. Elimination occurs by metabolizing enzymes of cytochrome P450 system, with biliary excretion (95%) of metabolites (majority) with minority through urine (2.4%). Demethylation and hydroxylation of tacrolimus occurs by hepatic and intestinal CYP3A isoforms (CYP3A4 and CYP3A5). Among the factors that play an important role in the pharmacokinetics of tacrolimus, thus affecting the tacrolimus trough levels in the body and in turn influencing the dosing of the drug required to maintain an adequate balance between reducing rejection and toxicities, genetics plays an important role. Increased expression of CYP3A5 causes more metabolism of tacrolimus and hence affecting the tacrolimus concentration/weight-adjusted dose (C/W-D) ratio in the body. The wild type (CYP3A5\*3) are slow metabolizers and mutant ones (CYP3A5 \*1/\*1 and CYP3A5 \*1/\*3) are fast metabolizers. Fast
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metabolizers have a low C/W-D ratio and require higher Tacrolimus dosing and are thus susceptible to renal and metabolic toxicities, EBV viremia and post transplant lymphoproliferative disorder. Polymorphisms in ABCB1 (c.3435C\>T) are also known to influence tacrolimus dosage in the first week of transplant (C/D ratio was lower in ABCB1 3435CC in comparison to CT and TT). There is no such data in pediatric liver transplant setting from Indian subcontinent. The aim of the study is to study the prevalence of CYP3A5 polymorphisms in the donors and ABCB1 polymorphisms in the recipients undergoing Paediatric liver transplant and their influence on Tacrolimus levels and graft function. conditions: Pediatric Liver Transplant studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: OTHER count: 80 type: ESTIMATED name: No intervention measure: Time (in days) to achieve transaminases within 1.5 times ULN (60 IU/L) in the pediatric Liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors. measure: Prevalence of CYP3A5 alleles in the donors of pediatric liver transplant recipients. measure: Influence of donor CYP3A5 alleles (slow versus fast metabolizers) on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months & 6 months and 1 year after liver transplantation. measure: Prevalence of ABCB1 3435 C/T alleles in the recipients of pediatric liver transplant. measure: Influence of recipient ABCB1 3435 C/T on tacrolimus concentration-weight adjusted dose ratio at 1 week, 4 weeks, 3 months and 6 months and 1 year after liver transplantation. measure: Comparison of the Number of Rejection episodes 1 year from LT. measure: Comparison of proportion of patients who were withdrawn from Mycophenolate or required addition of Mycophenolate 1 year from LT. measure: Comparison of proportion of patients with renal toxicity 1 year from LT. measure: Comparison of proportion of patients with Neurological toxicity 1 year from LT. measure: Comparison of e-GFRand cystatin-C levels in the two cohorts of pediatric liver transplant recipients with grafts from slow metabolizer (CYP3A5*3/3 allele) versus fast metabolizer (CYP3A5*1/3 and 1/1 alleles) donors. sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Institute of Liver and Biliary Sciences status: RECRUITING city: New Delhi zip: 110070 country: India name: Dr Snigdha Verma, MD role: CONTACT phone: 01146300000 email: [email protected] name: Dr Rajeev Khanna, MD role: CONTACT phone: 01146300000 email: [email protected] lat: 28.63576 lon: 77.22445 hasResults: False
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<|newrecord|> nctId: NCT06361719 id: 2312INF briefTitle: Efficacy of Two HMOs in Chinese Infants overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2026-11 date: 2027-06 date: 2024-04-12 date: 2024-04-12 name: Société des Produits Nestlé (SPN) class: INDUSTRY briefSummary: This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group. conditions: Healthy Infants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 262 type: ESTIMATED name: Experimental Group (EG) name: Control Group (CG) measure: Bifidobacteria abundance in fecal samples measure: Gut microbiota composition measure: Fecal metabolism measure: Fecal metabolism measure: Fecal markers of intestinal immune health measure: Fecal markers of gut barrier function measure: Fecal markers of gut barrier function measure: Fecal markers of gut barrier function measure: Fecal markers of inflammation measure: Fecal markers of inflammation measure: Fecal markers of inflammation measure: Stool patterns measure: Stool patterns measure: GI symptoms and behaviors measure: Immune competence measure: Infant sleep duration and night-time wakings per 24 hours measure: Infant Health Related Quality of Life measure: Growth measure: Growth measure: Growth measure: Growth measure: Growth measure: Physical Examination measure: Infant Illness measure: Infant illness, infections and medication usage measure: Medication use (type and duration) measure: Formula feeding measure: Breastfeeding measure: Infant dietary pattern sex: ALL minimumAge: 3 Days maximumAge: 14 Days stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06361706 id: 24/047-P briefTitle: VR-Enhanced Psychoeducation for Chronic Pain: A Primary Care Pilot Study acronym: REDOCVR overallStatus: RECRUITING date: 2023-12-04 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-26 name: Badalona Serveis Assistencials class: OTHER name: Department of Health, Generalitat de Catalunya briefSummary: This pilot study aims to evaluate the integration of virtual reality (VR) with a psychoeducational program for individuals experiencing chronic pain and central sensitization. Chronic pain significantly hampers daily life, and the condition of central sensitization intensifies this challenge by making the pain more acute. Our research is grounded in the hypothesis that VR, when used to complement conventional psychoeducational methods, can enhance engagement and understanding of pain management strategies, thus potentially improving patient outcomes.
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Key objectives and related measured variables include:
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Usability and Feasibility: Evaluated through the System Usability Scale (SUS) responses from both participants and healthcare professionals, assessing the ease of use and integration of VR into the psychoeducational program.
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Participant Engagement and Program Adherence: Determined by participants\' satisfaction with the VR system, using Likert scale questionnaires, and tracked through session attendance and program completion rates.
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Impact on Chronic Pain Management and Emotional Well-being: Assessed through changes in the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and the Hospital Anxiety and Depression Scale (HADS) collected at baseline, post-intervention, and 4-8 weeks follow-up Self-management of Chronic Pain: Monitored through the Central Sensitization Inventory (CSI) and changes in patient functionality and mobility using the EuroQol-5D-5L scale, measured at baseline, post-intervention, and 4-8 weeks follow-up.
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Healthcare Professionals\' Perceptions: Investigated using SUS scores and qualitative feedback on the applicability and benefits of VR in clinical practice for chronic pain management.
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Participants will complete eight 90-minute sessions, engaging with VR to supplement the program\'s content. This approach aims to provide immersive experiences that deepen the understanding and management of chronic pain. Participant feedback on the VR experience, alongside observed changes in pain management and overall well-being, will be critically examined.
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By targeting individuals suffering from chronic pain, this research aims to offer healthcare professionals an innovative tool for enhancing pain management strategies. Integrating VR into psychoeducational content, the study seeks to promote more engaging and effective learning experiences, potentially leading to improved outcomes in chronic pain management. conditions: Chronic Pain conditions: Central Sensitization studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The REDOCVR study utilizes a Single-Group Interventional Model, where all participants receive the same VR-enhanced psychoeducational intervention for chronic pain management. This model facilitates a focused evaluation of VR's effectiveness and usability within a structured psychoeducational framework, allowing for direct assessment of participant experiences and outcomes. primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: The statisticians and researchers involved in data analysis will be masked to the identity of participants, using a random code for each participant. count: 60 type: ESTIMATED name: VR-Enhanced Psychoeducational Program for Chronic Pain measure: Participant Satisfaction with the VR-enhanced Psychoeducational Program as measured by the Participants Satisfaction Questionnaire measure: Participants´ System Usability and VR Headset Comfort as assessed by the SUS for participants measure: Professionals System Usability as measured by the SUS for Professionals measure: Mental Well-being as assessed by the WEMWBS-7 measure: Anxiety and Depression Severity as measured by the HADS measure: Central Sensitization as measured by the CSI measure: Changes in Functionality and Mobility as assessed by the EuroQol-5D-5L Scale measure: Adherence to the VR-enhanced Psychoeducational Program as indicated by session attendance and program completion rates measure: Participant Feedback as recorded on the Participant Comment Sheet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Primary Care Progrès-Raval status: RECRUITING city: Badalona state: Barcelona zip: 08912 country: Spain name: Jose Ferrer Costa, MD role: CONTACT phone: 0034933951779 email: [email protected] name: Elena Villabona López, MSc role: CONTACT phone: 0034933890695 email: [email protected] name: Elena Villabona Lopez, MSc role: SUB_INVESTIGATOR name: Jose Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Melanie Rodriguez Belloso, BSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Primary Care Center Apenins-Montigalà status: RECRUITING city: Badalona state: Barcelona zip: 08917 country: Spain name: José Ferrer Costa, MD role: CONTACT phone: 0034933951779 email: [email protected] name: Christian Torrecillas Camacho, BSc role: CONTACT phone: 0034933951779 email: [email protected] name: José Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Christian Torrecillas Camacho, BSc role: SUB_INVESTIGATOR name: Alexandra Fernandez Brusco, BSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 facility: Primary Care Center Morera-Pomar status: RECRUITING city: Badalona state: Barcelona country: Spain name: Nuria Moran Blanco, MD role: CONTACT phone: 0034934655200 email: [email protected] name: Laura Villares Urgell, MSc role: CONTACT phone: 0034934655200 email: [email protected] name: Jose Ferrer Costa, MD role: PRINCIPAL_INVESTIGATOR name: Nuria Moran Blanco, MD role: SUB_INVESTIGATOR name: Laura Villare Urgel, MSc role: SUB_INVESTIGATOR lat: 41.45004 lon: 2.24741 hasResults: False
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<|newrecord|> nctId: NCT06361693 id: APHP240147 id: 2024-A00143-44 type: OTHER domain: France : Ministry of Health briefTitle: Descriptive Observational Study of Patient-performed Pre-oxygenation acronym: ApréOx overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-11 date: 2024-12 date: 2024-04-12 date: 2024-04-15 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: The aim of this research would be to determine the efficacy and effects of preoxygenation when performed by the patient (mask held by the patient).
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This is the concept of "self-preoxygenation". conditions: Anesthesia conditions: Anxiety conditions: ASA Physical Status I conditions: ASA Physical Status II studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Auto-preoxygenation name: APAIS scale name: Visual analog anxiety scale (VAS-A) name: Visual analog comfort scale (VAS-C) measure: FeO2>90% measure: APAIS anxiety score measure: Visual analog anxiety scale (VAS-A) score measure: Visual analog anxiety scale (VAS-A) score measure: Visual analog comfort scale (VAS-C) score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anesthesia-intensive care department - Cochin - Port-Royal hospital - APHP city: Paris state: Ile De France zip: 75014 country: France name: Sophie TOUSSAINT, Nurse anesthetist role: CONTACT phone: 00 33 1 58 41 45 17 email: [email protected] name: Claude LE STANG, Nurse anesthetist role: CONTACT email: [email protected] name: Christophe BAILLARD, PUPH role: SUB_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
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<|newrecord|> nctId: NCT06361680 id: Coenzyme Q10 on diabetic child briefTitle: Effect of Coenzyme Q10 on Diabetic Children overallStatus: NOT_YET_RECRUITING date: 2024-10-30 date: 2025-10-30 date: 2025-11-30 date: 2024-04-12 date: 2024-04-12 name: Assiut University class: OTHER briefSummary: Determine the effect of Coenzyme Q10 on random blood sugar and glycosylated haemoglobin conditions: Type 1 Diabetes Mellitus studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: Coenzyme Q10 Cap/Tab as natural factors capsules or kirkman tablets measure: Assess the effect of Coenzyme Q10 on glycated haemoglobin in type 1 diabetes mellitus measure: Control of random blood sugar and glycated haemoglobin in children with type 1 diabetes mellitus . sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06361667 id: 1/02.02.2024 briefTitle: Culture and Well-being: Art as Prescription Therapy ("Art on Prescription") acronym: AoP overallStatus: RECRUITING date: 2024-03-20 date: 2024-12-15 date: 2025-01-15 date: 2024-04-12 date: 2024-04-12 name: KAVADIA ELENI class: OTHER briefSummary: Cluster randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL). conditions: Mental Health Issue conditions: Anxiety Disorders conditions: Depressive Disorder conditions: Emotional Disorder conditions: Schizophrenia conditions: Autism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We will follow standard practice for RCTs and apply an ANCOVA model to estimate the effects of treatment. The formalism is:
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y \~ b0 + b1xtreatment_group + b2xtime + b3xtreatment_groupxtime + covariates (1)
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Where, y is each outcome, b1-b3 are the regression coefficients and covariates denotes covariates at randomisation (DETERMINE)
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The inference of interest for the model concerns b3, the interaction term, as we posit that there will be a difference in slopes between the treatment groups.
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The inference is going to happen via an estimation of the t-statistic, defined as follows"
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t = b3/SE (2)
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Where SE is the standard error for coefficient b3
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t \> 1.96 (3)
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And 1.96 is the critical value for statistical significance at alpha = 0.05. primaryPurpose: TREATMENT masking: NONE count: 384 type: ESTIMATED name: Arts measure: The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) measure: Generalised Anxiety Disorder Assessment (GAD-7) measure: The Patient Health Questionnaire-9 (PHQ-9) measure: UCLA 3-item Loneliness Scale measure: The Strengths and Difficulties Questionnaire (SDQ) sex: ALL minimumAge: 10 Years maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Eleni Kavadia status: RECRUITING city: Athens country: Greece name: Eleni Kavadia role: CONTACT phone: +30 210 6170804 email: [email protected] name: Nikos Stefanis, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.97945 lon: 23.71622 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-10 uploadDate: 2024-03-26T12:19 filename: Prot_000.pdf size: 390364 hasResults: False
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<|newrecord|> nctId: NCT06361654 id: 2023/0135/OB briefTitle: Effect of Muscular Imbalance Between Flexors and Extensors of the Fingers and Wrist on Upper Limb Injuries in Climbers acronym: CRIMPER overallStatus: RECRUITING date: 2024-03-25 date: 2025-03-25 date: 2025-09-01 date: 2024-04-12 date: 2024-04-15 name: University Hospital, Rouen class: OTHER briefSummary: Climbing is a booming sport with an increasing number of participants. When practicing this sport, there is a muscular imbalance between the flexor and extensor systems (especially in the fingers), with the flexors of the fingers exerting greater force than the extensors. In addition, upper limb injuries, particularly the fingers, are very common.
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The study will be carried out on club-licensed climbers, as they are better supervised. They will be recruited through requests sent to various clubs. The measurements will be taken during different climbing sessions, after the warm-up.
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The study will include measurements on different climbers. Informed consent and personal data will be collected from the climbers before the measurements are taken. The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer. The climbers will then continue their usual training for 1 year. For 1 year after the measurements, the climbers will be contacted every month by telephone to collect the different injuries they may have suffered in relation to climbing, as well as the number of hours they have spent climbing in the past month. After 1 year, the annual number of hours of climbing and the annual number of injuries can be calculated for each climber. Injury is defined as any medically diagnosed lesion of the musculoskeletal system of the upper limb or pain that prevents the practice of a sport whose aetiology is climbing. These data are used to calculate the "athlete exposure" (A-E), i.e. the incidence of injury per 1000 hours of practice. As the study population is large, this allows for variations in exposure between subjects. conditions: Climber studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 47 type: ESTIMATED name: The strength values of the flexors and extensors of the fingers and wrist will be measured using a dynamometer measure: Athlete exposure sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rouen, University Hospital status: RECRUITING city: Rouen state: Normandie zip: 76031 country: France name: timothee gillot, phd role: CONTACT phone: 0232880671 phoneExt: +33 email: [email protected] lat: 49.44313 lon: 1.09932 hasResults: False
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<|newrecord|> nctId: NCT06361641 id: 49RC23_0259 id: AO2721-44 type: OTHER domain: ANSM briefTitle: Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes acronym: PHEMOP overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2025-10-19 date: 2027-10-19 date: 2024-04-12 date: 2024-04-12 name: University Hospital, Angers class: OTHER_GOV briefSummary: Prospective study for functional and phenotypic characterization of monocytes in philadelphia-negative myeloproliferative neoplasms conditions: Myeloproliferative Neoplasm conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Primary Myelofibrosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 50 type: ESTIMATED name: Monocytes signatures in myeloproliferative neoplasms at diagnosis measure: WHO 2016 criteria for polycythemia vera, prefibrotic myelofibrosis, essential thrombocytosis and overt myelofibrosis diagnosis measure: Identify correlation between the monocytic signature and driver mutations (mutation in JAK2, CALR or MPL gene). measure: Identify correlation between the monocytic signature and the grade of fibrosis measure: prognostic value of the monocytic signature using a principal component analysis Response criteria according to Barosi et al., Leukemia, vol. 29,1 (2015): 20-6 measure: Prognostic value of the monocyte signature for disease worsening according to Sureau et al., Blood Cancer Journal, vol. 12,4, 56. 8 Apr. 2022 measure: leukemia-free survival measure: myelofibrosis-free survival measure: Monocytes parameters for hematological progression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GOUBAND Agathe city: Angers state: Maine Et Loire zip: 49933 country: France name: Agathe GOUBAND, PharmD role: CONTACT phone: 02 41 35 55 96 phoneExt: 33 email: [email protected] name: Damien LUQUE PAZ, PharmD role: CONTACT phone: 02 41 35 53 53 phoneExt: 33 email: [email protected] lat: 47.46667 lon: -0.55 facility: BESCOND Charles city: Cholet state: Maine Et Loire zip: 49325 country: France name: Charles BESCOND, MD role: CONTACT phone: 0241355880 email: [email protected] lat: 47.06667 lon: -0.88333 facility: TRUCHAN-GRACZYK Malgorzata city: Saumur state: Maine Et Loire zip: 49400 country: France lat: 47.26667 lon: -0.08333 hasResults: False
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<|newrecord|> nctId: NCT06361628 id: RIVER-EU WP4 briefTitle: Implementation and Evaluation of Tailored Interventions to Increase MMR and/or HPV Vaccine acronym: RIVER-EU overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-06-01 date: 2025-06-01 date: 2024-04-12 date: 2024-04-17 name: University Medical Center Groningen class: OTHER name: Prolepsis Institute for Preventive, Environmental and Occupational Medicine name: University in Zielona Góra name: Pavol Jozef Safarik University briefSummary: The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV \& MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated.
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The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia? conditions: Vaccination conditions: Health Systems conditions: Knowledge, Attitudes, Practice studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 1000 type: ESTIMATED name: multicomponent intervention on vaccination awareness measure: Intention to vaccinate MMR and/or HPV by questionnaire measure: Uptake of MMR and/or HPV vaccinations by questionnaire measure: Knowledge concerning MMR and/or HPV vaccinations in the target group using a questionnaire measure: Communication skills of health care professionals using a questionnaire measure: Satisfaction of the stakeholders as measured by a questionnaire measure: Improved access to vaccinations by addressing identified health system barriers - number of barriers addressed sex: ALL minimumAge: 12 Years maximumAge: 100 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Prolepsis city: Athens state: Athene zip: 151 25 country: Greece name: Pania Karnaki role: CONTACT phone: +30 210 6255700 email: [email protected] name: Nikole Papaevgeniou, PhD role: CONTACT email: [email protected] lat: 37.97945 lon: 23.71622 facility: University Medical Center Groningen city: Groningen zip: 9713 GZ country: Netherlands name: Janine de Zeeuw, PhD role: CONTACT phone: +31 6 45552994 email: [email protected] lat: 53.21917 lon: 6.56667 facility: University of Zielona Gora city: Zielona Góra state: Lubusz zip: 65 417 country: Poland name: Maria Ganczak, MD PhD role: CONTACT email: [email protected] lat: 51.93548 lon: 15.50643 facility: PJ Šafárik University city: Košice state: Košice Region zip: 04180 country: Slovakia name: Daniela Fiľakovská, PhD role: CONTACT phone: +421 55 234 3390 email: [email protected] lat: 48.71395 lon: 21.25808 hasResults: False
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<|newrecord|> nctId: NCT06361615 id: CEC_FP_2023042 briefTitle: Effect of a Dual-task Intervention Program on Physical and Cognitive Function overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-08 date: 2024-03-05 date: 2024-04-05 date: 2024-04-12 date: 2024-04-12 name: University of Americas class: OTHER briefSummary: Aim: to compare the effects of single-task (ST) and dual-task (DT) training on physical and cognitive function in institutionalized older adults in 1 month.
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Methods: Participants were assigned randomly into two groups, ST (multicomponent physical exercise) and DT training (multicomponent physical exercise + cognitive tasks). Both groups performed the exercise three times per week for 1 month. Short Physical Performance Battery (SPPB), handgrip strength, Barthel Index and Montreal Cognitive Assessment (MoCA) were used to assess physical and cognitive performance, respectively. Variables were measured at the beginning (V1),at the end of the exercise (V2), as well as one month later (V3). Paired Student's t-test and lineal logistic regressions models were used to explore the effect of the exercise interventions. conditions: Functional Movement Disorder conditions: Fragility studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Although blinding is not possible for participants in exercise-intervention research, the outcome assessors and data analysts were masked to group assignments. The study was unblinded after the statistical analyses were completed. whoMasked: PARTICIPANT count: 24 type: ACTUAL name: Single-Task name: Dual-Task measure: Short Physical Performance Battery (SPPB) measure: Montreal Cognitive Assessment (MoCA) measure: Barthel Index measure: Isometric Handgrip Strength (IHS) measure: Immobility Syndrome Scale sex: ALL minimumAge: 65 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: Universidad de las Americas city: Santiago de Chile state: Santiago zip: 7750495 country: Chile lat: -33.45694 lon: -70.64827 hasResults: False
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<|newrecord|> nctId: NCT06361602 id: SYSKY-2023-1015-01 briefTitle: Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers acronym: SYX-AN-01 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-05-01 date: 2024-04-12 date: 2024-04-12 name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University class: OTHER briefSummary: 1. 80 cases of healthy donors were subjected to peripheral blood single nucleated cells (PBMC) collection and analyzed the effects of age, body mass index (BMI), blood routine indexes before collection, collection of circulating blood volume, volume of processed blood and the number of circulations, etc., on the PBMC obtained from both men and women, and explored the effects of PBMC collection in different volunteers and the factors affecting the collection. and the influencing factors.
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2. The data obtained will provide a reference for the MNC threshold for the subsequent clinical trials of immunocell therapy in hospitals.
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3. From the screening of volunteers, PBMC collection and transportation conditions and other specific details of the operation, risk assessment and the establishment of a safe operation standard process, for the hospital to carry out subsequent clinical trials of immune cell therapy to provide an effective reference. conditions: Observational Study studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 80 type: ESTIMATED name: inapplicable measure: Exploring the effectiveness and factors affecting the collection of single nucleated cells from different volunteers sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06361589 id: EK2023003-1 briefTitle: Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients overallStatus: RECRUITING date: 2024-05-01 date: 2026-11-01 date: 2028-11-01 date: 2024-04-12 date: 2024-04-12 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients. conditions: ALK-positive Non-small Cell Lung Cancer conditions: Real World Study studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: Lorlatinib measure: PFS measure: OS measure: ORR measure: AE measure: PRO1 measure: PRO2 measure: PRO3 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan cancer hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610000 country: China name: Juan Li, MD role: CONTACT phone: 13880276636 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06361576 id: CA209-1443 briefTitle: Real-World Use of Nivolumab for the Treatment of Patients With Metastatic Upper Gastrointestinal Cancer in Canada overallStatus: COMPLETED date: 2023-09-05 date: 2024-01-25 date: 2024-01-25 date: 2024-04-12 date: 2024-04-12 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this observational study is to describe the demographics, and disease characteristics of participants with metastatic upper gastrointestinal cancer, along with the treatment characteristics of these patients when treated with nivolumab. conditions: Upper Gastrointestinal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 700 type: ACTUAL name: Nivolumab measure: Particpant sociodemographics measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant HER2 status measure: Participant comorbidities measure: Participant tumour location measure: Participant treatment history measure: Initial nivolumab dosage prescribed to participants measure: Number of nivolumab treatments received by participants measure: Planned combination chemotherapy treatment measure: Nivolumab treatment initiation date measure: Nivolumab dosage modification measure: Participant treatment duration measure: Reason for participant discharge measure: Participant adverse events (AEs) measure: Management of participant adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayshore Specialty Rx Ltd. city: Mississauga state: Ontario zip: L5K 2L3 country: Canada lat: 43.5789 lon: -79.6583 hasResults: False
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<|newrecord|> nctId: NCT06361563 id: CA209-1442 briefTitle: Real-World Use of Adjuvant Nivolumab in Patients With Upper Gastrointestinal Cancer in Canada overallStatus: COMPLETED date: 2023-09-05 date: 2024-01-25 date: 2024-01-25 date: 2024-04-12 date: 2024-04-12 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: The purpose of this observational study is to describe the patient, disease and treatment characteristics of eligible participants with upper gastrointestinal cancer treated with adjuvant nivolumab. conditions: Upper Gastrointestinal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 250 type: ACTUAL name: Nivolumab measure: Participant sociodemographics measure: Participant Eastern Cooperative Oncology Group (ECOG) score measure: Participant histology results measure: Participant comorbidities measure: Participant tumour location measure: Date of tumour resection measure: Participant primary upper gastrointestinal cancer diagnosis measure: Initial nivolumab dosage prescribed to participants measure: Number of nivolumab treatments received measure: Nivolumab dosage modification measure: Nivolumab treatment duration measure: Reason for participant discharge measure: Participant adverse events (AEs) measure: Management of participant adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bayshore Specialty Rx Ltd. city: Mississauga state: Ontario zip: L5K 2L3 country: Canada lat: 43.5789 lon: -79.6583 hasResults: False
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<|newrecord|> nctId: NCT06361550 id: AYTO_SALAMANCA_001 briefTitle: Nutritional Status Assessment and Dietary Recommendations Program (VENREDI) overallStatus: RECRUITING date: 2023-11-02 date: 2025-06-30 date: 2025-12-30 date: 2024-04-12 date: 2024-04-12 name: University of Salamanca class: OTHER name: Ayuntamiento de Salamanca briefSummary: Introduction: The Mediterranean diet has been related to beneficial effects in the prevention of cardiovascular diseases and other chronic pathologies related to diet, including some types of cancer. Specifically in the elderly population, it has been observed that the Mediterranean diet is inversely associated with all causes of mortality and that the greater the adherence to this type of diet, the lower the mortality in elderly adults.
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Objective: To evaluate the effect of a multifactorial intervention (seminar on shopping basket and food labeling, workshop on healthy cooking and subsequent tasting of the prepared products) in improving adherence to the Mediterranean diet in older adults.
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Methodology: Randomized controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be adults over 60 years of age, retired or pre-retired. A sample size of 200 participants has been estimated, 100 in each group to detect a difference of 0.83 points or more in the MEDAS questionnaire.
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All participants will receive an educational talk on healthy nutrition, with an estimated duration of 2 hours. The GI, in addition to this educational workshop, will receive a practical seminar on how to properly carry out the shopping cart. This will take place both in a market and later in a supermarket in Salamanca. In addition, a workshop will be held where participants will prepare a menu consisting of three dishes (starter, main and dessert) and will later taste them.
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An initial and post-intervention evaluation will be carried out after 3 months so that both groups can study the change variables related to Adherence to the Mediterranean Diet \[Mediterranean Diet Adherence Questionnaire (MEDAS)\], physical activity \[Short physical performance battery (SPPB)\], sleep quality (ATENAS questionnaire) and assessment of cognitive function (MOCA questionnaire). conditions: Adherence to the Mediterranean Diet studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: VENREDI group name: Health education measure: Adherence to the Mediterranean Diet measure: Physical activity measure: Sleep Quality measure: Cognitive function sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rosario Alonso Domínguez status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Rosario Alonso Domínguez, PhD role: CONTACT phone: 0034923294500 phoneExt: 3280 email: [email protected] lat: 40.96882 lon: -5.66388 hasResults: False
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<|newrecord|> nctId: NCT06361537 id: CONE-02 briefTitle: Phase 3 Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-12 date: 2025-12 date: 2024-04-12 date: 2024-04-12 name: Octapharma class: INDUSTRY briefSummary: Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks conditions: Acute Hereditary Angio Edema studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 124 type: ESTIMATED name: OCTA-C1-INH name: Placebo measure: Time (h) to beginning of unequivocal symptom relief at the defining site in blinded participants. measure: Percentage of participants responding to treatment measure: Time to beginning of unequivocal symptom relief at all sites involved measure: Changes in symptom severity at the defining site by VAS severity rating sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06361524 id: 44967 id: 5F32HL143916 type: NIH link: https://reporter.nih.gov/quickSearch/5F32HL143916 id: 856341 type: OTHER_GRANT domain: American Heart Association briefTitle: Gut Microbiome Profiling in Patients With Chronic Heart Failure overallStatus: ENROLLING_BY_INVITATION date: 2018-08-01 date: 2028-12 date: 2028-12 date: 2024-04-12 date: 2024-04-12 name: Stanford University class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) name: American Heart Association briefSummary: The goal of this observational study is to learn about the composition and function of the gut microbiome in adults with chronic heart failure with reduced ejection fraction. The main questions the study aims to answer are:
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1. How does the gut microbiome and its interactions with the host change over time in adults with chronic heart failure?
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2. How do these changes relate to heart failure disease severity and complications? conditions: Heart Failure With Reduced Ejection Fraction conditions: Nonischemic Cardiomyopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 150 type: ESTIMATED measure: Advanced heart failure-associated microbiome signatures measure: Temporal changes in the gut microbiome community composition in chronic heart failure measure: Comprehensive longitudinal metabolome profile in chronic heart failure measure: Comprehensive longitudinal cytokine profile in chronic heart failure measure: Longitudinal change in New York Heart Association (NYHA) functional class measure: Longitudinal change in the self-reported functional status sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Stanford University city: Stanford state: California zip: 94305-5210 country: United States lat: 37.42411 lon: -122.16608 hasResults: False
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<|newrecord|> nctId: NCT06361511 id: 2023H0284 briefTitle: The Foods & Oil to Repair, Correct and Enhance Strength (FORCES) Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2030-05-01 date: 2024-04-12 date: 2024-04-12 name: Ohio State University class: OTHER name: National Institutes of Health (NIH) briefSummary: The proposed research is a parallel arm, randomized placebo-controlled clinical trial designed to assess changes in muscle strength, volume, fatigue resistance, and mobility in older adults after daily consumption of 12g of linoleic acid-rich oil. conditions: Sarcopenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: High Linoleic Acid Foods name: High Oleic Acid Foods measure: Changes is leg extensor muscle strength measure: Changes in quadriceps muscle volume measure: Change in maximum leg press strength measure: Change in leg fatiguability measure: Change in muscle mitochondria function measure: Changes in cardiolipin species measure: Changes in grip strength measure: Changes in gait speed measure: Changes in chair rise time measure: Changes in stair climb power measure: Change in short physical performance battery score measure: change in blood fatty acids measure: Association of changes in plasma linoleic acid with muscle function measure: Association of changes in plasma linoleic acid with muscle strength measure: Association of changes in plasma linoleic acid with muscle volume measure: Association of changes 4-LA-cardiolipin with muscle function measure: Association of changes 4-LA-cardiolipin with muscle strength measure: Association of changes 4-LA-cardiolipin with muscle volume measure: Association of changes mitochondria function with muscle volume. measure: Association of changes mitochondria function with muscle function measure: Association of changes mitochondria function with muscle strength. sex: ALL minimumAge: 65 Years maximumAge: 80 Years stdAges: OLDER_ADULT facility: The Ohio State University city: Columbus state: Ohio zip: 43210 country: United States lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06361498 id: 23-3115 briefTitle: Ultrasound for Evaluation of Percutaneous G-tube Position overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-03 date: 2024-04-12 date: 2024-04-12 name: University of North Carolina, Chapel Hill class: OTHER briefSummary: The goal of this clinical trial is to compare using ultrasound imaging to look at the position of the gastrostomy tube (GT) against fluoroscopic imaging in pediatric patients who had a recent GT tube replacement.
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The main questions it aims to answer are:
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