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Rowing performance test will be conducted at the beginning and at the end of the training camp. Participants will perform a test on a rowing ergometer (Concept II, USA); each subject will have to cover a distance of 2000 m in the shortest possible time which is the distance starting in rowing competitions. The results of both tests will be considered in the selection for the championship team; therefore, athletes will be well motivated to perform both tests with maximum effort.
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Hypotesis:
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The krill oil will infleunce the gut barier integrity. conditions: Endothelial Dysfunction studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All competitors will be randomly divided into two groups (double-blind):
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A. supplemented (n = 15), who will receive one capsule of a supplement called THYROX (Atlantic krill oil) four times a day.
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B. control (n = 15) receiving placebo. The supplementation period will be six weeks. primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Triple whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: THYROX (Atlantic krill oil name: Placebo measure: I-FABP (intestinal fatty acid binding protein) measure: CLDN-3 measure: LBP (lipopolysaccharide binding protein) measure: Catechyloamines, cortisol measure: CD14 measure: Food intake sex: ALL minimumAge: 18 Years maximumAge: 24 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06271421 id: 01/24 briefTitle: NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme acronym: ANCHIALE overallStatus: RECRUITING date: 2024-01-01 date: 2027-02-01 date: 2027-09-01 date: 2024-02-21 date: 2024-02-26 name: Poznan University of Medical Sciences class: OTHER name: MagForce USA briefSummary: Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study.
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The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM.
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The main questions it aims to answer are:
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1. how NanoTherm therapy influences overall survival, and progression free survival;
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2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life.
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Participants will undergo:
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* initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life;
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* standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field;
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* between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation;
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* after the first activation (10th day), the catheter will be removed;
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* subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day;
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* for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed;
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* during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted.
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Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects. conditions: Glioblastoma Multiforme studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective longitudinal study will be performed recurrent glioblastoma multiforme patients who:
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1. are included for NanoTherm therapy (group A),
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2. are included for standard Stupp protocol (surgery/chemo-radiotherapy) (group B) primaryPurpose: TREATMENT masking: NONE maskingDescription: ANCHIALE is open-label study count: 100 type: ESTIMATED name: NanoTherm therapy name: Glioma Resection name: radiotherapy according to Stupp protocol name: chemotherapy according to Stupp protocol measure: Survival following the surgery [units months 1-24] measure: Progression free survival [units months 1-24] measure: Response Assessment in Neuro-oncology [1 - complete response; 4 -progressive disease] measure: EuroQuality of Life 5-dimensions-5 levels scale (EQ-5D-5L) [arbitraty units 0- worst ; 100 - best] measure: Neurologic Assessment in Neuro-Oncology (NanoScale 2) [0-best; 23-worst] measure: modified Rankin scale [0-best; 6-worst] measure: Barthel index [range 0-100; 0-best, 100-worst] sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital status: RECRUITING city: Poznań zip: 60-355 country: Poland name: Slawomir Michalak, Prof. role: CONTACT phone: +4861 8691 535 email: swami@ump.edu.pl name: Jakub Moskal, MD, PhD role: CONTACT phone: +4861 8691 422 email: jakub.moskal@usk.poznan.pl lat: 52.40692 lon: 16.92993 hasResults: False
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<|newrecord|> nctId: NCT06271408 id: POL-Xe-005 briefTitle: Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging overallStatus: RECRUITING date: 2024-02 date: 2024-04 date: 2024-04 date: 2024-02-21 date: 2024-02-21 name: Polarean, Inc. class: INDUSTRY name: Aerogen briefSummary: The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.
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Participants will:
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Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.
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Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.
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Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation). conditions: Chronic Obstructive Pulmonary Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 6 type: ESTIMATED name: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution name: Vibrating Mesh Nebulizer name: Metered Dose Inhaler name: Jet Nebulizer measure: Ventilation Defect Percent measure: Distribution of ventilated space measure: Membrane uptake of Xe 129 measure: Red blood cell Xe 129 transfer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Virginia Sheridan Snyder Translational Fontaine Research Unit status: RECRUITING city: Charlottesville state: Virginia zip: 22947 country: United States name: Roselove Roselove Nunoo-Asare role: CONTACT phone: 434-243-6074 email: rnn3b@virginia.edu lat: 38.02931 lon: -78.47668 hasResults: False
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<|newrecord|> nctId: NCT06271395 id: Chaoshengqiunang briefTitle: Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction overallStatus: RECRUITING date: 2024-02-28 date: 2024-10 date: 2024-10 date: 2024-02-21 date: 2024-03-07 name: Zeng Changhao class: OTHER briefSummary: Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations. conditions: Cricopharyngeal Achalasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Injectable Type A Botulinum Toxin measure: functional oral intake scale measure: Penetration-Aspiration Scale measure: The Fiberoptic Endoscopic Dysphagia Severity Scale measure: Murray secretion scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xinzhu Rehabilitation Hospital status: RECRUITING city: Xinzhu country: Taiwan name: Haim Liu role: CONTACT lat: 22.46205 lon: 120.47335 hasResults: False
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<|newrecord|> nctId: NCT06271382 id: AIBU-SBF-SA-05 briefTitle: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-02-15 date: 2025-02-15 date: 2024-02-21 date: 2024-02-21 name: Abant Izzet Baysal University class: OTHER briefSummary: This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes. conditions: Diabetes Mellitus, Type 2 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Acupressure Group name: Sham Acupressure Group name: Foot Ankle Exercise Group measure: Ankle Brachial Index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271369 id: CCTL019CUS13 briefTitle: Real-World HRU and Costs in DLBCL Pts With Tisa-cel and Axi-cel, a Medicare Study. overallStatus: COMPLETED date: 2022-08-11 date: 2023-02-15 date: 2023-02-15 date: 2024-02-21 date: 2024-02-21 name: Novartis Pharmaceuticals class: INDUSTRY briefSummary: This was a retrospective non-interventional cohort study design using the Centers for Medicare and Medicaid Services (CMS) 100% Medicare data (2015Q1-2020Q4).
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Eligible adult patients with r/r DLBCL who were treated with CAR-T therapy were identified from the CMS 100% Medicare data. Patients who received chimeric antigen receptor modified T cell (CAR-T) therapy were further classified into tisa-cel and axi-cel cohorts based on the type of CAR-T treatment received. The index date was defined as the date of tisa-cel or axi-cel therapy administration. Baseline period was defined as three months prior to the index date. Study period was defined from the index date to the end of health plan coverage based on insurance enrollment file or death, whichever occurred earlier. conditions: Diffuse Large B-cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 613 type: ACTUAL measure: Number of patients with IP admission measure: Number of IP admissions measure: IP days measure: Number of ICU stays measure: ICU days measure: Number of patients with OP visit measure: Number of OP visits measure: Number of patients with ER visit measure: Number of ER visits measure: Healthcare reimbursement costs measure: Overall survival (OS) measure: Time to next treatment (TTNT) or death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Novartis city: East Hanover state: New Jersey zip: 07936 country: United States lat: 40.8201 lon: -74.36487 hasResults: False
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<|newrecord|> nctId: NCT06271356 id: STU00220278 briefTitle: Breast Cancer - Navigate - Prospective Cohort overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-04 date: 2024-02-21 date: 2024-02-21 name: Northwestern University class: OTHER name: The Chrysalis Initiative briefSummary: The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.
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TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.
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Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach. conditions: Breast Cancer conditions: Quality of Life conditions: Chemotherapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: BC-Navigate measure: Demand of BC-Navi: Recruitment Rate measure: Demand of BC-Navi: Rentention Rate measure: Acceptability of BC-Navi measure: Preliminary Efficacy: Chemotherapy Initiation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States name: Diana Buitrago role: CONTACT phone: 312-503-2866 email: diana.buitrago@northwestern.edu lat: 41.85003 lon: -87.65005 hasResults: False
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<|newrecord|> nctId: NCT06271343 id: RC23_0394 briefTitle: Kidney Graft Tolerance KTOL acronym: KTOL overallStatus: RECRUITING date: 2024-03-20 date: 2026-03-01 date: 2026-06-01 date: 2024-02-21 date: 2024-03-21 name: Nantes University Hospital class: OTHER name: Institut National de la Santé Et de la Recherche Médicale, France briefSummary: Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.
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The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.
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The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens. conditions: Kidney Transplant Tolerance studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 15 type: ESTIMATED measure: To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection. measure: Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones. measure: Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nantes University Hospital status: RECRUITING city: Nantes state: Loire-Atlantique zip: 44093 country: France name: Christophe MASSET, PH role: CONTACT phone: 33 2 76 64 39 61 email: christophe.masset@chu-nantes.fr lat: 47.21725 lon: -1.55336 hasResults: False
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<|newrecord|> nctId: NCT06271330 id: AP_JBD_FarWest_004 briefTitle: Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD. acronym: FAR-WEST overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-09 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER name: Rennes University Hospital briefSummary: Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \[1\] and aflibercept \[2\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \[3\] is that it extends the injection interval in the Treat and Extend (T\&E) protocol, which is more extensive than with previous anti-VEGF agents.
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The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.
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As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication. conditions: AMD studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Faricimab measure: Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment. measure: Difference between time to recurrence before switch and after switch. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ducloyer city: Nantes zip: 44000 country: France name: Jean-Baptiste Ducloyer, MD role: CONTACT phone: 02 40 08 46 51 email: jeanbaptiste.ducloyer@chu-nantes.fr name: Yann Maucourant, MD role: CONTACT phone: 85 658 email: Yann.MAUCOURANT@chu-rennes.fr lat: 47.21725 lon: -1.55336 hasResults: False
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<|newrecord|> nctId: NCT06271317 id: AP_CL_001 briefTitle: Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-03 date: 2027-03 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique conditions: Obesity studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Study postoperative morbidity after nissen sleeve gastrectomy in Nantes measure: postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271304 id: BLUES briefTitle: Stabilizing Mood and Sleep With Blue Blocking Eyewear in Bipolar Disorder acronym: BLUES overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2026-03-01 date: 2026-06-01 date: 2024-02-21 date: 2024-04-17 name: Mental Health Services in the Capital Region, Denmark class: OTHER briefSummary: The study investigates whether add-on treatment with eyewear that blocks the short wavelengths of visible light (\<500nm) reduces manic symptoms and improves sleep in patients receiving outpatient treatment as usual for bipolar disorder.
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When in a hypomanic or manic phase, participants will be randomized to receive add-on treatment with either blue blocking or low filtration eyewear from 18 PM to 8 AM daily for 7 days.
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After this initial intervention phase, the eyewear is used daily for 3 months in either antimanic dose (14 hours) or maintenance dose (2 hours before bedtime). conditions: Bipolar Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Outcome assessors will be blinded to the treatment assignment. At the beginning of each assessment, participants will be instructed not to describe or discuss their glasses with the assessor. Because the two types of glasses are of different color (clear (LF) and orange (BB)), we cannot guarantee a full blinding of the participants. Participants will be informed that we are studying the effects of two different types of light filters without more detail so they will not be provided with certain knowledge of which condition is expected to yield the largest effect. We will assess the integrity of the blind by asking participants whether they think they received glasses with high or low filtration lenses at the end of the study. Participants will be discouraged from actively seeking information about sleep glasses during the study primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Participants are instructed not to discuss the appearance of their designated eyewear with their care providers or the investigator or outcome assessor. Participants are not informed of the exact filtration level of their eyewear. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: Blue blocking eyewear name: Low filtration eyewear measure: Manic symptoms measure: Mood instability measure: Objective sleep quality measure: Objective sleep quality measure: Subjective sleep quality measure: Subjective sleep quality sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06271291 id: 23-000161 id: NCI-2024-00504 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-000161 type: OTHER domain: Mayo Clinic in Rochester id: P30CA015083 type: NIH link: https://reporter.nih.gov/quickSearch/P30CA015083 id: U01CA210138 type: NIH link: https://reporter.nih.gov/quickSearch/U01CA210138 id: U24CA274496 type: NIH link: https://reporter.nih.gov/quickSearch/U24CA274496 briefTitle: Pancreatic Cancer Detection Consortium (PCDC) Prospective Cohorts overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2029-05-01 date: 2024-02-21 date: 2024-03-20 name: Mayo Clinic class: OTHER name: National Cancer Institute (NCI) briefSummary: This study evaluates individuals without pancreatic cancer, but who have been determined to be at higher-than-average lifetime risk of developing pancreatic cancer to help detect pancreatic cancer or other cancers at an earlier time when they might be more easily treated and cured. conditions: Pancreatic Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 15000 type: ESTIMATED name: Non-Interventional Study measure: Develop a biobank of biospecimens and data of subjects without pancreatic cancer who are at high risk for pancreatic cancer measure: Follow subjects longitudinally and collect biospecimens and follow-up data and record medical outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, Ph.D. role: CONTACT phone: 626-256-4673 phoneExt: 85200 name: Ajay Goel, Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Shounak Majumder, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: University of Pittsburgh city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Randall Brand, M.D. role: CONTACT phone: 412-864-7516 lat: 40.44062 lon: -79.99589 hasResults: False
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<|newrecord|> nctId: NCT06271278 id: 2023-17 briefTitle: The Effect of Emotional Freedom Techniques Application on Nurses overallStatus: RECRUITING date: 2023-11-02 date: 2024-02-28 date: 2024-02-28 date: 2024-02-21 date: 2024-02-22 name: Gurkan KAPIKIRAN class: OTHER briefSummary: Nurses working in surgical intensive care units face numerous health and safety stressors. The introduction of new health technologies, medical devices (such as bedside monitors, pump and perfuser devices, and mechanical ventilators), and changing health environments have contributed to increased work stress among nurses. This, in turn, has had negative effects on their physical and mental health outcomes. One of the hazards associated with medical devices is alarm fatigue. Noise pollution caused by bells, beeps, and horns in intensive care units can lead to alarm fatigue, defined as desensitisation to monitor alarms. Nurses are particularly susceptible to this due to their constant exposure to these sounds, which can also cause stress. Occupational stress is a recognised issue in this demanding field, characterised by disproportionate workloads and negative effects on performance.Work-related stress can lead to a loss of compassion towards patients and an increase in malpractice, negatively affecting the quality of care. Thus, this study aimed to investigate the impact of applying emotional freedom techniques on work-related stress and alarm fatigue experienced by nurses working in surgical intensive care units. conditions: Occupational Stress conditions: Alert Fatigue, Health Personnel studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study was conducted as a randomised controlled study with experimental and control groups. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Participants will be blinded to their group assignment. The subjects will be selected in a randomized order using software. Data collection will be conducted without involvement from research analysts. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 144 type: ESTIMATED name: Emotional Freedom Technique measure: Subjective Units of Disturbance Scale measure: Alarm Fatigue Scale measure: The General Work Stress Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inonu University Turgut OzaL Medical Center status: RECRUITING city: Malatya zip: 44090 country: Turkey name: Turgut Ozal Medical Center role: CONTACT phone: +904223770100 email: totm@inonu.edu.tr role: CONTACT email: gurkankpkrn@gmail.com name: Gurkan Kapikiran, Ph.D role: PRINCIPAL_INVESTIGATOR name: Seher Çevik Aktura, Ph.D role: SUB_INVESTIGATOR name: Şerafettin Okutan, Ph.D role: SUB_INVESTIGATOR name: Remziye Cici, Ph.D role: SUB_INVESTIGATOR lat: 38.35018 lon: 38.31667 hasResults: False
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<|newrecord|> nctId: NCT06271265 id: 402-C-125 briefTitle: Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-07 date: 2025-07 date: 2024-02-21 date: 2024-02-21 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA). conditions: Postoperative Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: EXPAREL name: bupivacaine measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: The following model-predicted PK endpoint will be determined: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Vitals change from Baseline: measure: Incidence of treatment-emergent adverse events (TEAEs) measure: Incidence of adverse events of special interest (AESIs) measure: Incidence of serious adverse events (SAEs) sex: ALL minimumAge: 0 Years maximumAge: 6 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06271252 id: OriCAR-017 US-P1 briefTitle: A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-12-01 date: 2026-04-01 date: 2024-02-21 date: 2024-04-16 name: OriCell Therapeutics Co., Ltd. class: INDUSTRY briefSummary: The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma.
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RIGEL Study conditions: Neoplasms, Plasma Cell conditions: Neoplasms by Histologic Type conditions: Neoplasms conditions: Hemostatic Disorders conditions: Vascular Diseases conditions: Cardiovascular Diseases conditions: Paraproteinemias conditions: Blood Protein Disorders conditions: Hematologic Diseases conditions: Hemorrhagic Disorders conditions: Lymphoproliferative Disorders conditions: Immunoproliferative Disorders conditions: Immune System Diseases conditions: Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 81 type: ESTIMATED name: OriCAR-017 measure: Maximum tolerated dose (MTD) of OriCAR-017 US-P1 measure: Dose-limiting toxicity (DLT) measure: Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM measure: Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM measure: Assessment of Duration of Response (DOR) of treatment in patients with RR/MM measure: Progress-Free Survival (PFS) of treatment in patients with RR/MM measure: Assessment of Overall Survival (OS) of treatment in patients with RR/MM measure: Assessment of MRD negative Rate measure: Assessment of Overall Response Rate (ORR) measure: Assessment of Disease Control Rate (DCR) measure: Assessment of Clinical Benefit Rate (CBR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northside Hospital city: Atlanta state: Georgia zip: 30342 country: United States name: Melhem Solh role: CONTACT email: msolh@bmtga.com name: Caitlin Guzowski role: CONTACT email: caitlin.guzowski@northside.com lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06271239 id: U1111-1299-9167 id: 65318722.0.0000.5336 type: OTHER domain: IRB-Pontifical Catholic University of Rio Grande do Sul id: RBR-2tq2jky type: OTHER domain: The Brazilian Registry of Clinical Trials (ReBEC) briefTitle: Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2025-03-30 date: 2024-02-21 date: 2024-02-21 name: Pontificia Universidade Católica do Rio Grande do Sul class: OTHER name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. briefSummary: This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.
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In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.
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Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months. conditions: Frailty conditions: Aging conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.
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The Group Suggestions for a Healthy Life (CG) will receive exercise suggestions and guidance for maintaining a healthy routine for three months. After, they will undergo a three-month intervention using the VIVIFRAIL® protocol.
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Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.
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Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The assessments will be conducted by trained researchers whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Intervention group (ViviFrail) name: Group Suggestions for a Healthy Life (CG) measure: Short physical performance battery measure: Barthel Index measure: ICOPE questionnaire measure: Lawton Scale measure: 4-meter gait speed measure: Five Times Sit-to-Stand measure: Balance test in three positions measure: Self-perceived health measure: Adverse health outcomes - falls measure: Adverse health outcomes - hospitalization measure: Adverse health outcomes - institutionalization sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06271226 id: OMUKAEK 2022/75 id: OMUKAEK 2022/75 type: OTHER domain: ONDOKUZ MAYIS UNIVERSTY briefTitle: The Effect of Acupressure Applied to Icu on Pain and Physiological Parameters acronym: EFFECTOFACU overallStatus: RECRUITING date: 2023-03-20 date: 2024-06-30 date: 2024-12-31 date: 2024-02-21 date: 2024-02-21 name: Ondokuz Mayıs University class: OTHER briefSummary: The aim of this experimental study is to determine the effect of acupressure applied to intensive care patients on pain and physiological parameters (blood pressure, heart rate, respiration and oxygen saturation).
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The main questions that the study aims to answer are:
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Acupressure applied to intensive care patients has no effect on pain. Acupressure applied to intensive care patients has an effect on pain. Acupressure applied to intensive care patients has no effect on physiological parameters.
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Acupressure applied to intensive care patients has an effect on physiological parameters.
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Participants will be included in the study after obtaining consent from patients who were treated in the intensive care unit, who scored 9 and above on the glaskow coma scale by evaluating their consciousness status, and had pain after evaluating their pain. conditions: Intensive Care Patients conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Since there will be variability in patient admissions to intensive care units, block randomization will be used. Three different groups will be coded with different letters (A,B,C) and blocks will be created. Then randomization will be performed by assigning random numbers on the computer. The letters determined in the randomization will be written in closed envelopes and stored, and the randomization process will be carried out by an independent researcher. After the patient who meets the inclusion criteria is identified, the independent researcher will be contacted to find out which group the patient is in. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: participant and statistical analysis expert is blind. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: acupressure name: placebo acupressure name: control group measure: neurological evaluation measure: evaluation of pain measure: evaluation of physiological parameters measure: evaluation of physiological parameters sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Giresun Eğitim Araştırma Hastanesi status: RECRUITING city: Giresun zip: 28000 country: Turkey name: emine yaman lezki role: CONTACT phone: +9005458026622 email: e_yaman95@hotmail.com lat: 40.91698 lon: 38.38741 hasResults: False
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<|newrecord|> nctId: NCT06271213 id: 303841 briefTitle: The Gut-Lung Axis and Respiratory Illness in Children overallStatus: RECRUITING date: 2024-02-04 date: 2027-11-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: NHS Greater Glasgow and Clyde class: OTHER name: University of Glasgow briefSummary: The goal of this single-centre observational study conducted at the Royal Hospital for Children in Glasgow, Scotland, is to employ a multi-omics approach to investigate the "gut-lung axis" in health and disease.
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Part A is a cross-sectional study design investigating the postulated bidirectional link between the gut and lung microbiomes in children suffering from respiratory or gastrointestinal conditions. Children with no GI or respiratory issues attending for orthopaedic care will be used as a benchmark for a healthy gut-lung axis. The main questions we aim to answer are:
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* What does a healthy gut-lung axis look like?
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* Do children with respiratory issues show an altered gut microbiome?
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