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2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;
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3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis conditions: AL Amyloidosis conditions: Smoldering Multiple Myeloma conditions: Monoclonal Gammopathy of Undetermined Significance studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 760 type: ESTIMATED name: no intervention measure: Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient measure: Assess the proportion of patients with deep haematological response after frontline therapy (best response evaluation) in the new enhanced, contemporary, real-world series of AL patients enrolled during the study. measure: 3. Identify associations of clonal light chain features with different clinical features at baseline. measure: Description of the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening measure: Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR measure: Identification of clinical and biological correlates of hematological response measure: To verify whether implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers measure: Identification of associations of clonal light chain features with event-free survival measure: Validation of existing algorithms for predicting AL amyloidosis status sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Policlinico Consorziale status: RECRUITING city: Bari country: Italy name: PELLEGRINO MUSTO, MD role: CONTACT phone: 080 5593471 email: [email protected] name: PELLEGRINO MUSTO, MD role: PRINCIPAL_INVESTIGATOR name: Angela Minervini, MD, PhD role: SUB_INVESTIGATOR lat: 41.11148 lon: 16.8554 facility: Azienda Ospedaliero Universitaria Policlinico G.Rodolico - San Marco status: RECRUITING city: Catania country: Italy name: Francesco Di Raimondo, MD role: CONTACT phone: 095/378.1956 email: [email protected] name: Francesco Di Raimondo, MD role: PRINCIPAL_INVESTIGATOR name: Concetta Maria Sebastiana Conticello, MD, PhD role: SUB_INVESTIGATOR lat: 37.49223 lon: 15.07041 facility: Fondazione Irccs Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: GIOVANNI PALLADINI, MD, PhD role: CONTACT phone: +390382502994 email: [email protected] name: GIOVANNI PALLADINI, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Luca Arcaini, MD role: PRINCIPAL_INVESTIGATOR name: Mario Ulisse Nuvolone, MD, PhD role: SUB_INVESTIGATOR lat: 45.19205 lon: 9.15917 facility: EMATOLOGIA - Città della Scienza e Salute - Torino status: RECRUITING city: Torino country: Italy name: FRANCESCA MARIA GAY, MD, PhD role: CONTACT phone: 011.633.5550 - 5935 email: [email protected] name: FRANCESCA MARIA GAY, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Stefania Oliva, MD, PhD role: SUB_INVESTIGATOR lat: 45.07049 lon: 7.68682 hasResults: False
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<|newrecord|> nctId: NCT06383130 id: 24SM8792 briefTitle: London Asthma Diagnostics Study acronym: LADS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-07 date: 2024-04-25 date: 2024-04-25 name: Imperial College London class: OTHER name: Asthma UK name: General Practitioners Research Institute briefSummary: The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:
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- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?
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Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.
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Participants will
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* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit
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* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma
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* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry conditions: Asthma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 225 type: ESTIMATED name: Oscillometry with reversibility testing name: Breath volatile testing name: Nasal eosinophil peroxidase name: Handheld capnometry measure: To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO measure: To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO measure: To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) measure: To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests measure: To evaluate the diagnostic accuracy of the targeted reactive aldehyde species (RASP) panel in breath for asthma diagnosis measure: To evaluate the diagnostic accuracy of nasal biomarker eosinophil peroxidase (EPX) measure: To evaluate the diagnostic accuracy of tidal breath CO2 waveforms using the N-Tidal handheld capnometry device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust city: London zip: W2 1PG country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Imperial College Healthcare NHS Trust city: London zip: W21NY country: United Kingdom name: Eleanor Quek, MBBS role: CONTACT phone: 07411429994 email: [email protected] name: Salman Siddiqui, PhD role: CONTACT email: [email protected] name: Salman Siddiqui, PhD role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Nottingham University Hospitals NHS Trust city: Nottingham zip: NG7 2UH country: United Kingdom name: Matthew Martin, PhD role: CONTACT email: [email protected] name: Matthew Martin, PhD role: SUB_INVESTIGATOR lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06383117 id: UL1TR002378 type: NIH link: https://reporter.nih.gov/quickSearch/UL1TR002378 id: KL2TR002381 type: NIH link: https://reporter.nih.gov/quickSearch/KL2TR002381 briefTitle: Understanding Effects of Calcium on the Gut-Bone Axis overallStatus: COMPLETED date: 2023-10-17 date: 2024-02-23 date: 2024-02-23 date: 2024-04-25 date: 2024-04-25 name: University of Georgia class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: The study team is inviting 13 healthy people to complete a study to explore how calcium affects hormones and bones after eating. Participants will be asked to complete two study visits within eight weeks. Before each visit, participants will be asked to not eat or drink (except water) for 9 hours. At each visit, participants will eat the same meal provided by the research team. Along with their meal, they will take a pill - in one session, this will be a calcium supplement, and in the other, a placebo (a pill with no calcium), but they won't know which one they are taking at which session. A phlebotomist will draw blood before the meal and pill, then again several times after eating. Blood draws will take place over three hours. During that time, participants will complete questionnaires about health, diet, and physical activity.
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Blood will be analyzed to check on various health indicators, like bone health markers and certain hormones, to see how they change after the meal. The difference in these health indicators between the calcium and placebo sessions will help the study team understand the impact of calcium on health after eating. This could help increase knowledge of the impact of calcium on hormones and bone health. conditions: Healthy conditions: Adult conditions: Calcium conditions: Bone Resorption conditions: Endocrine; Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized placebo crossover trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Investigator, participants, team distributing pills blinded to treatment arm whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 14 type: ACTUAL name: Calcium carbonate name: Placebo Control measure: Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo measure: Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo measure: Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo measure: Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo measure: Difference in insulin area under the curve between calcium and placebo measure: Difference in glucose area under the curve between calcium and placebo measure: Difference in PTH (parathyroid hormone) area under the curve between calcium and placebo sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: University of Georgia Clinical and Translational Research Unit city: Athens state: Georgia zip: 30606 country: United States lat: 33.96095 lon: -83.37794 hasResults: False
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<|newrecord|> nctId: NCT06383104 id: MyoLupus briefTitle: Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus. overallStatus: RECRUITING date: 2024-04-22 date: 2024-05-28 date: 2024-06-26 date: 2024-04-25 date: 2024-04-25 name: Universidad Católica San Antonio de Murcia class: OTHER briefSummary: Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.
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Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.
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Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.
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Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue. conditions: System; Lupus Erythematosus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Intervention measure: Change from baseline joint pain after treatment and at 4 weeks measure: Change from baseline functional capacity after treatment and at 4 weeks measure: Change from baseline functionality after treatment and at 4 weeks measure: Change from baseline joint pain after treatment and at 4 weeks sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Universidad Católica San Antonio, Murcia status: RECRUITING city: Murcia zip: 30107 country: Spain name: RUBEN CUESTA-BARRIUSO, PhD role: CONTACT phone: +34 968278545 email: [email protected] lat: 37.98704 lon: -1.13004 hasResults: False
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<|newrecord|> nctId: NCT06383091 id: IRB00380938 briefTitle: Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy acronym: Man Total Thy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-12 date: 2026-12 date: 2024-04-25 date: 2024-04-25 name: Johns Hopkins University class: OTHER briefSummary: In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.
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The main questions it aims to answer are:
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Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?
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Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?
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Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?
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Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy?
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Participants will:
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Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.
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Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.
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Complete a journal of the participant's Home Exercise Practice conditions: Total Thyroidectomy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is meant to be a parallel study. However, The Speech Language Pathologists will not be blinded as the Speech Pathologists are providing each regimen. If a participant in either group requires more intensive sessions or a differing regimen given the severity of complaints, the participants will receive it as per the recommendation of the Speech-Language Pathologist so as not to unblind the PI. An intent to treat analysis will be performed to accurately describe the data in the case of crossover and/or dropout. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: Anterior Neck Manual Therapy name: Pain Neuroscience Education name: Neck Stretches name: Scar massage name: Voice Exercises name: Placebo Anterior Neck Manual Therapy name: Placebo Pain Neuroscience Education name: Placebo Neck Stretches measure: Acoustic measures of voice clarity measure: Acoustic measures of speaking voice pitch measure: Acoustic measures of speaking voice quality subjectively measure: Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10 measure: Laryngeal sensation measure: Scar Tethering Distance measure: Scar Quality as assessed by The Patient and Observer Scar Assessment Scale measure: Voice Quality of Life as measures by the Voice Related Quality of Life - 10 measure: Adverse Effects in the Experimental Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Johns Hopkins Hospital city: Baltimore state: Maryland zip: 21287 country: United States name: Claire Ligon, Masters of Education role: CONTACT phone: 434-390-6387 email: [email protected] name: Kristine Pietsch, Masters of Arts role: CONTACT phone: 518-461-3610 email: [email protected] name: Claire Ligon, Masters of Education role: SUB_INVESTIGATOR name: Kristine Pietsch, Masters of Arts role: SUB_INVESTIGATOR name: Michelle Wilson, Masters of Science role: SUB_INVESTIGATOR lat: 39.29038 lon: -76.61219 facility: Suburban Hospital city: Bethesda state: Maryland zip: 20817 country: United States name: Claire Ligon, Masters of Education role: CONTACT phone: 434-390-6387 email: [email protected] name: Vaninder Dhillon, Medical Doctor role: CONTACT phone: 925-360-5939 email: [email protected] name: Vaninder Dhillon, Medical Doctor role: PRINCIPAL_INVESTIGATOR name: Claire Ligon, Masters of Education role: SUB_INVESTIGATOR name: Michelle Wilson, Masters of Science role: SUB_INVESTIGATOR lat: 38.98067 lon: -77.10026 hasResults: False
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<|newrecord|> nctId: NCT06383078 id: MA-PC-II-012 briefTitle: HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-03-01 date: 2027-12-30 date: 2024-04-25 date: 2024-04-25 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer. conditions: Efficacy and Safety studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: HR070803 name: Oxaliplatin name: Tegafur name: Folinic acid name: 5-Fluorouracil measure: 1-year Disease-free survival rate measure: Overall survival (OS) measure: Disease-free survival（DFS） sex: ALL minimumAge: 20 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06383065 id: YDU/2020/76-1007 briefTitle: Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery overallStatus: COMPLETED date: 2020-02-01 date: 2021-04-30 date: 2022-01-30 date: 2024-04-25 date: 2024-04-25 name: Near East University, Turkey class: OTHER briefSummary: The aim of this study is to investigate the early effects of Inspiratory Muscle Training (IMT) applied before and after bariatric surgery on respiratory function, respiratory muscle strength and functional capacity in individuals with type 2 diabetes.
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The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65. Individuals will be randomly assigned to the IMT (trained at 30% of maximum inspiratory pressure with an IMT threshold device) and control group. As measurement parameters, a 6-minute walk test for functional capacity, a spirometry test for respiratory function, and a portable device (Cosmed Pony FX Desktop Spirometer, USA) will be used for respiratory muscle strength. Hand grip strength will be measured with a Baseline dynamometer. All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery. conditions: Type 2 Diabetes conditions: Bariatric Surgery Candidate studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ACTUAL name: IMT Group measure: Respiratory Muscle Strength measure: Respiratory Function measure: Functional Capacity: The 6-minute walk test measure: Hand Grip Strength sex: ALL minimumAge: 25 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Near East University city: Nicosia country: Cyprus lat: 35.17531 lon: 33.3642 hasResults: False
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<|newrecord|> nctId: NCT06383052 id: NYM032Z01 briefTitle: A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC overallStatus: RECRUITING date: 2024-04-30 date: 2024-11-30 date: 2024-11-30 date: 2024-04-25 date: 2024-04-25 name: Norroy Bioscience Co., LTD class: INDUSTRY briefSummary: 177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA. conditions: Metastatic Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: 177Lu-NYM032 injection measure: Number of Patients With Dose Limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affliated Hospital of Jiangnan University status: RECRUITING city: Wuxi zip: 214000 country: China name: Chunjing Yu role: CONTACT phone: 15312238622 email: [email protected] lat: 31.56887 lon: 120.28857 hasResults: False
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<|newrecord|> nctId: NCT06383039 id: ZSoy briefTitle: Transcranial Direct Current Stimulation and Balance acronym: tDCS overallStatus: COMPLETED date: 2022-05-16 date: 2022-09-06 date: 2023-05-13 date: 2024-04-25 date: 2024-04-25 name: Zeynep Soy class: OTHER briefSummary: Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals. conditions: Balance studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: All participants received 3 different interventions at different times. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Participants were not informed which type of current was applied. whoMasked: PARTICIPANT count: 30 type: ACTUAL name: Transcranial Direct Current Stimulation measure: Demographic Information Form measure: Wii-Fit measure: balance error scoring system measure: star excursion balance test measure: Time Up & Go Test sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul Medipol University city: Istanbul state: Beykoz country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06383026 id: PRO00047199 briefTitle: Transgender and Gender-Diverse Breast Cancer Screening Pilot overallStatus: RECRUITING date: 2024-04-17 date: 2027-12 date: 2028-02 date: 2024-04-25 date: 2024-04-25 name: Medical College of Wisconsin class: OTHER briefSummary: This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED name: Breast Cancer Screening name: Survey/Interview name: Focus Group measure: Callback and Biopsy Rates after Breast Cancer Screening measure: Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons measure: Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening sex: ALL minimumAge: 30 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical College of Wisconsin status: RECRUITING city: Milwaukee state: Wisconsin zip: 53226 country: United States name: Chandler S Cortina, MD, MS role: CONTACT email: [email protected] lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06383013 id: BB-101-BBCBB1A briefTitle: Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers overallStatus: RECRUITING date: 2024-02-29 date: 2027-12-31 date: 2028-12-31 date: 2024-04-25 date: 2024-04-25 name: Blue Blood Biotech Corp. class: INDUSTRY briefSummary: This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer. conditions: Diabetic Foot Ulcer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 96 type: ESTIMATED name: BB-101 measure: Efficacy Evaluation measure: Safety Evaluation measure: Secondary Efficacy Evaluation measure: Exploratory Objectives sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare status: RECRUITING city: Taipei country: Taiwan name: Shug-Cheng Chang, MD role: CONTACT lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06383000 id: BLZ2024MOH briefTitle: Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-25 date: 2024-04-25 name: BLZ Technology (Wuhan) Co.,Ltd class: INDUSTRY briefSummary: The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.
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Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.
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Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200. conditions: General Anesthesia conditions: Blood Pressure conditions: Pulse Rate conditions: Arterial Line studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 55 type: ESTIMATED measure: Continuous Non -invasive Blood Pressure Measurement from MOH200 measure: Invasive Blood Pressure Measurement from Arterial Line measure: Pulse Rate Measurement from MOH200 measure: Pulse Rate Measurement from Pulse Oximeter measure: The Occurrence of Pressure Pores sex: ALL minimumAge: 4 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06382987 id: IM011-1124 briefTitle: A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect) acronym: RePhlect overallStatus: RECRUITING date: 2024-01-22 date: 2029-12-31 date: 2029-12-31 date: 2024-04-25 date: 2024-04-25 name: Bristol-Myers Squibb class: INDUSTRY briefSummary: This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast. conditions: Plaque Psoriasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: Deucravacitinib name: Apremilast measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. measure: Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up measure: Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) measure: Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast measure: Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up measure: Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up measure: Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up measure: Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up measure: Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up measure: Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up measure: Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up measure: Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up measure: Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up measure: Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up measure: Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mebix. Inc. status: RECRUITING city: Minato-ku state: Tokyo zip: 1070052 country: Japan name: Minoru Tonogai, Site 0001 role: CONTACT lat: 34.2152 lon: 135.1501 facility: Fukuoka University Hospital status: RECRUITING city: Fukuoka country: Japan lat: 33.6 lon: 130.41667 hasResults: False
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<|newrecord|> nctId: NCT06382974 id: 3-3-14 briefTitle: Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-12 date: 2026-03 date: 2024-04-25 date: 2024-04-25 name: Cairo University class: OTHER briefSummary: This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects. conditions: Infection conditions: Bone Loss studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A case series study. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Cyst enucleation and bone grafting measure: Shrinkage Rate measure: Inflammation sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Cairo University city: Cairo country: Egypt role: CONTACT phone: 23634965 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06382961 id: SZUS_231101 briefTitle: Postoperative Dexmedetomidine in Prevention of Postoperative Delirium overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-11 date: 2024-03-06 date: 2024-04 date: 2024-04-25 date: 2024-04-25 name: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. class: INDUSTRY name: Shenzhen People's Hospital name: Dongyuan People's Hospital name: Kunming Children's Hospital briefSummary: The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :
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1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
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2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.
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Participants will undergo routine postoperative care:
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1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
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2. Postoperative visit twice a day for at least seven days conditions: Delirium in Old Age conditions: Anesthesia; Adverse Effect studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 287 type: ACTUAL name: Dexmedetomidine injection name: Sufentanil injection measure: Incidence of postoperative delirium measure: Incidence of postoperative nausea and vomiting measure: incidence of postoperative complications measure: Pain intensities sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Kunming Children's Hospital city: Kunming state: Yunnan zip: 650100 country: China lat: 25.03889 lon: 102.71833 hasResults: False
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<|newrecord|> nctId: NCT06382948 id: MedOPP545 id: 2024-512926-27-00 type: CTIS briefTitle: Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. acronym: ADELA overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-09 date: 2028-04 date: 2024-04-24 date: 2024-04-26 name: MedSIR class: OTHER name: Stemline Therapeutics, Inc. briefSummary: This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.
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The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.
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Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations. conditions: Advanced Breast Cancer conditions: ER-positive Breast Cancer conditions: HER2-negative Breast Cancer conditions: ESR1 Gene Mutation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, parallel group (two arms: elacestrant plus everolimus, and elacestrant plus placebo). primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: A blinded, independent IRC will perform a review of radiographic images and clinical information collected on study to determine the protocol-defined endpoints of disease response and progression. Further information on the independent review process will be provided in the BIRC Charter. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 240 type: ESTIMATED name: Everolimus name: Elacestrant name: Placebo name: Auxiliary Medicinal Product - Dexamethasone name: Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues measure: To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients). measure: To compare overall survival (OS) between treatment groups, in all patients. measure: To compare investigator-assessed PFS based on local assessment between treatment groups, in all patients. measure: To compare objective response rate (ORR) between treatment groups, in all patients. measure: To compare clinical benefit rate (CBR) between treatment groups, in all patients. measure: To compare overall time to response (TTR) between treatment groups, in all patients. measure: To compare duration of response (DoR) between treatment groups, in all patients. measure: To compare best percentage of change in tumor burden between treatment groups, in all patients. measure: To describe the changes in health-related quality-of-life (HRQoL) from baseline using the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) scale. measure: To describe the changes in HRQoL from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). measure: To describe the changes in HRQoL from baseline using the EORTC Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR45). measure: To assess adverse events (AEs) between treatment groups in all patients. measure: To assess adverse events leading to study treatment withdrawal. measure: To assess adverse events leading to dose modification. measure: To assess the number of participants with abnormal hematology and/or chemistry values that are related to treatment. measure: To assess the number of participants with changes on vital signs and/or AEs that are related to treatment. measure: To assess the number of participants with changes on cardiac function measured by ECG QT Interval Corrected by Fridericia formula (QTcF) that are related to treatment effect . measure: To assess the number of participants with changes on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that are related to treatment. measure: Exploratory endpoint: protein expression studies using blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: analysis of allele mutation frequencies in circulating tumor DNA (ctDNA) in blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: Genetic studies using blood samples to investigate the potential association with clinical outcomes. measure: Exploratory endpoint: Analysis of medical imaging (radiomics) to identify potential biomarkers associated with clinical outcomes. measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of maximum (Peak) Observed Serum Concentration (Cmax). measure: Exploratory endpoint: Pharmacokinetic (PK) parameter of Plasma Through Concentration (Ctrough). sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06382935 id: 34-24 briefTitle: Impact of Non-surgical Periodontal Treatment of miRNome overallStatus: RECRUITING date: 2024-04-20 date: 2024-09-22 date: 2024-10-15 date: 2024-04-24 date: 2024-04-24 name: University of Catania class: OTHER briefSummary: A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid conditions: Periodontitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Non-surgical periodontal treatment Subgingival biofilm ultrasonic debridement with MINST or Q-SI primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Sealed envelopes whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Probin Pocket Depth reduction measure: Probing Pocket Depth sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico G. Rodolico status: RECRUITING city: Catania zip: 95124 country: Italy name: Gaetano Isola, DDS role: CONTACT phone: 0953785652 email: [email protected] lat: 37.49223 lon: 15.07041 hasResults: False
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<|newrecord|> nctId: NCT06382922 id: PAPAML022019 briefTitle: Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy overallStatus: RECRUITING date: 2023-03-29 date: 2024-07-30 date: 2025-06-01 date: 2024-04-24 date: 2024-04-29 name: University of Rome Tor Vergata class: OTHER briefSummary: In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \[43 probable (1.7%) and 13 proven (0.5%)\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).
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The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.
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In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP. conditions: Invasive Aspergillosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients measure: overall mortality rate sex: ALL minimumAge: 60 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tor Vergata University status: RECRUITING city: Roma state: RM zip: 00133 country: Italy name: Maria Ilaria Del Principe role: CONTACT phone: 3394080659 email: [email protected] lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06382909 id: 202302 briefTitle: Effect of Probiotic Compound K11T e K11TMax in ASD acronym: ASD overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-22 date: 2024-07-07 date: 2025-04-07 date: 2024-04-24 date: 2024-04-29 name: Deivis de Oliveira guimaraes class: NETWORK name: SENAI CIMATEC briefSummary: The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind, randomized, with placebo control primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 505 type: ACTUAL name: Inflammatory level name: Cognitive assessment name: Pedagogical assessment measure: Inflammation biomarker 1 measure: Inflammation biomarker 2 measure: Inflammation biomarker 3 measure: Inflammation biomarker 4 measure: Inflammation biomarker 5 measure: Neuropsychological Assessment measure: Psychiatric Assessment measure: Psychopedagogical Assessment measure: Comparative of outcomes between arm that took K11-T and arm that took K11-Tmax. sex: ALL minimumAge: 3 Years maximumAge: 11 Years stdAges: CHILD facility: Gon1 P&D city: Vitoria state: ES zip: 29050335 country: Brazil lat: -20.31944 lon: -40.33778 facility: Gon1 gestora de Projetos city: Vitória state: ES zip: 29050335 country: Brazil lat: -20.31944 lon: -40.33778 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-03-22 uploadDate: 2024-04-18T21:12 filename: Prot_000.pdf size: 369916 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-03-22 uploadDate: 2024-04-16T10:55 filename: ICF_001.pdf size: 192688 hasResults: False
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<|newrecord|> nctId: NCT06382896 id: FirstAHXiamenU-YB-2 briefTitle: Effect of Oliceridine on Rebound Pain overallStatus: RECRUITING date: 2024-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-24 date: 2024-04-25 name: The First Affiliated Hospital of Xiamen University class: OTHER briefSummary: The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors. conditions: Rebound Pain conditions: Arthroscopic Knee Surgery conditions: Oliceridine studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 320 type: ESTIMATED name: No intervention measure: Time of onset of postoperative rebound pain measure: The duration of the rebound pain measure: The degree of the rebound pain measure: age measure: sex measure: Surgical procedure measure: Previous surgical history measure: Movement recovery time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian zip: 361000 country: China name: Bin Yang, doctor role: CONTACT phone: 13859986036 email: [email protected] lat: 24.47979 lon: 118.08187 hasResults: False
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<|newrecord|> nctId: NCT06382883 id: FINELO2024 briefTitle: Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment acronym: ELO overallStatus: RECRUITING date: 2024-04-22 date: 2026-07-31 date: 2026-07-31 date: 2024-04-24 date: 2024-04-24 name: Filha ry class: OTHER name: University of Jyvaskyla name: Organisation for Respiratory Health in Finland name: Central Finland Hospital District briefSummary: The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity.
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The main questions the trial aims to answer are:
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* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA?
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* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA?
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* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior?
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Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group.
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In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group. conditions: Obstructive Sleep Apnea studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 300 type: ESTIMATED name: Individually tailored lifestyle and physical activity intervention name: Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) measure: Change in apnea-hypopnea-index (AHI) measure: Change on sleep apnea symptoms measure: Change in the mean daily total light physical activity time measure: Change in the mean daily total moderate to vigorous (MVPA) physical activity time measure: Change in the mean daily total sedentary time measure: Change in 6-minute walk distance (6MWD) in meters measure: Change in hand grip strength in kilograms measure: Change in waist circumference in centimeters measure: Change in body weight in kilograms measure: Change in visceral fat area (VFA) in square centimeters measure: Change in muscle mass in kilograms measure: Change in Quality of Life RAND 36-Item Health Survey sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Finland Hospital District status: RECRUITING city: Jyväskylä zip: 40620 country: Finland name: Merja Perhonen role: CONTACT email: [email protected] name: Antti Saarinen role: CONTACT email: [email protected] lat: 62.24147 lon: 25.72088 hasResults: False
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<|newrecord|> nctId: NCT06382870 id: 107.2023fbu briefTitle: Simulation-Based Training for Child Neglect and Abuse overallStatus: NOT_YET_RECRUITING date: 2024-05-29 date: 2024-06-15 date: 2024-06-29 date: 2024-04-24 date: 2024-04-24 name: Fenerbahce University class: OTHER briefSummary: Child abuse and neglect is a broad structure that includes physical abuse, sexual abuse, emotional abuse and neglect. Child neglect and abuse is one of the primary areas of responsibility of health professionals, which negatively affects child health and threatens public health in the long term. All healthcare professionals are legally obligated to report known or suspected cases of child abuse and neglect. Health professionals, in particular, play an important role in stopping child abuse by assessing children, identifying risk factors, and reporting suspected child maltreatment to authorities. Early diagnosis of a neglected and abused child is important in reducing the recurrence of maltreatment.
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Regarding the evaluation of child neglect and abuse, healthcare professionals should approach a child who presents with suspicious injuries, thinking that he or she may be abused. The key here is to be aware of the problem. Health professionals should carefully examine children and fulfill their responsibilities by identifying possible clues to abuse and neglect. It is recommended that clues to recognize neglect and abuse be taught within the scope of in-service training for healthcare professionals working in hospitals. conditions: Simulation-based Training studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 24 type: ESTIMATED name: education measure: The awareness level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06382857 id: 823779-MDF Niger briefTitle: Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition overallStatus: RECRUITING date: 2024-05-02 date: 2025-11-01 date: 2026-02-01 date: 2024-04-24 date: 2024-04-29 name: Epicentre class: OTHER name: Epicentre, Niger name: National Nutrition Direction, Niger name: Ministry of Public Health and Social Affairs, Niger name: Regional Direction of Public Health, Maradi briefSummary: This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission. conditions: Malnutrition, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 7356 type: ESTIMATED name: MDF name: RUTF name: RUSF measure: Programmatic recovery by 12 weeks from admission measure: Sustained recovery at 24 weeks from admission measure: Default measure: Non-response measure: Time to recovery measure: For MAM children: Deterioration to SAM measure: Change in weight gain measure: Change in weight-for-length Z (WLZ) measure: Change in length-for-age Z (LAZ) measure: Change in weight-for-age Z (WAZ) measure: Change in MUAC measure: Serious adverse events measure: Hospitalization measure: Death measure: Motor, cognitive, language, social-emotional, and mental health skills measure: Cost effectiveness measure: Dietary intake measure: Adherence measure: Microbiome profile at enrollment, week 4, program discharge, and study discharge measure: Plasma proteome profile at enrollment, week 4, program discharge, and study discharge measure: Environmental enteric dysfunction at enrollment, program discharge, and study discharge measure: Change of fat mass and fat-free mass at program discharge and study discharge measure: Micronutrient status at enrollment, program discharge and study discharge measure: Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only) sex: ALL minimumAge: 6 Months maximumAge: 23 Months stdAges: CHILD facility: Epicentre Niger status: RECRUITING city: Maradi country: Niger name: Ousmane Guindo, MD role: CONTACT email: [email protected] name: Ibrahim Ngoumboute, MD role: CONTACT email: [email protected] lat: 13.5 lon: 7.10174 hasResults: False
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<|newrecord|> nctId: NCT06382844 id: PI23/00486 id: PI2023 08 1416 type: REGISTRY domain: Ethics Committee for Drug Research of the Salamanca Health Area briefTitle: Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL overallStatus: RECRUITING date: 2024-01-01 date: 2026-09-30 date: 2026-12-31 date: 2024-04-24 date: 2024-04-25 name: Instituto de Investigación Biomédica de Salamanca class: OTHER name: Carlos III Health Institute briefSummary: Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry). conditions: Cutaneous T-Cell Lymphoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). measure: Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Instituto de Investigación Biomédica de Salamanca (IBSAL) status: RECRUITING city: Salamanca zip: 37007 country: Spain name: Ricardo López Pérez, PhD role: CONTACT phone: +34 923 29 12 00 phoneExt: 55144 email: [email protected] name: Esperanza López Franco, PhD role: CONTACT phone: +34 923 29 12 00 phoneExt: 55779 email: [email protected] lat: 40.96882 lon: -5.66388 hasResults: False
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<|newrecord|> nctId: NCT06382831 id: IndonesiaU240201 briefTitle: Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-08-01 date: 2024-10-01 date: 2024-04-24 date: 2024-04-24 name: Indonesia University class: OTHER briefSummary: Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery conditions: Anesthesia and Analgesia conditions: Anesthesia, Endotracheal studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 104 type: ESTIMATED name: Dexmedetomidine name: Fentanyl measure: Postoperative nausea and vomiting (PONV) measure: Pain score measure: Time to laryngeal mask exertion measure: Adverse effect sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06382818 id: PROICM 2023-10 PRO briefTitle: Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability acronym: PROBA overallStatus: NOT_YET_RECRUITING date: 2024-04-26 date: 2027-04-26 date: 2036-04-26 date: 2024-04-24 date: 2024-04-24 name: Institut du Cancer de Montpellier - Val d'Aurelle class: OTHER briefSummary: Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: * COHORT A = Low risk of recurrence / Low risk of breast toxicity
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* COHORT B = Low risk of recurrence / High risk of breast toxicity
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* COHORT C = High risk of recurrence / Low risk of breast toxicity
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* COHORT D = High risk of recurrence / High risk of breast toxicity primaryPurpose: TREATMENT masking: NONE count: 854 type: ESTIMATED name: COHORT A name: COHORT B name: COHORT C name: COHORT D measure: Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma measure: Acute toxicity measure: Late toxicity measure: Local recurrence rate (LRR) measure: Relapse-free survival (RFS) rate measure: Overall survival (OS) rate measure: Radiation-induced Breast Sarcoma prevalence sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institut Du Cancer de Montpellier city: Montpellier country: France name: MOUSSION AURORE role: CONTACT phone: 0467613102 email: [email protected] name: AZRIA DAVID role: PRINCIPAL_INVESTIGATOR name: MEGE ALICE role: PRINCIPAL_INVESTIGATOR name: BRETON-CALLU CHRISTEL role: PRINCIPAL_INVESTIGATOR lat: 43.61092 lon: 3.87723 hasResults: False
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<|newrecord|> nctId: NCT06382805 id: HasanKU_FTR_AA_02 briefTitle: Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-01 date: 2024-11-15 date: 2024-04-24 date: 2024-04-25 name: Hasan Kalyoncu University class: OTHER briefSummary: Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis. conditions: Tennis Elbow conditions: Physical Therapy conditions: Kinesiotaping conditions: Laser studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: There are three groups in the study. The groups consist of the control group, kinesio tape group and high intensity laser group primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Physiotherapy program name: Kinesio Tape name: High Intensity Laser therapy measure: Pain Measurement measure: Hand grip strength measure: Patient-Rated Tennis Elbow Evaluation measure: Pain Sensitivity Measurement sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Hasan Kalyoncu University city: Gaziantep zip: 27000 country: Turkey lat: 37.05944 lon: 37.3825 hasResults: False
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<|newrecord|> nctId: NCT06382792 id: 2024PI059 briefTitle: Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors overallStatus: ENROLLING_BY_INVITATION date: 2024-05-01 date: 2024-05-01 date: 2024-05-01 date: 2024-04-24 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).
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The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature). conditions: Shoulder Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 6 type: ESTIMATED name: proximal humeral resection for tumor and allograft prosthetic composite reconstruction measure: Osteolysis (bone stock in cm3) measure: Constant score measure: Complications measure: Revision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Hopital city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False
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<|newrecord|> nctId: NCT06382779 id: 2024PI057 briefTitle: Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite overallStatus: ENROLLING_BY_INVITATION date: 2024-04-15 date: 2024-05-01 date: 2024-05-01 date: 2024-04-24 date: 2024-04-24 name: Central Hospital, Nancy, France class: OTHER briefSummary: Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis. conditions: Shoulder Disease studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 32 type: ESTIMATED name: reverse shoulder arthroplasty measure: Constant score measure: complication measure: mortality measure: revision sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU - Centre chirurgical emile galle city: Nancy zip: 54000 country: France lat: 48.68439 lon: 6.18496 hasResults: False
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<|newrecord|> nctId: NCT06382766 id: SMU in malnutrition briefTitle: Skeletal Muscle Ultrasonography in Detection of Malnutrition overallStatus: NOT_YET_RECRUITING date: 2025-03 date: 2026-03 date: 2026-03 date: 2024-04-24 date: 2024-04-24 name: Assiut University class: OTHER briefSummary: * To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.
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* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools . conditions: Skeletal Muscle Ultrasonography studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: Skeletal Muscle Ultrasonography measure: accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools . sex: ALL minimumAge: 1 Month maximumAge: 5 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06382753 id: 20-24-PAR briefTitle: Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis overallStatus: RECRUITING date: 2024-04-20 date: 2024-06-30 date: 2024-06-30 date: 2024-04-24 date: 2024-04-24 name: University of Catania class: OTHER briefSummary: The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development. conditions: Gingivitis conditions: Periodontitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 150 type: ESTIMATED name: Gingival inflammation measure: Bleeding on Probing sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AOU Policlinico G. Rodolico status: RECRUITING city: Catania zip: 95124 country: Italy name: Gaetano Isola, DDS role: CONTACT phone: 0953785652 email: [email protected] lat: 37.49223 lon: 15.07041 hasResults: False
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<|newrecord|> nctId: NCT06382740 id: AOP2097 briefTitle: Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years acronym: Over70-LT overallStatus: RECRUITING date: 2022-10-01 date: 2025-10-01 date: 2025-10-01 date: 2024-04-24 date: 2024-04-24 name: Azienda Ospedaliera di Padova class: OTHER briefSummary: Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.
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This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years. conditions: End Stage Liver DIsease conditions: Liver Transplantation conditions: Old Age studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 18 type: ESTIMATED name: Liver transplantation measure: 1 year patient survival measure: 1 year graft survival measure: 3 months mortality and morbidity sex: ALL minimumAge: 71 Years maximumAge: 75 Years stdAges: OLDER_ADULT facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova status: RECRUITING city: Padova zip: 35128 country: Italy name: Umberto Cillo, MD role: CONTACT email: [email protected] lat: 45.40797 lon: 11.88586 hasResults: False
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<|newrecord|> nctId: NCT06382727 id: ER008 briefTitle: CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care acronym: CONTINUE overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2025-04 date: 2024-04-24 date: 2024-04-24 name: Emma Ridley class: OTHER briefSummary: Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.
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The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).
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The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.
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This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation. conditions: Critical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: CONTINUE is a multi-centre, open-label, prospective parallel, pilot randomised controlled trial being conducted in Australia. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 60 type: ESTIMATED name: EN will be continued up to extubation (EN will not be withheld prior to extubation) measure: Fasting time (hours) measure: Reintubation rate measure: Days alive and free of mechanical ventilation measure: Commencement of antibiotics measure: Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2) measure: ICU length of stay measure: In-hospital mortality measure: Nutrition delivery measure: Recruitment rate measure: Protocol compliance sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gold Coast University Hospital city: Southport state: Queensland zip: 4215 country: Australia name: James Mccullogh, Dr role: CONTACT lat: -27.96724 lon: 153.39796 facility: St Vincent's Hospital Melbourne city: Fitzroy state: Victoria zip: 3065 country: Australia name: Alastair Brown, Dr role: CONTACT lat: -37.79839 lon: 144.97833 facility: The Alfred Hospital city: Melbourne state: Victoria zip: 3004 country: Australia name: Emma Ridley, A/Prof role: CONTACT name: Sean Keem, Dr role: CONTACT lat: -37.814 lon: 144.96332 hasResults: False
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<|newrecord|> nctId: NCT06382714 id: 2023-12/13 briefTitle: Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2024-08-30 date: 2024-12-31 date: 2024-04-24 date: 2024-04-24 name: Cumhuriyet University class: OTHER briefSummary: The main purpose of dialysis used in the treatment of end-stage renal failure is; By relieving the patient from uremic symptoms, controlling excess fluid, electrolyte and acid base disorders, improving the well-being of the patients and also improving the quality of life of the patients. In addition to its contribution to the continuation of life, dialysis can significantly affect the biological and physiological balance and normal life order of patients. Some of these effects may be negative on patients. During this process, patients may frequently experience symptoms such as changes in fluid-electrolyte balance, increased fatigue, and weakness, as well as psychopathological conditions such as anxiety. In this context, it is extremely important to handle patients from a holistic perspective and keep their homeostatic balance under control during the hemodialysis process. In addition to pharmacological treatments, many integrative methods are used in the management of symptoms for reasons such as being low in cost, having fewer side effects than pharmacological treatments, and strengthening the immune system. Museum visit, one of these integrative treatment methods, has become an area of art therapy where help is received for various reasons such as coping with the symptoms of chronic diseases, reducing the side effects of medications, preventing mental depression, strengthening healthy behaviors, and avoiding tension and loss of control. In this context, the research was planned as a randomized controlled study investigating the effect of virtual museum tour on dialysis symptom index and anxiety in hemodialysis patients..T.R. The "https://sanalmuze.gov.tr" site belonging to the Ministry of Culture and Tourism will be shown to the patients five times and the virtual museum visit will be made by showing the patient's preferred museum five times among the 53 museums prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, and the Initiative Group, Control It will be compared with its group. Research data; It will be collected using the Patient Information Form, Dialysis Symptom Index and Beck Anxiety Scale (BAI). At the end of the study, the data will be evaluated in the SPSS program. The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension. conditions: DIALYSIS SYMPTOMS AND ANXIETY studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: For the intervention group, a museum visit with virtual reality glasses will be applied. measure: Dialysis Symptom Index (DSI) measure: Beck Anxiety Scale (BAI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mukadder city: Mollaoğlu state: Sivas zip: 58140 country: Turkey name: Mukadder Mollaoğlu, Prof Dr. role: CONTACT phone: 90 5055723985 email: [email protected] name: Songül Mollaoğlu, Assoc Prof role: CONTACT phone: 90 532 480 08 32 email: [email protected] lat: 39.70028 lon: 30.28306 hasResults: False
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<|newrecord|> nctId: NCT06382701 id: Kayseri briefTitle: Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation overallStatus: ACTIVE_NOT_RECRUITING date: 2021-09-06 date: 2024-06-30 date: 2024-06-30 date: 2024-04-24 date: 2024-04-24 name: TC Erciyes University class: OTHER briefSummary: The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety. conditions: Hemodialysis Patients studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was designed as a randomized controlled and double-blind study to evaluate the effect of clove oil applied to arterio-venous fistula on pain and anxiety caused by cannulation and to determine the effect of the application on satisfaction. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Pre-cannulation spray application to the intervention and placebo groups will be provided by an interviewer trained by the researchers. Cannulations will be performed by nurses in the institution where the study is conducted. Data will be collected by the responsible nurses in the institutions.
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Patients participating in the study, researchers, and the nurse in charge will not know who is in the intervention and placebo groups.
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The research will be completed in twelve sessions over four weeks. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: aromatherapy name: placebo measure: Visual Analog Scale (VAS) measure: State and Trait Anxiety Inventory (STAI) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erciyes University city: Melikgazi state: Kayseri zip: 38260 country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06382688 id: 23-08-0010 briefTitle: IV Administration of ChromaDex's Niagen® as Compared to NAD+ overallStatus: ACTIVE_NOT_RECRUITING date: 2023-11-13 date: 2024-03-08 date: 2024-08-31 date: 2024-04-24 date: 2024-04-24 name: Franklin Health Research class: OTHER briefSummary: This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV. conditions: Healthy Aging studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 53 type: ACTUAL name: NAD+ (nicotinamide adenine dinucleotide) IV name: Niagen® (nicotinamide riboside) IV name: Niagen® (nicotinamide riboside) oral name: Placebo measure: Blood Pressure measure: Heart rate measure: Total NAD measured through dried blood spot testing measure: Glucose measure: Insulin Levels measure: total NAD measured through blood and plasma measure: Tolerable Infusion Rate measure: Complete Blood Count measure: Comprehensive Metabolic Panel measure: Sleep Scale measure: Energy Scale measure: Subjective Experience sex: ALL minimumAge: 40 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nutraceuticals Research Institute city: Franklin state: Tennessee zip: 37067 country: United States lat: 35.92506 lon: -86.86889 hasResults: False
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<|newrecord|> nctId: NCT06382675 id: TA-PF-01-DE id: CIV-23-11-044643 type: OTHER domain: Unique identification number EUDAMED briefTitle: Clinical Performance of the New Plasma Filter PX2 in TPE Treatments acronym: plasmaFlux overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-03 date: 2024-04-24 date: 2024-04-24 name: Fresenius Medical Care Deutschland GmbH class: INDUSTRY name: KLIFO GmbH briefSummary: The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.
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The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment. conditions: Autoimmune Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Interventional, single arm, multi-centric, open-label primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 measure: Analysis of TPE treatments with the Plama Filter PX2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Klinikum Aschaffenburg-Alzenau city: Aschaffenburg state: Bavaria zip: 63739 country: Germany name: Stefan Büttner, Dr. med. role: CONTACT email: [email protected] lat: 49.97704 lon: 9.15214 facility: Städtisches Klinikum Braunschweig city: Braunschweig state: Niedersachsen zip: 38126 country: Germany name: Gabriele Eden, Dr. med. role: CONTACT email: [email protected] lat: 52.26594 lon: 10.52673 hasResults: False
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<|newrecord|> nctId: NCT06382662 id: PMDAC-01 briefTitle: Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants overallStatus: RECRUITING date: 2024-04-15 date: 2025-04-15 date: 2025-04-15 date: 2024-04-24 date: 2024-04-26 name: Primus Pharmaceuticals class: INDUSTRY name: Sun Valley Arthritis Center briefSummary: Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This is a prospective, randomized, single-blind, pilot study to assess degree of drowsiness, cognition, and driving risk following a single dose of oral metaxalone 640 mg (M640) versus metaxalone 800 mg in healthy subjects. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: metaxalone m640 name: Tizanidine measure: Change from baseline, Standard Deviation of Lateral Position measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test) measure: The number of product related adverse events experienced by participants from Visit 1 through Visit 4 sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Valley Arthritis Center status: RECRUITING city: Peoria state: Arizona zip: 85381 country: United States name: Study Investigator role: CONTACT phone: 623-566-3550 email: [email protected] name: Study Coordinator role: CONTACT phone: 623-566-3550 lat: 33.5806 lon: -112.23738 hasResults: False
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<|newrecord|> nctId: NCT06382649 id: 202403051 briefTitle: Rivastigmine for Antimuscarinic Delirium acronym: RIVA-AM overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-07 date: 2026-07 date: 2024-04-24 date: 2024-04-25 name: Washington University School of Medicine class: OTHER name: American Academy of Clinical Toxicology briefSummary: Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.
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Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo. conditions: Anticholinergic Toxicity studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 42 type: ESTIMATED name: Rivastigmine name: Placebo measure: Time to control of agitation and delirium measure: Duration of agitation and delirium measure: Total amount of sedatives administered measure: Use of sedative infusions measure: Use of physical restraints measure: Disposition measure: Time to medical clearance measure: Oversedation measure: Intubation measure: Seizure measure: Gastrointestinal upset measure: Bradycardia sex: ALL minimumAge: 10 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Kevin Baumgartner role: CONTACT phone: 314-273-1109 email: [email protected] lat: 38.62727 lon: -90.19789 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-10 uploadDate: 2024-04-19T15:42 filename: ICF_000.pdf size: 1060713 hasResults: False
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<|newrecord|> nctId: NCT06382636 id: 23-101 briefTitle: Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes acronym: OPUS overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-02-28 date: 2027-02-28 date: 2024-04-24 date: 2024-04-24 name: The Cleveland Clinic class: OTHER briefSummary: The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions.
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Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer. conditions: Prenatal Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 600 type: ESTIMATED name: Standard Care name: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot measure: Patient activation sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Neighborhood Family Practice city: Cleveland state: Ohio zip: 44102 country: United States name: Heidi Gullett, MD role: CONTACT phone: 216-368-0776 email: [email protected] lat: 41.4995 lon: -81.69541 facility: MetroHealth Medical Center city: Cleveland state: Ohio zip: 44109 country: United States name: Angela Ranzini, MD role: CONTACT phone: 216-778-3513 email: [email protected] lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic city: Cleveland state: Ohio zip: 44195 country: United States name: Ruth Farrell, MD, MA role: CONTACT phone: 216-445-7085 email: [email protected] name: Christina Collart, MEd role: CONTACT phone: 216-470-9796 email: [email protected] lat: 41.4995 lon: -81.69541 hasResults: False
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<|newrecord|> nctId: NCT06382623 id: 43 briefTitle: Efficacies of Different Managements in Patients With Trigger Finger overallStatus: COMPLETED date: 2022-10-01 date: 2023-06-30 date: 2023-06-30 date: 2024-04-24 date: 2024-04-24 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger. conditions: Trigger Finger studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: The percutaneous A1 pulley release name: The peritendinous Betamethasone group measure: Stage of the disease measure: Pain intensity measure: severity of triggering sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06382610 id: 2024-002 briefTitle: Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2024-12-15 date: 2024-12-15 date: 2024-04-24 date: 2024-04-24 name: University of Redlands class: OTHER briefSummary: Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body. conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Repeated measures crossover trial primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ESTIMATED name: Melatonin measure: Salivary melatonin level measure: Side effects sex: ALL minimumAge: 18 Years maximumAge: 22 Years stdAges: ADULT facility: University of Redlands city: Redlands state: California zip: 92373 country: United States lat: 34.05557 lon: -117.18254 hasResults: False
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<|newrecord|> nctId: NCT06382597 id: AWFiS/2024_2_P-GM briefTitle: Four Weeks of Nordic Hamstring Exercises Impact the Strength and Balance of the Hamstring Muscle Group overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-07-10 date: 2024-07-10 date: 2024-04-24 date: 2024-04-24 name: Gdansk University of Physical Education and Sport class: OTHER briefSummary: The aim of the study is to assess the impact of 4 weeks of eccentric Nordic Hamstring Exercise training on changes in the hamstring muscle group, as well as to analyze parameters such as maximum muscle strength of the knee flexors, RFD (rate of force development) and static balance, dynamics for the dominant leg. conditions: Hamstring Injury studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 2 type: ESTIMATED name: Nordic hamstring exercise measure: Biodex Balance System measure: Biodex System sex: ALL minimumAge: 19 Years maximumAge: 26 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06382584 id: IRB_23.09.01 briefTitle: Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur acronym: ANTI_XA overallStatus: COMPLETED date: 2022-01-01 date: 2023-06-01 date: 2023-06-01 date: 2024-04-24 date: 2024-04-24 name: Centre Hospitalier Universitaire de Nīmes class: OTHER briefSummary: In 2023, oral anticoagulant treatments (anti Xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly.
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In this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of \<30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk.
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Before considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023 conditions: Direct Oral Anticoagulants (DOACs) conditions: Femoral Fractures conditions: Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 610 type: ACTUAL name: Femoral fracture surgery measure: Hospital Mortality measure: Duration of the surgery measure: Transfusion measure: Postoperative comorbidities measure: Hospital stay measure: Anti Xa assay sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: CHU de NIMES city: Nimes zip: 30029 country: France lat: 43.83333 lon: 4.35 hasResults: False
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<|newrecord|> nctId: NCT06382571 id: 026/66 briefTitle: Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients overallStatus: COMPLETED date: 2016-01-01 date: 2020-12-31 date: 2021-12-31 date: 2024-04-24 date: 2024-04-24 name: Chulalongkorn University class: OTHER briefSummary: Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).
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