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<|newrecord|> nctId: NCT06270849 id: MTU-EC-SU-0-002/66 briefTitle: Validity and Reliability of ICIQ-FLUTS LF in Thai Version and Correlation With IPSS overallStatus: COMPLETED date: 2023-02-24 date: 2023-12-31 date: 2024-01-20 date: 2024-02-21 date: 2024-02-21 name: Thammasat University Hospital class: OTHER briefSummary: The investigators recruited participants, who were female with LUTS 50 participants for known group validity and 80 normal control females to evaluate for construct validity and test for reliability by statistical analysis. conditions: Validity of Thai Version of the ICIQ-FLUTS LF Questionnaire conditions: Reliability of Thai Version of the ICIQ-FLUTS LF studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ACTUAL name: Questionnaire measure: How well the ICIQ-FLUTS LF questionnaire in the Thai version can differentiate between females with LUTS and normal females, was assessed by the construction validity. measure: The correlation between items within a subscale of the ICIQ-FLUTS LF questionnaire assessed by internal consistency. measure: The consistency of the repeated measurements by the Thai version of the ICIQ-FLUTS LF was assessed by the test-retest reliability. measure: The correlation between the IPSS questionnaire and ICIQ-FLUTS LF questionnaire was assessed by convergent validity. sex: FEMALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Thammasat University Hospital city: Khlong Luang state: Pathumthani zip: 12120 country: Thailand lat: 14.06467 lon: 100.64578 hasResults: False
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<|newrecord|> nctId: NCT06270836 id: KS301P108 briefTitle: A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR) acronym: GLOW2 overallStatus: RECRUITING date: 2024-03-27 date: 2025-12-30 date: 2025-12-30 date: 2024-02-21 date: 2024-04-08 name: Kodiak Sciences Inc class: INDUSTRY briefSummary: This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR. conditions: Non-proliferative Diabetic Retinopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized 1:1 into one of two arms: KSI-301 or sham. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for examinations and safety assessments. The unmasked investigator will perform the injections and post-treatment assessments. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 250 type: ESTIMATED name: Tarcocimab name: Sham injection measure: Proportion of eyes improving ≥2 steps on the Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) measure: Proportion of eyes developing a Sight-Threatening Complication(s) of diabetic retinopathy measure: Proportion of eyes improving ≥3 steps on Early Treatment Diabetic Retinopathy Diabetic Retinopathy Severity Scale (ETDRS DRSS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Retina Consultants of Orange County status: NOT_YET_RECRUITING city: Fullerton state: California zip: 92835 country: United States lat: 33.87029 lon: -117.92534 facility: Global Research Management, Inc. - Lugene Eye Institute status: NOT_YET_RECRUITING city: Glendale state: California zip: 91204 country: United States lat: 34.14251 lon: -118.25508 facility: Northern California Retina Vitreous Associates status: NOT_YET_RECRUITING city: Mountain View state: California zip: 94040 country: United States lat: 37.38605 lon: -122.08385 facility: Retina Consultants of Southern California status: NOT_YET_RECRUITING city: Redlands state: California zip: 92374 country: United States lat: 34.05557 lon: -117.18254 facility: Blue Ocean Clinical Research status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33761 country: United States lat: 27.96585 lon: -82.8001 facility: Florida Eye Associates status: NOT_YET_RECRUITING city: Melbourne state: Florida zip: 32901 country: United States lat: 28.08363 lon: -80.60811 facility: Center for Retina and Macular Disease status: NOT_YET_RECRUITING city: Winter Haven state: Florida zip: 33880 country: United States lat: 28.02224 lon: -81.73286 facility: Southeast Retina Center status: NOT_YET_RECRUITING city: Augusta state: Georgia zip: 30909 country: United States lat: 33.47097 lon: -81.97484 facility: Springfield Clinic LLP status: NOT_YET_RECRUITING city: Springfield state: Illinois zip: 62703 country: United States lat: 39.80172 lon: -89.64371 facility: Cumberland Valley Retina Consultants status: NOT_YET_RECRUITING city: Hagerstown state: Maryland zip: 21740 country: United States lat: 39.64176 lon: -77.71999 facility: Envision Ocular, LLC status: NOT_YET_RECRUITING city: Bloomfield state: New Jersey zip: 07003 country: United States lat: 40.80677 lon: -74.18542 facility: Cascade Medical Research Institute status: NOT_YET_RECRUITING city: Springfield state: Oregon zip: 97477 country: United States lat: 44.04624 lon: -123.02203 facility: Mid Atlantic Retina status: NOT_YET_RECRUITING city: Bethlehem state: Pennsylvania zip: 18017 country: United States lat: 40.62593 lon: -75.37046 facility: Southeastern Retina Associates PC status: NOT_YET_RECRUITING city: Knoxville state: Tennessee zip: 37922 country: United States lat: 35.96064 lon: -83.92074 facility: Retina Research Institute of Texas status: RECRUITING city: Abilene state: Texas zip: 79606 country: United States lat: 32.44874 lon: -99.73314 facility: Panhandle Eye Group, LLP. - Southwest Retina Specialists status: NOT_YET_RECRUITING city: Amarillo state: Texas zip: 79106 country: United States lat: 35.222 lon: -101.8313 facility: Star Vision Research status: NOT_YET_RECRUITING city: Burleson state: Texas zip: 76028 country: United States lat: 32.54208 lon: -97.32085 facility: Texas Retina Associates status: NOT_YET_RECRUITING city: Plano state: Texas zip: 75075 country: United States lat: 33.01984 lon: -96.69889 facility: Strategic Clinical Research Group, LLC status: NOT_YET_RECRUITING city: Willow Park state: Texas zip: 76087 country: United States lat: 32.76263 lon: -97.65058 facility: Piedmont Eye Center status: NOT_YET_RECRUITING city: Lynchburg state: Virginia zip: 24502 country: United States lat: 37.41375 lon: -79.14225 facility: Emanuelli Research & Development Center, LLC status: NOT_YET_RECRUITING city: Arecibo zip: 00612 country: Puerto Rico lat: 18.47245 lon: -66.71573 hasResults: False
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<|newrecord|> nctId: NCT06270823 id: NIMR/HQ/R.8a/Vol.IX/4331 briefTitle: Reducing Respiratory Distress After Elective Caesarean Birth Through Knee-chest-flexion: a Randomized Controlled Trial overallStatus: RECRUITING date: 2024-02-14 date: 2025-02-14 date: 2025-02-14 date: 2024-02-21 date: 2024-02-21 name: Kilimanjaro Clinical Research Institute class: OTHER name: Leiden University Medical Center briefSummary: Planned caesarean birth is a risk factor for the development of neonatal respiratory distress commonly known as transient tachypnoea of the newborn. This is due to the absence of labor physiology which facilitates the clearance of fetal lung fluid. We hypothesized that by mimicking flexion induced by uterine contractions by manually performing knee-to-chest flexion directly at birth to achieve expulsion of excess lung liquid, we could reduce the incidence of respiratory distress in term children born by planned CS.
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The goal of this clinical trial is to test whether performing a knee-to-chest flexion maneuver directly after elective caesarean section will decrease the incidence of respiratory distress in term infants when compared to the standard care conditions: Transient Tachypnea of the Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 562 type: ESTIMATED name: Knee-to-chest-flexion manoeuvre measure: respiratory distress measure: adverse outcome of knee-to-chest flexion maneuver sex: ALL maximumAge: 30 Minutes stdAges: CHILD facility: Kilimanjaro Christian Medical Centre status: RECRUITING city: Moshi state: Kilimanjaro zip: P.O.Box 3010 country: Tanzania name: Febronia L Shirima, MD role: CONTACT phone: +255714143368 email: [email protected] name: Bariki Mchome, PhD role: CONTACT phone: +255784280027 email: [email protected] name: Febronia L Shirima, MD role: SUB_INVESTIGATOR name: Bariki Mchome, PhD role: PRINCIPAL_INVESTIGATOR name: Blandina T Mmbaga, PhD role: PRINCIPAL_INVESTIGATOR lat: -3.35 lon: 37.33333 hasResults: False
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<|newrecord|> nctId: NCT06270810 id: Aero-PA briefTitle: Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-11 date: 2025-03-18 date: 2025-06-01 date: 2024-02-21 date: 2024-03-15 name: Kastamonu University class: OTHER briefSummary: The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.
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The main question it aims to answer is:
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• Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?
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To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 32 type: ESTIMATED name: Aerobic Exercise name: Increasing non-Exercise Physical Activity measure: Low Density Lipoprotein (LDL) Cholesterol measure: High Density Lipoprotein (HDL) Cholesterol measure: Total Cholesterol measure: Glycated Hemoglobin (HbA1C) measure: Serum Triglycerides measure: Maximal Oxygen Consumption measure: Systolic Blood Pressure measure: Diastolic Blood Pressure measure: Body Fat Percentage measure: Fat-free Mass measure: Waist Circumference measure: Hip Circumference sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kastamonu University, Çatalzeytin Vocational School city: Çatalzeyti̇n state: Kastamonu zip: 37 country: Turkey hasResults: False
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<|newrecord|> nctId: NCT06270797 id: KMUHIRB-E(I)-20230184 briefTitle: Pre-anesthesia Imaging-based Respiratory Assessment and Analysis overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Kaohsiung Medical University Chung-Ho Memorial Hospital class: OTHER briefSummary: This study is to establish a preoperative respiratory imaging assessment database and develop a difficult intubation risk prediction model and further risk analysis. We attempt to construct it into a pre-anesthesia intubation risk assessment software as the clinical decision support system. conditions: Clinical Decision Support System studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30000 type: ESTIMATED name: intubation for general anesthesia measure: A pre-anesthesia evaluation measure: Perform non-invasive imaging capture. measure: difficult intubation prediction measure: time to successfully extubate the nasotracheal tube after anesthesia measure: safely discharged from post-anesthesia care unit (postoperative recovery room) measure: side effects and adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kaohsiung Medical University Chung-Ho Memorial Hospital status: RECRUITING city: Kaohsiung state: Sanmin Dist zip: 80756 country: Taiwan name: Tz Ping Gau, MD role: CONTACT phone: +886912060962 email: [email protected] lat: 22.61626 lon: 120.31333 hasResults: False
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<|newrecord|> nctId: NCT06270784 id: 09.2024.122 briefTitle: Traditional vs Orthodontic Extraction of Impacted Teeth Related to the Inferior Alveolar Nerve overallStatus: RECRUITING date: 2024-01-17 date: 2024-07-17 date: 2024-09-17 date: 2024-02-21 date: 2024-02-21 name: Marmara University class: OTHER briefSummary: The aim of this clinical study was to compare the effects of traditional and orthodontic extraction methods on postoperative nerve damage in impacted third molars associated with the inferior alveolar nerve. The main question it aims to answer is:
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-Does the orthodontic extraction method reduce the risk of nerve injury compared to traditional extraction?
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Participants will:
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* undergo either traditional or orthodontic extraction
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* be monitored for postoperative paresthesia.
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Researchers will compare traditional and orthodontic extraction methods to see if extraction methods affect postoperative nerve damage. conditions: Inferior Alveolar Nerve Injuries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Traditional Extraction name: Orthodontic Extraction measure: The effect of the extraction method on nerve injury measure: 2-point discrimination test sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Marmara University status: RECRUITING city: Istanbul state: Basibuyuk zip: 34854 country: Turkey name: Senem Askin Ekinci, DDS role: CONTACT phone: +902167775000 email: [email protected] lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06270771 id: 5823 briefTitle: OURA Ring Wearable Testing in MDS Patients: a Feasibility and Discovery Pilot Study acronym: OURA MDS overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-08-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Sunnybrook Health Sciences Centre class: OTHER briefSummary: A prospective, single center, single arm phase 2 cohort feasibility study of the OURA ring in adult MDS patients. Patients with MDS will wear the OURA ring and upload biometrics weekly. Quality of life measures will be clinically evaluated and correlated with biometrics. We hypothesize that it will be feasible for MDS patients to wear the OURA ring 70% of the time for 3 months. conditions: MDS conditions: Myelodysplastic Syndromes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: OURA Ring measure: Feasibility of patients with MDS wearing the OURA ring measure: Exploratory correlations between physiologic changes captured by the wearable device and physical functioning sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sunnybrook Health Sciences Research Centre city: Toronto state: Ontario zip: M4N 3M5 country: Canada name: Rena Buckstein role: CONTACT phone: 416-480-5000 phoneExt: 689565 email: [email protected] name: Geetha Yogendran role: CONTACT phone: 416-480-5000 phoneExt: 689565 email: [email protected] name: Rena Buckstein role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06270758 id: 453/2023/Sper/IOR briefTitle: Clinical Validation of BBCT-hip acronym: ValidaBBCT-hip overallStatus: RECRUITING date: 2023-11-07 date: 2030-11-06 date: 2030-11-06 date: 2024-02-21 date: 2024-02-21 name: Istituto Ortopedico Rizzoli class: OTHER briefSummary: The clinical study is aimed at assessing the accuracy of the in silico methodology BBCT-hip. BBCT-hip takes as inputs the subject-specific height and weight, and the CT scan of his femur to predict the risk of fracture for the femur upon falling. In the study, 150 subjects who suffered from a fracture will be enrolled, in addition to 150 control subjects. CT scans will be carried out for both groups (no later than 3 months for the fracture group) and BBCT-hip run,in order that the risk of fracture will be obtained. First, a transversal study will be performed, where the stratification accuracy of BBCT-hip will be assessed in terms of the ability of the predicted risk of fracture to separate fracture and control subjects. Furthermore, the control subjets will be followed up to assess BBCT-hip predictive accuracy through a longitudinal study. conditions: Osteoporosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: CT scan at the femur measure: Femoral fracture event measure: BBCT-hip risk prediction measure: T-score sex: FEMALE minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Rizzoli Orthopaedic Institute status: RECRUITING city: Bologna zip: 40136 country: Italy name: Alessandra Aldieri, PhD role: CONTACT phone: +390516366565 email: [email protected] name: Fabio Baruffaldi role: CONTACT phone: +390516366850 email: [email protected] lat: 44.49381 lon: 11.33875 facility: Rizzoli Orthopaedic Institute status: RECRUITING city: Bologna zip: 40136 country: Italy name: Alessandra Aldieri, PhD role: CONTACT phone: +39 051 636 6565 email: [email protected] name: Fabio Baruffaldi role: CONTACT phone: + 39 051 6366850 email: [email protected] lat: 44.49381 lon: 11.33875 hasResults: False
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<|newrecord|> nctId: NCT06270745 id: sdycllyy001 briefTitle: ICG Anastomotic Control in Digestive System Surgery overallStatus: RECRUITING date: 2018-01-01 date: 2024-02-01 date: 2024-06-01 date: 2024-02-21 date: 2024-02-23 name: Shandong Linglong Yingcheng Hospital class: NETWORK briefSummary: This was a parallel single-center retrospective cohort study conducted at Linglong Yingcheng Hospital, Shandong, China. The purpose of this study was to investigate the effect of indocyanine green (ICG) on patients undergoing digestive system surgery (subtotal gastrectomy, partial hepatectomy, transverse colectomy, left colectomy, including sigmoid resection, and splenic colic resection). ) of anastomotic leakage (AL). Secondary objectives were to detect and study the impact of various risk factors on AL and on morbidity and surgical performance within 30 days of surgery. conditions: Surgical Anastomosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED name: indocyanine green measure: Anastomotic leak at 30 days measure: Post-operative morbidity sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Linglong Yingcheng Hospital status: RECRUITING city: Yantai state: Shandong zip: 264000 country: China name: Xuan Qiu, MD role: CONTACT phone: 8618354280081 email: [email protected] name: Ni Wang, MD role: CONTACT phone: 8618705353551 email: [email protected] lat: 37.47649 lon: 121.44081 hasResults: False
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<|newrecord|> nctId: NCT06270732 id: PID2021-125444OB-100-II-iM briefTitle: Efficacy of iMentalize and MISC-SA to Foster Parents' Mentalization and Children Mental Health in General Population. acronym: iMentalize overallStatus: RECRUITING date: 2024-02-05 date: 2025-02-21 date: 2025-03-03 date: 2024-02-21 date: 2024-02-21 name: Universitat Autonoma de Barcelona class: OTHER name: Ministerio de Economía y Competitividad, Spain briefSummary: OBJECTIVES: The goal of this parallel randomized controlled trial is to test the efficacy of the iMentalize program and the Mediational Intervention for Sensitizing Caregivers - Self Administered version (MISC-SA) to foster parents' mentalization and children mental health in families from general population.
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PARTICIPANTS will randomly receive one of the 3 interventions, all based in 30 weekly online non-synchronic sessions extended across 1 year: the iMentalize program (based on parent-child sessions where they see and talk about cartoon shorts), the MISC-SA (self-administered MISC version based on guided video-feedback using recordings of one's own parent-child interactions), and MISC-R (also self-administered but mainly based on readings and cognitive exercises instead of video-feedback), which is used here as Treatment as Usual (TAU, control group) because it is the most similar to most other intellectual and mainly theoretical trainings.
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COMPARISONS: Researchers will compare all 3 groups among them to see to what extent:
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* iMentalize program shows efficacy in fostering mentalization compared with MISC-SA and TAU (control group).
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* iMentalize program shows efficacy in fostering children's mental health compared with TAU (control group).
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* MISC-SA shows efficacy in fostering parent's mentalization and children mental health compared with TAU (control group). conditions: Emotional Intelligence conditions: Social Interaction conditions: Mental Health Wellness 1 conditions: Well-Being, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, parallel group, randomized controlled trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: iMentalize Program (iMentalize) name: Mediational Intervention for Sensitizing Caregivers, Self-Administered version (MISC-SA) name: Mediational Intervention for Sensitizing Caregivers - Readings version (MISC-R): Treatment as Usual (TAU) measure: Parental Reflective Function Questionnaire (PRFQ) measure: Trait Meta-Mood Scale (24 items) (TMMS-24) measure: Basic Empathy Scale (BES) measure: Movie for the Assessment of Social Cognition (MASC) measure: Stirling Children's Wellbeing Scale (SCWBS) measure: Child Well-Being Level (CWBL) measure: Strengths and Difficulties Questionnaire (SDQ) measure: Achenbach System for Empirically Assessment (ASEBA) measure: Observing Mediational Interaction (OMI) measure: Parental Stress Questionnaire (PSI) measure: Goldberg Health Questionnaire (28 items) (GHQ-28) measure: Difficulties in Emotional Regulation Scale (DERS) measure: Oxford Happiness Questionnaire (OHQ) measure: Rosenberg's Self-Esteem Scale (RSES) measure: Parental Sense of Competence Scale (PSOC) measure: Self-Other Mentalization Scale (SOMS) measure: Reflective Functioning Scale - Youth (5 items version) (RFQ-Y5) measure: Trait Meta-Mood Scale - Children version (TMMS-C) measure: Big Five Questionnaire for Children and Adolescents (BFQ-NA) measure: BarOn Inventory of Emotional Intelligence for children aged 7 to 18 years old (BarOn) measure: Rosenberg's Self-Esteem Scale - Child version (RSES-C) measure: Battery of Socialization (BAS) measure: Inventory of Learning Patterns, reduced version (60 items) (ILP-60) measure: Relationship Questionnaire (RQ) measure: Time with the Child (TC) sex: ALL minimumAge: 25 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sergi Ballespí status: RECRUITING city: Barcelona zip: 08193 country: Spain name: Anna Ciraso, Researcher role: CONTACT phone: +34661858272 email: [email protected] name: Ana Carolina Pacheco, Researcher role: CONTACT phone: +573153561564 email: [email protected] lat: 41.38879 lon: 2.15899 facility: Universitat Autònoma de Barcelona status: RECRUITING city: Barcelona zip: 08193 country: Spain name: Anna Ciraso, Researcher role: CONTACT phone: +34661858272 email: [email protected] name: Ana Carolina Pacheco, Researcher role: CONTACT phone: +573153561564 email: [email protected] lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06270719 id: SRP-9001-401 briefTitle: An Observational Study Comparing Delandistrogene Moxeparvovec With Standard of Care in Participants With Duchenne Muscular Dystrophy acronym: ENDURE overallStatus: RECRUITING date: 2024-02-07 date: 2029-12-31 date: 2038-12-31 date: 2024-02-21 date: 2024-04-12 name: Sarepta Therapeutics, Inc. class: INDUSTRY briefSummary: This is a multicenter, prospective, observational Phase 4 study in the United States. The study is designed to collect both medical history and prospective data on Duchenne muscular dystrophy (DMD) treatment outcomes in participants receiving delandistrogene moxeparvovec as part of clinical care, compared to participants with DMD receiving or prescribed to start chronic glucocorticoid treatment at baseline in routine clinical practice. In addition, treatment outcomes will be collected prospectively from post-trial participants who have received delandistrogene moxeparvovec through participation in select SRP-9001 studies. conditions: Duchenne Muscular Dystrophy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: delandistrogene moxeparvovec name: Standard of Care measure: All Cohorts: Mean Change From Baseline in Time to Walk/Run 10 Meters (and Calculated Velocity) at Month 12 measure: All Cohorts: Time to Rise From Floor (Supine to Stand) measure: All Cohorts: Loss of Ambulation (LOA) measure: All Cohorts: Performance of Upper Limb (PUL) Version 2.0 Entry Item Score measure: All Cohorts: Patient-reported Outcomes Measurement Information (PROMIS) Domain Scores of Mobility, Upper Extremity and Fatigue measure: All Cohorts: Pulmonary Function, as Measured Forced Vital Capacity (FVC) (% Predicted) measure: All Cohorts: Cardiac Function, Including Left Ventricular Ejection Fraction (LVEF) as Measured by Echocardiogram (ECHO) measure: All Cohorts: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) measure: Delandistrogene Moxeparvovec Cohorts: Time to Walk/Run 10 Meters (Calculated Velocity) measure: Delandistrogene Moxeparvovec Post-trial Cohort: North Star Ambulatory Assessment (NSAA) sex: MALE minimumAge: 4 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Arkansas Children's Hospital status: RECRUITING city: Little Rock state: Arkansas zip: 72202 country: United States role: CONTACT email: [email protected] name: Aravindhan Veerapandiyan, MD role: PRINCIPAL_INVESTIGATOR lat: 34.74648 lon: -92.28959 facility: Penn State Health Milton S. Hershey Medical Center status: NOT_YET_RECRUITING city: Hershey state: Pennsylvania zip: 17033 country: United States role: CONTACT email: [email protected] name: Ashutosh Kumar, MD role: PRINCIPAL_INVESTIGATOR lat: 40.28592 lon: -76.65025 facility: Cook Children's Hospital status: RECRUITING city: Fort Worth state: Texas zip: 76104 country: United States role: CONTACT email: [email protected] lat: 32.72541 lon: -97.32085 facility: Children's Hospital of the King's Daughters status: RECRUITING city: Norfolk state: Virginia zip: 23507 country: United States role: CONTACT email: [email protected] name: Crystal Proud, MD role: PRINCIPAL_INVESTIGATOR lat: 36.84681 lon: -76.28522 hasResults: False
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<|newrecord|> nctId: NCT06270706 id: PLN-101095-ONC-101 briefTitle: A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors overallStatus: RECRUITING date: 2023-08-30 date: 2025-06 date: 2025-12 date: 2024-02-21 date: 2024-02-21 name: Pliant Therapeutics, Inc. class: INDUSTRY briefSummary: This is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab.
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The study will consist of 2 main parts:
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* Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design
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* Part 2: Dose-expansion cohorts using Simon's 2-stage design conditions: Metastatic Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 77 type: ESTIMATED name: PLN-101095 name: Pembrolizumab measure: Proportion of participants with treatment-emergent adverse events and serious adverse events per CTCAE Version 5.0. measure: Number of participants with a Dose Limiting Toxicity (DLT) defined as toxicities that meet predefined severity criteria, assess as having a suspected relationship to study drug, unrelated to disease, inter-current illness, or concomitant medications. measure: Maximum observed plasma concentration (Cmax) to characterize the plasma pharmacokinetics (PK). measure: Time to maximum observed concentration (Tmax) to characterize the plasma pharmacokinetics (PK). measure: Area under the concentration-time curve over a dosing interval (AUC0-τ) to characterize the plasma pharmacokinetics (PK). measure: Disease control rate (DCR) is defined by the proportion of participants who maintain disease control (iCR, iPR or iSD) per iRECIST Version 1.1. measure: Objective response rate (ORR) is defined by the proportion of participants with an iCR or iPR per iRECIST Version 1.1. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: South Texas Accelerated Research Therapeutics (START) status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: NEXT Austin status: RECRUITING city: Austin state: Texas zip: 78758 country: United States lat: 30.26715 lon: -97.74306 facility: University of Texas MD Anderson Cancer Center status: RECRUITING city: Houston state: Texas zip: 77030 country: United States lat: 29.76328 lon: -95.36327 facility: NEXT Virginia status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States lat: 38.84622 lon: -77.30637 hasResults: False
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<|newrecord|> nctId: NCT06270693 id: Dr Sushma briefTitle: hsCRP & CH Indices in Patients With Coronary Artery Disease With and Without Apical Periodontitis overallStatus: ACTIVE_NOT_RECRUITING date: 2022-11-01 date: 2024-02-01 date: 2024-04-01 date: 2024-02-21 date: 2024-02-21 name: Postgraduate Institute of Dental Sciences Rohtak class: OTHER briefSummary: Endodontic treatment is done in Patients with chronic pulp exposure in patients with Coronary Artery Disease and systemic inflammatory markers recorded before and and after treatment and compared with patients with Coronary Artery Disease without chronic pulp exposure. conditions: Apical Periodontitis conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Endodontic treatment measure: Serum hsCRP measure: complete hemogram indices measure: Periapical index SCORE CHANGE sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: PGIDS city: Rohtak state: Haryana zip: 124001 country: India lat: 28.89447 lon: 76.58917 hasResults: False
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<|newrecord|> nctId: NCT06270680 id: STUDY00023019 briefTitle: Carotenoids for Collision Athletes overallStatus: NOT_YET_RECRUITING date: 2024-08-01 date: 2024-12-20 date: 2024-12-20 date: 2024-02-21 date: 2024-03-18 name: Penn State University class: OTHER name: MacuHealth name: Orlando Regional Medical Center briefSummary: This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo. conditions: Head Injury conditions: Carotenoids studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 52 type: ESTIMATED name: Vision Edge Pro name: Placebo measure: Blood and saliva biomarkers via venous blood draw and spitting into sterile cup. measure: Visual Performance: Speed of visual processing measure: Visual Performance: Contrast Sensitivity measure: Skin carotenoid concentration measure: Retinal Nerve Fiber Layer Thickness measure: Macular Pigment Optical Density measure: Visual Quality of Life Scores measure: Visual Quality of Life Scores measure: Demographic information measure: Demographic information sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Pennsylvania State University city: University Park state: Pennsylvania zip: 16802 country: United States name: Semyon Slobounov, PhD role: CONTACT phone: 814-571-4298 email: [email protected] name: Jonathan Kelly, MS role: CONTACT phone: 9495565035 email: [email protected] name: Semyon Slobounov, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.80201 lon: -77.85639 hasResults: False
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<|newrecord|> nctId: NCT06270667 id: LYMfit briefTitle: Effects of Exercise Training in Survivors of Lymphoma acronym: LYMfit overallStatus: RECRUITING date: 2024-03-20 date: 2028-09-01 date: 2028-09-01 date: 2024-02-21 date: 2024-03-22 name: Norwegian School of Sport Sciences class: OTHER name: Uppsala University briefSummary: This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases. conditions: Lymphoma conditions: Physical Exercise conditions: Cardiotoxicity conditions: Cardiovascular Diseases conditions: Chemotherapeutic Toxicity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 280 type: ESTIMATED name: Aerobic Exercise name: Combined Aerobic and Resistance Exercise measure: VO2peak measure: Systolic- and diastolic heart chamber dimensions measure: Systolic- and diastolic longitudinal strain measure: Lean body mass measure: Fat mass measure: Forced Vital Capacity measure: Forced Expiratory Volume 1 sec measure: Maximal voluntary ventilation measure: Diffusion capacity measure: Physical activity measure: Physical activity measure: Global Health related Quality of life measure: Blood volume measure: Muscle fiber area measure: Muscle fiber type measure: Muscle mitochondria mass measure: Muscle genome-wide DNA methylation and gene expression measure: Adverse events sex: ALL minimumAge: 20 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Norweigan School of Sport Sciences status: NOT_YET_RECRUITING city: Oslo country: Norway name: Tormod S. Nilsen, PhD role: CONTACT lat: 59.91273 lon: 10.74609 facility: Helena Igelström status: RECRUITING city: Uppsala country: Sweden name: Helena Igelström, PhD role: CONTACT name: Anna Henriksson, PhD role: CONTACT phone: 709394175 phoneExt: 0046 email: [email protected] name: Helena Igelström, PhD role: PRINCIPAL_INVESTIGATOR name: Anna Henriksson, PhD role: SUB_INVESTIGATOR lat: 59.85882 lon: 17.63889 hasResults: False
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<|newrecord|> nctId: NCT06270654 id: 2023322-12280 briefTitle: Management of Perioperative Pain Using Erector Spinae Plane Block in Open Microscopic Lumbar Surgery overallStatus: RECRUITING date: 2023-06-01 date: 2024-05-01 date: 2024-06-01 date: 2024-02-21 date: 2024-02-21 name: University of Malaya class: OTHER briefSummary: The aim of this study is to compare patients receiving bilateral erector spinae block with ropivacaine vs control group in terms of pain score, total opioid consumption, hemodynamic changes intraoperatively, length of hospitalisation , time to ambulation post surgery and quality of recovery. conditions: Lumbar Spine Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Erector spinae plane block name: Skin infiltration LA measure: Pain score at recovery, 30mins, 1, 2, 4, 8,12, 24 hours post-surgery measure: Total opioid consumption intraoperative measure: Total opioid consumption post-operative measure: Timing of first rescue dose of iv morphine measure: The quality of recovery score (QoR)-15 questionnaire at 24 hours post-operation measure: Hemodynamic changes intraoperative measure: Hemodynamic changes intraoperative measure: Length of hospital stays measure: Time to ambulation after surgery sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universiti Malaya Medical Centre status: RECRUITING city: Kuala Lumpur state: Wilayah Persekutuan zip: 51100 country: Malaysia name: Wei Keang Tan, M.D. role: CONTACT phone: +60126655489 email: [email protected] name: Wei Keang Tan, MD. role: PRINCIPAL_INVESTIGATOR name: Tzi Sen Lee, MBBS role: SUB_INVESTIGATOR name: Dharmendra Ganesan, MBBS, FRCS role: SUB_INVESTIGATOR lat: 3.1412 lon: 101.68653 hasResults: False
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<|newrecord|> nctId: NCT06270641 id: STUDY00018628 briefTitle: Increasing Physical Activity for Adults With Multiple Sclerosis (MS) overallStatus: RECRUITING date: 2024-02-16 date: 2025-04-30 date: 2026-09-30 date: 2024-02-21 date: 2024-02-22 name: University of Washington class: OTHER briefSummary: This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS). conditions: Multiple Sclerosis (MS) conditions: Fatigue conditions: Physical Inactivity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 106 type: ESTIMATED name: ExerciseRx intervention measure: Physical activity: daily average step count measure: Activity volume measure: Minutes/week of moderate intensity aerobic activity measure: Fatigue - PROMIS Fatigue-MS Short Form 8a measure: Pain intensity - PROMIS Pain Intensity Short Form 3a measure: Depressive symptom severity - PROMIS Depression Short Form 8a measure: Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a measure: Physical functioning - PROMIS Physical Function 10a measure: Pain interference - PROMIS Pain Interference Scale Short Form 6a measure: Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a measure: Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UW Medicine status: RECRUITING city: Seattle state: Washington zip: 98133 country: United States name: Laurie Kavanagh, MPH role: CONTACT phone: 206-668-4168 email: [email protected] lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06270628 id: NL85029.018.23 briefTitle: Personalized Live-remote Exercise Training for Cancer Survivors acronym: LION overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2026-10-31 date: 2027-10-31 date: 2024-02-21 date: 2024-02-21 name: UMC Utrecht class: OTHER name: German Cancer Research Center (DKFZ), Heidelberg, Germany name: German Sport University Cologne (DSHS), Cologne, Germany name: Cabrini Health (CAB), Malvern, Australia name: Karolinska Institute (KI), Stockholm, Sweden name: Netherlands Cancer Institute (NKI), Amsterdam, The Netherlands name: Heidelberg University Clinic and National Center for Tumor Diseases, Heidelberg, Germany name: Fundacion Onkologikao (ONK), San Sebastian, Spain name: Associação de Investigação e Cuidados de Suporte em Oncologia (AISCO), Nova de Gaia, Portugal briefSummary: Background
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Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients.
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Goal of the study:
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The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy.
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Design of the study
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In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active.
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The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue.
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Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints.
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Measurements
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The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood.
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Conclusion:
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This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively. conditions: Neoplasms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: RCT with two study arms: exercise group and wait list control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 350 type: ESTIMATED name: Exercise group measure: Health-Related Quality of Life measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: A standardized symptom score, per patient, based on the individual patient's main side-effect defined at baseline measure: Health-related quality of life measure: Fatigue measure: Anxiety and Depression measure: CIPN_1 measure: CIPN_2 measure: Sleep measure: Pain measure: Cognitive problems measure: Work limitations measure: Body image measure: Fear of cancer recurrence measure: Habitual physical activity measure: Aerobic capacity on bike measure: Aerobic capacity on step measure: Handgrip strength measure: Upper body muscle strength measure: Lower body muscle strength measure: Sit to stand test measure: Physical function measure: Balance measure: Physical activity measure: Blood pressure measure: Resting heart rate measure: Weight measure: Height measure: Waist circumference measure: Hip circumference measure: Body composition measure: Inflammatory state measure: Growth factors measure: CRP measure: Hemoglobin measure: Leucocyte counts measure: Quality-adjusted life years measure: Health-care, patient and family costs measure: Productivity losses measure: Exercise-related (serious) adverse events measure: Participants experience of sensor-based guidance measure: Trainer experience of sensor-based guidance measure: Compliance sensor-based guidance measure: Technical feasibility of sensor-based guidance measure: Aerobic capacity measure: Upper body muscle strength measure: Lower body muscle strength measure: Core muscle strength measure: Physical functioning measure: Balance measure: Socio-demographics measure: Self-efficacy measure: Social Support measure: Medical history measure: Concomitant diseases measure: Cancer + concomitant medication measure: Cancer characteristics measure: Cancer treatment history sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Medical Center Utrecht city: Utrecht country: Netherlands lat: 52.09083 lon: 5.12222 hasResults: False
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<|newrecord|> nctId: NCT06270615 id: CRCBDD1712 briefTitle: Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model acronym: SHOCKMATRIX overallStatus: RECRUITING date: 2022-07-01 date: 2024-06 date: 2024-06 date: 2024-02-21 date: 2024-02-21 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Traumabase Group name: Capgemini Invent name: Ecole polytechnique name: EHESS (Ecole des hautes études en sciences sociales) name: CNRS (Centre national de la recherche scientifique) briefSummary: Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions. conditions: Wounds and Injuries conditions: Traumatic Shock conditions: Hemorrhagic Shock studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 1500 type: ESTIMATED name: Ambispective validation of machine learning-based predictive model measure: Fβ-score, with β = 4 measure: Common binary classification metrics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Clichy zip: 92110 country: France name: Mathilde Holleville, MD role: CONTACT email: [email protected] lat: 48.90018 lon: 2.30952 facility: Grenoble Alpes University Hospital status: RECRUITING city: La Tronche zip: 38700 country: France name: Tobias Gauss, MD role: CONTACT phone: +33476769288 email: [email protected] name: Samia Salah role: CONTACT phone: +33476769288 email: [email protected] lat: 45.20429 lon: 5.73645 facility: Bicêtre Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Le Kremlin-Bicêtre zip: 94270 country: France name: Marie Werner, MD role: CONTACT email: [email protected] lat: 48.81471 lon: 2.36073 facility: Lille University Hospital, Anaesthesia and Intensive Care Unit status: RECRUITING city: Lille zip: 59037 country: France name: Benjamin Bijok, MD role: CONTACT email: [email protected] lat: 50.63297 lon: 3.05858 facility: Pitié-Salpêtrière Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Paris zip: 75013 country: France name: Arthur James, MD role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: Georges-Pompidou European Hospital AP-HP, Anesthesia-Intensive Care Department status: RECRUITING city: Paris zip: 75015 country: France name: Nathalie Delhaye, MD role: CONTACT email: [email protected] lat: 48.85341 lon: 2.3488 facility: University Hospitals Strasbourg, Anaesthesia, Intensive Care and Peri-Operative Medicine Department status: RECRUITING city: Strasbourg zip: 67200 country: France name: Alain Meyer, MD role: CONTACT email: [email protected] lat: 48.58392 lon: 7.74553 facility: University Hospital of Toulouse, Polyvalent Intensive Care status: RECRUITING city: Toulouse zip: 31059 country: France name: Véronique Ramonda, MD role: CONTACT email: [email protected] lat: 43.60426 lon: 1.44367 hasResults: False
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<|newrecord|> nctId: NCT06270602 id: ONCOCAMP id: 6/23 oss type: OTHER domain: IRCCS I.N.T. "G. Pascale" briefTitle: The ONCOCAMP Study overallStatus: RECRUITING date: 2023-07-14 date: 2024-07 date: 2026-07 date: 2024-02-21 date: 2024-02-21 name: National Cancer Institute, Naples class: OTHER briefSummary: The present study is a retrospective-prospective observational and multicentric study aiming to collect data relating to all patients included in the ROC platform. All ROC centers will be involved in the present study. conditions: Oncology studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 15000 type: ESTIMATED name: Data collection (retrospective) name: Data collection (prospective) measure: Incidence for each tumor of the patients included in the ROC platform measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Evaluation of the time interval between GOM activities measure: Frequency of use of the services of the ROC platform measure: Descriptive analysis of each subgroup of patients (subdivision by tumor type) measure: Spatial analysis for each patient measure: Frequency of adherence to guidelines of the Diagnostic Therapeutic Assistance Paths (PDTA) measure: Percentage of patient included in clinical trial measure: Assessment of costs arising due to inefficiencies (repetition and inappropriateness of diagnostic tests; passive health mobility rate measure: Prevalence for each tumor of the patients included in the ROC platform measure: Description of pharmacological strategies measure: Description of diagnostic activities measure: Description of surgical strategies measure: Appropriateness of diagnostic tests (taking as reference the guidelines reported in each PDTA) measure: Description of each surgical approach measure: Description of the different surgical techniques among the centers measure: Patients' quality of life measure: Patients' reported outcome measure: Patients' satisfaction and evaluation of the diagnostic / therapeutic path measure: Correlation analysis among risk factors and diagnostic / therapeutic delay or poor prognosis measure: Dependence analysis between the conditions of social deprivation of ROC patients and the time to the first GOM visit measure: Dependence analysis among costs, socio-demographic characteristics and some variables related to the diagnostic / therapeutic path measure: Survival analysis for each tumor measure: Life status assessment for each patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Asl Napoli 2 Nord status: RECRUITING city: Casavatore state: Napoli zip: 80020 country: Italy name: Filomena Sibilio, M.D. role: CONTACT lat: 40.89921 lon: 14.27663 facility: Asl Napoli 3 Sud status: RECRUITING city: Ercolano state: Napoli zip: 80056 country: Italy name: Mario Fusco, M.D. role: CONTACT lat: 40.80783 lon: 14.35012 facility: A.O. Moscati status: RECRUITING city: Avellino zip: 83100 country: Italy name: Cesare Gridelli, M.D. role: CONTACT lat: 40.91494 lon: 14.79103 facility: Asl Avellino status: RECRUITING city: Avellino zip: 83100 country: Italy name: Giuseppe Genua, M.D. role: CONTACT lat: 40.91494 lon: 14.79103 facility: A.O. Rummo status: RECRUITING city: Benevento zip: 82100 country: Italy name: Antonio Grimaldi, M.D. role: CONTACT lat: 41.1307 lon: 14.77816 facility: Asl Benevento status: RECRUITING city: Benevento zip: 82100 country: Italy name: Elena Fossi, M.D. role: CONTACT lat: 41.1307 lon: 14.77816 facility: Asl Caserta status: RECRUITING city: Caserta zip: 81035 country: Italy name: Antonella Guida, M.D. role: CONTACT lat: 41.07262 lon: 14.33231 facility: A.O. S.Anna S. Sebastiano status: RECRUITING city: Caserta zip: 81100 country: Italy name: Michele Orditura, M.D. role: CONTACT lat: 41.07262 lon: 14.33231 facility: A.O. Cardarelli status: RECRUITING city: Napoli zip: 80131 country: Italy name: Ferdinando Riccardi, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: A.O. Dei Colli status: RECRUITING city: Napoli zip: 80131 country: Italy name: Vincenzo Montesarchio, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Federico II status: RECRUITING city: Napoli zip: 80131 country: Italy name: Sabino De Placido, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: I.N.T. Pascale status: RECRUITING city: Napoli zip: 80131 country: Italy name: Sandro Pignata, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: A.O.U. Luigi Vanvitelli status: RECRUITING city: Napoli zip: 80138 country: Italy name: Fortunato Ciardiello, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Asl Napoli 1 Centro status: RECRUITING city: Napoli zip: 80145 country: Italy name: Tiziana Spinosa, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Ospedale del Mare status: RECRUITING city: Napoli zip: 80147 country: Italy name: Bruno Daniele, M.D. role: CONTACT lat: 40.85216 lon: 14.26811 facility: Asl Salerno status: RECRUITING city: Salerno zip: 84124 country: Italy name: Giuseppe Di Lorenzo, M.D. role: CONTACT lat: 40.67545 lon: 14.79328 facility: A.O.U. Ruggi status: RECRUITING city: Salerno zip: 84126 country: Italy name: Stefano Pepe, M.D. role: CONTACT lat: 40.67545 lon: 14.79328 hasResults: False
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<|newrecord|> nctId: NCT06270589 id: IRB-2023-1684 briefTitle: Acute Effects of High-intensity Interval Training With Mindfulness-based Recovery on Executive Function in Children overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2026-05 date: 2026-05 date: 2024-02-21 date: 2024-02-21 name: Purdue University class: OTHER name: University of Oregon briefSummary: The goal of this randomized cross-over trial is to learn about the effect of a single bout of 20-min mindfulness-based high-intensity interval training (MF-HIIT), MF-only, and HIIT-only in relative to sitting rest on executive function (EF) in 10-12 years old children. The main question it aims to answer are:
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Question 1: Whether a single bout of 20-min MF-HIIT has larger beneficial effect on EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest
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Question 2: Whether a single bout of 20-min MF-HIIT has a larger beneficial effect on brain functioning, as measured by the N2 and P3 components of event-related potential (ER) during EF performance than that following a 20-min session of MF-only and HIIT-only in relative to the sitting rest
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Participants will visit the laboratory on 5 separate days (\> 2-day washout between days) in which they have not previously participated in structured physical activities.
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Participants will complete the testing and/or receive treatments below:
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Day 1:
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* Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
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* Treadmill-based exercise test to measure cardiorespiratory fitness (maximum oxygen consumption)
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Days 2-5
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* Each day, participants will complete each of the four intervention conditions (MF-HIIT, MF-only, HIIT-only, sitting)
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* Participants' heart rate and self-reported affect and rating of physical exertion will be measured
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* Participants will complete a modified flanker task and a task-switching task to assess inhibitory control and cognitive flexibility
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* Participants will wear an EEG cap to measure the N2 and P3 components of the event-related potential during the inhibitory control and cognitive flexibility performance
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Researcher will compare the cognitive outcome measures following the MF-HIIT, MF-only, and HIIT-only conditions with the sitting condition to see if MF and HIIT has beneficial effects on children's EF.
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Further, researcher will compare the cognitive outcome measures following the MF-HIIT compared with MF-only and HIIT-only conditions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: MF-HIIT name: MF-only name: HIIT-only name: Sitting rest measure: Inhibition speed measure: Inhibition accuracy measure: Shifting speed measure: Shifting accuracy measure: N2-ERP measure: P3-ERP measure: State Mindfulness Scale for Physical Activity (SMSPA) measure: Rating of perceived exertion measure: Heart Rate measure: Dispositional mindfulness sex: ALL minimumAge: 10 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06270576 id: HS3131 briefTitle: Nasal Inflammation Following Endotoxin Challenge in Patients With Asthma acronym: Nasal-LPS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-04 date: 2028-06 date: 2024-02-21 date: 2024-02-21 name: National Jewish Health class: OTHER briefSummary: A phase I clinical research study aimed at determining mechanisms that regulate airway mucosal inflammation in asthma endotypes using intranasal administration of endotoxin (lipopolysaccharide from E. coli) in healthy controls and subjects diagnosed with asthma. conditions: Asthma; Eosinophilic conditions: Asthma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 60 type: ESTIMATED name: Lipopolysaccharides measure: Neutrophil heterogeneity using single cell RNA sequencing sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States name: William J Janssen, MD role: CONTACT phone: 303-398-1366 name: Olivia M VerBurg, BA role: CONTACT phone: 303-398-1201 name: William J Janssen, MD role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 hasResults: False
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<|newrecord|> nctId: NCT06270563 id: P.T.REC/012/003967 briefTitle: High Intensity Laser Therapy Versus Scapular Stabilization Exercises on Ventilatory Function in Forward Head Posture overallStatus: COMPLETED date: 2022-10-01 date: 2023-12-01 date: 2023-12-01 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: The purpose of the study is to compare between the efficacy of high intensity LASER therapy and scapular stabilization exercises on ventilatory functions in forward head posture patients conditions: Forward Head Posture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Postural advice name: Traditional exercise treatment name: Scapular stabilization exercises name: High intensity Laser therapy measure: Forced vital capacity (FVC) measure: Forced expiratory volume at one second (FEV1) measure: FEV1/FVC measure: Maximum voluntary ventilation (MVV) measure: Craniovertebral angle (CVA) measure: Neck Disability Index (NDI) measure: Upper thoracic chest expansion measure: Middle thoracic chest expansion measure: Lower thoracic chest expansion measure: Visual analogue scale (VAS) sex: ALL minimumAge: 30 Years maximumAge: 40 Years stdAges: ADULT facility: Cairo University city: Giza country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06270550 id: DMI in Spastic Diplegia briefTitle: Role of Dynamic Movement Intervention in Children With Spastic Diplegia overallStatus: RECRUITING date: 2024-03-01 date: 2024-11-01 date: 2024-12-01 date: 2024-02-21 date: 2024-02-21 name: Cairo University class: OTHER briefSummary: The study aims to investigate the effect of dynamic movement intervention approach on static and dynamic balance, quality of step length and cadence of walking pattern of children with spastic diplegic cerebral palsy. conditions: Spastic Diplegia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: Dynamic Movement Intervention measure: Effect of Dynamic movement intervention on balance and quality of walking of the study group compared to control group, measured using Humac Balance System. sex: ALL minimumAge: 4 Years maximumAge: 7 Years stdAges: CHILD facility: Cairo University status: RECRUITING city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06270537 id: Dominus PMCF briefTitle: Post-market Clinical Trial of the Dominus® Stent-Graft acronym: DominusPMCF overallStatus: RECRUITING date: 2023-10-24 date: 2025-07-30 date: 2029-02-28 date: 2024-02-21 date: 2024-02-21 name: Braile Biomedica Ind. Com. e Repr. Ltda. class: INDUSTRY briefSummary: Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use conditions: Thoracic Aortic Dissection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: Stent-Graft Dominus® Endoprosthesis measure: Early occurrence of adverse events (Safety Outcome) measure: Device Success measure: Absence of endoprosthesis fracture measure: Endoleak measure: Reintervention-free measure: Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Evangélico de Vila Velha status: NOT_YET_RECRUITING city: Vila Velha state: Espirito Santo zip: 29118-060 country: Brazil name: Rodrigo Argenta role: CONTACT lat: -20.32972 lon: -40.2925 facility: Hospital Nossa Senhora da Conceição status: NOT_YET_RECRUITING city: Porto Alegre state: Rio Grande Do Sul zip: 91350-200 country: Brazil name: Eduardo A Silva role: CONTACT lat: -30.03306 lon: -51.23 facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo status: RECRUITING city: Ribeirão Preto state: São Paulo zip: 14048-900 country: Brazil name: Ewaldo Joviliano role: CONTACT lat: -21.1775 lon: -47.81028 hasResults: False
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<|newrecord|> nctId: NCT06270524 id: RCAPHM21_0433 briefTitle: Study of the C5a/C5aR1 Axis in IgG4-associated Disease: a Potential Therapeutic Target acronym: C5-MAG4 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Assistance Publique Hopitaux De Marseille class: OTHER briefSummary: This is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the C5a-C5aR1 axis between a population of patients with active IgG4-associated disease (MAG4) and two control groups: healthy subjects without MAG4 and patients with MAG4 in remission. conditions: Immunoglobulin G4-Related Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: NONE count: 66 type: ESTIMATED name: Blood sampling measure: Serum C5a concentration measure: frequency of C5aR1+ monocytes among total monocytes measure: frequency of Tumor Growth Factor B+ (TGF-B+) monocytes among total monocytes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270511 id: 2222T1412 briefTitle: A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants overallStatus: RECRUITING date: 2024-03-13 date: 2024-05-31 date: 2024-06-19 date: 2024-02-21 date: 2024-03-19 name: Shionogi class: INDUSTRY briefSummary: The aim of this study is to investigate different formulations of S-337395. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE maskingDescription: Part A will be open label; Part B will be double blind count: 50 type: ESTIMATED name: S-337395 name: Placebo measure: Part A: Plasma Concentration of S-337395 measure: Part B: Number of Participants Experiencing Treatment-emergent Adverse Events measure: Part A: Number of Participants Experiencing Treatment-emergent Adverse Events measure: Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples) measure: Part B: Plasma Concentration of S-337395 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: ICON Lenexa status: RECRUITING city: Lenexa state: Kansas zip: 66219 country: United States lat: 38.95362 lon: -94.73357 hasResults: False
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<|newrecord|> nctId: NCT06270498 id: 24811 briefTitle: Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure acronym: RISE-HF overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-06-01 date: 2024-02-21 date: 2024-02-21 name: Raffaele De Caterina class: OTHER name: University of Pisa, Italy briefSummary: The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID).
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The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo.
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One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo. conditions: Chronic Heart Failure conditions: Iron-deficiency conditions: Left Ventricular Systolic Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Sucrosomial iron name: Placebo measure: Exercise capacity measure: Quality of life measure: 6MWT distance improvement measure: Quality of life improvement measure: Exercise capacity (peak oxygen consumption) measure: F2-isoprostanes measure: Soluble NOX2-derived peptide (sNOX2-dp) measure: H2O2 measure: Phosphate measure: Fibroblast growth factor (FGF)-23 measure: N-terminal pro-B-type natriuretic peptide (NTproBNP) measure: Transferrin saturation (TSAT) measure: Ferritin measure: Serum iron measure: Soluble transferrin receptor (sTfR) measure: Hepcidin measure: Cardiac structure and function 1 measure: Cardiac structure and function 2 measure: Cardiac structure and function 3 measure: Cardiac structure and function 4 measure: Cardiac structure and function 5 measure: Cardiac structure and function 6 measure: Clinical outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270485 id: EA2/224/23 briefTitle: Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children acronym: IPCOM overallStatus: RECRUITING date: 2023-11-27 date: 2024-12 date: 2025-06 date: 2024-02-21 date: 2024-02-21 name: Charite University, Berlin, Germany class: OTHER name: University Medical Center Groningen briefSummary: Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \< 5 years of age conditions: Ventilation Therapy; Complications conditions: Congenital Heart Disease conditions: Children, Only conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: PEEP measure: Cardiac Output measure: TAPSE (cm) measure: respiratory mechanics measure: TAPSV (cm/s) measure: Global Strain RV (%/sec) measure: Lung Compliance (ml/Min/kg) measure: Esophageal Pressure (mbar) measure: EIT sex: ALL minimumAge: 1 Day maximumAge: 5 Years stdAges: CHILD facility: Deutsches Herzzentrum der Charité status: RECRUITING city: Berlin zip: 13353 country: Germany name: Jan Clausen, MD role: CONTACT phone: 004917620808764 email: [email protected] name: Michael Emeis, MD role: SUB_INVESTIGATOR lat: 52.52437 lon: 13.41053 facility: UMCG status: RECRUITING city: Groningen country: Netherlands name: Martin Kneyber, PhD, MD role: CONTACT email: [email protected] name: Richard Hollander, MD role: CONTACT email: [email protected] lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06270472 id: tipp technique briefTitle: Transinguinal Periperitoneal Technique in Inguinal Hernioplasty overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Assiut University class: OTHER briefSummary: evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in Assiut university hospitals conditions: Hernia, Inguinal studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: hernioplasty measure: Recurrence rate of inguinal hernia 2 years follow up . measure: Numerical rating score of pain sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06270459 id: DSRB 2023/00954 briefTitle: Telerehabilitation Robotics for Upper Limb Rehabilitation After STroke acronym: TRUST overallStatus: NOT_YET_RECRUITING date: 2024-02-15 date: 2025-08-14 date: 2025-08-14 date: 2024-02-21 date: 2024-02-21 name: Tan Tock Seng Hospital class: OTHER name: National University Hospital, Singapore name: Singapore General Hospital briefSummary: There has been an observed decrease in motor and functional ability and non-use of the impaired limb in chronic patients. This is due to the immediate drop in intensive daily therapy (5 days per week for 3 hours/day) that is usually provided during the inpatient (acute) phase upon discharge from the hospital.
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In this study, the investigators plan to address the low dosage of therapy in the post-acute discharge phase for stroke survivors. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The study is a multi-site prospective clinical trial, with single-arm study design with independent assessment of outcome measures (i.e., robotic metrics, standardized outcomes, quality of life, subjective measures). primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: HMAN Robot measure: Compliance Rates measure: Fugl Meyer Motor Assessment (FMA) measure: Action Research Arm Test (ARAT) measure: Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded) measure: System Usability Scale (SUS) measure: Intrinsic Motivation Inventory (IMI) sex: ALL minimumAge: 21 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270446 id: DSRB 2019/01135 briefTitle: Community Based Rehabilitation Model After Total Knee Replacement overallStatus: COMPLETED date: 2021-01-01 date: 2022-07-01 date: 2022-07-01 date: 2024-02-21 date: 2024-02-21 name: Tan Tock Seng Hospital class: OTHER briefSummary: To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE maskingDescription: Data analysis blinded count: 59 type: ACTUAL name: Community based physiotherapy name: Outpatient physiotherapy measure: TUG measure: 30 sec chair stand test measure: Pain intensity measure: Knee flexion and extension measure: Passive range of motion measure: Presence of lag measure: OKS sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tan Tock Seng Hospital city: Singapore country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06270433 id: 2023-KY142-01 briefTitle: Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder overallStatus: RECRUITING date: 2024-02-19 date: 2024-12-31 date: 2024-12-31 date: 2024-02-21 date: 2024-04-29 name: Jiangsu Province Nanjing Brain Hospital class: OTHER briefSummary: The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use. conditions: Anhedonia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Toludesvenlafaxine hydrochloride sustained-release tablets name: Desvenlafaxine succinate sustained-release tablets measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Total Score measure: Snaith-Hamilton Pleasure Scale (SHAPS) Reductive Rate measure: Dimensional Anhedonia Rating Scale (DARS) Score measure: Montgomery-Asberg Depression Rating Scale (MADRS) Score measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score measure: Sheehan Disability Scale (SDS) Score measure: Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Score measure: Rating Scale for Side Effects (SERS) Score measure: Arizona Sexual Experience Scale (ASEX) Score measure: Count of red blood cell in blood measure: Count of white blood cell in blood measure: Count of platelet in blood measure: Concentration of hemoglobin in blood measure: Concentration of alanine aminotransferase in blood measure: Concentration of aspartate aminotransferase in blood measure: Concentration of gamma-glutamyltransferase in blood measure: Concentration of blood glucose in blood measure: Concentration of serum creatinine in blood measure: Concentration of urea in blood measure: Concentration of total cholesterol in blood measure: Concentration of high density lipoprotein in blood measure: Concentration of low density lipoprotein in blood measure: Concentration of triglyceride in blood measure: Concentration of thyroid-stimulating hormone in blood measure: Concentration of protein in urine measure: Concentration of sugar in urine measure: Count of white blood cell in urine measure: Count of red blood cell in urine measure: ECG QT Interval measure: Changes in weight measure: Changes in pulse measure: Changes in both systolic and diastolic blood pressure measure: Changes in respiration rate measure: Changes in armpit temperature sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanjing Brian Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210024 country: China name: Hao Tang, MD role: CONTACT phone: +8618913821366 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06270420 id: 2022.04 briefTitle: Technological Devices and Home Automation System in Neurological Rehabilitation acronym: SMART overallStatus: RECRUITING date: 2023-02-05 date: 2024-03-31 date: 2024-05-30 date: 2024-02-21 date: 2024-02-21 name: IRCCS San Camillo, Venezia, Italy class: OTHER briefSummary: The use of home automation system may be useful in rehabilitation to collect data about the environment and the amount of therapy. Then, the data may be stored in a cloud and integrated with data collected during training provided by technological devices.
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The main goal of this longitudinal pilot study is to define the productivity of the rehabilitation room (i.e., HoSmartAI room) in the IRCCS San Camillo Hospital (Venice, Italy) service, where the investigators will install home automation sensors and treat patients with neurological disease using technological devices (e.g., robotic and virtual reality). The secondary goals are to define the patients' satisfaction, usability of the system and the clinical effect of treatments delivered with technological devices in the HoSmartAI room. The patient will be assessed to personalized the treatment based on their needs. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). At the end of the study, the patients will be assessed to define any clinical improvements. Finally, the investigators will define the characteristics of the patients who will benefit from the rehabilitation provided in the HoSmartAI room. conditions: Neurological Disease conditions: Motor Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Longitudinal Pilot study primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Technological Motor Rehabilitation measure: Key performance indicator (KPI) of the room - Number of treatments measure: Key performance indicator (KPI) ot the room - Number of sessions measure: Room Key performance indicator (KPI) of the room - Number of minutes of therapy measure: Key performance indicator (KPI) of the room - Number of physiotherapists involved measure: Key performance indicator (KPI) of the room - Number of adverse events measure: Box and Blocks Test measure: Reaching Performance Scale measure: Nine Hole Pegboard Test measure: Berg balance scale (BBS) measure: 10 Meter Walk Test (10MWT) measure: Functional Ambulation Categories (FAC) measure: Trunk Control Test (TCT) measure: EuroQol questionnaire (EQ-5D) measure: System Usability Scale (SUS) measure: Short Form Patient Satisfaction Questionnaire (PSQ-18) measure: User Experience Questionnaire (UEQ) measure: Number of falls sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Camillo Hospital status: RECRUITING city: Venice-Lido state: Venice zip: 30126 country: Italy name: Giorgia Pregnolato role: CONTACT phone: +0412207 phoneExt: 214 email: [email protected] lat: 45.4131 lon: 12.3742 hasResults: False
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<|newrecord|> nctId: NCT06270407 id: 270777 id: 2022-001580-28 type: EUDRACT_NUMBER id: 2023-510381-28-00 type: REGISTRY domain: CTIS European Clinical Trial Identification System briefTitle: The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery. overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-12-31 date: 2029-12-31 date: 2024-02-21 date: 2024-02-21 name: St. Olavs Hospital class: OTHER name: Smerud Medical Research International AS name: Sykehuset Asker og Baerum name: Oslo universitetssykehus HF name: Sykehuset Telemark name: Sykehuset Innlandet HF name: Molde Hospital name: Haukeland University Hospital name: Haraldsplass Deaconess Hospital name: Helse Stavanger HF name: University Hospital of North Norway name: Bodø sykehus name: Helsinki University Central Hospital briefSummary: Study objective:
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This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.
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Eligible patients:
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Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.
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Study intervention:
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Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules. conditions: Surgical Complication studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Randomized controlled prospective interventional trial primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Identically shaped ampoules containing traneamic acid (Cyklokapron, Pfizer) and 0.9% NaCl (Lavoisier, France) have been identified. The ampoule top part is camouflaged with a tight-fitting black tube which preserves the breaking point on the neck of the ampoule. The ampoules will be re-labeled with study-specific labels (text will be in accordance with Regulation 546/2014, annex VI). Randomized study envelopes will be provided in packages of two, with a 1:1 TXA:Placebo randomization, enabling a within-patient randomization in bilateral procedures.
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Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 3000 type: ESTIMATED name: Tranexamic Acid 100 MG/ML name: 0.9%sodium chloride measure: Postoperative re-bleeding measure: Postoperative wound infection measure: Postoperative wound rupture measure: Postoperative thromboembolic events measure: Postoperative seroma measure: Any other postoperative complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270394 id: MJX briefTitle: FAP PET/CT or PET/MR Production in the Diagnosis, Staging, and Efficacy Assessment of Malignant Tumors Application overallStatus: SUSPENDED date: 2022-04-28 date: 2023-07-28 date: 2027-03-31 date: 2024-02-21 date: 2024-02-21 name: The First Affiliated Hospital of Anhui Medical University class: OTHER name: National Natural Science Foundation of China briefSummary: This clinical trial aims to investigate the value of fibroblast activation protein PET/CT(PET/MR) in the diagnosis, staging, and evaluation of treatment outcomes in malignant tumors. The main question it aims to answer is:
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Fibroblast Activation Protein PET/CT(PET/MR) whether or in which cases this assay is superior to conventional FDG examination in the diagnosis, staging, and assessment of therapeutic efficacy of malignant tumors, thinking about the reasons behind this.
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Investigators will screen suitable participants among patients undergoing routine FDG examination.
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* Participants will sign an informed consent form
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* Undergo 68Ga-FAPI PET/CT (PET/MR) before surgery or biopsy
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* Surgical resection or puncture biopsy to obtain pathologic results. Diagnosis of patients with malignant tumors at first diagnosis; clinical staging of tumors; and clinical outcomes of patients with confirmed diagnoses will be assessed after postoperative investigator follow-up.
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The researchers will compare the FDG exams the participants have had to determine the effectiveness of the fibroblast activating protein test. conditions: Malignant Tumors conditions: Positron-Emission Tomography studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 60 type: ESTIMATED name: 68Ga-Fibroblast activation protein inhibitor measure: 68Ga-Fibroblast Activation Protein Inhibitor-04 Uptake in Gastrointestinal Cancer: Comparison with 18F-FDG measure: Utility of 68Ga-FAPI-04 PET/MRI combines 18F-FDG PET/CT in the postoperative evaluation of gastrointestinal cancers sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: FirstHAnhuiMU city: Hefei state: Anhui zip: 230032 country: China lat: 31.86389 lon: 117.28083 hasResults: False
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<|newrecord|> nctId: NCT06270381 id: UIDB/05299/2020 briefTitle: Empower-Grief: A Study on a Selective Intervention to Prevent Prolonged Grief Disorder overallStatus: RECRUITING date: 2023-08-07 date: 2024-11-01 date: 2024-11-01 date: 2024-02-21 date: 2024-02-21 name: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida class: OTHER briefSummary: The goal of this clinical trial is to test, through a Randomized Controlled Trial (RCT), the efficacy of a selective and short intervention based on second and third-wave cognitive-behavioral interventions (named EMPOWER) for the initial problematic grief reactions and to study potential predictors of adherence and efficacy in bereaved relatives of palliative and oncological patients. The main question is whether EMPOWER intervention is more effective than Treatment as Usual (TAU) in preventing Prolonged Grief Disorder (PGD). Participants with initial indicators of risk of developing PGD will be randomly allocated to EMPOWER and TAU. The primary outcome considered will be symptoms of PGD. The assessment also includes measures of anxiety and depression, attachment, coping, psychological flexibility, posttraumatic growth, and therapeutic alliance. Apart from screening, three assessment moments will be considered: T1: before the first session; T2: at the last session (up to twelve weeks); and T3: follow-up assessment period at 6 months after the previous assessment. conditions: Grief Disorder, Prolonged studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 44 type: ESTIMATED name: EMPOWER name: Treatment as usual (TAU) measure: Prolonged Grief measure: Anxiety and depression measure: Sociodemographic data measure: Risk Assessment for Grief measure: Coping strategies measure: Adult attachment measure: Psychological inflexibility measure: Social Support measure: Therapeutic alliance measure: Posttraumatic Growth sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unidade Local de Saúde Santa Maria status: RECRUITING city: Lisboa country: Portugal name: Alexandra Coelho, PhD role: CONTACT phone: 919957534 email: [email protected] lat: 38.71667 lon: -9.13333 hasResults: False
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<|newrecord|> nctId: NCT06270368 id: PREHMO briefTitle: Children Born Preterm: Sustainable Health Monitoring overallStatus: RECRUITING date: 2020-08-05 date: 2025-08-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Meyer Children's Hospital IRCCS class: OTHER name: IRCCS Fondazione Stella Maris briefSummary: Children born preterm are recognized to be at higher risk of short and long term complications and a formal follow-up of infants and children born preterm is recommended by international and national scientific societies. However, in Italy as well as in Tuscany, such a follow up is not usually done, and data are not collected in a structured way. The goal of this observational study is to evaluate the association between a large number of early life exposures and health outcomes and access to care during childhood in infants born preterm. The main questions it aims to answer are: • what is the role of prenatal and perinatal factors in influencing health outcomes during childhood in preterm infants? • What is the role of prenatal and perinatal factors in influencing access to care during childhood? Participants will be asked to attend a follow-up visit for the purpose of collecting health data. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 650 type: ESTIMATED measure: Infant development measure: Childhood development measure: Presence of visual or hearing impairement measure: Presence of asthma measure: Access to care sex: ALL minimumAge: 20 Months maximumAge: 66 Months stdAges: CHILD facility: Azienda Ospedaliero-Universitaria Careggi (AOUC) status: RECRUITING city: Firenze country: Italy name: Simone Pratesi role: CONTACT lat: 43.77925 lon: 11.24626 facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Vieri Lastrucci role: CONTACT email: [email protected] lat: 43.77925 lon: 11.24626 facility: Azienda Ospedaliero Universitaria Pisana (AOUP) status: RECRUITING city: Pisa country: Italy name: Rosa Scaramuzzo role: CONTACT lat: 43.70853 lon: 10.4036 facility: Azienda Ospedaliero Universitaria Senese (AOUS) status: RECRUITING city: Siena country: Italy name: Carlo Valerio Bellieni role: CONTACT lat: 43.31822 lon: 11.33064 hasResults: False
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<|newrecord|> nctId: NCT06270355 id: 2023-06555-01 briefTitle: Stockholm Mammography Risk Stratified Trial acronym: SMART overallStatus: NOT_YET_RECRUITING date: 2024-04-08 date: 2028-04-08 date: 2032-04-08 date: 2024-02-21 date: 2024-02-28 name: Karolinska Institutet class: OTHER briefSummary: SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either individualised screening or screening according to the Swedish National Breast Cancer Screening Program. Women randomised to individualised screening get their 2-year risk of breast cancer assessed and women with the highest short-term risk are offered contrast enhanced mammography and a mammogram at 12 months. conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 70000 type: ESTIMATED name: Risk based screening measure: Incidence of interval cancers measure: Number of recalled women measure: Number of biopsies measure: Breast cancer measure: Tumor characteristics - Stage measure: Tumor characteristics - Multifocality measure: Tumor characteristics - Receptor status measure: Tumor characteristics - Proliferation measure: Cancer worry measure: Cancer anxiety measure: Side effects related to contrast enhanced mammography measure: Cost-effectiveness measure: Willingness-to-pay sex: FEMALE minimumAge: 40 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06270342 id: DTMS briefTitle: The Effect of Dual Task On Upper Extremity Functions In Multiple Sclerosis Patients overallStatus: COMPLETED date: 2023-06-01 date: 2023-09-01 date: 2023-12-15 date: 2024-02-21 date: 2024-02-21 name: Kutahya Health Sciences University class: OTHER briefSummary: The primary aim of this study was to investigate the effect of dual tasking on upper extremity functions in individuals with multiple sclerosis (MS) and compare with healthy controls. Additionally, another aim of our study was to compare the cognitive status, quality of life, fatigue and emotional states of individuals with MS and healthy controls. conditions: Multiple Sclerosis studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 60 type: ACTUAL name: dual task assessment measure: The Minnesota Manual Dexterity Test measure: Dual Task Questionnaire measure: Edinburgh Handedness Questionnaire measure: Expanded Disability Status Scale measure: Brief International Cognitive Assessment Battery for Multiple Sclerosis measure: Beck Depression Scale measure: Fatigue Impact Scale measure: Multiple Sclerosis Quality of Life Questionnaire-54 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Sciences University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False
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<|newrecord|> nctId: NCT06270329 id: NMTwithKOA briefTitle: Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis) acronym: OA overallStatus: COMPLETED date: 2022-01-15 date: 2023-01-15 date: 2023-06-15 date: 2024-02-21 date: 2024-02-21 name: Kutahya Health Sciences University class: OTHER briefSummary: The aim of this study was to compare the effects of neuromuscular training program and conventional physical therapy program on pain, functional status, physical performance, balance, muscle strength and quality of life in patients with knee osteoarthritis (KOA). conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled clinical trial design primaryPurpose: TREATMENT masking: NONE count: 70 type: ACTUAL name: Neuromuscular training program name: conventional physical therapy program measure: Visual Analog Scale measure: Western Ontario and McMasterUniversities Osteoarhritis Index measure: Time on One Leg Standing measure: Five Times Sit to Stand Test measure: Manual Muscle Test measure: Short Form sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kutahya Health Science University city: Kütahya zip: 43100 country: Turkey lat: 39.42417 lon: 29.98333 hasResults: False
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<|newrecord|> nctId: NCT06270316 id: CT-AMT-191-01 briefTitle: Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2027-04-01 date: 2027-04-29 date: 2024-02-21 date: 2024-02-21 name: UniQure Biopharma B.V. class: INDUSTRY briefSummary: This is an open-label multi-center study to evaluate safety and biomarkers of efficacy of a single dose of intravenously-administered AMT-191. The study will also include exploratory functional efficacy assessments. The plan is to investigate 2 sequential dose cohorts in 3-6 Participants per cohort. Participants will be monitored for 24 hours following AMT-191 administration then follow-up study visits will continue for 24 months, during which safety, pharmacokinetics/pharmacodynamics, biomarkers, and efficacy assessments will be performed. Participants will continue receiving their regularly scheduled enzyme replacement therapy (ERT) until they meet the criteria for withdrawal. conditions: Fabry Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 12 type: ESTIMATED name: AMT-191 measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] measure: Duration of Vector deoxyribonucleic acid (DNA) shedding presented in blood, saliva, feces, semen, and urine sex: MALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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