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Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive).
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Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits. conditions: Anemia, Sickle Cell studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be allocated to SCThrive or SCHealthED (uniform standard care) using a randomized block design for age group (13-17 years of age or 18-21 years of age) with a predefined block size of 4. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Investigator and Outcomes assessors will not know the condition to which participants have been randomized. whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 310 type: ESTIMATED name: SCThrive name: SCHealthED measure: Patient Activation measure: Self-Management Behaviors measure: Daily Functioning measure: Emergency Room (ER) Visits measure: Self-Management Skills measure: Health-related quality of life sex: ALL minimumAge: 13 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06290388 id: 23ME-01473-CLIN-001 briefTitle: Study of 23ME-01473 in Patients With Advanced Solid Malignancies overallStatus: RECRUITING date: 2024-03-07 date: 2026-06-30 date: 2026-06-30 date: 2024-03-04 date: 2024-03-22 name: 23andMe, Inc. class: INDUSTRY briefSummary: This is a first-in-human open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of 23ME-01473 given by intravenous infusion in participants with advanced solid cancers who have progressed or are intolerant of available standard therapies. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 82 type: ESTIMATED name: 23ME-01473 measure: Phase 1:Incidence and severity of dose-limiting toxicities (DLTs) measure: Phase 1: Incidence and severity of adverse events (AEs) measure: Phase 1 Incidence and severity of serious adverse events (SAEs) measure: ORR based on investigator assessment against RECIST 1.1 criteria measure: Phase 1: Prevalence and incidence of antidrug antibodies (ADA) to 23ME-01473 measure: Phase 1: Objective response rate (ORR) measure: Duration of response (DoR) measure: Disease Control Rate (DCR) measure: Progression free survival (PFS) measure: Time of maximum serum concentration (Tmax) following a single dose of 23ME-01473 measure: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) following a single dose of 23ME-01473 measure: Last measurable serum concentration (Clast) following a single dose of 23ME-01473 measure: Area under the concentration-time curve from zero extrapolated to infinity (AUCinf) following a single dose of 23ME-01473 measure: Terminal half-life (T1/2) following a single dose of 23ME-01473 measure: Maximum serum concentration (Cmax) following multiple doses of 23ME-01473 measure: Time of maximum serum concentration (Tmax) following multiple doses of 23ME-01473 measure: Area under the concentration-time curve from time zero to the end of the dosing interval (AUCtau) following multiple doses of 23ME-01473 measure: Serum concentration at the end of the dosing interval (Ctau) following multiple doses of 23ME-01473 measure: Terminal half-life (T1/2) following multiple doses of 23ME-01473 sex: ALL minimumAge: 18 Years maximumAge: 110 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Center for Cancer Care status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06290375 id: HSK21542-T-202 briefTitle: A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population. overallStatus: NOT_YET_RECRUITING date: 2024-03-08 date: 2024-03-08 date: 2025-04-11 date: 2024-03-04 date: 2024-03-04 name: Xizang Haisco Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: This is a two- stage study. Stage I is a multicenter, open-label trial；Stage II was a multi-center, randomized, double-blind, placebo-controlled trial. About 250 maintenance peritoneal dialysis patients with moderate or above pruritus are planned to be enrolled. conditions: Pruritus studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 250 type: ESTIMATED name: HSK21542 tablet name: Placebo measure: Proportion of subjects with an improvement of ≥ 4points from baseline in the weekly average of the daily Worst Itch Numeric Rating Scale (WI-NRS) after 12 weeks of treatment. measure: Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment. measure: Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) after 12 weeks of treatment. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06290362 id: EgeTrial4 briefTitle: Exploring Digitalized Interventions for Stress and Problem Solving overallStatus: COMPLETED date: 2021-04-16 date: 2021-07-30 date: 2021-11-28 date: 2024-03-04 date: 2024-03-07 name: Ege University class: OTHER briefSummary: Excessive and prolonged stress can have detrimental effects on both psychological and physiological health, compromising overall well-being and functioning. This study examines the impact of telepsychiatric group consultation using Instagram as an unexplored online social media platform on stress levels and problem-solving skills among young adults. conditions: Stress conditions: Problem-solving studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The current 8-week randomized, single-blind factorial trial was conducted with a control group and one intervention group. Over eight weeks, participants received cognitive behavioral-based intervention through online sessions. Pre-/post-test and follow-up assessments employed. primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 54 type: ACTUAL name: Cognitive Behavioural Theory-based group consultation measure: Perceived Stress Scale (first evaluation with posttest) measure: Problem Solving Inventory (first evaluation with posttest) measure: Perceived Stress Scale (second evaluation with follow up) measure: Problem Solving Inventory (second evaluation with follow up) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: İzmir zip: 35100 country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
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<|newrecord|> nctId: NCT06290349 id: DA5221_DM_III briefTitle: Efficacy and Safety of DA5221-T When Added to Ongoing DA5221-B1 and DA5221-B2 Combination Therapy in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control overallStatus: NOT_YET_RECRUITING date: 2024-02-28 date: 2025-05-31 date: 2025-11-30 date: 2024-03-04 date: 2024-03-04 name: Dong-A ST Co., Ltd. class: INDUSTRY briefSummary: This study evaluates the efficacy and safety of adding the SGLT-2 inhibitor DA5221-T to the combination therapy of DA5221-B1 and the DPP-4 inhibitor DA5221-B2 in patients with type 2 diabetes who have inadequate blood glucose control. The study focuses on assessing the effectiveness and safety of the triple combination therapy. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 162 type: ESTIMATED name: DA5221-T1 name: DA5221-T2 name: Placebo name: DA5221-B1 name: DA5221-B2 measure: Change from the baseline in HbA1c (%) after 24 weeks measure: Change from the baseline in fasting plasma glucose(mg/dL) after 24 weeks measure: Change from the baseline in HbA1c response rate(<7.0%, <6.5%) after 24 weeks measure: Change from the baseline in weight after 24 weeks sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Severance Hospital, Yonsei University college of Medicine city: Seoul country: Korea, Republic of name: Cha Bong Soo, Ph.D role: CONTACT email: BSCHA@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06290336 id: PROTEKT briefTitle: Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement acronym: PROTEKT overallStatus: RECRUITING date: 2023-12-20 date: 2025-12-30 date: 2026-12-30 date: 2024-03-04 date: 2024-03-04 name: Linkoeping University class: OTHER_GOV name: Region Östergötland name: Region Jönköping County briefSummary: The goal of this multi-center randomized controlled trial is to investigate the effect of pre-operative exercise therapy and education for patients awaiting knee replacement surgery on subjective knee function, patient satisfaction and enablement compared to standard care.
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The main questions it aims to answer are:
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* Does pre-operative exercise therapy and education lead to better subjective knee function compared to standard care one year after surgery?
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* Does pre-operative exercise therapy and education lead to a higher level of patient satisfaction compared to standard care one year after surgery?
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* Does pre-operative exercise therapy and education lead to better patient enablement compared to standard care six weeks after surgery?
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* Does pre-operative exercise therapy and education lead to better objective knee function compared to standard care six weeks after surgery?
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Participants will be randomized stratified by age (≤ 67 years, \> 67 years) to either pre-operative supervised individualized exercise therapy combined with education two sessions/week (intervention group) or to standard care (control group). The intervention will be continuously ongoing for at least eight weeks from the point of decision for surgery until as close to the surgery as possible. conditions: Knee Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-center randomized controlled trial primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome assessor blinded to group allocation whoMasked: OUTCOMES_ASSESSOR count: 110 type: ESTIMATED name: Pre-operative exercise therapy and education name: Standardized pre-operative information session measure: Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery measure: Patient satisfaction at 1 year after surgery measure: Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery measure: Change in active knee range of motion from baseline to 6 weeks after surgery measure: Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery measure: Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery measure: Change in active knee range of motion from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery measure: Change in 30sCST from baseline to 8 weeks after start of intervention and 1-2 weeks before surgery measure: Change in Knee Osteoarthritis Outcome Score (KOOS) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: : Change in EuroQol 5 Dimensions 3 Levels (EQ5D-3L) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: Change in International Physical Activity Questionnaire - short form (IPAQ-sf) from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: Change in Mod-PEI-2 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery, 6 weeks, 3 months and 1 year after surgery measure: Change in FJS-12 from baseline to 8 weeks after start of intervention, 1-2 weeks before surgery and 6 weeks and 3 months after surgery sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Linkoping University status: RECRUITING city: Linkoping state: Ostergotland zip: 58183 country: Sweden name: Joanna Kvist, Professor role: CONTACT phone: +46 (0) 13 284664 email: joanna.kvist@liu.se name: Joanna Kvist, Professor role: PRINCIPAL_INVESTIGATOR lat: 58.41086 lon: 15.62157 hasResults: False
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<|newrecord|> nctId: NCT06290323 id: 11/05/2022-9/VIII briefTitle: Effects of Quadratus Lumborum Block on Lower Urinary System Symptoms overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-25 date: 2024-05-15 date: 2024-05-30 date: 2024-03-04 date: 2024-03-04 name: Muğla Sıtkı Koçman University class: OTHER briefSummary: The most common reason for applying to a hospital in the postoperative period due to the double J stent inserted during operations of the uteroscopic lithotripsy is reflected pain (T11-L2). The posterior approximation QL block (QL-P) is known to extend more easily to the thoracic paravertebral cavity or thoracolumbar plane, creating analgesia from T 7' to L 1'. The effects of double J catheter in patients are followed by 'Ureteral Stent Symptom Scoring Survey'. QL-P for postoperative analgesia after URS operations Our primary hypothesis in this prospective, randomized, controlled study is that the symptoms of the sub-urinary system associated with the DJS of the QL-P block will decrease. Our secondary hypotheses in the study are to investigate the effects of the unilateral QL-P block, made under ultrasound guidance, on pain scores that occur after ureteroscopic lithotripsy operations due to unilateral ureteral stones made under spinal anesthesia. conditions: Lower Urinary Tract Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients with double J catheter inserted into ureteroscopic lithotripsy surgeries due to urethral stones primaryPurpose: PREVENTION masking: SINGLE maskingDescription: The researcher evaluating the survey does not know which group the patients are. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: Quadratus lumborum block name: Placebo measure: Quadratus posterior block measure: Pain Score sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mugla Sitki Kocman Training and Research Hospital city: Mugla zip: 48000 country: Turkey lat: 37.21807 lon: 28.3665 hasResults: False
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<|newrecord|> nctId: NCT06290310 id: PAVELA briefTitle: Assessment of Patient-ventilator Asynchrony by Electric Impedance Tomography acronym: PAVELA overallStatus: NOT_YET_RECRUITING date: 2024-04-12 date: 2024-09-01 date: 2024-09-01 date: 2024-03-04 date: 2024-03-04 name: Kiskunhalas Semmelweis Hospital the Teaching Hospital of the University of Szeged class: OTHER_GOV name: Hochschule Furtwangen University name: Budapest University of Technology and Economics name: Szeged University briefSummary: Patient-ventilator asynchrony (PVA) has deleterious effects on the lungs. PVA can lead to acute lung injury and worsening hypoxemia through biotrauma. Little is known about how PVA affects lung aeration estimated by electric impedance tomography (EIT). Artificial intelligence can promote the detection of PVA and with its help, EIT measurements can be correlated to asynchrony. conditions: Acute Lung Injury studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: EIT name: patient-ventilator asynchrony assessment measure: distribution measure: connecting asysnchrony cycles with electric impedance tomography measurements measure: identifying unic electric impedance tomography signs of asynchrony sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kiskunhalas Semmelweis Hopsital the Teaching Hospital of the University of Szeged city: Kiskunhalas zip: 6400 country: Hungary name: András Lovas, M.D. Ph.D. role: CONTACT phone: 003677522000 phoneExt: 2045 email: landras@halasi-korhaz.hu lat: 46.43402 lon: 19.48479 hasResults: False
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<|newrecord|> nctId: NCT06290297 id: Progetti di Rete (RIN-IDEA) briefTitle: Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project) overallStatus: RECRUITING date: 2020-09-30 date: 2024-06-30 date: 2024-06-30 date: 2024-03-04 date: 2024-03-04 name: IRCCS Fondazione Stella Maris class: OTHER name: Fondazione Don Carlo Gnocchi Onlus name: IRCCS Eugenio Medea name: Oasi Research Institute-IRCCS name: Ospedale Pediatrico Bambin Gesù name: IRCCS San Raffaele Roma name: IRCCS National Neurological Institute "C. Mondino" Foundation name: IRCCS Centro Neurolesi "Bonino-Pulejo" name: Istituto Giannina Gaslini name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta name: IRCCS Ospedale San Raffaele name: IRCCS Istituto delle Scienze Neurologiche di Bologna briefSummary: The development and application of new technologies to support functional assessment and rehabilitation pathways for neurodevelopmental disabilities allow the evaluation and enhancement of cognitive, motor, and speech abilities within a more playful and motivating context. In fact telerehabilitation programs foster access to rehabilitative services and permit the delivery of a wide range of neuropsychological, motor, speech and communication interventions, even for patients unable to frequently attend a clinical institution (distance from the hospital, parental work employment, etc.), by overcoming geographic barriers. In this scenario, new technologies guarantee significant time- and cost-saving, shortening hospitalization and delivering the rehabilitative process at home, in a more ecological context (American Telemedicine Association, 2017) therefore enforcing the generalization of the achieved competences. Another great advantage provided by using innovative technologies in clinical practice to foster therapies tailored to patient's needs concerns both the possibility of collecting comprehensive and accurate quantitative data, thus supporting a better intervention monitoring, and of offering multi domain activities, also integrating peripheral devices (i.e. sensors). Using innovative technologies in clinical practice also give the possibility to propose neuropsychological and motor activities in a playful and motivating context, thus enhancing participation and enjoyment, especially for the pediatric population, while maintaining high levels of efficiency. Such telerehabilitation pathways allow to increase dosage and intensity of the intervention and ensure caregivers' involvement in the rehabilitation process. This multicenter study aims to assess the feasibility of using technological systems, primarily validated in the adult population, in children with congenital and acquired disabilities by administering ad-hoc questionnaires. conditions: Neurodevelopmental Cognitive, Motor and Speech-language Disabilities studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 350 type: ESTIMATED name: Telerehabilitation VRRS measure: Scores of One shot feasibility questionnaire (5-point likert scale) measure: Tele-rehabilitation feasibility measures: Adherence to the study measure: Tele-rehabilitation feasibility measures: Adherence to the training measure: Tele-rehabilitation feasibility measures: Number of dropouts measure: Tele-rehabilitation feasibility measures: Number of sessions completed in the target time measure: Tele-rehabilitation feasibility measures: Technical problems encountered that prevent the program from running measure: Scores of training feasibility questionnaire (5-point likert scale) measure: Changes in the Sustained attention subtest of Leiter 3 measure: Changes in the visual attention subtest (CP) of Italian battery for ADHD (BIA) measure: Changes in the Conners' Parent Rating Scale - Brief version measure: Changes in the Visuo-motor precision subtest of NEPSY II measure: Changes in the Developmental Test Of Visuo-Motor Integration (VMI) measure: Changes in the digit span forwards and backward subtests of BVN both for children aged 5-11 and for children aged 12-18 measure: Changes in the Corsi Block Tapping test subtest of BVS-Corsi measure: Changes in the Behaviour Rating inventory of executive function (BRIEF 2/P ) for parents measure: Changes in the route finding subtest of NEPSY II measure: Changes in the arrow subtest of NEPSY II measure: Changes in the Gross Motor Function Measure 88 (GMFM-88) measure: Changes in the Assisting Hand Assessment (AHA) measure: Changes in Both Hand Assessment (BoHA) measure: Changes in the Melbourne Assessment of Unilateral Upper Limb Function o Melbourne Assessment 2 (MUUL o MA2) measure: Changes in the Abilhand Kids measure: Changes in the Box and Block test (BBT) measure: Changes in the Movement Disorders - Childhood Rating Scale 4-18 revised (MD-CRS 4-18 R) measure: Changes in the 6 minutes walk test (6MWT) measure: Changes in the Functional Reach Test (FRT) measure: Changes in the Pediatric Berg Balance Scale (PBS) measure: Changes in the Timed up and go (TUG) sex: ALL minimumAge: 4 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: IRCCS Fondazione Stella Maris status: RECRUITING city: Pisa state: PI zip: 56128 country: Italy name: Giuseppina Sgandurra, MD, PhD role: CONTACT phone: 050 886233/224 phoneExt: +39 email: g.sgandurra@fsm.unipi.it lat: 43.70853 lon: 10.4036 hasResults: False
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<|newrecord|> nctId: NCT06290284 id: 6322 briefTitle: Comparison Between Mini-midline and the Peripheral Intravenous Catheter acronym: INSERT/2022 overallStatus: COMPLETED date: 2023-09-25 date: 2023-11-17 date: 2023-12-28 date: 2024-03-04 date: 2024-03-04 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: The goal of this randomized controlled trial is to investigate the difference between LPC (mini-midline) and PIVC (peripheral venous catheter) on the need of further venipuncture for blood withdrawal or placement of a new vascular access.
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The main questions it aims to answer are:
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* Whether the number of patients with LPC and PIVC differ in terms of repeated venipunctures;
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* Whether the number of patients with LPC and PIVC differ in terms of adverse events associated with the use of such vascular catheters.
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Researchers will compare the proportion of patients with repeated venipunctures between LPC and PIVC arms. conditions: Vascular Access Devices conditions: Venous Puncture studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The statistician will be provided an anonymized dataset. whoMasked: OUTCOMES_ASSESSOR count: 294 type: ACTUAL name: Long Peripheral Catheter name: Peripheral Intra-Venous Catheter measure: Difference in proportion measure: Adverse events associated with use of LPC and PIVC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico city: Milan zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06290271 id: CISTAR briefTitle: Arterial Wall Shear Stress After Intracranial Artery Recanalization overallStatus: RECRUITING date: 2023-08-01 date: 2024-06 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Chonbuk National University Hospital class: OTHER name: Seoul National University Hospital name: Chungnam National University Hospital name: Asan Medical Center name: Chonnam National University Hospital name: Korea University Ansan Hospital name: SMG-SNU Boramae Medical Center briefSummary: There has been consistent research on the cerebral blood flow features in ischemic stroke patients with acute occlusion of major intracranial arteries. However, studies analyzing the overall features of the major intracranial artery blood flow in the periods of pre and post-recanalization are still lacking. Time-of-flight magnetic resonance angiography (TOF-MRA) is extensively utilized to evaluate the intracranial arteries. The arterial signal intensity from MRA-TOF varies across subjects and arterial subtypes, leading to the development of the Signal Intensity Gradient (SIG) concept. SIG has demonstrated a strong correlation with Computational Fluid Dynamics (CFD), a known method for reflecting wall shear stress. SIG could be associated with the pathophysiology of wall shear stress. We aim to investigate the blood flow patterns and characteristics in the periods of pre and post-recanalization using SIG. conditions: Intracranial Artery Occlusion studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 160 type: ESTIMATED name: Intracranial artery flow pattern measure: Neurological Severity at discharge sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Korea University Ansan Hospital status: NOT_YET_RECRUITING city: Ansan state: Gyeonggi-do zip: 15355 country: Korea, Republic of name: Sang-Heon Lee, Prof. role: CONTACT email: huny0029@naver.com lat: 37.32361 lon: 126.82194 facility: Jeonbuk National University Hospital status: NOT_YET_RECRUITING city: Jeonju state: Jeollabuk Do zip: 54907 country: Korea, Republic of name: Hyo Sung Kwak, Prof. role: CONTACT email: kwakhs8140@gmail.com lat: 35.82194 lon: 127.14889 facility: Chungnam National University Hospital status: RECRUITING city: Daejeon zip: 35015 country: Korea, Republic of name: Hee Jung Song, Prof. role: CONTACT email: nrsono@naver.com lat: 36.32139 lon: 127.41972 facility: Chonnam National University Hospital status: RECRUITING city: Gwangju zip: 61469 country: Korea, Republic of name: Man-Seok Park, Prof. role: CONTACT email: mspark@chonnam.ac.kr lat: 35.15472 lon: 126.91556 facility: Seoul National University Hospital status: NOT_YET_RECRUITING city: Seoul zip: 03080 country: Korea, Republic of name: Keun-Hwa Jung, Prof. role: CONTACT email: jungkh@gmail.com lat: 37.566 lon: 126.9784 facility: Asan Medical Center status: RECRUITING city: Seoul zip: 05505 country: Korea, Republic of name: Beom-Jun Kim, Prof. role: CONTACT email: medicj80@hanmail.net lat: 37.566 lon: 126.9784 facility: SMG-SNU Boramae Medical Center status: NOT_YET_RECRUITING city: Seoul zip: 07061 country: Korea, Republic of name: Yong-Seok Lee, Prof. role: CONTACT email: mercades@snu.ac.kr lat: 37.566 lon: 126.9784 facility: Ulsan University Hospital status: RECRUITING city: Ulsan zip: 44033 country: Korea, Republic of name: Chan-Hyuk Lee, Prof. role: CONTACT email: bluewave0210@gmail.com lat: 35.53722 lon: 129.31667 hasResults: False
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<|newrecord|> nctId: NCT06290258 id: 202202143A0 briefTitle: Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-07-31 date: 2024-03-04 date: 2024-03-04 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis. conditions: Autism Spectrum Disorder conditions: Gastrointestinal Diseases conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Fecal microbiota transplantation measure: Changes of gastrointestinal symptoms of patients with ASD after FMT measure: Changes of autistic symptoms of patients with ASD after FMT measure: Changes of the diversity of intestinal microbiota of patients with ASD after FMT measure: Changes of cytokine levels of patients with ASD after FMT measure: Changes of repetitive behavior symptoms of patients with ASD after FMT measure: Changes of autistic behavior symptoms of patients with ASD after FMT measure: Changes of emotion and behavior symptoms of patients with ASD after FMT measure: Changes of inattention and hyperactivity of patients with ASD after FMT measure: Changes of quality of life of patients with ASD after FMT measure: Changes of objective sleep of patients with ASD after FMT by actigraphy recording measure: Changes of subjective sleep of patients with ASD after FMT measure: Changes of intelligence of patients with ASD after FMT measure: Changes of attention and impulse control of patients with ASD after FMT sex: ALL minimumAge: 7 Years maximumAge: 30 Years stdAges: CHILD stdAges: ADULT facility: Wei-Chih Chin city: Taoyuan city zip: 333423 country: Taiwan name: Wei-Chih Chin role: CONTACT phone: +886 3 3281200 phoneExt: 3836 email: auaug0327@cgmh.org.tw lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06290245 id: P.T.REC/012/005045 briefTitle: PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients overallStatus: RECRUITING date: 2024-03 date: 2024-10 date: 2024-12 date: 2024-03-04 date: 2024-03-04 name: Cairo University class: OTHER briefSummary: Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.
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A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.
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PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life. conditions: Pulmonary Disease, Chronic Obstructive studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: PEP Buddy name: aerobic exercise measure: dyspnea measure: pulmonary function measure: exercise capacity measure: Sleep quality measure: Health-related quality of life (HRQoL) sex: ALL minimumAge: 55 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Physical Therapy status: RECRUITING city: Giza state: Dokki zip: 11432 country: Egypt name: Ebtesam N Nagy role: CONTACT phone: +201278141946 email: Dr.EbtesamNagy2@outlook.com lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06290232 id: IRB-P00044498 briefTitle: Fetoscopic Laser Photocoagulation in Management of Vasa Previa acronym: FLUMEN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2027-12-31 date: 2024-03-04 date: 2024-03-12 name: Boston Children's Hospital class: OTHER briefSummary: In this research study, the investigators want to learn more about the safety and effectiveness of a fetal surgery, known as fetoscopic laser photocoagulation (FLP), for the treatment of a pregnancy condition called vasa previa (VP). Vasa previa is a pregnancy complication that happens when blood vessels from the fetus grow over the entrance to the womb. In a VP pregnancy, natural vaginal birth is deadly for the baby in more than half of cases due to the bursting of VP vessels and severe blood loss. Currently, VP patients are recommended to be closely monitored and often hospitalized once they reach the third trimester of pregnancy. An early delivery by C-section would typically be performed in order to avoid breaking the exposed fetal vessels.
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Fetoscopic laser photocoagulation is a minimally invasive surgery in the womb to remove or correct abnormal blood vessels and tissues. In the FLP procedure, the surgeon uses a fetoscope (a tiny telescope) and a laser device to seal off unprotected vessels. While this surgery has been used to treat other pregnancy conditions, it has not yet been proven to be safe and/or effective for the treatment of vasa previa. This treatment aims to eliminate the VP, and, if successful, may have the potential to minimize the risk of bleeding, thereby enabling patients to avoid long hospitalization before delivery. This procedure may enable VP patients to have a vaginal delivery instead of C-section. conditions: Vasa Previa conditions: Pregnancy Complications conditions: Maternal; Procedure conditions: In Utero Procedure Affecting Fetus or Newborn studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Fetoscopic Laser Photocoagulation measure: Mode of delivery measure: Gestational age at delivery measure: Successful visualization and mapping of vasa previa measure: The rate of successful coagulation of the vasa previa - intraoperative imaging measure: The rate of successful coagulation of the vasa previa - postoperative imaging measure: The rate of successful coagulation of the vasa previa - pathology measure: Placental function measure: GA at hospital admission measure: Duration of hospital stay measure: Cause for hospital admission measure: The rate of spontaneous preterm labor measure: The rate of preterm premature rupture of membranes (PPROM) measure: The rate of placental abruption measure: The rate of chorioamnionitis measure: The rate of chorioamniotic separation measure: Interval from procedure to delivery measure: The rate of fetal growth restriction measure: Fetal brain structure measure: The rate of NICU admission measure: NICU length of stay measure: Short term neonatal morbidity measure: Neonatal survival measure: Maternal mental health score measure: Postnatal examination of the placenta sex: FEMALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06290219 id: CF23509A briefTitle: The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction acronym: PRP overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-09-30 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Taichung Veterans General Hospital class: OTHER briefSummary: The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia. conditions: Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis) conditions: Effect of Drug studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: platelet-rich plasma combined with hyaluronic acid name: Zinc Gluconate 10 MG Oral Tablet name: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil measure: phenyl ethyl alcohol odor detection threshold test measure: traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT) measure: Visual Analogue Scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Taichung Veterans General Hospital city: Taichung zip: 40705 country: Taiwan name: Rong-San Jiang, MD, PhD role: CONTACT phone: 800-555-5555 phoneExt: 4088 email: rsjiang@vghtc.gov.tw name: Kai-Li Liang, MD role: CONTACT phone: +886423592525 phoneExt: 82620 email: kellyliang1107@gmail.com name: Rong-San Jiang, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06290206 id: UU_IRB_00161649 id: 1R01CA279973-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01CA279973-01 id: DSS_10065815 type: OTHER domain: University of Utah, Document Summary Sheet (DSS) Number briefTitle: PREVENT HPV-Related Cancers acronym: PREVENT overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2026-12-30 date: 2027-06-01 date: 2024-03-04 date: 2024-03-29 name: University of Utah class: OTHER name: Kaiser Permanente name: University of Arizona name: Sea Mar Community Health Centers name: National Cancer Institute (NCI) briefSummary: This study will serve as one of the first to develop and test the effectiveness of strategies to promote HPV vaccination among diverse rural parents and caregivers of children ages 9-17 years in the Mountain West. Once implemented into practice, our intervention could significantly reduce disparities in the burden of HPV-associated cancers among rural populations in the United States. The proposed study will assess the effectiveness of clinic-based outreach to increase vaccination rates for HPV at four community clinics in rural counties in Washington. The proposed study includes the following: (1) boot camp translation to tailor messaging based on patient and provider input; (2) PREVENT randomized controlled trial (RCT) that will assign adult parent/caregiver participants to a timeline for receiving intervention; and (3) qualitative interviews with parents/caregivers, providers, and other healthcare team members and development of best practices, implementation guides and dissemination of findings for other clinics to implement the program on a broader scale. At the end of the trial, personal interviews with parents/caregivers, clinical staff, and providers will be conducted to understand reactions to the program and persistent barriers to initiating and completing HPV vaccination. conditions: Vaccine Hesitancy conditions: HPV Vaccination conditions: Vaccine; Uptake conditions: Vaccination; Series Completion conditions: Vaccine Refusal studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: The investigators will use intervention mapping (IM) to plan each intervention step. The investigators will apply IM to develop and test HPV vaccination reminders for parents/caregivers (P/C). Bootcamp Translation (BCT) will engage diverse stakeholders using an iterative schedule of meetings. The BCT process will define the format and content of vaccination messages.
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Intervention: The investigators propose a 3-arm RCT to compare rates of completing the next step in the HPV vaccination series at six months and completing the HPV vaccination series at 13 months between Auto, Auto-Plus, and UC arms. P/C of children/adolescents (C/A) who have not completed the series will be randomized 1:1:1 to study arms. Participants will be assessed for eligibility and enrolled, with a total participant time in the study of 13 months, for a total of 25 months of enrollment, participation, and follow-up. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Clinic analysts will create a real-time list of patients due for an initial HPV vaccine dose. P/C of remaining C/A patients will be individually randomized to either Auto or Auto-Plus intervention or usual care (UC) in a 1:1:1 ratio. The PREVENT study will only target one child/adolescent per parent/caregiver (siblings will be excluded from intervention assessments). The investigators will use automated codes to manage interventions so that eligible patients get initial HPV vaccines on time and P/C are prompted to repeat vaccination, as recommended. The investigators will select a cohort of approximately 1,038 P/C patients from the 4 clinics, randomized to intervention arms (UC, Auto, and Auto-Plus). Intervention activities largely mimic clinic processes, and clinicians and participants will be unaware of which intervention study arm the P/C has been assigned. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 519 type: ESTIMATED name: PREVENT measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion measure: Intervention Reach: Vaccination Next Step Initiation (Next HPV dose completion) measure: RCT Arm Effectiveness: Next HPV Vaccination Step Completion sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sea Mar Community Health Centers city: Seattle state: Washington zip: 98108 country: United States name: PREVENT Sea Mar CHC, Study Medical Coordinator, MsPH, MS role: CONTACT phone: 206-764-5504 email: LudyVillegas@seamarchc.org name: PREVENT Research Assistant role: CONTACT phone: 801-587-4565 email: Kepka-Research@hci.utah.edu name: Amanda Petrik, PhD role: PRINCIPAL_INVESTIGATOR lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06290193 id: 23-392 briefTitle: Study of Acute Normovolemic Hemodilution (ANH) in People With Ovarian Cancer Who Are Having Primary Cytoreductive Surgery overallStatus: RECRUITING date: 2024-02-23 date: 2029-02-23 date: 2029-02-23 date: 2024-03-04 date: 2024-03-04 name: Memorial Sloan Kettering Cancer Center class: OTHER briefSummary: Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive surgery. conditions: Ovarian Cancer conditions: Fallopian Tube Carcinoma conditions: Ovarian Carcinoma conditions: Peritoneal Carcinoma conditions: Ovarian Cancer Stage IIIC conditions: Fallopian Tube Cancer Stage IIIC conditions: Ovarian Cancer Stage IV conditions: Fallopian Tube Cancer Stage IV conditions: Fallopian Tube Cancer conditions: Peritoneal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: Acute Normovolemic Hemodilution/ANH measure: Comparison of the rate of allogenic red blood cell transfusions between the Acute Normovolemic Hemodilution (ANH) and standard of care arm sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Memoral Sloan Kettering at Basking Ridge (Limited Protocol Activities) status: RECRUITING city: Basking Ridge state: New Jersey zip: 07920 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.70621 lon: -74.54932 facility: Memorial Sloan Kettering Monmouth (Limited protocol activities) status: RECRUITING city: Middletown state: New Jersey zip: 07748 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.39652 lon: -74.09211 facility: Memorial Sloan Kettering Bergen (Limited protocol activities) status: RECRUITING city: Montvale state: New Jersey zip: 07645 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 41.04676 lon: -74.02292 facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) status: RECRUITING city: Commack state: New York zip: 11725 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.84288 lon: -73.29289 facility: Memorial Sloan Kettering Westchester (Limited protocol activities) status: RECRUITING city: Harrison state: New York zip: 10604 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.96899 lon: -73.71263 facility: Memorial Sloan Kettering Cancer Center (All protocol activities) status: RECRUITING city: New York state: New York zip: 10065 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.71427 lon: -74.00597 facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities) status: RECRUITING city: Uniondale state: New York zip: 11553 country: United States name: Dennis Chi, MD role: CONTACT phone: 212-639-5016 lat: 40.70038 lon: -73.59291 hasResults: False
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<|newrecord|> nctId: NCT06290180 id: 13632 id: 1S06GM146095 type: NIH link: https://reporter.nih.gov/quickSearch/1S06GM146095 briefTitle: Healing Lodge First Face Training Evaluation Study overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2025-03-31 date: 2025-03-31 date: 2024-03-04 date: 2024-03-04 name: Cambridge Health Alliance class: OTHER name: National Institute of General Medical Sciences (NIGMS) briefSummary: The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the help they need. All Healing Lodge staff are being asked to complete First Face training.
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To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations. conditions: Addiction conditions: Depression/Anxiety conditions: Trauma, Psychological conditions: Self-harm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pre/post/3-month follow-up model primaryPurpose: PREVENTION masking: NONE count: 100 type: ESTIMATED name: First Face for Mental Heatlh measure: Attitudes Towards Serious Mental Illness - Adolescent Version measure: First Face knowledge assessment measure: Perceived Competence to Respond measure: Satisfaction with Training measure: Use of First Face learnings in professional/personal life measure: Intended Use of First Face learnings in professional/personal life sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Healing Lodge of the Seven Nations city: Spokane Valley state: Washington zip: 99212 country: United States name: Melinda Bowman, EdD role: CONTACT phone: 509-795-8342 email: melindab@healinglodge.org name: Michelle Zuckerman, EdD role: CONTACT phone: 509-533-6910 email: michellez@healinglodge.org name: Melinda Bowman, EdD role: PRINCIPAL_INVESTIGATOR lat: 47.67323 lon: -117.23937 typeAbbrev: SAP hasProtocol: False hasSap: True hasIcf: False label: Statistical Analysis Plan date: 2024-02-21 uploadDate: 2024-02-21T11:51 filename: SAP_000.pdf size: 52477 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-02-28 uploadDate: 2024-02-28T13:20 filename: ICF_001.pdf size: 251558 hasResults: False
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<|newrecord|> nctId: NCT06290167 id: 30M201 briefTitle: A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab acronym: DUAL-Rehab overallStatus: RECRUITING date: 2023-07-03 date: 2026-04-10 date: 2026-04-10 date: 2024-03-04 date: 2024-03-04 name: Istituto Auxologico Italiano class: OTHER briefSummary: The main objective of this project is two-fold
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1. to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
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2. to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.
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Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.
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Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments. conditions: Cognitive Decline studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: 360° media name: Treatment As Usual (TAU) name: In hospital sessions name: at home sessions name: Mild Cognitive Impairment name: Subjective Memory Complain measure: Cognitive functions measure: Motor functions sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milan state: MI zip: 20149 country: Italy name: Elisa Pedroli, PsyD role: CONTACT phone: 02 61911 2707 email: e.pedroli@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
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<|newrecord|> nctId: NCT06290154 id: RG2024-022-02 briefTitle: Factors Associated With Posttransplant Cardiac Outcomes overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-31 date: 2027-12-31 date: 2024-03-04 date: 2024-03-05 name: Sun Yat-sen University class: OTHER briefSummary: Cardiovascular disease has become the leading cause of death early after liver transplantation (LT). The aging LT population is accompanied with the increasing prevalence of cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Furthermore, cirrhosis has been known to cause alterations in the systemic haemodynamic system and cardiac muscle dysfunction, systolic and/or diastolic, known as Cirrhotic cardiomyopathy (CCM). Hence, transthoracic echocardiography is required in all LT candidates for preprocedural evaluation and risk stratification. However, traditional echocardiographic indices of cardiac function have low sensitivity. It is unclear whether comprehensive echocardiographic multiparameters, including speckle tracking echocardiograph (STE) and tissue doppler imaging (TDI) can help improve preoperative risk stratification. Therefore, we sought to analyze the ability of clinical and comprehensive echocardiography variables to predict intraoperative and perioperative cardiac events and cardiac mortality in our LT patient experience up to early post-liver transplant. conditions: Cardiovascular Diseases conditions: Liver Transplantation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: a composite outcome of new cardiovascular disease after liver transplantation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06290141 id: EFC18156 id: U1111-1295-3363 type: REGISTRY domain: ICTRP id: 2023-508338-33 type: REGISTRY domain: CTIS briefTitle: A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) acronym: VITALIZE overallStatus: NOT_YET_RECRUITING date: 2024-04-18 date: 2025-11-05 date: 2027-05-19 date: 2024-03-04 date: 2024-03-29 name: Sanofi class: INDUSTRY briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. conditions: Chronic Inflammatory Demyelinating Polyneuropathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part A is a double-blind treatment period and Part B is an open-label period. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 160 type: ESTIMATED name: riliprubart name: Placebo name: riliprubart name: Placebo name: IVIg name: Placebo name: IVIg premedication measure: Percentage of participants experiencing a response measure: Percentage of participants randomized to riliprubart who responded during the double-blind period and had a lasting response during the open-label period measure: Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score measure: Change from baseline in grip strength (kilopascals, dominant hand) measure: Change from baseline in Medical Research Council Sum Score (MRC-SS) measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) measure: Percentage of participants experiencing a relapse measure: Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L) measure: Number of participants with TEAEs, including SAEs and AESIs measure: Number of participants with treatment-emergent ADA in participants treated with riliprubart measure: Number of participants with TEAEs, including SAEs and AESIs measure: Percentage of participants randomized to riliprubart experiencing a relapse measure: Percentage of participants randomized to IVIg continuation experiencing a relapse measure: Number of participants and titer of anti-drug antibodies (ADA) measure: Change from baseline in I-RODS measure: Change from baseline in adjusted INCAT score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in MRC-SS measure: Change from baseline in RT-FSS measure: Change from baseline in EQ-5D-5L score measure: Percentage of participants randomized to riliprubart who experience a response during the open-label period without prior response in the double-blind period (delayed response) measure: Percentage of participants randomized to IVIg continuation who experience a response sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06290128 id: EFC17236 id: U1111-1295-5755 type: REGISTRY domain: ICTRP id: 2023-506503-26 type: REGISTRY domain: CTIS briefTitle: A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work acronym: MOBILIZE overallStatus: RECRUITING date: 2024-04-09 date: 2026-02-03 date: 2027-10-12 date: 2024-03-04 date: 2024-03-28 name: Sanofi class: INDUSTRY briefSummary: The purpose of the study is to evaluate efficacy of riliprubart compared to placebo in adult participants with CIDP whose disease is refractory to standard of care. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up. conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy conditions: Polyneuropathy, Inflammatory Demyelinating, Chronic studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a double-blind treatment in part A and open-label treatment in Part B. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 140 type: ESTIMATED name: Riliprubart name: Placebo name: Riliprubart name: Placebo measure: Percentage of participants refractory to standard of care (SOC) experiencing a response measure: Percentage of participants randomized to riliprubart with lasting response measure: Percentage of participants randomized to placebo who experience a response measure: Percentage of participants randomized to riliprubart who experience a response measure: Change from baseline in Inflammatory Raschbuilt Overall Disability Scale (IRODS) score measure: Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in Medical Research Council Sum Score (MRCSS) measure: Percentage of participants refractory to immunoglobulins experiencing a response measure: Change from baseline in the EuroQol 5 Dimension, 5Level Health Scale (EQ5D5L) measure: Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS) measure: Number of participants with treatmentemergent adverse events (TEAEs), including serious adverse events (SAEs) and adverse events of special interest (AESIs) measure: Incidence and titer of anti-riliprubart antibodies (ADA) measure: Number of participants with TEAEs, including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) measure: Incidence and titer of anti-riliprubart antibodies measure: Change from baseline in I RODS score measure: Change from baseline in adjusted INCAT score measure: Change from baseline in grip strength (kilopascals; dominant hand) measure: Change from baseline in MRC-SS measure: Change from baseline in EQ-5D-5L score measure: Change from baseline in RT-FSS sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alabama Neurology Associates Site Number : 8400019 status: RECRUITING city: Birmingham state: Alabama zip: 35209 country: United States lat: 33.52066 lon: -86.80249 hasResults: False
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<|newrecord|> nctId: NCT06290115 id: 202301 briefTitle: Adolescents' Non-suicidal Behavior and Perception of Parents' Negative Emotional Expression and Family Communication overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-31 date: 2024-12-31 date: 2024-03-04 date: 2024-03-13 name: Sun Yat-sen University class: OTHER briefSummary: The starting point of this project is to study young people and adolescents, aiming to explore the correlation between non-suicidal behavior of young people and adolescents and the negative emotional expression of their parents and family communication. The purpose of this project is to investigate the non-suicidal self-injury behavior of teenagers aged 15-25 years by issuing questionnaires (sample size: 327 people). In order to find out whether there is any connection between family communication and non-suicidal self-injury behavior of young people and adolescents. conditions: Adolescents studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 324 type: ESTIMATED name: Questionnaires set 1 name: Questionnaires set 2 name: Questionnaires set 3 measure: Non-suicidal self-injury behavior of young people and adolescents measure: Expression of negative emotions of parents measure: Parent-Adolescent communication scale measure: Childhood Trauma Questionnaire measure: Parental Bongding Instrument measure: The parent-child relationship intimacy scale sex: ALL minimumAge: 15 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06290102 id: TV56248-RES-10204 briefTitle: Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old overallStatus: RECRUITING date: 2024-05-02 date: 2024-10-02 date: 2024-11-09 date: 2024-03-04 date: 2024-04-24 name: Teva Branded Pharmaceutical Products R&D, Inc. class: INDUSTRY briefSummary: The primary objectives of this study are:
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* To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma
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* To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
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* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248
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The secondary objective is:
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• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI conditions: Asthma studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 22 type: ESTIMATED name: TEV-56248 name: Fp MDPI measure: Maximum Observed Plasma Drug Concentration (Cmax) of Fluticasone Propionate (Fp) measure: Maximum Observed Plasma Drug Concentration (Cmax) of Albuterol Sulfate(ABS) measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Fp measure: Area Under the Plasma Drug Concentration-Time Curve from Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for ABS measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for Fp measure: Time to Maximum Observed Plasma Drug Concentration (tmax) for ABS measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of Fp measure: Terminal Phase (Apparent Elimination) Half-Life (t½) of ABS measure: Last Measurable Concentration Above the Quantification Limit (Clast) of Fp measure: Last Measurable Concentration Above the Quantification Limit (Clast) of ABS measure: Time of Last Measurable Concentration (tlast) of Fp measure: Time of Last Measurable Concentration (tlast) of ABS measure: Number of Participants with Adverse Events (AEs) measure: Number of Participants with Serious Adverse Events (SAEs) measure: Number of Participants Who Withdrawal From Trial Due to Treatment Emergent Adverse Events (TEAEs) sex: ALL minimumAge: 4 Years maximumAge: 11 Years stdAges: CHILD facility: Teva Investigational Site 12001 status: RECRUITING city: Boerne state: Texas zip: 78006 country: United States lat: 29.79466 lon: -98.73197 hasResults: False
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<|newrecord|> nctId: NCT06290089 id: OEV-131 briefTitle: Pre-Study of Wild Type Enterotoxigenic E. Coli (ETEC) Strain for Verification of a Planned Challenge Dose overallStatus: RECRUITING date: 2024-02-12 date: 2024-06 date: 2024-09 date: 2024-03-04 date: 2024-04-12 name: Scandinavian Biopharma AB class: INDUSTRY name: Johns Hopkins Bloomberg School of Public Health briefSummary: This is an open label study with the aim to estimate the incidence of moderate and severe diarrhea among participants challenged with an enterotoxigenic E. coli (ETEC) strain. This strain is planned to be used in a subsequent challenge study on the efficacy of an oral inactivated ETEC vaccine.
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The study will be conducted at one site; the Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, United States. conditions: ETEC Diarrhea studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Enterotoxigenic E. coli (ETEC) strain measure: The incidence of moderate and severe diarrhea sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health status: RECRUITING city: Baltimore state: Maryland zip: 21205 country: United States name: Kawsar R. Talaat, MD role: CONTACT phone: 410-502-9627 email: ktalaat@jhu.edu name: Kawsar R. Talaat, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06290076 id: IAT-PROACT briefTitle: A Predictive Model and Scoring System for Severe Complications After Endovascular Thrombectomy overallStatus: COMPLETED date: 2020-01-01 date: 2023-06-30 date: 2023-09-30 date: 2024-03-04 date: 2024-03-04 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: To establish a predictive model and scoring system for predicting severe complications after thrombectomy. This scoring system can be used to identify high-risk patients after endovascular thrombectomy, guide the early use of adjunctive interventions, and provide reference for future clinical trials. conditions: Acute Ischemic Stroke conditions: Endovascular Thrombectomy conditions: Symptomatic Intracranial Hemorrhage conditions: Malignant Cerebral Edema studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 1500 type: ACTUAL measure: Rate of severe complications measure: Rate of mRS score of 3-6 measure: Rate of mRS score of 5-6 measure: Rate of symptomatic intracranial hemorrhage measure: Rate of malignant cerebral edema measure: Change of NIHSS score measure: Rate of modified Rankin Scale (mRS) score of 0-2 measure: All-cause mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing state: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06290063 id: 22-08-0138 briefTitle: Cannabidiol and Older Adult Cannabis Users acronym: QUARTz overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2028-08-31 date: 2028-08-31 date: 2024-03-04 date: 2024-03-04 name: University of Colorado, Boulder class: OTHER briefSummary: Cannabis use increased 10 fold among adults over the age of 65 between 2014 and 2016 but very little data exists on the extent of their harmful effects on health and behavior. The overarching goal of this project is to test a novel harm reduction strategy in which older individuals who seek to use cannabis for pain, anxiety or mood problems (depression/anxiety) will be randomly assigned to one of three conditions in an 8 week randomized controlled trial: hemp-derived CBD+THC, hemp-derived CBD-THC, or placebo. This work has the ability to directly inform individual choices regarding the use of cannabis products among older adults, and direct policy decisions regulating cannabis formulations on the legal market. conditions: Sleep conditions: Anxiety conditions: Depression conditions: Pain studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 385 type: ESTIMATED name: fsCBD Cannabidiol name: bsCBD Cannabidiol name: Placebo measure: Subjective Motor Function measure: Balance measure: Anxiety measure: Depression measure: Blood Cytokine Levels measure: Depression/Anxiety measure: Drug Effects measure: Inhibitory Control measure: Cognitive Function measure: Pain Intensity and Interference measure: Cognitive Ability measure: Pain Intensity measure: Change in Condition measure: Sleep Disturbance measure: Sleep-Related Impairment measure: Memory measure: Polypharmacy-Pain Medications measure: Polypharmacy-Psychiatric Medications measure: Polypharmacy-Sleep Medications measure: Strength and Endurance measure: Sleep Quality sex: ALL minimumAge: 60 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado at Boulder city: Boulder state: Colorado zip: 80309 country: United States name: Ellie Sundali, BA role: CONTACT email: ellie.sundali@colorado.edu lat: 40.01499 lon: -105.27055 hasResults: False
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<|newrecord|> nctId: NCT06290050 id: TAK-279-1006 briefTitle: A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults overallStatus: RECRUITING date: 2024-03-29 date: 2024-05-03 date: 2024-05-16 date: 2024-03-04 date: 2024-04-24 name: Takeda class: INDUSTRY briefSummary: The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.
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During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally). conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 20 type: ESTIMATED name: Midazolam name: Repaglinide name: TAK-279 measure: Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279 measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279 measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Celerion status: RECRUITING city: Tempe state: Arizona zip: 85283 country: United States name: Study Contact role: CONTACT phone: 480-415-7404 email: mara.baier@celerion.com name: Mara Baier, DO role: PRINCIPAL_INVESTIGATOR lat: 33.41477 lon: -111.90931 hasResults: False
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<|newrecord|> nctId: NCT06290037 id: 2024-01-003 briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers. overallStatus: RECRUITING date: 2024-03-15 date: 2024-12-31 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Seoul National University Hospital class: OTHER briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.
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This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result conditions: Automobile Driving studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SCREENING masking: NONE count: 100 type: ESTIMATED name: VR Driving Simulator name: Computerized Neurocognitive Function Test name: Driver Test Station name: Short Physical Performance Battery name: On-road field driving Test measure: Feasibility of VR driving simulator measure: Driving performance in simulator, measured by driving errors sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT facility: Seoul National University Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Ja-Ho Leigh, M.D. Msc. role: CONTACT email: mazican@gmail.com lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06290024 id: XH-23-013 briefTitle: A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data overallStatus: RECRUITING date: 2023-08-15 date: 2024-08-15 date: 2024-08-15 date: 2024-03-04 date: 2024-04-02 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function conditions: Pain studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 2000 type: ESTIMATED name: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function measure: Visual Analogue Scale/Score（VAS） measure: digital pain grading method (NRS) measure: neuropathic pain assessment scale (DN4) measure: sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale) measure: EEG measure: Barrett impulse scale (BIS) measure: (Generalized Anxiety Disorder,GAD-7) measure: (Patient Health Questionnaire-9 measure: Montreal cognitive assessment scale (MoCA) measure: ocial support assessment scale (SSQ) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ke Ma status: RECRUITING city: Shanghai state: Yangpu zip: 200092 country: China name: Ke NA Ma, PHD role: CONTACT phone: 13361879260 email: marke72@163.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06290011 id: XH-23-014 briefTitle: A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR overallStatus: RECRUITING date: 2023-10-11 date: 2024-10-11 date: 2024-10-11 date: 2024-03-04 date: 2024-03-04 name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine class: OTHER briefSummary: A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain conditions: Pain studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 132 type: ESTIMATED name: Pain key group measure: Visual Analogue Scale/Score（VAS） sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ke Ma status: RECRUITING city: Shanghai state: Yangpu zip: 200092 country: China name: Ke NA Ma, PHD role: CONTACT phone: 13361879260 email: marke72@163.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06289998 id: RP014-01 briefTitle: Study of Tamibarotene in Patients With ADPKD overallStatus: RECRUITING date: 2023-12-22 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: Rege Nephro Co., Ltd. class: INDUSTRY briefSummary: Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 70 type: ESTIMATED name: Tamibarotene name: Placebo measure: Changes in TKV from baseline measure: Changes in TLV from baseline measure: Changes in eGFR from baseline measure: Incidence of adverse events sex: ALL minimumAge: 26 Years maximumAge: 55 Years stdAges: ADULT facility: Kurume University Hospital status: RECRUITING city: Kurume state: Fukuoka zip: 830-0011 country: Japan lat: 33.31667 lon: 130.51667 facility: Hokkaido University Hospital status: RECRUITING city: Sapporo state: Hokkaido zip: 060-8648 country: Japan lat: 43.06667 lon: 141.35 facility: Shonan Kamakura General Hospital status: RECRUITING city: Kamakura state: Kanagawa zip: 247-8533 country: Japan lat: 35.30889 lon: 139.55028 facility: Toranomon Hospital Kajigaya status: RECRUITING city: Kawasaki state: Kanagawa zip: 213-8587 country: Japan lat: 35.52056 lon: 139.71722 facility: Juntendo University School of Medicine Juntendo Hospital status: RECRUITING city: Bunkyo-ku state: Tokyo zip: 113-8431 country: Japan lat: 35.37517 lon: 139.92991 facility: Toranomon Hospital status: RECRUITING city: Minato-ku state: Tokyo zip: 105-8470 country: Japan lat: 34.2152 lon: 135.1501 facility: Tokyo Women's Medical University Hospital status: RECRUITING city: Shinjukuku state: Tokyo zip: 162-8666 country: Japan lat: 35.2946 lon: 139.57059 facility: Kyoto University Hospital status: RECRUITING city: Kyoto zip: 606-8507 country: Japan lat: 35.02107 lon: 135.75385 hasResults: False
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<|newrecord|> nctId: NCT06289985 id: STEP id: 1OT2NS129366-01 type: NIH link: https://reporter.nih.gov/quickSearch/1OT2NS129366-01 briefTitle: StrokeNet Thrombectomy Endovascular Platform acronym: STEP overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2028-09 date: 2024-03-04 date: 2024-03-04 name: Medical University of South Carolina class: OTHER name: National Institute of Neurological Disorders and Stroke (NINDS) name: University of Cincinnati name: University of Virginia name: Berry Consultants name: University of California, Los Angeles name: MOUNT SINAI HOSPITAL name: The Cooper Health System name: University of Pittsburgh Medical Center name: Stony Brook University name: University at Buffalo briefSummary: STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO). conditions: Ischemic Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 2000 type: ESTIMATED name: Endovascular thrombectomy with any FDA-approved category POL or NRY device name: Medical Management measure: Global disability measured by Modified Rankin Score measure: Global disability measured by Modified Rankin Score measure: Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS) measure: Symptomatic intracranial hemorrhage measure: Any radiologic intracranial hemorrhage measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06289972 id: HUvbayraktaroglu1 briefTitle: Development,Validity and Reliability of a Caregiver Version of the Breathlessness Beliefs Questionnaire overallStatus: RECRUITING date: 2024-02-20 date: 2025-02-20 date: 2025-02-20 date: 2024-03-04 date: 2024-03-06 name: Halic University class: OTHER briefSummary: The goal of this methodological study is to determine the reliability and validity of the The Breathlessness Beliefs Questionnaire Caregiver Version (BBQ-C) version in assessing dysfunctional breathlessness beliefs in caregivers of children with cystic fibrosis. conditions: Cystic Fibrosis conditions: Parents studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 22 type: ESTIMATED measure: The Breathlessness Beliefs Questionnaire (Caregiver Version) (BBQ-C) measure: Cystic Fibrosis Questionnaire Revised (CFQ-R) for parent version measure: Parent Attitude Scale (PAS) measure: Perceived Social Support Scale (PSS) measure: Parent Attitude Scale sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Haliç University status: RECRUITING city: Istanbul state: Eyup zip: 34060 country: Turkey name: Vildan Bayraktaroglu, PT, MSc role: CONTACT phone: (0212) 924 24 44 email: vildanbayraktaroglu@halic.edu.tr name: Seda Saka, PT, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06289959 id: JD-LC2023006-I01 briefTitle: Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL overallStatus: NOT_YET_RECRUITING date: 2024-02-25 date: 2029-01-01 date: 2029-01-01 date: 2024-03-04 date: 2024-03-04 name: Second Affiliated Hospital of Soochow University class: OTHER briefSummary: A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients. conditions: Lymphoma, Large B-Cell, Diffuse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: cfDNA measure: Progression-free survival（PFS） measure: Sensitivity, and specificity of plasma cfDNA in DLBCL patients measure: Overall survivals(OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Second Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215000 country: China name: Bingzong Li, Professor role: CONTACT phone: 0086-13776054037 email: lbzwz0907@hotmail.com lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06289946 id: NitroRadialLHC briefTitle: Topical Nitro or Placebo Pre-Cath overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-31 date: 2024-03-04 date: 2024-03-04 name: Thomas Jefferson University class: OTHER briefSummary: Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 256 type: ESTIMATED name: NitroBid name: Placebo measure: Crossover rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06289933 id: BR-EMC-CT-103 briefTitle: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers overallStatus: RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-03-04 date: 2024-03-04 name: Boryung Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers conditions: Type2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: BR3005 name: BR3005-1 name: BR3005-2 measure: AUCτ measure: Cmax sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center, H PLUS Yangji Hospital status: RECRUITING city: Seoul state: Gwanakgu zip: 08779 country: Korea, Republic of name: Seunghyun Kang role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06289920 id: BR-EMC-CT-102 briefTitle: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers overallStatus: RECRUITING date: 2024-03 date: 2024-03 date: 2024-03 date: 2024-03-04 date: 2024-03-04 name: Boryung Pharmaceutical Co., Ltd class: INDUSTRY briefSummary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 46 type: ESTIMATED name: BR3005 name: BR3005-1 name: BR3005-2 measure: AUCτ measure: Cmax sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Clinical Research Center, H PLUS Yangji Hospital status: RECRUITING city: Seoul state: Gwanakgu zip: 08779 country: Korea, Republic of name: Seunghyun Kang role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06289907 id: LH-BH-ADV-01 briefTitle: Hot Flash and Night Sweat Virtual Study overallStatus: ACTIVE_NOT_RECRUITING date: 2023-07-09 date: 2024-05-30 date: 2024-07-30 date: 2024-03-04 date: 2024-03-04 name: Bonafide Health class: INDUSTRY name: Lindus Health briefSummary: The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65. conditions: Menopause studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Decentralized, double-blind, placebo-controlled, randomized primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Bonafide-HF3.0 name: Placebo measure: To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms measure: To determine the effects of the SP compared to placebo on hot flash symptoms measure: To determine the effects of the SP compared to placebo on hot flash symptoms measure: To determine the effects of the SP compared to placebo on vasomotor symptoms measure: To determine the effects of the SP compared to placebo on overall menopausal symptoms measure: To determine the effects of the SP compared to placebo on overall menopausal symptoms measure: To determine the effects of the SP compared to placebo on quality of life sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lindus Health, Inc. city: London country: United Kingdom lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06289894 id: BRY805-101 briefTitle: A Study of BRY805 in Participants With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-05 date: 2027-09 date: 2024-03-04 date: 2024-03-04 name: BioRay Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors. conditions: Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: BRY805 injection measure: Occurrence of Drug Limited Toxicities (DLTs) measure: Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs) measure: BRY805 Serum Concentrations measure: Number of Participants with BRY805 Antibodies measure: Overall Response Rate (ORR) measure: Disease Control Rate (DCR) measure: Progression-Free Survival (PFS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Shandong Tumor hospital city: Jinan state: Shandong zip: 250117 country: China name: Jinming Yu, MD role: CONTACT phone: (+86)0531-67627156 email: sdyujinming@126.com lat: 36.66833 lon: 116.99722 hasResults: False
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<|newrecord|> nctId: NCT06289881 id: SIL-026-21 briefTitle: Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets overallStatus: NOT_YET_RECRUITING date: 2025-02-04 date: 2025-03-11 date: 2025-03-25 date: 2024-03-04 date: 2024-03-04 name: Bio-innova Co., Ltd class: INDUSTRY briefSummary: The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 3 days washout period between the doses. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: NONE count: 36 type: ESTIMATED name: Sildenafill-Test product name: Sildenafill-Reference product measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t) measure: Maximal measured plasma concentration (Cmax) measure: Number of subjects with adverse events sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06289868 id: DC-TR23-0222 id: HAV-EU-11-23 type: OTHER domain: Beckman Coulter, Inc briefTitle: Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23) overallStatus: NOT_YET_RECRUITING date: 2024-02-27 date: 2024-05-27 date: 2024-08-27 date: 2024-03-04 date: 2024-03-04 name: Beckman Coulter, Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer.
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This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays. conditions: HAV studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 1150 type: ESTIMATED name: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays name: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays measure: Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity measure: Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Cerba Xpert city: Frepillon zip: 95740 country: France name: Chloé Puisney, PhD role: CONTACT phone: 06.30.15.34.65 email: cpuisney@cerbaresearch.com lat: 49.05216 lon: 2.20528 facility: Eurofins Biomnis city: Ivry-sur-Seine zip: 94208 country: France name: Catherine Coignard, MD role: CONTACT phone: +33 149 59 63 37 email: catherine.coignard@biomnis.eurofinseu.com lat: 48.81568 lon: 2.38487 hasResults: False
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<|newrecord|> nctId: NCT06289855 id: Parkinson's disease briefTitle: Impulse Control Disorder Among Parkinson's Disease Patients overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-08-31 date: 2025-03-31 date: 2024-03-04 date: 2024-03-08 name: Assiut University class: OTHER briefSummary: The goal of this observational study is to learn about impulse control disorders in Parkinson's disease patients.
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The main question: it aims to answer:
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* Detect Relative frequency of impulse control disorder among Parkinson's disease patients
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* Detect Relation between impulse control disorders, and other non motor and motor symptoms in Parkinson's disease patients, using clinical, neurophysiological and radiological assessment conditions: Parkinson's Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 56 type: ESTIMATED name: MDS-UPDRS measure: number of patients with impulse control disorder among Parkinson's disease patients measure: percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients measure: volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients measure: cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06289842 id: ZU-IRB #9697 briefTitle: Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients overallStatus: RECRUITING date: 2024-02-01 date: 2025-01 date: 2026-01 date: 2024-03-04 date: 2024-03-04 name: Zagazig University class: OTHER_GOV briefSummary: The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression conditions: Suicide and Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 34 type: ESTIMATED name: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark) measure: Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS) measure: Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zagazig University status: RECRUITING city: Zagazig zip: 44519 country: Egypt name: Medhat M Bassiony, Professor role: PRINCIPAL_INVESTIGATOR name: Usama M Youssef, Professor role: SUB_INVESTIGATOR name: Ghada M Salah El-Deen, Professor role: SUB_INVESTIGATOR name: Hayam M El-Gohary, Professor role: SUB_INVESTIGATOR name: Alaa E Zayed, Ass.Lecturer role: SUB_INVESTIGATOR lat: 30.58768 lon: 31.502 hasResults: False
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<|newrecord|> nctId: NCT06289829 id: 4-2023-1605 briefTitle: The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam. overallStatus: RECRUITING date: 2024-03-02 date: 2025-07-29 date: 2025-07-29 date: 2024-03-04 date: 2024-03-04 name: Yonsei University class: OTHER briefSummary: The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion, and the newly developed benzodiazepine, remimazolam, is gaining attention as one of them. Remimazolam has rapid onset and recovery times, hemodynamic stability, and is often co-administered with opioids like remifentanil for more effective LMA insertion. This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain, one of the recently developed LMAs, during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose. Starting with an initial concentration of remifentanil of 3.0 μg/mL, the success or failure of LMA insertion will determine the dosage for the next subject. Data will be collected from a total of 60 patients, and subsequent analysis will be conducted. conditions: Adult, Laryngeal Masks, Remimazolam, Remifentanil studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 67 type: ESTIMATED name: remifentanil of the assigned dose name: Ambu Auragain for airway management measure: Success/failure of LMA insertion on the first attempt measure: Difficulty of LMA insertion measure: Optimality of the LMA insertion based on the administered remifentanil dose measure: The number of attempts required for successful LMA insertion and whether intubation was performed. measure: Air leak volume during positive-pressure ventilation measure: Systolic blood pressure measure: Heart rate measure: Patient State Index (PSI) measure: Severity of hoarseness measure: Severity of coughing measure: Severity of sore throat measure: Diastolic blood pressure sex: ALL minimumAge: 19 Years maximumAge: 64 Years stdAges: ADULT facility: Severance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Darhae Eum, Assistant Clinical Professor role: CONTACT phone: 82-2-2228-2431 email: deum@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06289816 id: 28/01/2023 briefTitle: Spleen Preserving Surgery for Splenic Hydatidosis: A Cohort Study on Short and Long-Term Outcomes overallStatus: COMPLETED date: 2015-01-01 date: 2021-06-30 date: 2021-06-30 date: 2024-03-04 date: 2024-03-04 name: Yarmouk University class: OTHER briefSummary: This retrospective cohort study examines the effectiveness of minimally invasive spleen-preserving surgeries compared to total splenectomy for treating primary splenic hydatidosis in Jordan. Covering 18 patients from January 2015 to June 2021, the research highlights similar recurrence rates between both surgical approaches, emphasizing the benefits of spleen preservation in maintaining immune function and reducing septic risks, particularly in pediatric patients. conditions: Spleen-Preserving Surgery conditions: Echinococcus Granulosus Infection conditions: Hydatid Disease conditions: Minimally Invasive Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 18 type: ACTUAL name: Minimally Invasive Surgery measure: Incidence of Postoperative Short-Term Complications measure: Incidence of Postoperative Long-Term Complications sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anas Aljaiuossi city: Irbid zip: 22110 country: Jordan lat: 32.55556 lon: 35.85 hasResults: False
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<|newrecord|> nctId: NCT06289803 id: Huadong Hospital of FudanU briefTitle: The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery overallStatus: RECRUITING date: 2023-09-01 date: 2025-01-31 date: 2025-06-30 date: 2024-03-04 date: 2024-03-04 name: Fudan University class: OTHER briefSummary: Aim of the study: To evaluate the value of Probe Confocal Laser Endomicroscopy (PCLE) in surgery for pancreatic tumor.
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Methods:
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Patients who are diagnosed with pancreatic tumor based on preoperative radiographic findings and will undergo radical resection are included in this clinical study. PCLE will be used in surgery to identify tumor is malignant or not, and surgeons will decide procedures of surgery based on outcomes of PCLE. In this present study, clinical trials will be divided into two phases. In the first phase, based on the definitive postoperative pathologic diagnosis, characteristic imaging structures that were collected by PCLE will be identified and primary diagnostic imaging criteria for pancreatic cancer would be developed. In the second phase, this criterion will be used for rapid intraoperative diagnosis of pancreatic cancer and predicting status of resection margin. In addition, accuracy of PCLE will be verified based on postoperative pathologic reports. conditions: Pancreatic Cancer conditions: Diagnosis conditions: Pancreatoduodenectomy conditions: Distal Pancreatectomy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients diagnosed with pancreatic tumours will undergo surgical resection, and PCLE will be used for identifying the behaviour of tumours (benign or malignant neoplasms) and predicting the status of resection margin. primaryPurpose: TREATMENT masking: NONE count: 200 type: ESTIMATED name: probe confocal laser endomicroscopy measure: diagnostic efficacy measure: Rate of R0 resection sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Huadong Hospital affiliated to Fudan University status: RECRUITING city: Shanghai state: Shanghai zip: 200040 country: China name: Chunjing Li, M.S role: CONTACT phone: 14790068967 email: Lcj1479006@163.com name: Chongyi Jiang, M.D role: CONTACT phone: +8618101802916 email: jiangzhongyi9@126.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06289790 id: 16/BW/2023' briefTitle: Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS) overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-11-07 date: 2024-11-07 date: 2024-03-04 date: 2024-03-04 name: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland class: OTHER briefSummary: The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups conditions: Thoracic Surgery, Video-Assisted studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Erector Spinae Plane (ESP) block name: Lignocaine measure: pain score on numerical rating score measure: cumulative opioid dose measure: incidence of severe hypotension measure: incidence of nausea and vomiting measure: incidence of priuritis measure: incidence of local anaesthetic systemic toxicity symptoms measure: intra-operative cumulative opioid dose measure: time to discharge from hospital sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Medical Institute of the Ministry of the Interior and Administration city: Warsaw state: Mazowieckie zip: 02-507 country: Poland role: CONTACT phone: 722 14 50 phoneExt: (47) email: anestezja@cskmswia.gov.pl name: Antoni Okniński, MD role: PRINCIPAL_INVESTIGATOR name: Iwona Pikto-Pietkiewicz, MD role: SUB_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False
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<|newrecord|> nctId: NCT06289777 id: aortic remodeling briefTitle: Aortic Remodeling After Endovascular Management of Type B Aortic Dissection. overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2026-04-01 date: 2024-03-04 date: 2024-03-04 name: Assiut University class: OTHER briefSummary: Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair. conditions: Type B Aortic Dissection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: TEVAR measure: Analysis of aortic remodeling measure: technical success sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Medicine city: Asyut zip: 71515 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06289764 id: 7/02/2024/131 briefTitle: The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS acronym: Aromatherapy overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-20 date: 2024-05-30 date: 2024-03-04 date: 2024-03-04 name: Esra ÖZER class: OTHER name: KTO Karatay University briefSummary: Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.
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Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints.
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Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms. conditions: Premenstrual Syndrome-PMS studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Bergamot Essential Oil name: Grapefruit Essential Oil name: Sweet almond oil measure: Premenstrual syndrome scale (PMS) measure: Menstrual Symptom Scale sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Ankara Medipol Unıversty status: RECRUITING city: Ankara state: Altındağ zip: 06000 country: Turkey name: Esra ÖZER, Asisst. Prof. role: CONTACT phone: +905433630475 email: esraozellllll@gmail.com name: Şerife İrem DÖNER, research assistant role: SUB_INVESTIGATOR name: Hafize DAĞ TÜZMEN, lecturer role: PRINCIPAL_INVESTIGATOR lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06289751 id: NACI-CerV-004 briefTitle: Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-03-01 date: 2031-01-01 date: 2024-03-04 date: 2024-03-04 name: Tongji Hospital class: OTHER name: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial) name: Women Hospital, School of Medicine, Zhejiang University name: Southwest Hospital, China name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University name: Sichuan Cancer Hospital and Research Institute name: Qilu Hospital of Shandong University name: Beijing Friendship Hospital name: Tianjin Medical University name: West China Second University Hospital name: Xiangya Hospital of Central South University name: Gansu Provincial Maternal and Child Health Care Hospital name: Zhejiang Cancer Hospital name: Shengjing Hospital briefSummary: This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients. conditions: Cervical Cancer conditions: Neoadjuvant Chemoimmunotherapy conditions: Radical Hysterectomy conditions: Fertility Preservation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: a multicentre, single-arm, phase 2 trial primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Cadonilimab name: Paclitaxel-albumin name: Cisplatin name: Extrafascial hysterectomy measure: Percentage of patients meeting ConCerV criteria measure: Objective Response Rate, ORR measure: Proportion of patients requiring postoperative adjuvant therapy measure: Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.0 measure: the surgical complication measure: Pathologic Complete Response measure: Overall survival, OS measure: progression-free survival, PFS sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430030 country: China name: Gang Chen role: CONTACT phone: 086-027-8362 email: gumpc@126.com name: Jing Chen role: CONTACT phone: 086-027-8362 email: chenjing3223@126.com name: Gang Chen role: PRINCIPAL_INVESTIGATOR name: Kezhen Li role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
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<|newrecord|> nctId: NCT06289738 id: ICF in Takayasu Arteritis briefTitle: ICF in Takayasu Arteritis overallStatus: RECRUITING date: 2024-02-21 date: 2024-03-20 date: 2024-03-25 date: 2024-03-04 date: 2024-03-04 name: Pamukkale University class: OTHER briefSummary: The aim was to analyze the problem in patients with Takayasu Arteritis based on the International Classification of Functioning, Disability and Health.The sample of our study will consist of individuals between the ages of 18-65 who have been diagnosed with Takayasu Arteritis by rheumatologists and are followed by Pamukkale University Rheumatology Clinic. conditions: Takayasu Arteritis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: ICF measure: 6 open-ended questions sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elif Gur Kabul status: RECRUITING city: Uşak country: Turkey name: Elif Gur Kabul, Assistant Professor role: CONTACT phone: 00.90.2582964282 phoneExt: 4282 email: elifgur1988@hotmail.com lat: 38.67351 lon: 29.4058 hasResults: False
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<|newrecord|> nctId: NCT06289725 id: IRB-VN01002-23932 briefTitle: Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B overallStatus: RECRUITING date: 2024-01-01 date: 2026-01-01 date: 2026-01-01 date: 2024-03-04 date: 2024-03-18 name: Ly Hoa Anh Minh class: OTHER briefSummary: The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response. conditions: Chronic Hepatitis b studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 84 type: ESTIMATED name: antiviral treatment measure: Serological response for HBeAg measure: Virological response measure: Biochemical response sex: ALL minimumAge: 2 Years maximumAge: 16 Years stdAges: CHILD facility: Children's Hospital 1 status: RECRUITING city: Ho Chi Minh City country: Vietnam name: Minh Hoa Anh Ly role: CONTACT phone: 0902352622 email: lhaminh.ncs.nhi23@ump.edu.vn lat: 10.82302 lon: 106.62965 facility: City Children's Hospital status: RECRUITING city: Ho Chi Minh City country: Vietnam name: Minh Hoa Anh Ly role: CONTACT email: lhaminh.ncs.nhi23@ump.edu.vn lat: 10.82302 lon: 106.62965 hasResults: False
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<|newrecord|> nctId: NCT06289712 id: APHP231660 briefTitle: Evaluation of the Ablation of Hepatic Lesions by Electroporation acronym: EVALHEP overallStatus: RECRUITING date: 2023-11-23 date: 2025-05-23 date: 2025-05-23 date: 2024-03-04 date: 2024-03-04 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Inria Team MONC briefSummary: Irreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation.
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The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures. conditions: Liver Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 50 type: ESTIMATED measure: Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up measure: Calculation of the tumor coverage rate by the various electric field isolines at different relevant values (for example, three-dimensional isolines between 300 and 700V.cm-1 will be simulated numerically). measure: Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up measure: Identification and assessment of imaging biomarkers (radiomics-based) using numerical simulation and post-therapeutic imaging for treatment response evaluation. measure: Digital resolution of electrical potential and tissue conductivity values from test pulses at the start of the procedure. measure: Develop software solutions potentially usable in real-time and tailored for clinical use. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD status: RECRUITING city: Bobigny zip: 93009 country: France name: Olivier SUTTER role: CONTACT phone: 01 72 40 00 12 email: olivier.sutter@aphp.fr lat: 48.9 lon: 2.45 hasResults: False
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<|newrecord|> nctId: NCT06289699 id: WARD-CSS international 1251 briefTitle: Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures overallStatus: RECRUITING date: 2024-02-26 date: 2024-08-01 date: 2024-12-31 date: 2024-03-04 date: 2024-03-04 name: Christian S. Meyhoff class: OTHER name: Rigshospitalet, Denmark briefSummary: The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction. conditions: User Experience conditions: Postoperative Complications conditions: Acute Medical Conditions studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data measure: Technical feasibility measure: Alert relay to smartphones measure: Response to alerts measure: Patients experiences from being monitored with wCSVM. measure: Relevance of alarms measure: Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day measure: Frequency of delivered alarms on respiration rate (RR) pr patient pr day measure: Frequency of delivered alarms on heart rate (HR) pr patient pr day measure: Frequency of delivered alarms on blod pressure (BP) pr patient pr day measure: Overall score of user satisfaction from use of WARD24/7 app measure: Subscale MAUQ scores measure: Monitoring practices prior to the wCVSM measure: Cumulative duration of SpO2<88% and SpO2 < 85% measure: Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1 measure: Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1 measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o measure: Cumulative duration of Circulatory failure measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o measure: Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88% sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Cleveland Clinic Foundation, General Anesthesiology status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44195 country: United States name: Daniel Sessler, MD role: CONTACT name: Daniel Sessler, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie status: NOT_YET_RECRUITING city: Hamburg zip: 20246 country: Germany name: Bernd C Saugel, MD, Dr. Med. role: CONTACT name: Bernd C Saugel, MD, Dr. Med. role: PRINCIPAL_INVESTIGATOR lat: 53.57532 lon: 10.01534 facility: University Medical Center Groningen, Department of Anesthesiology status: NOT_YET_RECRUITING city: Groningen zip: 9700 country: Netherlands name: Marjolein Haveman, TP role: CONTACT name: Marjolein Haveman, TP role: PRINCIPAL_INVESTIGATOR lat: 53.21917 lon: 6.56667 facility: St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin status: RECRUITING city: Trondheim zip: 7006 country: Norway name: Erlend Skraastad, MD, PhD role: CONTACT name: Erlend Skraastad, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 63.43049 lon: 10.39506 facility: Liverpool University Hospitals NHS Foundation Trust status: NOT_YET_RECRUITING city: Liverpool zip: L7 8YE country: United Kingdom name: Ingeborg Welters, Dr. Med. role: CONTACT name: Ingeborg Welters, Dr. Med. role: PRINCIPAL_INVESTIGATOR lat: 53.41058 lon: -2.97794 hasResults: False
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<|newrecord|> nctId: NCT06289686 id: C.2023.080 briefTitle: MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation overallStatus: RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-03-04 date: 2024-03-05 name: Brooke Army Medical Center class: FED name: Sparta Biopharma name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness briefSummary: Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair. conditions: Rotator Cuff Tears conditions: Rotator Cuff Injuries conditions: Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Rotator cuff repairs with BioEnthesis augmentation name: Rotator cuff repairs without BioEnthesis augmentation measure: Rates of re-tear measure: Change in the Visual Analogue Scale (VAS) from before surgery to after surgery measure: Change in the return to activities of daily living (ADL) from before surgery to after surgery measure: Change in the Concomitant medications (ConMeds) from before surgery to after surgery measure: Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery measure: Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery measure: Change in the Constant-Murley Score from before surgery to after surgery measure: Change in the shoulder immobilization status from before surgery to after surgery measure: Change in strength measurements from before surgery to after surgery measure: Change in range of motion measurements from before surgery to after surgery measure: Number of medical events/adverse events after surgery measure: Cumulative number of steroid injections after surgery measure: Number of unscheduled visits after surgery measure: Number of for-cause imaging procedures sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: NOT_YET_RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Kelly Kilcoyne, MD role: CONTACT phone: 301-295-2441 email: Kelly.G.Kilcoyne.mil@health.mil lat: 38.98067 lon: -77.10026 facility: Brooke Army Medical Center status: RECRUITING city: San Antonio state: Texas zip: 78234 country: United States name: Andrew Sheean, MD role: CONTACT phone: 210-916-1280 email: Andrew.J.Sheean.mil@health.mil lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06289673 id: INITIALL id: NCI-2024-01659 type: REGISTRY domain: NCI Clinical Trial Registration Program briefTitle: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2034-05 date: 2039-05 date: 2024-03-04 date: 2024-03-15 name: St. Jude Children's Research Hospital class: OTHER briefSummary: The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.
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Primary Objectives
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* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
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* To develop a central database of genomic and clinical findings.
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Secondary Objectives
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* To assess event free and overall survival data of patients enrolled on this study. conditions: Acute Lymphoblastic Leukemia conditions: Lymphoblastic Lymphoma conditions: Mixed Phenotype Acute Leukemia studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 850 type: ESTIMATED name: Dexamethasone name: Vincristine name: Daunorubicin name: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) name: Methotrexate name: Cytarabine measure: Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy). measure: Complete data within the INITIALL database measure: Event Free Survival (EFS) measure: Overall Survival (OS) sex: ALL minimumAge: 1 Year maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: United States, Tennessee St. Jude Children's Research Hospital city: Memphis state: Tennessee zip: 38105 country: United States name: Seth E. Karol, MD role: CONTACT phone: 866-278-5833 email: referralinfo@stjude.org name: Seth E. Karol, MD role: PRINCIPAL_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False
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<|newrecord|> nctId: NCT06289660 id: PED-TB22 briefTitle: Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age overallStatus: RECRUITING date: 2022-12-22 date: 2033-01-02 date: 2033-03-01 date: 2024-03-04 date: 2024-03-04 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide. conditions: Tuberculosis Infection studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1000 type: ESTIMATED measure: Epidemiology of Tuberculosis sex: ALL minimumAge: 1 Week maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Florence state: Firenze zip: 50139 country: Italy name: Luisa Galli role: CONTACT email: luisa.galli@meyer.it lat: 43.77925 lon: 11.24626 facility: Ospedale Pediatrico Giovanni XXIII status: RECRUITING city: Bari country: Italy name: Desiree Caselli role: CONTACT email: desiree.caselli@policlinico.ba.it lat: 41.11148 lon: 16.8554 facility: Ospedale di Belluno status: RECRUITING city: Belluno country: Italy name: Giangiacomo Nicolini role: CONTACT email: gnicolini@gmail.com lat: 46.14262 lon: 12.2156 facility: Università di Bologna status: RECRUITING city: Bologna country: Italy name: Marcello Lanari role: CONTACT email: marcello.lanari@unibo.it lat: 44.49381 lon: 11.33875 facility: IRCCS Istituto Giannina Gaslini status: RECRUITING city: Genova country: Italy name: Elio Castagnola role: CONTACT email: eliocastagnola@gaslini.org lat: 44.40478 lon: 8.94438 facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico status: RECRUITING city: Milano country: Italy name: Samantha Bosis, MD role: CONTACT email: samantha.bosis@policlinico.mi.it lat: 45.46427 lon: 9.18951 facility: Ospedale Luigi Sacco status: RECRUITING city: Milano country: Italy name: Vania Giacomet role: CONTACT email: vania.giacomet@unimi.it lat: 45.46427 lon: 9.18951 facility: Policlinico di Modena status: RECRUITING city: Modena country: Italy name: Barbara Maria Bergamini role: CONTACT email: bergamini.barbaramaria@unimo.it lat: 44.64783 lon: 10.92539 facility: Università Federico II status: RECRUITING city: Napoli country: Italy name: Andrea Lo Vecchio role: CONTACT email: andrea.lovecchio@unina.it lat: 40.85216 lon: 14.26811 facility: Ospedale dei Bambini "G.Di Cristina" status: RECRUITING city: Palermo country: Italy name: Claudia Colomba, MD role: CONTACT email: claudia.colomba@unipa.it lat: 38.13205 lon: 13.33561 facility: Ospedale di Parma status: RECRUITING city: Parma country: Italy name: Susanna Maria Roberta Esposito role: CONTACT email: susannamariaroberta.esposito@unipr.it lat: 44.79935 lon: 10.32618 facility: IRCCS Policlinico San Matteo status: RECRUITING city: Pavia country: Italy name: Gian Luigi Marseglia role: CONTACT email: gl.marseglia@smatteo.pv.it lat: 45.19205 lon: 9.15917 facility: Azienda Ospedaliero Universitaria Pisana status: RECRUITING city: Pisa country: Italy name: Diego Peroni role: CONTACT email: diego.peroni@unipi.it lat: 43.70853 lon: 10.4036 facility: Azienda USL Toscana Centro status: RECRUITING city: Prato country: Italy name: Per Luigi Vasarri role: CONTACT email: pvasarri@usl4.toscana.it lat: 43.8805 lon: 11.09699 facility: IRCCS Ospedale Pediatrico Bambin Gesù status: RECRUITING city: Roma country: Italy name: Laura Lancella role: CONTACT email: laura.lancella@opbg.net lat: 41.89193 lon: 12.51133 facility: Policlinico Universitario Agostino Gemelli IRCCS status: RECRUITING city: Roma country: Italy name: Danilo Buonsenso, MD role: CONTACT email: danilo.buonsenso@policlinicogemelli.it lat: 41.89193 lon: 12.51133 facility: Ospedale Regina Margherita status: RECRUITING city: Torino country: Italy name: Silvia Garazzino role: CONTACT email: silvia.garazzino@unito.it lat: 45.07049 lon: 7.68682 hasResults: False
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