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Athletes must have a high level of fitness, strength, coordination, agility, speed and motor control to perform at an elite level with minimal injury risk.
Repetitive upper extremity movements imposed by freestyle swimming may lead to changes in muscle length and tension by paving the way for postural misalignment in adolescent swimmers.
As can be seen in the studies, young swimmers who are preparing for the competition have postural disorders and injuries related to use, such as decreased posture, shoulder joint range of motion and subacromial distance.
Pectoralis minor stretching exercise to be performed in swimmers is aimed to improve swimming performance and prevent possible postural disorders by contributing to the increase of maximal shoulder muscle strength as well as correcting the incorrectly developed posture in children. conditions: The Study Will Not be Based on Any Disease conditions: Ability to Swim 100m Independent Freestyle conditions: Be Between the Ages of 9-16 conditions: Continuing Running as Part of a Sports Club studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: three groups as intervention, exercises group non- exercises group and scham primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 91 type: ACTUAL name: pektoralis minor shortnes name: Group in which the Pectoralis Minor stretching exercise was performed in a sham manner name: The group in which Pectoralis Minor stretching exercise was not applied measure: Speed Tests measure: Apley test measure: Round Shoulder measure: Anthropometric Measurement: measure: Posture analysis: (ANNEX2) measure: Anthropometric Measurement 2 measure: Y Balance Test measure: Eurofit Test Battery measure: Eurofit Test Battery 2 measure: Eurofit Test Battery 3 sex: ALL minimumAge: 9 Years maximumAge: 16 Years stdAges: CHILD facility: Galatasaray Ergün Gürsoy Olympic Swimming Pool city: Üsküdar state: Nuhkuyusu zip: 34662 country: Turkey lat: 41.02252 lon: 29.02369 hasResults: False
<|newrecord|> nctId: NCT06344507 id: TAILOR-EUS briefTitle: Iconographic Registry of Pancreatobiliary Endoscopy Procedures acronym: TAILOR-EUS overallStatus: RECRUITING date: 2022-03-28 date: 2027-12-31 date: 2027-12-31 date: 2024-04-03 date: 2024-04-03 name: IRCCS San Raffaele class: OTHER briefSummary: The aim of the TAILOR-EUS study (Iconographic Registry of Bilio-Pancreatic Endoscopic Ultrasound Procedures) is to establish a clinical registry comprising images and videos generated during endoscopic procedures conducted for the investigation of pancreatic diseases (PD). The study will compile historical, pathological, and imaging data from approximately 12,000 patients (2,000 retrospectively and 10,000 prospectively) who underwent endoscopic ultrasound procedures for inflammatory pancreatic conditions (e.g., acute, recurrent, chronic pancreatitis), autoimmune bilio-pancreatic diseases (e.g., autoimmune pancreatitis), neoplastic bilio-pancreatic conditions, and screenings for individuals at high risk of developing such diseases at the Bilio-Pancreatic Endoscopy and Endoscopic Ultrasound Unit of the IRCCS San Raffaele Hospital between 2000 and 2027.
Participants have undergone or will undergo the standard diagnostic pathway appropriate for their conditions as part of routine clinical practice. All instrumental examinations and endoscopic ultrasound procedures are integral to the standard diagnostic and therapeutic approach for pancreatic diseases. conditions: Pancreas Neoplasm conditions: Cancer of Pancreas conditions: Pancreatitis conditions: Neuroendocrine Tumors studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 12000 type: ESTIMATED measure: Registry for images and videos sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS San Raffaele Hospital status: RECRUITING city: Milan zip: 20132 country: Italy name: Matteo Tacelli, MD role: CONTACT email: [email protected] lat: 45.46427 lon: 9.18951 hasResults: False
<|newrecord|> nctId: NCT06344494 id: INTELICE-CTP-2401 briefTitle: Cardiac Interventional ICE Imaging Trial acronym: INTELICE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-03 date: 2024-04-04 name: ICE Intelligent Healthcare Co., Ltd class: INDUSTRY briefSummary: The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process. conditions: Structural Heart Diseases conditions: Atrial Septal Defect conditions: Patent Foramen Ovale conditions: Arrhythmias, Cardiac conditions: Atrial Fibrillation conditions: Supraventricular Tachycardia conditions: Valve Disease, Heart studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 130 type: ESTIMATED name: Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system name: SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system measure: Image quality measure: Image quality measure: Procedure success measure: Technical success measure: Procedure time measure: Device performance sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital, Capital Medical University city: Beijing state: Bejing zip: 100011 country: China name: Deyong Long, MD, PhD role: CONTACT phone: 64412431 phoneExt: 0086010 email: [email protected] name: Ribo Tang, MD, PhD role: SUB_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The First People's Hospital of Changzhou city: Changzhou state: Jiangsu zip: 213004 country: China name: Ling Yang, MD role: CONTACT phone: 68873108 phoneExt: 00860519 email: [email protected] name: Ling Yang, MD role: PRINCIPAL_INVESTIGATOR name: Bo Qian, MD role: SUB_INVESTIGATOR lat: 31.77359 lon: 119.95401 facility: The First Hospital Of Jilin University city: Changchun state: Jilin zip: 130021 country: China name: Shuyan Li, MD, PhD role: CONTACT phone: 88782222 phoneExt: 00860431 email: [email protected] name: Shuyan Li, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Hongbo Meng role: SUB_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: Shanghai General Hospital city: Shanghai state: Shanghai zip: 200081 country: China name: Songwen Chen, MD, PhD role: CONTACT phone: 18017638339 phoneExt: 0086 name: Songwen Chen, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Juan Sun role: SUB_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344481 id: CL-00003 briefTitle: The Hyalex First-in-Human Study overallStatus: RECRUITING date: 2024-03-07 date: 2026-09 date: 2026-09 date: 2024-04-03 date: 2024-04-12 name: Hyalex Orthopaedics, Inc. class: INDUSTRY briefSummary: The Hyalex First-in-Human Study is a prospective, multicenter, open-label, single-arm, 2-phase, first-in-human study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment. conditions: Cartilage Injury studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: Surgical (Hyalex Cartilage Knee Implant) measure: Freedom from implant rejection and infection. measure: Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months. sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SPORTO status: RECRUITING city: Łódź zip: 09-038 country: Poland name: Klaudia Marchewa role: CONTACT email: [email protected] name: Marcin Domzalski, M.D. role: PRINCIPAL_INVESTIGATOR lat: 51.75 lon: 19.46667 hasResults: False
<|newrecord|> nctId: NCT06344468 id: 531393 briefTitle: The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU overallStatus: COMPLETED date: 2023-04-12 date: 2023-06-05 date: 2024-03-04 date: 2024-04-03 date: 2024-04-03 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: The goal of this is randomized controlled study to examine the effect of early mobilization on sleep, physiological parameters, and length of stay in the intensive care unit (ICU).
The hypothesis are:
Hypothesis I: Early mobilization positively affects the sleep quality of patients.
Hypothesis II: Early mobilization positively affects the physiological parameters of patients (respiratory rate, heart rate, blood pressure, body temperature, pain).
Hypothesis III: Early mobilization shortens the length of stay of patients in the intensive care unit (ICU).
Early mobilization will begin in the experimental group after sedation is discontinued within the first 12 hours and its effects disappear. In early mobilization, in the evaluation of in-bed mobilization, physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Surgical wounds and dressing areas, if any, are protected, drains are identified, care is taken not to remove equipment such as urinary catheters or nasogastric tubes, when the patient is seated on the edge of the bed with the help of a nurse, when he/she is stood up next to the bed with the support of the nurse, when he/she is made to sit in a chair next to the bed and when he/she is in a chair. While sitting, 1st minute, 5th minute, 10th minute respiratory rate, sPO2, heart rate, blood pressure, body temperature values and pain levels will be recorded and these data will be evaluated on their own. During mobilization, if the patient develops chest pain, arrhythmia, hypertension (systolic pressure\>160 mmHg), or hypotension (systolic pressure\<90 mmHg), tachypnea, or hypoxia, a break will be taken and the physician will be consulted. The same procedures will be repeated during the mobilization of the patient in the first 24-36 hours and the necessary records will be made by the researcher.
Control Group:
After admission to the Cardiovascular Surgery ICU, the type, purpose and implementation process of the study will be explained to the patients, and a routine/standard postoperative mobilization procedure will be applied to the patients in the control group. Accordingly, patients will be mobilized in the first 24 hours after surgery, and in the evaluation of in-bed mobilization, their physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be evaluated and recorded in the supine, semi-fowler position. In out-of-bed mobilization, the patient's physiological parameters (respiratory rate, sPO 2, heart rate, blood pressure, body temperature, pain) will be determined and recorded before mobilization and when the head is in a 45˚ upward position. Again, arterial blood gas monitoring of the patients in the control group will be performed at maximum 4-hour intervals, and respiratory parameters will be frequently evaluated and recorded. conditions: Early Mobilization conditions: Sleep Quality conditions: Critical Care conditions: Nursing Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 82 type: ACTUAL name: Early Mobilization measure: The length of stay of patients in the intensive care unit measure: The Richards-Campbell Sleep Questionnaire (RCSQ) measure: The Glasgow Coma Scale (GCS) measure: Physiological Parameter - for the experimental group measure: Physiological Parameter - for the control group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06344455 id: RCT Delay Discounting briefTitle: Influence of Educational Stimuli From the Pé-de-Meia Program on Delay Discounting Propensity overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-07-01 date: 2024-04-03 date: 2024-04-03 name: Federal Institute of Education, Science and Technology of the State of Mato Grosso class: OTHER briefSummary: The goal of this randomized clinical trial is to investigate how the Stay-and-Complete School Incentive Savings, part of the Pé-de-Meia Program, affects decision-making among low-income high school students, particularly their tendency towards delay discounting. This concept describes the preference for immediate gratifications over larger future rewards. The main questions it seeks to answer are:
Can exposure to the specific educational stimuli of the Pé-de-Meia Program alter students' propensity for delay discounting? How do different levels of delay discounting influence students' decision-making regarding their studies and the utilization of the program's incentives?
Participants will:
Engage in a modified version of the Iowa Gambling Task (IGT), a computerized game that simulates decision-making under uncertainty, adapted to reflect the stimuli and choices related to the Pé-de-Meia Program.
Complete questionnaires that measure their propensity for delay discounting and gather demographic and socioeconomic information.
Researchers will compare the outcomes among groups of students exposed to different types of stimuli (aligned with the program's objectives, contrasting, and a control group without modifications) to see if the specific financial and educational incentives of the Pé-de-Meia Program influence how students value immediate rewards compared to future benefits. This study is expected to contribute to the improvement of public educational policies, encouraging school retention and promoting the educational success of low-income adolescents. conditions: Delay Discounting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: School Retention and Completion Incentive Savings via Modified Iowa Gambling Task A name: Iowa Gambling Task name: School Retention and Completion Incentive Savings via Modified Iowa Gambling Task B measure: Delay Discounting 1 measure: Delay Discounting 2 measure: decision-making performance under risk and uncertainty measure: loss aversion measure: Loss Frequency-Based Decision Strategy measure: Learning sex: ALL minimumAge: 14 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06344442 id: APHP220827 briefTitle: Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial) overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2026-06-05 date: 2026-06-05 date: 2024-04-03 date: 2024-04-03 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Liver transplantation (LT) is a high-risk surgery for hemodynamic instability and haemorrhagic shock with a high-risk of acute kidney injury (AKI). Indeed, the incidence of post-transplant AKI exceeds 50% in some series with 15% of patients requiring renal replacement therapy. Acute kidney injury after LT is a predisposing factor for chronic renal failure which is independently associated with higher morbidity and mortality.
Arginine vasopressin (AVP), an essential stress hormone released in response to hypotension, binds to AVPR1a to promote vasoconstriction. Furthermore, it may have nephroprotective effects with a preferential vasoconstriction of the post-glomerular arteriole resulting in increased glomerular filtration
The hypothesis of the present work is that low-dose arginine-vasopressin supplementation reduce posttransplant AKI in liver transplantation. conditions: Acute Kidney Injury Post Liver Transplantation studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, national multicentre, double-blinded, randomized ,controlled superiority trial with two parallel arms primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: All the clinical teams involved intraoperatively (anaesthetists, nurse anaesthetists and surgeons) and postoperatively (doctors and nurses who will take care of the patient postoperatively) and the families will ignore the allocation of treatments for the duration of the trial,except the nurse in charge of preparing the infusions ,She will ensure respect for the blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 304 type: ESTIMATED name: Arginine vasopressin name: Norepinephrine measure: The primary objective is to compare the effect of intraoperative low-dose supplementation of AVP vs norepinephrine infusions on post-transplant Acute Kidney Injury after liver transplantation. measure: To compare into the two arms the number of packed red blood cellsand fresh frozen plasma transfused measure: To compare into the two arms the number of the Number of AKI KDIGO 1 measure: To compare into the two arms the Number of AKI KDIGO 2 measure: To compare into the Number of AKI KDIGO 3 measure: The need for renal replacement for replacement therapy (RRT) in ICU measure: The number of patients remaining on dialysis at the end of the study measure: Average intraoperative norepinephrine concentrations measure: Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine) measure: Number of platelets transfused intraoperatively measure: Amount of vascular filling solutions intraoperatively measure: Sequential Organ Failure Assessment (SOFA score) measure: Number of days alive outside intensive care unit measure: Mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: URC Lariboisière-Fernand Widal-saint Louis city: Paris zip: 75010 country: France name: Nabila PIZZI role: CONTACT phone: 01 40 05 49 83 phoneExt: +33 email: [email protected] name: Jaques DURANTEAU, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
<|newrecord|> nctId: NCT06344429 id: STL_CT_0001 briefTitle: Stellest Lenses and Low-concentration Atropine Myopia Control Among Children overallStatus: RECRUITING date: 2023-08-20 date: 2024-08-20 date: 2025-08-20 date: 2024-04-03 date: 2024-04-04 name: Essilor-Polylite Taiwan Co., Ltd. class: INDUSTRY briefSummary: The prevalence of myopia is increasing globally, especially in Asian countries. 70-80% of the young population suffers from myopia, and almost 20% have high myopia. High myopia can easily lead to blinding diseases, including retinal detachment, macular degeneration, and glaucoma. In Taiwan, according to a survey by the National Health Administration, the proportion of myopia among Grade 1 students has exceeded 81%.
There are many ways to control myopia progression. High concentrations of atropine have been reported highly effective in the control of the myopia progression. However the accompanied side effects such as photophobia and near blurred vision. Recent research shows that low-concentration atropine can achieve similar control effect and more acceptable with much minimal side effect compared to high concentration of atropine.
Multiple animal experiments have confirmed that giving retinal myopia defocus signals can effectively decrease the growth of the eye, thereby inhibiting the progression of myopia. Therefore, regarding lens design, myopic defocus does play an important role in myopia control, including orthokeratology lenses, multifocal soft contact lenses, and peripheral defocus lenses.
Stellest, a myopia control lens based on the myopia defocus theory, is equipped with highly aspheric lenslet technology. In a recent study, compared with single vision lenses, Stellest significantly slowed down the myopia progression reaching 67% and retard axial elongation reaching 64% The purpose of this study is to explore the effectiveness of Stellest Lenses in controlling myopia in Taiwanese children and whether Stellest Lenses combined with low-concentration atropine eye drops can increase the effect of myopia control. conditions: Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Stellest Lenses name: Stellest Lenses+0.05% atropine name: Single vision Lenses+0.05% atropine measure: Spherical equivalent refraction power measure: Axial length sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Kaohsiung Chang Gung Memorial Hospital status: RECRUITING city: Kaohsiung zip: 833401 country: Taiwan name: Pei-Chang Wu role: CONTACT name: Pei-Chang Wu role: PRINCIPAL_INVESTIGATOR lat: 22.61626 lon: 120.31333 hasResults: False
<|newrecord|> nctId: NCT06344416 id: RXG-001-2024-CLP (Rex-002) briefTitle: Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-03-30 date: 2026-01-30 date: 2024-04-03 date: 2024-04-03 name: Dosentrx Ltd. class: INDUSTRY briefSummary: Primary Objective:
• To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation.
Secondary Objective:
• To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group. conditions: Any Solid Oral Medication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Study groups primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group. whoMasked: PARTICIPANT count: 200 type: ESTIMATED name: Use of ReX to dispense and monitor solid oral medication therapy. measure: Outcome MeasureReX Platform Study Group sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: OHC city: Cincinnati state: Ohio zip: 45242 country: United States lat: 39.12713 lon: -84.51435 hasResults: False
<|newrecord|> nctId: NCT06344403 id: KY2024-045-02 briefTitle: Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain overallStatus: RECRUITING date: 2024-04-01 date: 2024-10-01 date: 2025-03-01 date: 2024-04-03 date: 2024-04-03 name: Beijing Tiantan Hospital class: OTHER briefSummary: Herpes zoster (HZ) is a skin infection disease which cause severe zoster-associated pain (ZAP) along sensory nerve in the corresponding segment. Evidence for the efficacy of existing local therapies for acute/subacute ZAP is limited. The hypothesis is that patients with acute/subacute ZAP treated with TPIs with local anesthetic and steroids under the basis of standard treatment will show better clinical outcomes compared with subjects treated with standard antiviral medicine treatment only. conditions: Herpes Zoster conditions: Local Infiltration conditions: Acute Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: analgesic name: Tender point infiltration measure: The presence of postherpetic neuralgia using VAS score measure: visual analogue scale score at each time point measure: Proportion of patients receiving repeated TPIs and block points measure: Consumption of oral drugs at each time point measure: The presence of PHN 3 and month 6 post treatment measure: Patient satisfaction scores on the 5-point Likert scale measure: Quality of life on the Scores on the WHOQOL-BREF measure: Adverse reactions through study completion sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Tiantan Hospital status: RECRUITING city: Beijing state: Beijing zip: 100070 country: China name: Luo Fang, M.D role: CONTACT phone: +86 13611326978 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06344390 id: 20210327 briefTitle: Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke overallStatus: RECRUITING date: 2024-04-10 date: 2024-10-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-03 name: The First Hospital of Hebei Medical University class: OTHER briefSummary: Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function. The patients with cognitive impairment and non-dementia PSCIND after ischemic stroke were randomly divided into two groups. In addition to the basic drugs of ischemic stroke, the patients were given pentothemine sustained release tablets and blank control respectively to observe the effects of pentothemine on cognitive function and neuronal electrical signals in the patients with ischemic PSCIND. It is expected to explore the possible internal biological mechanism by using transcranial Doppler, oxygen-dependent functional magnetic resonance imaging and craniocerebral magnetic resonance pop analysis. Finally, statistical correlation analysis was used to elucidate the specific mechanism of pentoxifylline in improving cognitive function of non-dementia patients with cognitive impairment after ischemic stroke. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: Pentoxifylline measure: Pentoxifylline can improve cognitive impairment after ischemic stroke sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: BHan status: RECRUITING city: Shijiazhuang country: China name: Jiaying Rong role: CONTACT phone: 15241876265 email: [email protected] lat: 38.04139 lon: 114.47861 hasResults: False
<|newrecord|> nctId: NCT06344377 id: BETadiposeWOMEN briefTitle: Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women overallStatus: NOT_YET_RECRUITING date: 2024-04-21 date: 2025-12-30 date: 2026-12-30 date: 2024-04-03 date: 2024-04-05 name: Poznan University of Life Sciences class: OTHER briefSummary: Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity.
This study is designed in a placebo-controlled, double-blinded, randomized fashion. The participants will be overweight or obese pre-menopausal females. Upon enrollment, participants will be randomly assigned to one of two parallel groups: betaine (3g/d) or placebo. The supplementation period will last for 8 weeks. There will be three study meetings: T1 before supplementation, T2 after 4 weeks of supplementation, and T3 after 8 weeks of supplementation. Blood will be drawn and body composition measured, and adipose tissue biopsy taken at meetings T1 and T3. The T2 meeting will involve only body composition measurement. Study outcomes will include body mass and composition (including body fat percent), lipid profile, and the expression of genes related to lipid metabolism in adipose tissue and peripheral blood mononuclear cells. conditions: Overweight and Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Betaine name: Placebo measure: Body composition measure: Body mass measure: Waist and hips circumference measure: Lipid profile measure: Gene expression measure: Liver function test measure: Dietary intake sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Poznan University of Life Sciences city: Poznań zip: 60-637 country: Poland name: Agata Chmurzynska role: CONTACT phone: +48 618466181 email: [email protected] name: Agata Chmurzynska role: PRINCIPAL_INVESTIGATOR name: Emilia Zawieja role: SUB_INVESTIGATOR name: Monika Młodzik-Czyżewska role: SUB_INVESTIGATOR name: Paweł Juszczak role: SUB_INVESTIGATOR lat: 52.40692 lon: 16.92993 hasResults: False
<|newrecord|> nctId: NCT06344364 id: PHN 1-080-23 briefTitle: Digital Pathology and AI for Liver Outcomes in MASLD acronym: DPAILO-1 overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-04-03 date: 2024-04-08 name: PharmaNest, Inc class: INDUSTRY name: Chinese University of Hong Kong name: University of Edinburgh name: University of Seville name: Imperial College London name: Icahn School of Medicine at Mount Sinai name: Fundacio Clinic Barcelona briefSummary: The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital pathology liver biopsy images, in predicting clinical hepatic decompensation events in patients with metabolic dysfunction-associated steatohepatitis (MASH). conditions: Metabolic Dysfunction-associated Steatotic Liver Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS) measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS measure: Performance of Hepatic Decompensation Event predictive value of the FIB-4 biomarker, a non-invasive test measure: Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test measure: Performance of Hepatic Decompensation Event predictive value of the FibroNest Parenchymal Tissue Adjusted Phenotypic Fibrosis Composite Score (Pt-Ph-FCS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Icahn School of Medicine at Mount Sinai city: New York state: New York zip: 10029 country: United States name: Meena Bansal, MD role: CONTACT email: [email protected] lat: 40.71427 lon: -74.00597 facility: The Chinese University of Hong Kong city: Sha Tin country: Hong Kong name: Vincent Wong, PhD role: CONTACT email: [email protected] lat: 22.38333 lon: 114.18333 facility: Fundació de Recerca Clinic Barcelona city: Barcelona country: Spain name: Isabel Graupera, PhD role: CONTACT email: [email protected] lat: 41.38879 lon: 2.15899 facility: University of Seville city: Sevilla zip: 41004 country: Spain name: Manuel R Gómez, PhD role: CONTACT email: [email protected] lat: 37.38283 lon: -5.97317 facility: University of Edinburgh city: Edinburgh state: Scotland country: United Kingdom name: Jonathan Fallowfield, PhD role: CONTACT email: [email protected] name: Timothy Kendall, PhD role: CONTACT email: [email protected] lat: 55.95206 lon: -3.19648 facility: University of Edinburgh city: Edinburgh state: Scotland country: United Kingdom name: Quentin Anstee, PhD role: CONTACT email: [email protected] name: Jo Boyle role: CONTACT email: [email protected] lat: 55.95206 lon: -3.19648 facility: Imperial College London city: London country: United Kingdom name: Pinelopi Manousou, PhD role: CONTACT email: [email protected] lat: 51.50853 lon: -0.12574 hasResults: False
<|newrecord|> nctId: NCT06344351 id: TQB3006-I-01 briefTitle: A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer overallStatus: RECRUITING date: 2024-04-25 date: 2025-03 date: 2026-08 date: 2024-04-03 date: 2024-04-26 name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This study includes two stage: dose escalation and dose extension, with a single dose and a multiple dose study. This is a single-center, open, non-randomized, single arm, study to evaluate the safety, tolerability and pharmacokinetics of TQB3006 tables in patients with advanced malignant cancer. conditions: Advanced Malignant Neoplasm studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 93 type: ESTIMATED name: TQB3006 tablets measure: Dose limiting toxicity (DLT) measure: Maximum tolerated dose (MTD) measure: Recommended phase II dose (RP2D) measure: Adverse events (AE) measure: Serious adverse events (SAE) measure: Time to reach maximum plasma concentration (Tmax) measure: Peak concentration (Cmax) measure: Half-life (t1/2) measure: Area under the concentration-time curve (AUC [0-infinity]) measure: Area under the concentration-time curve (AUC [0-t]) measure: Apparent clearance (CL/F) measure: Apparent volume of distribution (Vd/F) measure: Objective response rate (ORR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Harbin Medical University Cancer Hospital status: RECRUITING city: Harbin state: Heilongjiang zip: 150000 country: China name: Tongsen Zheng, Doctor role: CONTACT phone: 15134569619 email: [email protected] lat: 45.75 lon: 126.65 hasResults: False
<|newrecord|> nctId: NCT06344338 id: Z211100002921030 briefTitle: Application of tDCS Stimulation in Controlling Refractory Status Epilepticus acronym: tDCS overallStatus: RECRUITING date: 2024-03-31 date: 2024-12-31 date: 2025-03-31 date: 2024-04-03 date: 2024-04-03 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus conditions: Refractory Status Epilepticus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 32 type: ESTIMATED name: tDCS stimulation name: TDCS sham-stimulation measure: Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus measure: Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group sex: ALL minimumAge: 14 Years maximumAge: 80 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University status: RECRUITING city: Beijing state: Beijing zip: 100053 country: China name: Weibi Chen role: CONTACT phone: +8615010255903 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06344325 id: EDPP briefTitle: ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-31 date: 2026-03-31 date: 2024-04-03 date: 2024-04-19 name: Tongji Hospital class: OTHER briefSummary: Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia conditions: Elective Surgery studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: fospropofol measure: Sedation score measure: Postoperative adverse reactions sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji hospital city: Wuhan state: Hubei zip: 430030 country: China name: Aijun Xu, Dr. role: CONTACT phone: +8618627784217 email: [email protected] lat: 30.58333 lon: 114.26667 hasResults: False
<|newrecord|> nctId: NCT06344312 id: M2023551 briefTitle: Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2025-06-01 date: 2024-04-03 date: 2024-04-03 name: Peking University Third Hospital class: OTHER briefSummary: Evaluate the effectiveness of Yangxue Qingnao Granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism conditions: Stroke, Acute Ischemic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Yangxue Qingnao Granules measure: The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06344299 id: HuaDong Hosiptal of FUDAN briefTitle: Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-09-30 date: 2024-04-03 date: 2024-04-03 name: Fudan University class: OTHER briefSummary: More and more older adults are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but the rate of surgical resection in patients with resectable tumour is still low. Clinical workers need to take more attention to oncologic care in this group. It's significant to explore potential predictors for impacting elderly patients chose to abandon surgical resection. conditions: Pancreatic Ductal Adenocarcinoma studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 5302 type: ACTUAL name: potential predictors measure: ORs of potential predictors measure: Overall survival (OS) sex: ALL minimumAge: 75 Years maximumAge: 100 Years stdAges: OLDER_ADULT facility: Huadong Hospital affiliated to Fudan University city: Shanghai zip: 200040 country: China lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344286 id: IstanbulTRH-DArman-002 briefTitle: The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE overallStatus: COMPLETED date: 2020-09-01 date: 2022-08-31 date: 2022-10-31 date: 2024-04-03 date: 2024-04-03 name: Istanbul Training and Research Hospital class: OTHER_GOV briefSummary: The goal of this clinical trial is to evaluate the effects of minimal enteral nutrition (MEN) on mesenteric blood flow and oxygenation with Doppler USG and Near Infrared Spectroscopy (NIRS) during therapeutic hypo¬thermia (TH) in babies with hypoxic ischemic encephalopathy. The main question it aims to answer is:
1- How do the mesenteric blood flow and oxygenation get affected with MEN during TH? Participants will be either fed with MEN during TH or given placebo. conditions: Hypoxic-Ischemic Encephalopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: An enteral intake of breast milk with a volume of 10-20 mL/kg/day was defined as minimal enteral feeding. Minimal enteral feeding was initiated at postnatal 24 hours with breast milk via an orogastric tube. A total daily intake of 120 ml/kg/day was defined as full enteral feeding.
The babies were randomized into two groups based on whether they received MEN during TH. While the babies fed with MEN during TH constituted the study group, the control group was composed of the babies who were given the same amount of distilled water according to the same protocol. Two groups were compared in terms of demographic characteristics, clinical outcomes, NIRS and Doppler measurements. primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: The feeding materials were prepared inside an opaque syringe and serially numbered by Total Parenteral Nutrition Department in our institution. The investigators who made all measurements, examinations and collected data, and the nurses of the babies were blinded. All of the infants in the study group were fed with breast milk during the trial. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: Minimal enteral nutrition name: Distilled water measure: Cerebral and mesenteric blood flow velocities and oxygenation measure: Cerebral and mesenteric rSO2 values measure: Development of NEC measure: Feeding intolerance measure: Time to full enteral feeding sex: ALL minimumAge: 0 Days maximumAge: 1 Day stdAges: CHILD facility: IstanbulTRH city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<|newrecord|> nctId: NCT06344273 id: Burcu01 briefTitle: The Effect of Lower Extremity ROM Exercises on Hypotension, Fatigue, and Hemodialysis Comfort in Individuals overallStatus: COMPLETED date: 2023-07-01 date: 2023-08-01 date: 2023-10-01 date: 2024-04-03 date: 2024-04-03 name: Duzce University class: OTHER briefSummary: Range of motion (ROM) is a term used to describe the amount of motion in each joint in our body. Every joint in the body has a normal range of motion. Maintaining the normal opening of the joints is achieved through movement. ROM exercises reduce contractures and are very important in terms of helping to preserve muscle movements. ROM exercises are an inexpensive method that can be applied in any environment, either as a group or individually, covering all muscle-joint groups. Individuals with disabilities can perform ROM exercises individually or receive support from healthcare professionals. It provides support to venous return by increasing muscle strength in patients who are immobilized for a long time.
Based on this information, the aim of our study is to investigate the effect of lower extremity ROM exercises during hemodialysis on hypotension, fatigue and hemodialysis comfort.
The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session. conditions: Hemodialysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients will be divided into the intervention group (n=32) in which 20 minutes of ROM exercise was applied and the control group (n=32) in which routine nursing care was given. For the sample calculation of the study, G power analysis was performed, type 1 error was 0.05; type 2 error 0.20; With a power of 0.80, a minimum sample size of 64 people for the experimental and control groups. The case group will be given lower extremity ROM exercises for a total of two weeks. Each individual in the case group will have lower extremity ROM exercises, each of which will last 20 minutes, at the beginning of the session and at the beginning of the hour until the end of the session. "Piper's Fatigue Scale" and Hemodialysis Comfort Scale" in the data collection form will be applied again at the end of the 1st and 2nd weeks after the sessions have started. The vital signs of the individual will be followed and recorded at each session. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: You are completely free to participate in the research or not. Not participating in this research will certainly not affect the service you receive. You have the right to withdraw from the study at any time by giving notice; you may also be excluded from the study by the investigator, if deemed necessary, provided that no harm is done to your medical condition.
If you participate in the research, you will not be charged or paid any fees for the expenses to be made in the study. In addition, at the end of the research, your information will only serve scientific purposes without revealing your identity. whoMasked: PARTICIPANT count: 70 type: ACTUAL name: ROM exercises measure: follow-up form measure: Piper Fatigue Scale measure: comfort condition sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duzce University city: Düzce zip: 81000 country: Turkey lat: 40.83889 lon: 31.16389 hasResults: False
<|newrecord|> nctId: NCT06344260 id: hNSCALSII briefTitle: Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS) acronym: STEMALS overallStatus: RECRUITING date: 2024-01-25 date: 2027-03 date: 2027-09 date: 2024-04-03 date: 2024-04-03 name: Casa Sollievo della Sofferenza IRCCS class: OTHER name: Ministry of Health, Italy briefSummary: A Not for Profit Phase II Study to Evaluate Safety, Efficacy and Biomarkers secondary endpoints of Human Neural Stem cell intracerebroventricular transplantation in amyotrophic lateral sclerosis patients: a randomized, placebo controlled, triple blind study.
This is an approximate 24-months study (PHASE B) consisting, per patient, of a 30-day screening period, 12-month enrollment and follow up period. A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses. The study will be stopped when all the subjects included in the treatment period complete the study visits. The study uses an ATMP, for that reason all the patients follow up will be prosecuted long life. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is an approximate 24-months triple-blinded, randomized, controlled vs placebo, in three arms study (PHASE B). A preliminary 3+3 dose-escalation open-label phase (PHASE A) will be performed in order to test the toxicity of the two proposed cell doses.
In the phase B three arms will be: 1) hNSCs 20 milion cells 2) hNSCs 40 milion cells 3) Saline (comparator) primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: In order to blind also the statistician that will analyse the results the protocol has been designed as a triple-blinded protocol. This means that both the researchers, which include neurologist, neurosurgeon and biologist, as well as the patients and the statisticians are unaware of whether the participant received the treatment or the placebo (only IMP Manufacturer QP is unblinded since release the cell drug to the use in the surgery room) whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: human Neural Stem Cells (hNSC) name: Saline (Placebo) measure: Safety of treatment measure: Biological Endpoints sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Casa Sollievo Della Sofferenza IRCCS status: NOT_YET_RECRUITING city: San Giovanni Rotondo state: Foggia zip: 71013 country: Italy lat: 41.70643 lon: 15.7277 facility: Centro SLA Azienda Ospedaliera Università Maggiore della Carità status: RECRUITING city: Novara zip: 28100 country: Italy name: Letizia Mazzini, MD role: CONTACT phone: +39 0321 3733962 email: [email protected] lat: 45.44694 lon: 8.62118 facility: Azienda Ospedaliera di Padova status: NOT_YET_RECRUITING city: Padua zip: 35128 country: Italy name: Gianni Sorarù, MD role: CONTACT phone: +39049-8213645/646 email: [email protected] lat: 45.40797 lon: 11.88586 facility: Azienza Ospedaliera Universitaria - Policlinico "P. Giaccone" Università degli Studi di Palermo status: NOT_YET_RECRUITING city: Palermo zip: 90129 country: Italy name: Vincenzo La Bella, MD role: CONTACT phone: +39 091 6555158 email: [email protected] lat: 38.13205 lon: 13.33561 hasResults: False
<|newrecord|> nctId: NCT06344247 id: IIT-2023-0253 briefTitle: Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease overallStatus: RECRUITING date: 2023-09-01 date: 2025-09-01 date: 2025-12-01 date: 2024-04-03 date: 2024-04-03 name: RenJi Hospital class: OTHER briefSummary: The goal of this clinical trial is to exploring the changes in 24-hour urinary protein and renal function in obese patients with kidney disease after the application of sodium glucose cotransporter 2 inhibitors (SGLT2i) and glucagon like peptide-1 receptor agonists (GLP-1RA).
Eligible patients were randomly and non-blindly allocated to four groups in a 1:1:1:1 ratio.The first group is the optimized treatment group, and patients in this group maintain the maximum dose/maximum tolerated dose of RAS blocker therapy.
The second group is the optimized treatment + SGLT2i group. Participants in this group are titrated to the target dose (10 mg qd) in combination with dapagliflozin on the basis of optimized treatment.
The third group is the optimized treatment + GLP-1RA group. Participants in this group will be titrated to the target dose (1mg qw) in combination with semaglutide on the basis of optimized treatment.
The last group is the optimized treatment + SGLT2i + GLP-1RA treatment group, that is, based on the optimized treatment, combined with dapagliflozin titrated to the target dose (10 mg qd) and semaglutide titrated to the target dose (1 mg qw). conditions: Obesity conditions: Chronic Kidney Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: RAS inhibitors：Losartan®️/Valsartan®️ name: dapagliflozin：Forxiga®️ name: simagliptin：Forxiga®️ measure: Change of 24-hour urine protein quantification measure: Decline in glomerular filtration rate measure: Changes in BMI measure: changes in fasting blood glucose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: wei jin role: CONTACT phone: +8615026696535 email: [email protected] lat: 31.22222 lon: 121.45806 hasResults: False
<|newrecord|> nctId: NCT06344234 id: 0049191 briefTitle: Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE) acronym: INSPIRE overallStatus: RECRUITING date: 2023-11-01 date: 2026-05-01 date: 2026-06-01 date: 2024-04-03 date: 2024-04-03 name: University of Bari class: OTHER briefSummary: The goal of this observational study is to evaluate whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of P0.1, driving pressure, plateau pressure, pressure-muscle index, and diaphragm ultrasound as noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.
The main questions this trial aims to answer are:
- Primary Outcome: whether the airway occlusion pressure recorded during a sudden end-expiratory breath-hold (ΔPocc) is correlated with esophageal swing in pressure and the reliability of various noninvasive estimates of inspiratory effort and lung distension in hypoxemic patients undergoing NIV.