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## Brain Criticality, Oculomotor Control, and Cognitive Effort - NCT ID: NCT06344559 - Study ID: 2023001006 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-06-01 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - transcranial magnetic stimulation ### Outcomes Primary Outcomes - Critical dynamics - immediate effects of cTBS versus sham stimulation - Functional E/I balance - immediate effects of cTBS versus sham stimulation - Avalanche branching ratio - immediate effects of cTBS versus sham stimulation - Critical dynamics - immediate effects of iTBS versus sham stimulation - Functional E/I balance - immediate effects of iTBS versus sham stimulation - Avalanche branching ratio - immediate effects of iTBS versus sham stimulation - Memory-guided saccade accuracy - effects of cTBS versus sham stimulation - Memory-guided saccade accuracy - effects of iTBS versus sham stimulation - Anti-saccade accuracy - effects of cTBS versus sham stimulation - Anti-saccade accuracy - effects of iTBS versus sham stimulation - Subjective effort discounting - cTBS versus sham stimulation - Subjective effort discounting - iTBS versus sham stimulation - Subjective effort rating - cTBS versus sham stimulation - Subjective effort rating - iTBS versus sham stimulation Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome - NCT ID: NCT06344546 - Study ID: K 2023-10247 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-06 - Lead Sponsor: Karolinska University Hospital ### Study Description The overall aim of the study is to improve understanding of refeeding syndrome (RFS) in patients admitted to the intensive care unit (ICU) using metabolomics. Patients are included as part of a prospective multicenter observational study on phosphate disorders in the ICU. Blood samples are collected day 1-7 of ICU stay. Samples from patients who develop refeeding hypophosphatemia and matched controls without hypophosphatemia are analysed for metabolomics and proteomics. Untargeted analyses will be performed to identify the affected metabolic pathways. The investigators will also perform AUROC analyses to identify potential biomarkers for early detection of RFS. ### Conditions - Critical Illness - Refeeding Syndrome - Hypophosphatemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Metabolomics ### Outcomes Primary Outcomes - Metabolomics Secondary Outcomes - Metabolomics ### Location - Facility: University Hospital Královské Vinohrady, Prague, N/A, N/A, Czechia @@
## Study of JMKX003142 Injection in Chinese Healthy Subjects - NCT ID: NCT06344533 - Study ID: JMKX003142iv-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-05-30 - Lead Sponsor: Jemincare ### Study Description To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects ### Conditions - Healthy Adult ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - JMKX003142 Injection - Placebo ### Outcomes Primary Outcomes - Number of the Adverse Events that are related to the single dose treatment - Number of the Adverse Events that are related to the multiple dose treatment Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, Beijing, 100191, China @@
## Pectoralis Minor Shorthening and Swimming Performance - NCT ID: NCT06344520 - Study ID: IsiU - Status: COMPLETED - Start Date: 2022-12-29 - Completion Date: 2023-10-30 - Lead Sponsor: Istinye University ### Study Description Swimming is one of the sports branches that includes many factors such as aerobic and anaerobic endurance, strength, flexibility, speed, quickness, rhythm, coordination as well as sportive performance and technical skills.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 - Ability to Swim 100m Independent Freestyle - Be Between the Ages of 9-16 - Continuing Running as Part of a Sports Club ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - pektoralis minor shortnes - Group in which the Pectoralis Minor stretching exercise was performed in a sham manner - The group in which Pectoralis Minor stretching exercise was not applied ### Outcomes Primary Outcomes - Speed Tests - Apley test - Round Shoulder - Anthropometric Measurement: - Posture analysis: (ANNEX2) - Anthropometric Measurement 2 - Y Balance Test - Eurofit Test Battery - Eurofit Test Battery 2 - Eurofit Test Battery 3 Secondary Outcomes ### Location - Facility: Galatasaray Ergün Gürsoy Olympic Swimming Pool, Üsküdar, Nuhkuyusu, 34662, Turkey @@
## Iconographic Registry of Pancreatobiliary Endoscopy Procedures - NCT ID: NCT06344507 - Study ID: TAILOR-EUS - Status: RECRUITING - Start Date: 2022-03-28 - Completion Date: 2027-12-31 - Lead Sponsor: IRCCS San Raffaele ### Study Description 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 - Cancer of Pancreas - Pancreatitis - Neuroendocrine Tumors ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Registry for images and videos Secondary Outcomes ### Location - Facility: IRCCS San Raffaele Hospital, Milan, N/A, 20132, Italy @@
## Cardiac Interventional ICE Imaging Trial - NCT ID: NCT06344494 - Study ID: INTELICE-CTP-2401 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: ICE Intelligent Healthcare Co., Ltd ### Study Description 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 - Atrial Septal Defect - Patent Foramen Ovale - Arrhythmias, Cardiac - Atrial Fibrillation - Supraventricular Tachycardia - Valve Disease, Heart ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system - SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system ### Outcomes Primary Outcomes - Image quality Secondary Outcomes - Image quality - Procedure success - Technical success - Procedure time ### Location - Facility: Beijing Anzhen Hospital, Capital Medical University, Beijing, Bejing, 100011, China @@
## The Hyalex First-in-Human Study - NCT ID: NCT06344481 - Study ID: CL-00003 - Status: RECRUITING - Start Date: 2024-03-07 - Completion Date: 2026-09 - Lead Sponsor: Hyalex Orthopaedics, Inc. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Surgical (Hyalex Cartilage Knee Implant) ### Outcomes Primary Outcomes - Freedom from implant rejection and infection. - Change in the Knee Injury & Osteoarthritis Outcome Score (KOOS) from baseline at 12 months. Secondary Outcomes ### Location - Facility: SPORTO, Łódź, N/A, 09-038, Poland @@
## The Effect of Early Mobilization on Sleep, Physiological Parameters, and Length of Stay in ICU - NCT ID: NCT06344468 - Study ID: 531393 - Status: COMPLETED - Start Date: 2023-04-12 - Completion Date: 2024-03-04 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description 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 - Sleep Quality - Critical Care - Nursing Caries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Early Mobilization ### Outcomes Primary Outcomes - The length of stay of patients in the intensive care unit Secondary Outcomes - The Richards-Campbell Sleep Questionnaire (RCSQ) - The Glasgow Coma Scale (GCS) - Physiological Parameter - for the experimental group - Physiological Parameter - for the control group ### Location - Facility: İstanbul University-Cerrahpaşa Cerrahpaşa School of Medicine, Istanbul, N/A, N/A, Turkey @@
## Influence of Educational Stimuli From the Pé-de-Meia Program on Delay Discounting Propensity - NCT ID: NCT06344455 - Study ID: RCT Delay Discounting - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-07-01 - Lead Sponsor: Federal Institute of Education, Science and Technology of the State of Mato Grosso ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - School Retention and Completion Incentive Savings via Modified Iowa Gambling Task A - Iowa Gambling Task - School Retention and Completion Incentive Savings via Modified Iowa Gambling Task B ### Outcomes Primary Outcomes - Delay Discounting 1 - Delay Discounting 2 Secondary Outcomes - decision-making performance under risk and uncertainty - loss aversion - Loss Frequency-Based Decision Strategy - Learning ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Low-dose Arginine-vasopressin Supplementation on Post-transplant Acute Kidney Injury After Liver Transplantation (AVENIR Trial) - NCT ID: NCT06344442 - Study ID: APHP220827 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2026-06-05 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description 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 filtrationThe 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Arginine vasopressin - Norepinephrine ### Outcomes Primary Outcomes - 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. Secondary Outcomes - To compare into the two arms the number of packed red blood cellsand fresh frozen plasma transfused - To compare into the two arms the number of the Number of AKI KDIGO 1 - To compare into the two arms the Number of AKI KDIGO 2 - To compare into the Number of AKI KDIGO 3 - The need for renal replacement for replacement therapy (RRT) in ICU - The number of patients remaining on dialysis at the end of the study - Average intraoperative norepinephrine concentrations - Average intraoperative concentrations of other vasopressors and inotropes (Adrenalin, Dobutamine) - Number of platelets transfused intraoperatively - Amount of vascular filling solutions intraoperatively - Sequential Organ Failure Assessment (SOFA score) - Number of days alive outside intensive care unit - Mortality ### Location - Facility: URC Lariboisière-Fernand Widal-saint Louis, Paris, N/A, 75010, France @@
## Stellest Lenses and Low-concentration Atropine Myopia Control Among Children - NCT ID: NCT06344429 - Study ID: STL_CT_0001 - Status: RECRUITING - Start Date: 2023-08-20 - Completion Date: 2025-08-20 - Lead Sponsor: Essilor-Polylite Taiwan Co., Ltd. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stellest Lenses - Stellest Lenses+0.05% atropine - Single vision Lenses+0.05% atropine ### Outcomes Primary Outcomes - Spherical equivalent refraction power - Axial length Secondary Outcomes ### Location - Facility: Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, N/A, 833401, Taiwan @@
## Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform - NCT ID: NCT06344416 - Study ID: RXG-001-2024-CLP (Rex-002) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-30 - Completion Date: 2026-01-30 - Lead Sponsor: Dosentrx Ltd. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Use of ReX to dispense and monitor solid oral medication therapy. ### Outcomes Primary Outcomes - Outcome MeasureReX Platform Study Group Secondary Outcomes ### Location - Facility: OHC, Cincinnati, Ohio, 45242, United States @@
## Clinical Efficacy and Safety of Tender Point Infiltration (TPI) for Acute and Subacute Zoster Associated Pain - NCT ID: NCT06344403 - Study ID: KY2024-045-02 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description 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 - Local Infiltration - Acute Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - analgesic - Tender point infiltration ### Outcomes Primary Outcomes - The presence of postherpetic neuralgia using VAS score Secondary Outcomes - visual analogue scale score at each time point - Proportion of patients receiving repeated TPIs and block points - Consumption of oral drugs at each time point - The presence of PHN 3 and month 6 post treatment - Patient satisfaction scores on the 5-point Likert scale - Quality of life on the Scores on the WHOQOL-BREF - Adverse reactions through study completion ### Location - Facility: Beijing Tiantan Hospital, Beijing, Beijing, 100070, China @@
## Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke - NCT ID: NCT06344390 - Study ID: 20210327 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12-31 - Lead Sponsor: The First Hospital of Hebei Medical University ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pentoxifylline ### Outcomes Primary Outcomes - Pentoxifylline can improve cognitive impairment after ischemic stroke Secondary Outcomes ### Location - Facility: BHan, Shijiazhuang, N/A, N/A, China @@
## Betaine Supplementation and Lipid Metabolism in Overweight and Obese Pre-menopausal Women - NCT ID: NCT06344377 - Study ID: BETadiposeWOMEN - Status: NOT_YET_RECRUITING - Start Date: 2024-04-21 - Completion Date: 2026-12-30 - Lead Sponsor: Poznan University of Life Sciences ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Betaine - Placebo ### Outcomes Primary Outcomes - Body composition - Body mass - Waist and hips circumference - Lipid profile - Gene expression Secondary Outcomes - Liver function test - Dietary intake ### Location - Facility: Poznan University of Life Sciences, Poznań, N/A, 60-637, Poland @@
## Digital Pathology and AI for Liver Outcomes in MASLD - NCT ID: NCT06344364 - Study ID: PHN 1-080-23 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: PharmaNest, Inc ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS) ### Outcomes Primary Outcomes - Performance of Hepatic Decompensation Event predictive value of the FibroNest Ph-FCS Secondary Outcomes - Performance of Hepatic Decompensation Event predictive value of the FIB-4 biomarker, a non-invasive test - Performance of Hepatic Decompensation Event predictive value of the elastography (Fibroscan) biomarker, a non-invasive test - Performance of Hepatic Decompensation Event predictive value of the FibroNest Parenchymal Tissue Adjusted Phenotypic Fibrosis Composite Score (Pt-Ph-FCS) ### Location - Facility: Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States @@
## A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant Cancer - NCT ID: NCT06344351 - Study ID: TQB3006-I-01 - Status: RECRUITING - Start Date: 2024-04-25 - Completion Date: 2026-08 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TQB3006 tablets ### Outcomes Primary Outcomes - Dose limiting toxicity (DLT) - Maximum tolerated dose (MTD) - Recommended phase II dose (RP2D) Secondary Outcomes - Adverse events (AE) - Serious adverse events (SAE) - Time to reach maximum plasma concentration (Tmax) - Peak concentration (Cmax) - Half-life (t1/2) - Area under the concentration-time curve (AUC [0-infinity]) - Area under the concentration-time curve (AUC [0-t]) - Apparent clearance (CL/F) - Apparent volume of distribution (Vd/F) - Objective response rate (ORR) ### Location - Facility: Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, 150000, China @@
## Application of tDCS Stimulation in Controlling Refractory Status Epilepticus - NCT ID: NCT06344338 - Study ID: Z211100002921030 - Status: RECRUITING - Start Date: 2024-03-31 - Completion Date: 2025-03-31 - Lead Sponsor: Xuanwu Hospital, Beijing ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - tDCS stimulation - TDCS sham-stimulation ### Outcomes Primary Outcomes - 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 Secondary Outcomes - Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group ### Location - Facility: Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100053, China @@
## ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia - NCT ID: NCT06344325 - Study ID: EDPP - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-03-31 - Lead Sponsor: Tongji Hospital ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - fospropofol ### Outcomes Primary Outcomes - Sedation score Secondary Outcomes - Postoperative adverse reactions ### Location - Facility: Tongji hospital, Wuhan, Hubei, 430030, China @@
## Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction - NCT ID: NCT06344312 - Study ID: M2023551 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-06-01 - Lead Sponsor: Peking University Third Hospital ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Yangxue Qingnao Granules ### Outcomes Primary Outcomes - The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment Secondary Outcomes ### Location - Facility: Peking University Third Hospital, Beijing, N/A, N/A, China @@
## Predictors for Low Rates of Surgical Resection in Elderly Patients With Resectable Pancreatic Ductal Adenocarcinoma - NCT ID: NCT06344299 - Study ID: HuaDong Hosiptal of FUDAN - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-09-30 - Lead Sponsor: Fudan University ### Study Description 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 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - potential predictors ### Outcomes Primary Outcomes - ORs of potential predictors Secondary Outcomes - Overall survival (OS) ### Location - Facility: Huadong Hospital affiliated to Fudan University, Shanghai, N/A, 200040, China @@
## The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE - NCT ID: NCT06344286 - Study ID: IstanbulTRH-DArman-002 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2022-10-31 - Lead Sponsor: Istanbul Training and Research Hospital ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Minimal enteral nutrition - Distilled water ### Outcomes Primary Outcomes - Cerebral and mesenteric blood flow velocities and oxygenation - Cerebral and mesenteric rSO2 values Secondary Outcomes - Development of NEC - Feeding intolerance - Time to full enteral feeding ### Location - Facility: IstanbulTRH, Istanbul, N/A, N/A, Turkey @@
## The Effect of Lower Extremity ROM Exercises on Hypotension, Fatigue, and Hemodialysis Comfort in Individuals - NCT ID: NCT06344273 - Study ID: Burcu01 - Status: COMPLETED - Start Date: 2023-07-01 - Completion Date: 2023-10-01 - Lead Sponsor: Duzce University ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - ROM exercises ### Outcomes Primary Outcomes - follow-up form - Piper Fatigue Scale - comfort condition Secondary Outcomes ### Location - Facility: Duzce University, Düzce, N/A, 81000, Turkey @@
## Neural Stem Cell Treatment for Amyotrophic Lateral Sclerosis (STEMALS) - NCT ID: NCT06344260 - Study ID: hNSCALSII - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2027-09 - Lead Sponsor: Casa Sollievo della Sofferenza IRCCS ### Study Description 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 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - human Neural Stem Cells (hNSC) - Saline (Placebo) ### Outcomes Primary Outcomes - Safety of treatment Secondary Outcomes - Biological Endpoints ### Location - Facility: Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, 71013, Italy @@
## Comparison of the Efficacy and Safety of SGLT2i and GLP-1 Receptor Agonists in Obese Patients With Kidney Disease - NCT ID: NCT06344247 - Study ID: IIT-2023-0253 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-12-01 - Lead Sponsor: RenJi Hospital ### Study Description 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 - Chronic Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RAS inhibitors：Losartan®️/Valsartan®️ - dapagliflozin：Forxiga®️ - simagliptin：Forxiga®️ ### Outcomes Primary Outcomes - Change of 24-hour urine protein quantification Secondary Outcomes - Decline in glomerular filtration rate - Changes in BMI - changes in fasting blood glucose ### Location - Facility: Renji Hospital Affiliated to Shanghai JIAO TONG University school of medicine, Shanghai, Shanghai, 200127, China @@
## Non-invasive Assessment of Inspiratory Effort and Tidal Distension During Non-invasive Ventilation (INSPIRE) - NCT ID: NCT06344234 - Study ID: 0049191 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2026-06-01 - Lead Sponsor: University of Bari ### Study Description 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.Secondary outcomes will include:* Statistic metric of association between P0.1, ΔP, PMI and ΔPes* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF%* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF%* Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort.Participants will undergo the following tasks and treatments:* Complete written informed consent before enrollment.* Post-extubation noninvasive ventilation via nose-to-mouth and full-face masks.* Monitoring of esophageal pressure (in all patients the catheter will be placed before extubation, according to clinical judgment, and its correct position will be verified through a positive pressure occlusion test)* Continuous recording of airway pressure, flow, and esophageal pressure (Pes), using a dedicated pneumotachograph and pressure transducer.* Sudden end-inspiratory and end-expiratory occlusion maneuvers, to measure plateau pressure (Pplat) and end-expiratory airway occlusion pressure (ΔPocc), respectively.* Collection of hemodynamic and arterial blood-gas parameters, performed according to clinical judgment, along with assessments of dyspnea and discomfort using a modified visual analogue scale (VAS).* Diaphragm ultrasound during occlusion maneuvers, measuring diaphragm displacement, diaphragm thickening fraction (DTF%), and diaphragmatic excursion (Ex) under various conditions. ### Conditions - Respiratory Disease - Artificial Respiration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - End-inspiratory Maneuvers ### Outcomes Primary Outcomes - Statistic metric of association between ΔPocc and ΔPes Secondary Outcomes - Statistic metric of association between P0.1, ΔP, PMI and ΔPes - Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and PaO2/FiO2 ratio - Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and tidal volume - Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and DTF% - Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and Ex/DTF% - Statistic metric of association between P0.1, ΔPocc, ΔP, PMI and respiratory rate, VAS dyspnea and VAS discomfort ### Location - Facility: Azienda ospedaliero-universitaria consorziale policlinico di Bari, Bari, N/A, 70124, Italy @@
## Post-stroke Haptic Feedback Use Deficit: A Comparative and Reliability Study - NCT ID: NCT06344221 - Study ID: 2023-A00954-41 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-07-15 - Lead Sponsor: Centre Hospitalier St Anne ### Study Description The aim of this comparative and reliability study is to highlight a deficit in the use of vibrotactile sensory feedback (haptic effect) in the planning and execution of fine manual dexterity movements after stroke. The investigators will include 3 groups of subjects, 1 group of young healthy subjects, 1 of older subjects matched in age and sex to the group of chronic stroke patients. Participants will take part in clinical tests of fine motor skills and sensitivity and will use a device to assess the key components of manual dexterity, to which vibrotactile sensors will be added. If they so wish, participants will be able to take part in a transcranial magnetic stimulation (TMS) study to assess the facilitation of cortical excitability due to the haptic effect. ### Conditions - Stroke - Upper Extremity Paresis - Manual Dexterity - Sensory Integration Dysfunction - Vibration; Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Dextrain Manipulandum and haptic feedback device ### Outcomes Primary Outcomes - Assessing haptic effect during a dexterity exercise with and without sensory feedback: finger independence Secondary Outcomes - Assessing haptic effect during another dexterity exercise with and without sensory feedback: the force control of the index - Assessing haptic effect during another dexterity exercise with and without sensory feedback: the rhythm capacity - Correlation between clinical assessment and haptic measure - Assessment of the feasibility of the haptic measures - Assessment of the benefits of the haptic measures - Study the test re-test reliability of the haptic device by comparing the haptic effect on dexterity assessed at the beginning and end of the session by the same evaluator - Assessment of the impact of age on the dexterity performances (Finger independence, force control of the index and rhythm capacity) - Measurement of the manual dexterity facilitation between tactile (haptic device with vibrations on the fingers) and auditory feedback (sounds during the dexterity tasks) - Transcranial magnetic stimulation (TMS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Predicting Toxicity in Elderly Patients With Head and Neck Cancer - NCT ID: NCT06344208 - Study ID: IEO 1647 - Status: RECRUITING - Start Date: 2022-03-15 - Completion Date: 2024-12-31 - Lead Sponsor: European Institute of Oncology ### Study Description Predicting toxicity in elderly patients with head and neck cancer:validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes. ### Conditions - Head and Neck Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Predicting toxicity in elderly patients with head and neck cancer Secondary Outcomes ### Location - Facility: European Institute of Oncology, Milan, MI, 20141, Italy @@
## Valacyclovir Monotherapy in Pain Management of Acute Periapical Abscesses After Emergency Chamber Opening - NCT ID: NCT06344195 - Study ID: 2517 - Status: RECRUITING - Start Date: 2024-03-27 - Completion Date: 2024-05 - Lead Sponsor: Dow University of Health Sciences ### Study Description This study is aimed to evaluate the efficacy of valacyclovir in reducing postoperative pain following emergency chamber opening for acute apical abscess .There will be 82 participants, (41 in each group) Group A will receive Valacyclovir Group B will receive standard treatment i.e. Naproxen Sodium. Pain level will be assessed by using Numeric rating scale for 6 days ### Conditions - Acute Apical Abscess ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Valacyclovir 500 mg - Naproxen Sodium 550mg ### Outcomes Primary Outcomes - Changes in pain score using Numeric Rating Scale (NRS) Secondary Outcomes ### Location - Facility: Dr. Yumna Shaheen Ali, Karachi, Sindh, 75290, Pakistan @@
## Reliability, Concurrent Validity and Minimal Detectable Change of the Step Up and Down Test in Patients With Total Knee Arthroplasty - NCT ID: NCT06344182 - Study ID: STarkan - Status: COMPLETED - Start Date: 2021-02-01 - Completion Date: 2021-05-15 - Lead Sponsor: Dokuz Eylul University ### Study Description The aim of the study is to measure the validity and reliability of the StUD test in patients with TKA. Forty-seven patients with primary TKA included in this study. The test-retest reliability of the StUD test was measured with 1-hour interval. Validity was assessed that the 30s Chair Stand Test (30sCS), the Hospital for Special Surgery score (HSS) and Short Form-12 Quality Life Questionnaire (SF-12) were used as comparator instruments. ### Conditions - Total Knee Arthroplasty ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Step Up and Down Test ### Outcomes Primary Outcomes - Step Up and Down Test Secondary Outcomes - 30 Seconds Chair Stand Test ### Location - Facility: Dokuz Eylul University, Izmir, N/A, N/A, Turkey @@
## Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section - NCT ID: NCT06344169 - Study ID: DTCRD112(2)-I-15 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-06-14 - Lead Sponsor: Dalin Tzu Chi General Hospital ### Study Description Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP. ### Conditions - Postsurgical Pain - Cesarean Section - Chronic Post-surgical Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sebacoyl Dinalbuphine Ester - Morphine ### Outcomes Primary Outcomes - Intensity of surgical pain after operation as assessed by visual analogue scale - Rescue doses of analgesics administered after operation Secondary Outcomes - Incidence of chronic post-surgical pain - Satisfaction of living after surgery as assessed by the HRQoL short-form (SF)-12 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy as an Adjuvant Therapy for Pancreatic Cancer - NCT ID: NCT06344156 - Study ID: PDAC-Neoantigen - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-04-01 - Lead Sponsor: Sichuan University ### Study Description The aim of this single center, single arm and prospective study is to explore the safety and efficacy of Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy in postoperative adjuvant treatment of Pancreatic Cancer ### Conditions - Pancreatic Cancer - Adjuvant Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Neoantigen Vaccine Plus Anti-PD1 and Chemotherapy ### Outcomes Primary Outcomes - 18-month RFS - Incidence of Treatment-Related Adverse Events [Safety and Tolerability] Secondary Outcomes - 18-month OS ### Location - Facility: West China Hospital, Sichuan University, Chengdu, Sichuan, 610000, China @@
## Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma - NCT ID: NCT06344143 - Study ID: 24-324 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2030-12-31 - Lead Sponsor: The Cleveland Clinic ### Study Description The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes. ### Conditions - Mild Autonomous Cortisol Secretion (MACS) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Various labs and imaging tests ### Outcomes Primary Outcomes - Evaluate best diagnostic test(s) Secondary Outcomes ### Location - Facility: The Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States @@
## Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma - NCT ID: NCT06344130 - Study ID: 10001859 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: National Cancer Institute (NCI) ### Study Description Background:Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.Objective:To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.Eligibility:People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.Design:Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years. ### Conditions - Astrocytoma - Glioma - Recurrent Glioblastoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Radiation Therapy ### Outcomes Primary Outcomes - MTD of daily re-irradiation in participants with recurrent grade 4 gliomas Secondary Outcomes - Progression free survival - Overall survival - Compliance and feasibility of administering PRO in this participant population - Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother - Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities - Meaningful change in disease and treatment-related symptoms by using anchors ### Location - Facility: National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States @@
## Assessment of Volatile Organic Compounds (VOC) for the Diagnosis of Invasive Aspergillosis (IA) in Lung Transplant Recipients - NCT ID: NCT06344117 - Study ID: MF3 UHN (IA) - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2025-12 - Lead Sponsor: Owlstone Ltd ### Study Description Prospective observational pilot study to evaluate the utility of breath VOCs to detect invasive aspergillosis in lung transplant recipients that are suspected of invasive fungal disease (IFD). ### Conditions - Invasive Aspergillosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Identifying a statistical relationship between Volatile Organic Compounds detection and the diagnosis of IA by existing International Society for Heart and Lung Transplantation (ISHLT) and MSG/EORTC criteria. Secondary Outcomes - Identifying a statistical relationship between the set of VOCs found in exhaled breath and the diagnosis of Aspergillus colonization as defined by ISHLT criteria ### Location - Facility: University Health Network, Toronto, Ontario, M5G 2N2, Canada @@
## A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Asian Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension - NCT ID: NCT06344104 - Study ID: D6970C00008 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2026-05-20 - Lead Sponsor: AstraZeneca ### Study Description The purpose of this study is to measure the efficacy and safety of baxdrostat in Asian participants with uHTN or rHTN. The main objective is to compare the difference in SBP change from baseline at Week 12 of treatment between participants receiving 2 mg baxdrostat or 1 mg baxdrostat tablets and participants receiving placebo tablets. ### Conditions - Uncontrolled Hypertension - Resistant Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Baxdrostat - Placebo ### Outcomes Primary Outcomes - Change from baseline in siSBP at Week 12 Secondary Outcomes - Change from baseline in siSBP at Week 12 - Change from RWD baseline (Week 24) in siSBP at Week 32 - Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM - Change from baseline in the mean ambulatory 24-hour SBP at Week 12 as measured by ABPM - Change from baseline in siDBP at Week 12 - Achieving siSBP < 140 mmHg at Week 12 - Change from baseline in siDBP at Week 12 - Achieving siSBP < 140 mmHg at Week 12 - Change from baseline in siSBP at Week 12 - Change from baseline in siSBP at Week 12 ### Location - Facility: Research Site, Caba, N/A, C1426, Argentina @@
## A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients - NCT ID: NCT06344091 - Study ID: ZYWB-ZM-AHP-A-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-06 - Completion Date: 2026-10-12 - Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd. ### Study Description The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world. ### Conditions - Local Analgesia Via Infiltration ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Bupivacaine Liposome Injection ### Outcomes Primary Outcomes - The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system Secondary Outcomes - The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration - Time to first rescue analgesia of opioid - The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration - The proportion of patients using patient-controlled intravenous analgesia (PCIA) - Pain intensity score at rest after administration for children aged 6 to 7 years - Pain intensity score at rest after administration for children aged 8 years and older - Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years - Pain intensity score on movement (or cough) after administration for children aged 8 years and older - Length of Stay ### Location - Facility: Guangzhou Women and Children's Medical Center, Guangzhou, Guangdong, 510000, China @@
## Surgical Italian Guide for the Management of Complicated Acute Diverticulitis Emergency Setting (SIGMA-D). A Prospective Observational Multicenter Study on Behalf of the Italian Society of Colorectal Surgery (SICCR). - NCT ID: NCT06344078 - Study ID: SIGMA-d - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Societa Italiana di Chirurgia ColoRettale ### Study Description This study will include data collected from surgical units performing emergency surgery in Italy during 2024, with a one-year follow-up period for each patient. Data for each center will be prospectively collected through a database filled out by the Italian Society of Colorectal Surgery (SICCR) members who participate to the study. Specific data will include: WSES diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of Hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. Postoperative data will focus on complication rates and mortality at one, six, and twelve months. ### Conditions - Acute Diverticulitis - Stoma Colostomy - Stoma Ileostomy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - sigmoid resection and anastomosis / stoma ### Outcomes Primary Outcomes - adhesion to guidelines Secondary Outcomes - stoma reversal ### Location - Facility: Azienda ospedaliera universitaria paolo giaccone, Palermo, N/A, N/A, Italy @@
## Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants - NCT ID: NCT06344065 - Study ID: 20220102C - Status: RECRUITING - Start Date: 2023-12-21 - Completion Date: 2028-12-25 - Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd ### Study Description The purpose of this study is to evaluate the safety and immunogenicity of the DTaP in 3-month-old infants. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Diphtheria, tetanus and acellular pertussis (component) combined vaccine (adsorbed) - Diphtheria, tetanus and acellular pertussis combined vaccine (adsorbed) - Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine ### Outcomes Primary Outcomes - Immunogenicity results of experimental group and active control group (DTaP) - Immunogenicity results of experimental group and active control group (DTaP-IPV//PRP-T) - Immunogenicity results of experimental group Secondary Outcomes ### Location - Facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, Guangxi, 530028, China @@
## To Assess the Safety and Efficacy of SP-002 With Vismodegib for the Treatment of Locally Advanced Basal Cell Carcinoma - NCT ID: NCT06344052 - Study ID: SP-002-004 - Status: RECRUITING - Start Date: 2024-04-09 - Completion Date: 2029-03-30 - Lead Sponsor: Stamford Pharmaceuticals, Inc. ### Study Description The goal of this clinical trial is to evaluate the efficacy of using SP-002 in participants with locally advanced Basal cell carcinoma. The main question it aims to answer is what the objective response rate for a basal cell carcinoma tumor is following 1 or 3 cycles of SP-002 treatment given as an add-on to hedgehog pathway inhibitor therapy.Researchers will compare the objective response rate for treated Basal cell carcinoma tumors between 3 treatment Arms.* Arm 1 participants will receive daily hedgehog pathway inhibitor, and 3 cycles of SP-002 treatment.* Arm 2 participants will receive daily hedgehog pathway inhibitor, and 1 cycle of SP-002 treatment.* Arm 3 participants will receive daily hedgehog pathway inhibitor only. ### Conditions - Basal Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SP-002 - Vismodegib ### Outcomes Primary Outcomes - Objective response rate Secondary Outcomes - Duration of response - Progressive free survival - Overall survival (OS) - Objective Response Rate (ORR) / Complete Response (CR) / Partial Response (PR) - Number of subjects discontinuing treatment with SP-002 and/or vismodegib due to toxicity. - Number of subjects with delays to SP-002 and/or vismodegib dosing due to toxicity. - Incidence and severity of SP-002 and/or vismodegib related AEs. ### Location - Facility: Research Site, Phoenix, Arizona, 85006, United States @@
## Epidemiological Study of Floating Hip Injuries in Assiut University Hospitals - NCT ID: NCT06344039 - Study ID: Floating hip - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Assiut University ### Study Description Aim of the study is to describe and study the patterns of floating hip injuries and assess the current management in Assiut University Hospitals Trauma Centre to help reach the best approach to plan treatment for these severe and difficult injuries. ### Conditions - Hip Fractures - Hip Injuries ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of floating hip injuries - Patterns of injury Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase 1/2a Study of ANPD001 in Parkinson Disease - NCT ID: NCT06344026 - Study ID: ANPD001-02 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-23 - Completion Date: 2030-04-30 - Lead Sponsor: Aspen Neuroscience ### Study Description This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells. ### Conditions - Parkinson Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - ANPD001 - Custom Device ### Outcomes Primary Outcomes - Incidence and severity of treatment emergent adverse events (Safety and Tolerability) Secondary Outcomes - "ON" time without troublesome dyskinesia - Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV) - Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state - Post-injection change in the 18F-DOPA uptake in the putamen - Incidence and severity of treatment emergent adverse events during long term follow-up (Continued Safety and Tolerability) ### Location - Facility: University of Arizona - Banner Health, Tucson, Arizona, 85724, United States @@
## The ABCDEF Bundle in Critical Care: a French National Survey Still a Long Way to go! - NCT ID: NCT06344013 - Study ID: 29BRC24.0034 - BUNDLE ABCDEF - Status: COMPLETED - Start Date: 2022-07-01 - Completion Date: 2022-07-31 - Lead Sponsor: University Hospital, Brest ### Study Description The goal of this observational study is to evaluate the knowledge and compliance of French intensive care units with the ABCDEF (A: Assessment, Prevention, Management of Pain, B: Both Spontaneous Awakening Trials and Spontaneous Breathing Trials, C: Choice of Sedation and Analgesia, D: Delirium Assessment, Prevention, and Management, E: Early Mobility and Exercise, F: Family Engagement and Empowerment) bundle. French ICU doctors will be asked to answer a questionnaire available online. ### Conditions - Delirium ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - knowledge and compliance of French intensive care units with the ABCDEF Secondary Outcomes ### Location - Facility: Chu Brest, Brest, N/A, 29609, France @@
## Study on Disease Progression and Nutritional Status in Bronchiectasis - NCT ID: NCT06344000 - Study ID: RICU20240323 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-04-15 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description Bronchiectasis is a common lung disease. The Bronchiectasis Severity Index (BSI) is a widely used assessment system. The body mass index (BMI) is a commonly used measure of nutritional status, but it has its limitations. To provide a more comprehensive assessment, the investigators also consider other nutrition-related indices such as upper arm circumference, calf circumference, skinfold thickness and grip strength. The investigators will specify the relationship between nutritional status and disease progression by measuring nutrition-related indicators and tracking participants' disease progression. ### Conditions - Bronchiectasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - inapplicable ### Outcomes Primary Outcomes - Frequency of acute exacerbations of bronchiectasis Secondary Outcomes - Deterioration of lung function - Severity of dyspnoea - Bhalla scores on CT of participants' lungs - Frequency of hospitalisation - Death ### Location - Facility: Wuhan Union Hospital, Wuhan, Hubei, 430022, China @@
## The FEMA Study: Feasibility of Exercise in Patients With Metastatic Breast Cancer and Adiposity - NCT ID: NCT06343987 - Study ID: 1-10-72-165-23 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2025-03 - Lead Sponsor: Aarhus University Hospital ### Study Description The goal of this clinical trial is to test a physical activity program in patients with metastatic breast cancer and overweight receiving endocrine-based treatment.The aim of the study is to assess the feasibility and metabolic efficacy of a 12-week physical activity program in this patient group. The hypothesis is that improving metabolic health through physical activity can optimize cancer care.Participants will randomized 2:1 to either a physical activity program or care as usual. ### Conditions - Metastatic Breast Cancer - Estrogen-receptor-positive Breast Cancer - Adiposity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physical Activity ### Outcomes Primary Outcomes - Adherence as assessed by attendance rate - Metabolic efficacy assessed by change in metabolic score Secondary Outcomes - Perceived satisfaction assessed by qualitative interviews - Health-related quality of life as assessed by EORTC-QLQ-30 - Cancer coping as assessed by CBI-12 - Sleep quality as assessed by PSQI - Insomnia as assessed by ISI - Change in C-reactive protein - Change in leukocytes - Change in HbA1c - Change in LDL cholesterol - Change in HDL cholesterol - Change in BMI - Fat mass - Muscle mass - Visceral fat - VO2 max - Handgrip strength - Sit-rising ### Location - Facility: Department of Oncology, Aarhus University Hospital, Aarhus N, Central Denmark Region, 8200, Denmark @@
## Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics - NCT ID: NCT06343974 - Study ID: 0843 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-05-01 - Lead Sponsor: Turku University Hospital ### Study Description The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls.The main questions it aims to answer are:* Are fetal liver ultrasound radiomic features reproducible?* Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls?Participants will undergo ultrasound examination to collect ultrasound data for the analyses. ### Conditions - Pregnancy in Diabetic - Diabetes Mellitus, Type 1 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Fetal liver ultrasound texture Secondary Outcomes - Birth weight in grams - Birth weight centile - Large for gestational age (LGA) - Interventricular septum (IVS) width - Number of pregnancies with neonatal hypoglycemia - Rate of neonatal hypoglycemia treated with oral dextrose gel - Rate of neonatal hypoglycemia treated with intravenous (IV) glucose - Length of treatment for neonatal hypoglycemia - Number of neonates admitted to neonatal intensive care unit (NICU) - Length of NICU admission - Number of pregnancies with neonatal respiratory complications related to maternal diabetes - Number of pregnancies with neonatal hyperbilirubinemia - Maternal HbA1c concentration - Glucose management indicator (GMI) - Time in glycemic range (TIR) - Time above glucose range - Time below glucose range ### Location - Facility: Turku University Hospital, Turku, N/A, N/A, Finland @@
## Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy - NCT ID: NCT06343961 - Study ID: 2024-76 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-12 - Lead Sponsor: Jie Zhong ### Study Description The study used a new surgical technique: intraoperative fluorescence imaging,In the 1980s, some scholars proposed the concept of intraoperative fluorescein angiography.During vitrectomy, intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapy.Through this technology, the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery, providing effective imaging evidence support for the design of further treatment. ### Conditions - Vascular Retinopathy of Left Eye (Disorder) - Vascular Retinopathy of Right Eye (Disorder) - Diabetic Retinopathy - Retinal Vein Occlusion - Retinal Vasculitis - Vitreous Hemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intraoperative Fluorescein Angiography ### Outcomes Primary Outcomes - best corrected visual acuity - Central retinal thickness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer - NCT ID: NCT06343948 - Study ID: BL-B01D1-306 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. ### Study Description This trial is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+HER2- breast cancer after failure of at least one prior line of chemotherapy. ### Conditions - HR+HER2- Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BL-B01D1 - Eribulin - Vinorelbine - Gemcitabine - Capecitabine ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective Response Rate (ORR) - Disease Control Rate (DCR) - Duration of Response (DOR) - Treatment Emergent Adverse Event (TEAE) - Anti-drug antibody (ADA) ### Location - Facility: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, N/A, China @@
## A National Multicenter, Real-world Study of Linperlisib in the Treatment of Lymphoma - NCT ID: NCT06343935 - Study ID: YY-20394-014 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-04-30 - Lead Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. ### Study Description This is a national multicenter, randomized controlled, open, dose-optimized Phase IV study. It is expected to enroll approximately 88 patients with relapsed/refractory indolent B-cell lymphoma. The aim is to evaluate the efficacy and safety of linperlisib in the treatment of patients with relapsed/refractory indolent B-cell lymphoma at two doses/modes of administration (clinically recommended dose/mode and optimized dose/mode). ### Conditions - Indolent B-cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Linperlisib ### Outcomes Primary Outcomes - Progression free survival Secondary Outcomes - Objective response rate - Overall survival - Adverse event - Serious adverse event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Motor Facilitation Technique And Traditional Exercises on Children With Cerebral Palsy - NCT ID: NCT06343922 - Study ID: Sadaf Riphah - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-04 - Lead Sponsor: Riphah International University ### Study Description Cerebral palsy is a motor disorder caused by the damage to the developing brain. Feeding and swallowing difficulties are common in children with cerebral palsy (CP). Poor postural control and oral motor dysfunction results in extended feeding time, frequent coughing, choking and excessive drooling affecting their health and quality of life. The brain damage in CP is permanent that cannot be fixed however different oral motor exercises, oral facial facilitation and oral sensorimotor interventions are widely used for drool reduction and feeding difficulties in children with CP. Spastic cerebral palsy is one of most prevalent type of CP that is characterized by increased tone and stiffness of muscles. This research will be conducted to evaluate the comparative effects of oral motor facilitation technique (OMFT) and traditional oral motor exercises on drooling and feeding skills of children with spastic CP. OMFT is a complete protocol with a combination of techniques to deal with oral motor difficulties This study will be a randomized control trial. A total number of 12 children with Spastic cerebral palsy ( GMFS III-V) both male/female, between age range 3-12 and with feeding difficulties will be included in the study. Children with cerebral palsy and other co morbidities, seizures, risk of aspiration and who are on tube feeding will be excluded. Participants will be randomly allocated to two groups, either Group A (receiving OMFT) or Group B (receiving traditional oral motor exercise). Baseline scores will be recorded by using standardized tools OMAS for oral motor skill during feeding and DIS for drool severity with the consent of authors. Therapeutic sessions will be scheduled 3 days per week and 30 min a day for each group. The effects of interventions on drooling and feeding skills will be assessed after 8 and 16 weeks of sessions. Recorded data of all variables will be analyzed by using statistical package for social sciences (SPSS) for Windows Software, version 21. ### Conditions - Cerebral Palsy (CP) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - oral motor facilitation technique group - traditional oral motor exercises group ### Outcomes Primary Outcomes - Change in Drooling - Change in feeding skills Secondary Outcomes ### Location - Facility: Mobilty Quest, Lahore, Punjab, 54000, Pakistan @@
## Foot and Hip Abductor Strengthening in Patients With Knee Osteoarthritis. - NCT ID: NCT06343909 - Study ID: REC/RCR & AHS/23/0197Ayesha - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2024-06-01 - Lead Sponsor: Riphah International University ### Study Description The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore ### Conditions - Knee Osteoarthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hip abductor strengthening exercise - Intrinsic foot muscle strengthening along with conventional exercises ### Outcomes Primary Outcomes - Knee Osteoarthritis Outcome Score (KOOS) - Berkemann foot prints Secondary Outcomes - Frontal plane projection - Goniometer - 30 seconds chair stand test - Overall self-perception by Global Rating of Change Score - 9 step stairs climb test. - 40-m fast-paced walk test ### Location - Facility: THQ hospital KRK., Lahore, Punjab, N/A, Pakistan @@
## Evaluation of Sedation Depth and Reliability With Integrated Pulmonary Index (IPI) Follow-up in Pediatric Radiological Interventions - NCT ID: NCT06343896 - Study ID: AnkaraCHBilkent-tntaygurt - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-15 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description In this study, we aimed to investigate the predictability of possible respiratory complications and the effect of the addition of the integrated pulmonary (EPI) score to the evaluation of the patient's respiratory index status in addition to the SPO2 measurement available in standard ASA monitoring in pediatric patients undergoing interventional radiological procedures under sedoanesthesia. ### Conditions - Sedation - BIS - Integrated Pulmonary Index ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - monitorization reliability ### Outcomes Primary Outcomes - EVALUATION OF IPI RELIABILITY IN PEDIATRIC PATIENTS Secondary Outcomes - BİS correlation with the IPI - pulse oximetry correlation with the IPI - noninvasive blood pressure - heart rate - respiratory rate - end tidal carbondioxide - apnea and hypoxia conditions that develop in the patient during anesthesia - postoperative recovery time - intraoperative total dose of medication used - postoperative nausea and vomiting ### Location - Facility: Ankara City Hospital, Bilkent, Ankara, N/A, N/A, Turkey @@
## Investigation of Low-intensity Focused Ultrasound Pressure - NCT ID: NCT06343883 - Study ID: 24-353 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-07 - Lead Sponsor: Virginia Polytechnic Institute and State University ### Study Description Investigating the relationship between input pressure of low-intensity focused ultrasound and an evoked potential in both eeg and fMRI. ### Conditions - Somatic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - low-intensity focused ultrasound - low pressure - low-intensity focused ultrasound - medium pressure - low-intensity focused ultrasound - high pressure ### Outcomes Primary Outcomes - Report of Symptoms Questionnaire - MRI Secondary Outcomes - EEG - fMRI ### Location - Facility: Fralin Biomedical Research Institute at VTC, Roanoke, Virginia, 24016, United States @@
## Estradiol and Testosterone Subdermal Implants for Menopause Treatment (ESTIME) - NCT ID: NCT06343870 - Study ID: ESTIME - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2025-04-30 - Lead Sponsor: University of Sao Paulo General Hospital ### Study Description Estrogen and androgen deficiencies negatively impact the quality of life of women at different stages of life, especially after menopause. New modalities and new therapeutic alternatives have been researched. Parenteral administration of estradiol and testosterone could be effective to treat symptoms secondary to estrogen and androgen deficiencies and minimize these adverse events. This study evaluates the efficiency of subdermal implant-bioabsorbable use in women with menopausal symptoms associated with secondary estrogen and androgen deficiencies in women with natural menopause, premature ovarian failure or surgical menopause due to cervical cancer. Pharmacokinetic, biochemical, metabolic, thromboembolic and hormonal data will be evaluated, as well as the effects on quality of life, menopausal symptoms and sexual function after treatment. ### Conditions - Menopause - Testosterone Deficiency - Estrogen Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - testosterone pellet (100 mg) - Placebo ### Outcomes Primary Outcomes - Evaluate hormonal, metabolic thromboembolic and clinical effects on climacteric symptoms Secondary Outcomes - Evaluate response in quality of life and sexual function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Joint Self-Assessment Forms for Knee, Ankle and Shoulder - NCT ID: NCT06343857 - Study ID: CE-AVEC 878/2022/Oss/AOUFe - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-05-01 - Completion Date: 2024-04-30 - Lead Sponsor: University Hospital of Ferrara ### Study Description The present study represents the pilot phase of the project aimed at developing anatomical site-specific self-assessment questionnaires (shoulder, knee and ankle) that can advise the subject of the need for an orthopaedic specialist examination.The pilot phase of the project involves the collection of data from questionnaires in a population of subjects who have requested an orthopaedic consultation for the anatomical site covered by the questionnaire. Each questionnaire consists of questions designed to collect information about the patient's subjective condition.The data collected from the questionnaires will be used to evaluate the statistical significance (p value) of each question in the questionnaire in relation to the outcome of the orthopaedic specialist visit. Through a multivariate logistic analysis of the answers given by the subject, it will be possible to 'weight' each answer to obtain a final value that gives an indication of an orthopaedic specialist visit. ### Conditions - Osteoarthritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - self-assessment questionnaire ### Outcomes Primary Outcomes - Observation of the distribution of questionnaire responses for each anatomical site. Secondary Outcomes - Therapeutic indication of the orthopaedic specialist for each subject participating in the study ### Location - Facility: IRCCS Istituto Ortopedico Rizzoli, Clinica Ortopedica e Traumatologica II, Bologna, BO, N/A, Italy @@
## Disparities in Myocardial Infarction Remodeling According to Gender - NCT ID: NCT06343844 - Study ID: 49RC23_0070 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2040-07-01 - Lead Sponsor: University Hospital, Angers ### Study Description Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study. ### Conditions - Myocardial Infarction - Ventricular Remodeling ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - cardiac imaging to assess left ventricular volumes and function ### Outcomes Primary Outcomes - Asses left ventricular remodeling disparities between genders Secondary Outcomes - Evaluate the evolution of remodeling at Month 3 - Assess remodeling changes between inclusion and Month 12 - Assess the prevalence of comorbidities and their impact on the effect on the outcome: post-infarction cardiac remodeling with gender (cardiovascular risk factors, renal function, hepatic functionperipheral artery disease, way of life) - Explore prognostic disparities between men and women. - Evaluate lifestyle habits up to 10 years: outcome anxiety/depression - Evaluate lifestyle habits up to 10 years: outcome diet score - Evaluate lifestyle habits up to 10 years: outcome physical activity - Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis - Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary - Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma - Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy - Assess the risk of remodeling based on specific parameters in female subjects: date of first period - Assess the risk of remodeling based on specific parameters in female subjects: pregnancy - Assess the risk of remodeling based on specific parameters in female subjects: children - Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event - Assess the risk of remodeling based on specific parameters in female subjects: menopause ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Quantitative Assessment of Autologous Fat Transfer - NCT ID: NCT06343831 - Study ID: IRB23-1646 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: University of Chicago ### Study Description This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6. ### Conditions - Autologous Fat Grafting ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - 2-Dimensional (2-D) Photographs (Visit 1/ Follow up Visit 3-6) - 3-Dimensional (3-D) Photographs (Visit 1- 6) - Ultrasound Soft Tissue Assessment (Visit 1/ Follow up Visit 4-6) - Magnetic Resonance Imaging Volume Assessment (Visit 1/ Follow up Visit 4-6) - BREAST-QTM questionnaire (Visit 1/ Follow up Visit 4-6) ### Outcomes Primary Outcomes - Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging. Secondary Outcomes - Change from baseline in quality of life as measured by the BREAST-QTM survey. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Compassion Project: Developing an Empathy-Based Stress Intervention - NCT ID: NCT06343818 - Study ID: NIHR301578 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-01 - Completion Date: 2027-08-31 - Lead Sponsor: University of Bath ### Study Description Compassion is recognising that someone is suffering and wanting to help them. Compassion fatigue is a reduction in capacity to feel compassion for others. Secondary trauma is the experience of traumatic responses to hearing about someone else's trauma. Burnout is depersonalisation, emotional exhaustion, and feeling less good at one's job. Compassion fatigue, secondary trauma and burnout can all be referred to as empathy-based stress. This is a problem for healthcare staff and their patients.Staff experiencing empathy-based stress deliver less high quality care, which can lead to serious consequences for patients. Empathy-based stress is also associated with staff sickness, which is bad for staff and costly to the United Kingdom's National Health Service (NHS).Child and adolescent mental health (CAMHS) wards are busy, high-pressure environments where families and young people are often upset, resources are stretched, and staff are managing high levels of patient risk of self-harm or suicide.The principal investigator has already reviewed research on empathy-based stress and interventions to prevent and/or reduce it in mental health ward staff. This evidence has been presented to CAMHS ward staff, managers, commissioners, patients and families and these stakeholders have co-designed an intervention for wards, to reduce empathy-based stress. The intervention aims to help staff to feel better and care better.This pilot study aims to test and improve our intervention on two CAMHS wards, measuring how useful and well-liked it is, and how feasible it would be to use it and to test it on more wards. Staff on CAMHS wards will be offered a modular intervention including psychoeducation about empathy based stress and ways of combatting it, and workplace stressor and management toolkits. NHS CAMHS ward staff and patients will be asked to complete questionnaires and a subsample of staff will be asked to complete interviews about the process of the intervention. ### Conditions - Reduction of Empathy-Based Stress in Healthcare Staff ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - The Compassion Project: Intervention to Reduce Empathy-Based Stress in Staff ### Outcomes Primary Outcomes - Acceptability of intervention - Feasibility of intervention - Perceived usefulness of intervention - Feasibility of Study - Feasibility of gathering data on staff empathy-based stress using the Professional Quality of Life Scale at multiple timepoints Secondary Outcomes - Feasibility of assessing health economics data using a Health-related Quality of Life questionnaire - Process measures to assess potential mechanisms of change - Feasibility of gathering young person and parent/carer data on compassionate care - Feasibility of gathering young person and parent/carer data on experience of service ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i) - NCT ID: NCT06343805 - Study ID: AJX-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-15 - Completion Date: 2027-02-15 - Lead Sponsor: Ajax Therapeutics, Inc. ### Study Description AJX-101 is a first-in-human (FIH), phase 1, non-randomized, multi-center, open-label clinical trial designed to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an orally administered type II JAK2 inhibitor, AJ1-11095, in subjects with primary or secondary myelofibrosis previously treated with at least one type I JAK2 inhibitor. ### Conditions - Primary Myelofibrosis - Post-Essential Thrombocythemia Myelofibrosis - Post-Polycythemia Vera Myelofibrosis - PMF - PPV-MF - PET-MF ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AJ1-11095 ### Outcomes Primary Outcomes - Number of patients with treatment-emergent adverse events as assessed by CTCAE v 5.0. - Number of patients with Dose Limiting Toxicities (DLTs) - To establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of AJ1-11095 Secondary Outcomes - To assess clinical response to AJ1-11095 evaluated by the Total Symptom Score (TSS). - To assess clinical response to AJ1-11095 evaluated by spleen volume assessments. - To assess clinical response to AJ1-11095 evaluated by spleen length assessments. - To assess clinical response to AJ1-11095 evaluated through spleen size improvement. - To evaluate the Area Under the Curve (AUC) of AJ1-11095 - To evaluate the Cmax of AJ1-11095 - To evaluate the Tmax of AJ1-11095 - To evaluate the half-life of AJ1-11095 ### Location - Facility: Moffitt Cancer Cancer Center, Tampa, Florida, 33612, United States @@
## Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease - NCT ID: NCT06343792 - Study ID: RLS-0071-203 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-09 - Lead Sponsor: ReAlta Life Sciences, Inc. ### Study Description This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory. ### Conditions - Steroid Refractory GVHD ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - RLS-0071 ### Outcomes Primary Outcomes - Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) - Overall Response Rate (ORR) of RLS-0071 Secondary Outcomes - Incidence of refractoriness (to RLS-0071 +/- ruxolitinib) - Overall corticosteroid use - Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent) - Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria - Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD - Change or shift in overall Grade of aGvHD - Overall survival - Non-relapse mortality - Duration of hospital stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema - NCT ID: NCT06343779 - Study ID: PHA022121-C306 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2026-03 - Lead Sponsor: Pharvaris Netherlands B.V. ### Study Description This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1 or type 2 (HAE-1/2), a proportion of whom are using long-term prophylactic medication for HAE. ### Conditions - Hereditary Angioedema - Hereditary Angioedema Type I - Hereditary Angioedema Type II - Hereditary Angioedema Types I and II - Hereditary Angioedema Attack - Hereditary Angioedema With C1 Esterase Inhibitor Deficiency - Hereditary Angioedema - Type 1 - Hereditary Angioedema - Type 2 - C1 Esterase Inhibitor [C1-INH] Deficiency - C1 Esterase Inhibitor Deficiency - C1 Esterase Inhibitor, Deficiency of - C1 Inhibitor Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Deucrictibant, Placebo ### Outcomes Primary Outcomes - Time to onset of symptom relief, defined as Patient Global Impression of Change (PGI-C) rating of at least "a little better" for 2 consecutive timepoints within 12 hours post-treatment. Secondary Outcomes - Proportion of study drug-treated attacks achieving PGI-C rating of at least "a little better" at 4 hours post-treatment. - Time to substantial symptom relief, defined as achieving PGI-C rating of at least "better" for 2 consecutive timepoints within 12 hours post-treatment. - Time to substantial symptom relief by Patient Global Impression of Severity (PGI-S). - Time to complete symptom resolution, defined as achieving PGI-S rating of "none" within 48 hours post-treatment. - Time to End of Progression (EoP) in attack symptoms within 12 hours. - Proportion of study drug-treated attacks requiring rescue medication within 24 hours post-treatment. - Proportion of attacks achieving symptom resolution. - Time to substantial symptom relief by Angioedema Symptom Rating Scale (AMRA). - Time to almost complete or complete symptom relief by AMRA. - Proportion of study drug-treated attacks reaching almost complete or complete symptom relief by AMRA. - Time to EoP in attack symptoms within 12 hours. ### Location - Facility: Study Site, Paradise Valley, Arizona, 85258, United States @@
## Polymorphisms in ENAM, AMBN, and KLK4 Contribute to DCS. - NCT ID: NCT06343766 - Study ID: RECO6U/24-2022 - Status: COMPLETED - Start Date: 2022-11-06 - Completion Date: 2023-11-05 - Lead Sponsor: Amina Fouad Farag ### Study Description A Cross-Sectional Study aims to shed light on potential genetic determinants influencing dental caries susceptibility within this demographic and significantly understanding of genetic factors associated with dental caries, particularly within the context of the Egyptian population, providing valuable insights into the genetic aspects of oral health. The research methodology involved a comprehensive examination of these polymorphic loci ENAM, AMBN, TUFT1 and KLK4 and their prevalence, employing rigorous statistical analyses to establish potential correlations between these genetic variants and susceptibility to dental caries. ### Conditions - Dental Caries Secondary to Polymorphisms - Polymorphisms in Enamel Encoding Genes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - DNA collation and genotyping ### Outcomes Primary Outcomes - Polymorphisms in genes associated with enamel formation and mineralization and dental caries susceptibility. Secondary Outcomes ### Location - Facility: Faculty of Dentistry, October 6 University, Giza, N/A, 12511, Egypt @@
## Quality of Recovery After Laparoscopic Cholecystectomy Comparing Opioid Free Analgesia Versus Opioid Free Anesthesia - NCT ID: NCT06343753 - Study ID: FMASU MD46/2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-10-01 - Lead Sponsor: Ain Shams University ### Study Description The aim of this study is to compare the quality of recovery from general anesthesia and surgery using the quality of recovery 15 item scale (QoR-15) for participant's receiving opioid-Sparing anesthesia with those receiving standard opioid-containing anesthesia in Patients undergoing a scheduled laparoscopic cholecystectomy. ### Conditions - Quality of Recovery - Pain, Postoperative - Elective Laparoscopic Cholecystectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Opioid free analgesia - Opioid based Anesthesia ### Outcomes Primary Outcomes - Quality of recovery Secondary Outcomes - Post operative pain - Postoperative Hypoxia - Postoperative nausea and vomiting - Postoperative bradycardia - Postoperative hypotension - Postoperative hypertension ### Location - Facility: Ain Shams University, Cairo, N/A, N/A, Egypt @@
## First Evaluation of COMET-Y - NCT ID: NCT06343740 - Study ID: PSY-2324-S-0136 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Accare ### Study Description The goal of this pilot study is to evaluate COMET-Y in 22 adolescents (11-18 years) with various mental health problems and low self-esteem. The main questions is: Does COMET-Y, parallel to care as usual (CAU), improve self-esteem?Before and after the training participants fill in questionnaires to measure self-esteem, mental health problems, resilience, quality of life, emotions and individual goals. Some of the outcomes are measured through diary methods. Youth and therapists will be assessed to evaluate feasibility and acceptability of the COMET-Y training. ### Conditions - Self Esteem - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - COMET-Y ### Outcomes Primary Outcomes - Self Esteem Secondary Outcomes - Domain-specific Self Esteem - Mental Health Problems - Quality of life - Affect - Resilience - Ecological Momentary Assessments - Global self-esteem - Ecological Momentary Assesments - Goal Based Outcome (GBO) tool for young people - Ecological Momentary Assesments - Domain-specific self-esteem ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF) - NCT ID: NCT06343727 - Study ID: HS25870 (H2023:026) - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-07-01 - Lead Sponsor: Seven Oaks Hospital Chronic Disease Innovation Centre ### Study Description The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:* To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.* To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.* To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood and urine. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks. ### Conditions - Kidney Failure - Frailty - Kidney Disease, Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Egg white protein pudding - : Ensure Plus ### Outcomes Primary Outcomes - Eligibility to randomization ratio - Weekly recruitment rate - Adherence to Egg pudding Secondary Outcomes - Serum albumin - Hand grip strength - Change in gait speed - Five rep chair stand time - Tandem balance time - Serum bicarbonate - Calcium - Urine albumin - chloride - phosphorus - Potassium - Sodium - HbA1c ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of FB1003 in Healthy Subject - NCT ID: NCT06343714 - Study ID: FB1003-04-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-03 - Completion Date: 2025-06-30 - Lead Sponsor: 4B Technologies Limited ### Study Description The purpose of this study is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - FB1003 - Placebo ### Outcomes Primary Outcomes - The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo. Secondary Outcomes - FB1003 serum concentrations over time - PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC0-∞) of FB1003 - Presence of anti-FB1003 antibodies over time ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigation of Motor Imaging Skills in Children With Spastic Cerebral Palsy - NCT ID: NCT06343701 - Study ID: BAİBÜ-SAT4 - Status: RECRUITING - Start Date: 2023-07-18 - Completion Date: 2024-06-25 - Lead Sponsor: Abant Izzet Baysal University ### Study Description The aim of this study was to investigate implicit and explicit motor imagery skills in children with spastic cerebral palsy and typically developing children. The main questions it aims to answer are:* There is a difference between the implicit motor imagery skills of children with bilateral and unilateral CP.* There is a difference between the explicit motor imagery skills of children with bilateral and unilateral CP.* There is a difference between the implicit motor imagery skills of children with cerebral palsy and typically developing children.* There is a difference between the explicit motor imagery skills of children with cerebral palsy and typically developing children. ### Conditions - Cerebral Palsy, Spastic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Implicit motor imagery - Explicit motor imagery ### Outcomes Primary Outcomes - Explicit motor imagery -1 Secondary Outcomes - Explicit motor imagery - 2 - Explicit motor imagery - 3 - Implicit motor imagery ### Location - Facility: Kdz. Ereğli Gökkuşağı Özel Eğitim ve Rehabilitasyon Merkezi, Zonguldak, Ereğli, 67300, Turkey @@
## "Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy - NCT ID: NCT06343688 - Study ID: BAIBU-FTR-SAT-5 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-04-01 - Lead Sponsor: Abant Izzet Baysal University ### Study Description " Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval." ### Conditions - Diplegic Cerebral Palsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - "Assessment of Balance and Lower Extremity Gross Motor Function with and without DAFO" ### Outcomes Primary Outcomes - Wii Balance Board - "The Gross Motor Function Measure-88 (D-E) (GMFM-88) - The Functional Reach Test - "The Pediatric Berg Balance Scale (PBBS) Secondary Outcomes - "The Eating and Drinking Ability Classification System (EDACS) - "The Manual Abilities Classification System (MACS) - "The Gross Motor Function Classification System (GMFCS) - "The Communication Function Classification System (CFCS) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Systematic Health-promoting Work Environment Management in Dentistry - NCT ID: NCT06343675 - Study ID: Dnr 2024-00620-01 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-12-31 - Lead Sponsor: Linkoeping University ### Study Description Research shows that the workplace is an important arena where much can be done to promote a sustainable working life while maintaining health. However, there is a lack of knowledge that is specific to dental care with regard to managers' and employees' perceptions of the work environment, systematic work environment management and work adaptations, as well as what measures in the workplace are necessary to create a health-promoting and sustainable work environment. There is also a lack of knowledge regarding what support employees and managers need in the systematic work environment management and what individual workplace adaptations that can work within dental care organizations. ### Conditions - Occupational Health ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - There is no intervention ### Outcomes Primary Outcomes - Work Ability Single Item Scale (WAS) - Work Ability physical demands - Work Ability mental demands - Sick leave Secondary Outcomes - Structured Multidisciplinary Work Evaluation Tool (SMET) - Satisfaction with work - Global Health - Perceived stress - Health problems related to work - Pain during last 7 days - Psychological safety - Work environment problems - Health related problems - Questions about workplace improvements, work adjustments, and support in the workplace - Work adjustment and discomfort - Support and meaning in work - Sustainable work life - Systematic work environment management and safety - Targeted questions to managers - Work environment responsibility and measures - Work environment management support and education ### Location - Facility: Occupational and Environmental Medicine Centre, Linköping, N/A, 581 85, Sweden @@
## Group Music Therapy for Acquired Brain Injury - NCT ID: NCT06343662 - Study ID: Meraki_Acquired Brain Injury - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-07 - Lead Sponsor: University of Valencia ### Study Description The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI. ### Conditions - Acquired Brain Injury ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MERAKI_ABI ### Outcomes Primary Outcomes - Change in Discomfort ( Baseline (3 Assessments), Pre- Post) Secondary Outcomes - Barthel Index - Pfeiffer Short Form Mental State Questionnaire, SPMSQ - Charlson Comorbidity Index (CCI), ### Location - Facility: Hospital Dr. Moliner, Serra, Valencia, N/A, Spain @@
## Explicit Motor Imagery in Persistent Pelvic Pain - NCT ID: NCT06343649 - Study ID: CEUMA 187-2023-H - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2023-11-30 - Lead Sponsor: University of Valencia ### Study Description The goal of this clinical trial is to compare the response of Explicit Motor Imagery interventions in patients suffering Persistent Pelvic Pain. The main question it aims to answer is:• Does the modality of application of Explicit Motor Imagery, either through visual or auditory stimuli, influence the response in patients suffering Persistent Pelvic Pain?Participants will receive an online Explicit Motor Imagery program either through visual inputs or auditory inputs. They will be instructed to follow the program en register their response.Researchers will compare visual Explicit Motor Imagery and auditory Explicit Motor Imagery to see if different inputs generate different responses in patients suffering Persistent Pelvic Pain. ### Conditions - Pelvic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Visual - Auditory ### Outcomes Primary Outcomes - Numerical Rating Scale - Pain Vigilance and Awareness Questionnaire Secondary Outcomes - Movement Imagery Questionnaire-Revised ### Location - Facility: University of Valencia, Valencia, N/A, 46010, Spain @@
## A Phase 1 Study of VG-3927 in Healthy Adults - NCT ID: NCT06343636 - Study ID: VG3927-02.101 - Status: ENROLLING_BY_INVITATION - Start Date: 2023-09-27 - Completion Date: 2024-12-31 - Lead Sponsor: Vigil Neuroscience, Inc. ### Study Description A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - VG-3927 - Placebo ### Outcomes Primary Outcomes - Adverse Events Secondary Outcomes ### Location - Facility: Clinical Pharmacology of Miami, Miami, Florida, 33014, United States @@
## Superiorly Based Pharyngeal Flap Versus Myomucosal Resection and Direct Closure - NCT ID: NCT06343623 - Study ID: fac.med.2018.15 - Status: COMPLETED - Start Date: 2018-10-12 - Completion Date: 2022-10-16 - Lead Sponsor: Minia University ### Study Description Patients were classified into two groups. Group (A) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected by the superiorly based pharyngeal flap. Group (B) patients included fifty patients had velopharyngeal insufficiency and were surgically corrected with myomucosal resection and direct closure of the posterior pharyngeal wall ### Conditions - Velopharyngeal Insufficiency ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - myomucosal resection and direct closure - superiorly based flap ### Outcomes Primary Outcomes - Improvement in the speech outcome Secondary Outcomes - obstructive sleep apnea ### Location - Facility: Faculty of medicine, Minya, N/A, 61511, Egypt @@
## The Effect of 8-week Dietary Intake of Novel Food Supplement on Minimal Erythema Dose - NCT ID: NCT06343610 - Study ID: VIST TO-UV 01-2024 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2024-10 - Lead Sponsor: VIST - Faculty of Applied Sciences ### Study Description This is a double-blind, randomized, placebo-controlled interventional study of the effect of multiple-dose dietary intake on minimal erythema dose and other skin parameters. ### Conditions - Minimal Erythema Dose ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Active product - Placebo ### Outcomes Primary Outcomes - Change of minimal erythema dose Secondary Outcomes - Change of redness formation ### Location - Facility: VIST - Faculty of Applied Sciences, Institute of Cosmetics, Ljubljana, N/A, 1000, Slovenia @@
## Volume Outcome Relationships and Effects - NCT ID: NCT06343597 - Study ID: 037.HPB.2020.R - Status: RECRUITING - Start Date: 2020-06-15 - Completion Date: 2025-06-15 - Lead Sponsor: Methodist Health System ### Study Description This is a retrospective analysis to assess if high-volume hospital facilities experience greater or lesser rates of incidence in patients with esophageal cancer than low-volume facilities. ### Conditions - Esophageal Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Esophageal Cancer resection in patients in high volume (more than 5 esophagectomy performed per year) and low volume (less than 5 esophagectomy performed per year) hospital facilities Secondary Outcomes ### Location - Facility: Methodist Richardson Medical Center, Richardson, Texas, 75082, United States @@
## Are Personal Smartphones Hurting Work-Life Balance for Nurse Managers? - NCT ID: NCT06343584 - Study ID: 023.NUR.2021.M - Status: COMPLETED - Start Date: 2021-07-01 - Completion Date: 2022-05-06 - Lead Sponsor: Methodist Health System ### Study Description For leadership positions with only a handful of staff under their direct chain of command, this may not be all-consuming and detrimental to work-life balance. But for NMs with upwards of 100 direct reports, this can make for a never-ending stream of contact points. This study will implement several communication and behavioral strategies to determine how using provided smartphone tools impact work-life balance and professional burnout. ### Conditions - Burnout ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Study will conducted over a six-month period using a quasi-experimental Pre-test/Post-test design using Stamm's (2009) ProQOL Scale. ### Outcomes Primary Outcomes - • Impact of smartphone tool utilization will be measured using a pre-study survey and post-study survey using the Professional Quality of Life (ProQOL) Scale (Stamm, 2009). Secondary Outcomes - • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the number of tools implemented during the study duration. - • Participants in Group 1 will self-report on the post-study survey (Appendix D1) the frequency of tool utilization during the study duration using a Likert scale. - • Participants in Group 2 will self-report on the post-study survey (Appendix D2) using the ProQOL Scale. - • Responses to the post-study survey from participants in Group 2 will be compared to participants in Group 1 to determine if utilizing a separate work smartphone during business hours has a greater improvement on work-life balance and burnout. ### Location - Facility: Methodist Mansfield Medical Center, Mansfield, Texas, 76063, United States @@
## Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode - NCT ID: NCT06343571 - Study ID: MED-EL_CRD_2022_12 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-08 - Lead Sponsor: MED-EL Elektromedizinische Geräte GesmbH ### Study Description This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array. ### Conditions - Cochlear Implants ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Evaluate short and long term longitudinal clinical performance data from MED-EL CIs to assess their clinical effectiveness and safety. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Gait and Balance Impairment in Rare and Very Rare Neurological Diseases - NCT ID: NCT06343558 - Study ID: 24C302 - Status: RECRUITING - Start Date: 2023-05-30 - Completion Date: 2027-05-01 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Rare and very rare neurological diseases primarily or exclusively affect the nervous system with a prevalence of \< 5 out of 10'000 and 100'000 people, respectively. Besides these, there are undiagnosed neurological diseases: neurological conditions without a diagnosis after completing a full diagnostic examination.Rare, very rare, and undiagnosed neurological diseases are complicated and progressive and often cause variegated motor signs, impairments, and syndromes.Balance and gait are frequently affected in these conditions, already at the clinical examination. These balance and gait impairments limit activities and cause an increased risk of falling. Falls can eventually result in injuries, even severe.There are only a few studies about these diseases, likely because of their rarity. Hence, the clinical presentation and the course of rare and very rare diseases are poorly known or even unknown. Essential information for these conditions' diagnosis, prognosis, treatment and rehabilitation is missing.MaNeNeND is an observational study underway at the Fondazione IRCCS Istituto Neurologico "Carlo Besta" (Milano) aimed at detailing the clinical and biological features of very rare and undiagnosed neurological diseases.Research questions:1. Do patients with rare (Ra), very rare (V) and undiagnosed (U) neurological diseases suffer a balance and gait impairment?2. Is there a correlation between the clinical and instrumental severity of the balance and gait impairment in RaVU neurological diseases?3. Are instrumental measures more sensitive in detecting balance and gait impairments in patients affected by a RaVU neurological disease than the clinical measures?4. Do the balance and gait impairments in RaVU neurological diseases worsen in time?The current project aims at diagnosing, quantifying and detailing the balance and gait impairment in rare, very rare and undiagnosed neurological diseases.To this aim, questionnaires, clinical scales and instrumental tests will be administered to these patients to collect a wide range of balance and gait measures.These measures will also integrate those collected with MaNeNeND to provide a more detailed description of patients with rare, very rare and diagnosed neurological diseases.Participants will complete two questionnaires: the Dizziness Handicap Inventory - short form (DHI-sf, an ordinal score of self-perceived balance) and the Modified Fatigue Impact Scale (MFIS, an ordinal score of self-perceived fatigue).Moreover, a clinician will administer the Mini Balance Evaluation Systems Test (Mini-BESTest, an ordinal score of balance), the 10 m walking test (for measuring the gait speed and other gait parameters) and the Timed Up and Go test (an instrumental measure of mobility and balance). Walking and the Timed Up and Go tests will be recorded with a trunk-worn inertial measurement unit.Finally, participants will be asked to complete an instrumental upright stance and gait assessment, the first consisting of standing on posturographic plates and the second of walking on a treadmill equipped with force sensors. When walking on the treadmill, an optoelectronic system will also record the position in time of limbs and trunk.The quantification of the severity of the balance and gait impairment of the patients suffering a rare, very rare or undiagnosed neurological disease will highlight these persons' therapeutic and rehabilitative needs.Comparing the balance and gait impairment of rare, very rare and undiagnosed diseases with those of multiple sclerosis, Parkinson's disease and peripheral neuropathy will highlight if the formers' balance and gait impairment has unique characteristics that could help ease the diagnosis of these uncommon conditions.The longitudinal measurements on rare, very rare and undiagnosed diseases will be paramount to identifying prognostic factors.In addition, the data collected in the current study will be crucial for future studies, for example, for estimating the sample size in clinical trials. ### Conditions - Multiple Sclerosis - Parkinson Disease - Peripheral Neuropathy - Rare Diseases - Healthy - Healthy Aging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaires, clinical scales and instrumental tests ### Outcomes Primary Outcomes - Balance (Mini-BESTest) - Balance (Timed Up and Go test) - Gait speed - Gait analysis - kinematic - stride length - Gait analysis - kinematic - duration - Gait analysis - kinematic - width of the base of support - Gait analysis - kinematic - dorsal ankle angle - Gait analysis - dynamic - reaction force - Gait analysis - dynamic - ankle power - Gait analysis - dynamic - energy - Posturography - static - centre of pressure position - Posturography - static - centre of mass position - Posturography - dynamic - centre of pressure position - Posturography - dynamic - centre of mass position Secondary Outcomes ### Location - Facility: IRCCS Istituto Auxologico Italiano, Milano, Milan, N/A, Italy @@
## Evaluation of the Impact of Rehabilitation Strategies and Early Discharge After Respiratory Failure - NCT ID: NCT06343545 - Study ID: Rehab_PROADI - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Hospital Israelita Albert Einstein ### Study Description To evaluate, through a randomized clinical trial in groups/clusters (stepped wedge), the impact of specific bundles for disability prevention and early rehabilitation, focused on 3 domains (ICU, Ward and post-discharge), on health-related quality of life and other long- and short-term outcomes in critically ill patients affected by hypoxemic acute respiratory failure with suspected COVID-19. ### Conditions - Acute Respiratory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Standard of Care - Rehabilitation ### Outcomes Primary Outcomes - Quality of life Secondary Outcomes - Mortality - Days alive and free of hospital - Rehospitalization - Return to work - Anxiety and Depression - New disability - Disability - Clinical Status - Cognitive impairment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SXC-2023 Cocaine Interaction Study - NCT ID: NCT06343532 - Study ID: NIDA-SXC-Ph1b-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-12 - Lead Sponsor: National Institute on Drug Abuse (NIDA) ### Study Description The goal of this clinical trial is to determine whether there are any interactions between the study drug and cocaine. Researchers will compare a treatment group and a placebo group to see if they experience any effects when administered cocaine after taking the treatment/placebo. ### Conditions - Cocaine Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SXC-2023 - SXC-2023 Placebo ### Outcomes Primary Outcomes - Determine Safety and Tolerability of Oral SXC-2023 Co-administered with Intravenous Cocaine by Collecting Vital Signs and Adverse Events Secondary Outcomes ### Location - Facility: Altasciences Clinical Kansas, Inc., Overland Park, Kansas, 66212, United States @@
## Echocardiographic and Laboratory Findings in Hemodynamic Monitoring of Shocked Patients - NCT ID: NCT06343519 - Study ID: Shocked Patients Monitoring - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Assiut University ### Study Description Shocked patients require prompt and accurate assessment of their hemodynamic status to guide appropriate management. Echocardiography is a valuable tool for assessing cardiac function, while laboratory parameters such as mixed venous oxygen saturation and arterial blood lactate provide insights into tissue perfusion and oxygen metabolism. This study aims to compare echocardiographic findings, including cardiac index, speckle tracking parameters, and tissue Doppler indices, with laboratory findings in the evaluation of hemodynamic monitoring in shocked patients. ### Conditions - Shock ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography ### Outcomes Primary Outcomes - Change in Shock Status After Fluid Therapy Based on Echocardiographic Assessment of Fluid Responsiveness Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Ankle Dorsiflexion Changes With Assisted Stretching Device - NCT ID: NCT06343506 - Study ID: 2023-929-EXPEDITED - Status: RECRUITING - Start Date: 2023-10-30 - Completion Date: 2024-12-31 - Lead Sponsor: Montana State University ### Study Description Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion. ### Conditions - Physical Therapy Modality ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Grassroots Ankle Flex ### Outcomes Primary Outcomes - Ankle Range of Motion Secondary Outcomes - Ankle Strength ### Location - Facility: Neuromuscular Biomechanics Laboratory, Bozeman, Montana, 59717, United States @@
## Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery - NCT ID: NCT06343493 - Study ID: JALTAF - Status: COMPLETED - Start Date: 2023-06-16 - Completion Date: 2023-12-31 - Lead Sponsor: Rawalpindi Medical College ### Study Description Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.KEY WORDS:* Chronic rhinosinusitis (CRS)* Endoscopic sinus surgery* Boezaart score ### Conditions - Rhinosinusitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Normal saline heated up to 50 °C ### Outcomes Primary Outcomes - Boezaart Score Secondary Outcomes - Bleeding in ml - Duration of Surgery ### Location - Facility: Benazir Bhutto Hospital, Rawalpindi, Punjab, 46000, Pakistan @@
## Misoprostol Versus Oxytocin for Induction of Labour in Parturients With Spontaneous Rupture of Fetal Membranes at Term - NCT ID: NCT06343480 - Study ID: SMVOT2024CT - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2021-11-30 - Lead Sponsor: Federal Teaching Hospital Abakaliki ### Study Description Intravenous oxytocin titration has a prime position as a choice agent for induction of labour following term PROM as it has been shown to be efficacious for such purpose. Recent evidence however has shown that misoprostol is associated with better outcomes and merits evaluation in our environment. This study compared the efficacy of misoprostol and oxytocin for induction of labour in parturients with term Prelabour Ruptuture of Membranes. ### Conditions - Labor Onset and Length Abnormalities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Labour Induction ### Outcomes Primary Outcomes - Mean induction delivery interval Secondary Outcomes ### Location - Facility: Alex Ekwueme Federal University Teaching Hospital, Abakaliki, Ebonyi, 480001, Nigeria @@
## Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? - NCT ID: NCT06343467 - Study ID: A17-376 - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2023-04-30 - Lead Sponsor: HealthPartners Institute ### Study Description Across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (ORIF) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. At the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. From a quality perspective each patient will be monitored both short and long term for complication and reoperation. This will be done through chart review. ### Conditions - Distal Radius Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Generic Volar Locking Plate - Conventional Volar Locking Plate ### Outcomes Primary Outcomes - 90-day reoperation rate - 90-day readmission rate - 90-day mortality rate Secondary Outcomes - Implant Cost - Tourniquet Time - Estimated Blood Loss ### Location - Facility: Regions Hospital, Saint Paul, Minnesota, 55101, United States @@
## The Effect of Different Head Positions on Occlusal Contacts During Digital Interocclusal Bite Registration - NCT ID: NCT06343454 - Study ID: 2023/04-03(KA-22111) - Status: COMPLETED - Start Date: 2023-10-25 - Completion Date: 2024-03-03 - Lead Sponsor: Hacettepe University ### Study Description The goal of this clinical trial is to learn about different head position's effect on occlusal contacts during digital interocclusal record. The main question aims to answer is:• Are different head positions in physiological limits can be affected the occlusal contact during interocclusal record? Participants will be asked to stand in three different physiological head positions (neutral, forward and backward) which are common in daily routine. In these positions, after maxillary and mandibular arch scans three different interocclusal records will be taken. Also for assessment of these records in digital occlusal analysis module (oJMA, zebras), three different oJMA record will be taken.Researchers will compare neutral, forward and backward head positions to see if there are any difference in number, density and location of occlusal contacts. ### Conditions - Occlusion ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Digital Interocclusal Record In Different Head Positions ### Outcomes Primary Outcomes - Number of Occlusal Contacts - Density of Occlusal Contacts - Location of Occlusal Contacts Secondary Outcomes ### Location - Facility: Hacettepe University, Ankara, N/A, N/A, Turkey @@
## Accuracy of Two Methods of Making Impressions for Complete-arch Implant Supported Fixed Prosthesis - NCT ID: NCT06343441 - Study ID: SH9H-2024-T29-2 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2024-12-31 - Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University ### Study Description To compare the accuracy of digital impression and conventional impression for complete-arch implant-supported fixed prosthesis ### Conditions - Edentulous Jaw ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intraoral scan - open tray impression ### Outcomes Primary Outcomes - Grade of framework passive fit Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients - NCT ID: NCT06343428 - Study ID: IEO 1519 - Status: RECRUITING - Start Date: 2021-07-19 - Completion Date: 2026-07-19 - Lead Sponsor: European Institute of Oncology ### Study Description The 2017 World Health Organization (WHO) introduced a new category of high-grade, well-differentiated neuroendocrine neoplasms (NENs) that called neuroendocrine tumors (NETs) G3 in pancreatic NENs classification and, then, in 2019, for all gastro-entero-pancreatic (GEP) tract NENs.The new classification made it possible to separate NETs G3 from high-grade, poorly-differentiated, NENs that are called neuroendocrine carcinomas (NECs).However, in clinical practice, we observed that several clinical, pathological and radiological differences are arising among NET G3 patients, suggesting that a multiparametric definition of NET G3 is needed. ### Conditions - Neuroendocrine Neoplasm ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Immunohistochemical characteristics analysis Secondary Outcomes - Review of the functional imaging ### Location - Facility: European Institute of Oncology, Milan, N/A, 20141, Italy @@
## Robot-assisted Training After Traumatic Brain Injury and Disorders of Consciousness - NCT ID: NCT06343415 - Study ID: H-23052844 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2025-07-31 - Lead Sponsor: Christina Kruuse ### Study Description The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after traumatic brain injury and disorders of consciousness. The main questions it aims to answer are:* Is the protocol feasible concerning inclusion in the study?* Is the protocol feasible concerning protocol completion? Participants will randomly be assigned to either five days of robot-assisted gait training (GAIT), two days of pause, then five days of robot-assisted step training (STEP) or vice versa.The investigators will explore and compare safety events, physiological measures and physical activity levels, behavioural measures, and functional disability outcomes. Further, the investigators report intervention and technical parameters in detail. ### Conditions - Traumatic Brain Injury - Disorders of Consciousness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - GAIT-assisted training - STEP-assisted training ### Outcomes Primary Outcomes - Inclusion Rate - Completion Ratio of protocols Secondary Outcomes - Exploratory Safety Outcomes ### Location - Facility: Department of brain and spinal cord injury, Glostrup, Greater Copenhagen, 2600, Denmark @@
## Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer - NCT ID: NCT06343402 - Study ID: TBBO8520-101 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-02 - Lead Sponsor: TheRas, Inc ### Study Description A first in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-8520, a KRAS G12C (ON) inhibitor, single agent and in combination with pembrolizumab in patients with advanced non-small cell lung cancer ### Conditions - Non-small Cell Lung Cancer - Metastatic Non-Small Cell Lung Cancer - NSCLC - KRAS G12C - Metastatic Lung Cancer - Advanced Lung Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - BBO-8520 - Pembrolizumab ### Outcomes Primary Outcomes - Adverse Events - Dose-limiting toxicities (DLTs) Secondary Outcomes - To evaluate preliminary antitumor activity of BBO-8520 - To evaluate preliminary antitumor activity of BBO-8520 - Overall Survival (OS) - To characterize the pharmacokinetics (PK) of BBO-8520 - To characterize the pharmacokinetics (PK) of BBO-8520 - To characterize the pharmacokinetics (PK) of BBO-8520 - To characterize the pharmacokinetics (PK) of BBO-8520 ### Location - Facility: Cleveland Clinic, Cleveland, Ohio, 44195, United States @@
## Acute Kidney Injury in Patients With Liver Cirrhosis - NCT ID: NCT06343389 - Study ID: Soh-Med-24-03-14MS - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Sohag University ### Study Description In our locality, limited studies have discussed AKI in patients with liver cirrhosis and its outcome, therefore we aim to highlight the incidence, patterns, risk factors, and outcomes of acute kidney injury in patients with liver cirrhosis at Sohag University Hospital. ### Conditions - Acute Kidney Injury in Patients With Liver Cirrhosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - serum creatinine ### Outcomes Primary Outcomes - Incidence of acute kidney injury in cirrhotic patients in Sohag University Hospital Secondary Outcomes ### Location - Facility: Sohag University Hospital, Sohag, N/A, N/A, Egypt @@
## Genetically Engineered Cells (EGFRt/19-28z/IL-12 CAR T Cells) for the Treatment of Relapsed or Refractory CD19+ Hematologic Malignancies - NCT ID: NCT06343376 - Study ID: I-3641523 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2029-04-15 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description This phase I trial tests the safety, side effects, and best dose of genetically engineered cells called EGFRt/19-28z/IL-12 CAR T cells, and to see how they work in treating patients with hematologic malignancies that makes a protein called CD19 (CD19-positive) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Chimeric Antigen Receptor (CAR) T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. To improve the effectiveness of the modified T cells and to help the immune system fight cancer cells better, the modified T cells given in this study will include a gene that makes the T cells produce a cytokine (a molecule involved in signaling within the immune system) called interleukin-12 (IL-12). The researchers think that IL-12 may improve the effectiveness of the modified T cells, and it may also strengthen the immune system to fight cancer. Giving EGFRt/19-28z/IL-12 CAR T cells may be safe and tolerable in treating patients with relapsed or refractory CD19+ hematologic malignancies. ### Conditions - Recurrent Chronic Lymphocytic Leukemia - Recurrent Diffuse Large B-Cell Lymphoma - Recurrent Follicular Lymphoma - Recurrent High Grade B-Cell Lymphoma - Recurrent Mantle Cell Lymphoma - Recurrent Transformed Chronic Lymphocytic Leukemia - Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma - Refractory Chronic Lymphocytic Leukemia - Refractory Diffuse Large B-Cell Lymphoma - Refractory Follicular Lymphoma - Refractory High Grade B-Cell Lymphoma - Refractory Mantle Cell Lymphoma - Refractory Transformed Chronic Lymphocytic Leukemia - Refractory Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biopsy - Biospecimen Collection - Bone Marrow Aspiration - Bone Marrow Biopsy - Computed Tomography - Cyclophosphamide - Echocardiography - EGFRt/19-28z/IL-12 CAR T-lymphocytes - Fludarabine Phosphate - Leukapheresis - Multigated Acquisition Scan - Positron Emission Tomography ### Outcomes Primary Outcomes - Incidence of adverse events - Maximal tolerated dose (MTD) of EGFRt/19-28z/IL-12 chimeric antigen receptor T-cells Secondary Outcomes - Incidence of complete remission (CR)/complete remission with incomplete count recovery (CRi) - Incidence of CR/CRi + partial response (PR) (ORR) - Event free survival - Overall survival - Progression-free survival - Modified T-cell persistence ### Location - Facility: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States @@
## Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety - NCT ID: NCT06343363 - Study ID: 318352 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-12 - Lead Sponsor: Oxford University Hospitals NHS Trust ### Study Description Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.This prospective, observational cohort study will examine the safety and feasibility of this practice. ### Conditions - Mitral Regurgitation - Tricuspid Regurgitation - Mitral Repair - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Early discharge protocol ### Outcomes Primary Outcomes - Proportion of patients discharged 'early' after edge -to-edge repair - All - cause rehospitalisation after completion of procedure - All cause death after completion of procedure Secondary Outcomes - Hospital length of stay - Proportion of patients requiring intensive care unit care - Safety outcomes a. Major adverse events at the time of the procedure b. Major adverse events (procedure/device related) up to 30 days - Symptomatic improvement - Heart failure hospitalisation ### Location - Facility: John Radcliffe Hospital, Oxford, Oxfordshire, OX3 9DU, United Kingdom @@
## OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection - NCT ID: NCT06343350 - Study ID: OPTDR01P - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-30 - Lead Sponsor: Optain Health ### Study Description In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates.A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR. ### Conditions - Diabetic Retinopathy - Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OPTDR01 software application ### Outcomes Primary Outcomes - Enrollment rate of eligible participants at clinical site Secondary Outcomes ### Location - Facility: Precision Research Institute, San Diego, California, 92114, United States @@
## The Effects of Pregnancy on Oral Health - NCT ID: NCT06343337 - Study ID: MSKUDİSCLİNİCALTRİALS_FYİLMAZ. - Status: COMPLETED - Start Date: 2022-05-20 - Completion Date: 2023-04-01 - Lead Sponsor: Muğla Sıtkı Koçman University ### Study Description The aim of this study was to evaluate the effects of pregnancy on salivary pH, flow rate, caries experience and periodontal status.The main questions it aims to answer are:* Does pregnancy affect caries experience and periodontal status?* Does pregnancy affect salivary pH and flow rate?* Is there a difference between pregnant and non-pregnant woman with respect to caries experience, periodontal status, salivary pH and flow rate?* Is there a difference among first, second and third trimester with respect to caries experience, periodontal status, salivary pH and flow rate? ### Conditions - Pregnancy Related - Dental Caries - Periodontal Diseases - Saliva Altered ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: DIAGNOSTIC ### Interventions - Evaluation of DMFT index, CPI scores, salivary pH and flow rate in pregnant and non-pregnant woman ### Outcomes Primary Outcomes - The effects of pregnancy on caries experience - The effects of pregnancy on periodontal status. - The effects of pregnancy on salivary pH. - The effects of pregnancy on salivary flow rate. Secondary Outcomes ### Location - Facility: Fatma Yilmaz, Mentese, Mugla, 48000, Turkey @@
## Effect of Web-Based Adaptation and Insomnia Severity in Individuals Using Noninvasive Ventilators at Home - NCT ID: NCT06343324 - Study ID: 2023/012 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2024-04-01 - Lead Sponsor: KTO Karatay University ### Study Description Home use of the NIV device, which is used to manage respiratory failure, one of the most disturbing symptoms due to COPD, will continue to increase. There is a need for studies evaluating the effectiveness of the use of WEB-based training programs in making patients and their families independent in the use of this device. This study will produce evidence for this effect and contribute to the awareness of healthcare professionals working in this field. The WEB-based training module to be developed aims to increase compliance with NIV in patients using NIV at home for a long time and to manage symptoms such as insomnia that may develop due to NIV. ### Conditions - Noninvasive Ventilation - COPD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Web-based education ### Outcomes Primary Outcomes - Patient Identifiable Characteristics Form Secondary Outcomes - S³-NIV Questionnaire ### Location - Facility: Health Sciences University Konya Beyhekim Training and Research Hospital, Konya, Selçuklu, 42060, Turkey @@
## T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) - NCT ID: NCT06343311 - Study ID: EBUS22CD19AR100 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2027-12-31 - Lead Sponsor: Estrella Biopharma, Inc. ### Study Description This is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase. ### Conditions - B-Cell Non-Hodgkin's Lymphoma (NHL) - Lymphoma, Non-Hodgkins - Lymphomas Non-Hodgkin's B-Cell - Non-Hodgkin Lymphoma - Non-Hodgkin's Lymphoma - Large B-Cell Lymphoma - Lymphoma, Non-Hodgkin's, Adult - Lymphoma - Refractory Non-Hodgkin Lymphoma - Relapsed Non-Hodgkin Lymphoma - Lymphoma, Non-Hodgkin - HIV Associated Lymphoma - CNS Lymphoma - High-grade B-cell Lymphoma - Refractory B-Cell Non-Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - EB103 ### Outcomes Primary Outcomes - To assess the Dose Limiting Toxicities of EB103. - Incidence rates of Treatment-Emergent Adverse Events of EB103. - Incidence rates Treatment-Emergent Laboratory Abnormalities reported for EB103. - To determine the Recommended Phase II Dose (RP2D) of EB103. Secondary Outcomes - To assess the Overall Response Rate of EB103 in our study subject population. - To assess the Disease Control Rate of EB103 in our study subject population. - To assess the Duration of Response of EB103 in our study subject population. - To assess the Progression-Free Survival rate of EB103 in our study subject population. - To assess the Event-Free Survival rate of EB103 in our study subject population. - To assess the Overall Survival rate of EB103 in our study subject population. - To characterize the pharmacokinetic (PK) profile of EB103 by measuring the peak exposure (Cmax). - To characterize the pharmacokinetic (PK) profile of EB103 by measuring the time to reach peak exposure (Tmax). - To characterize the pharmacokinetic (PK) profile of EB103 by measuring the partial area under the curve (pAUC). ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension - NCT ID: NCT06343298 - Study ID: ES_MANP_2001 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-08-01 - Lead Sponsor: E-Star BioTech, LLC ### Study Description This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action. ### Conditions - Difficult to Control Hypertension ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MANP - Placebo Matched control ### Outcomes Primary Outcomes - Change from baseline in mean daytime SBP derived from 24-hour ABPM at approximately Day 42. - Incidence and severity of Adverse events through 4- weeks post end of treatment. - Incidence and severity of Serious Adverse Events through 4- weeks post end of treatment. - Incidence and severity of Treatment Emergent Adverse Events through 4- weeks post end of treatment. Secondary Outcomes - Change in Clinic sitting systolic blood pressure - Pharmacokinetics - Cmax - Pharmacokinetics - Tmax - Anti-drug Antibody ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Upper Limb Tremor Reduction in Essential Tremor Patients - NCT ID: NCT06343285 - Study ID: 20231215 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-06 - Lead Sponsor: Encora, Inc. ### Study Description This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor. ### Conditions - Essential Tremor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - Encora Therapeutics Tremor Reduction Device ### Outcomes Primary Outcomes - Tolerability - Safety Secondary Outcomes - Bain & Findley Activity of Daily Living (BF-ADL) #2 - BF-ADL #4 - BF-ADL #17 - BF-ADL #21 - Patient Global Impression of Change (PGI-C) - Clinician Global Impression of Change (CGI-C) - Tremor power as measured by gyroscope ### Location - Facility: Encora Therapeutics, Cambridge, Massachusetts, 02139, United States @@
## Lymphocyte Enhancement in Gastroenteric Oncology - NCT ID: NCT06343272 - Study ID: LEGO - Status: RECRUITING - Start Date: 2022-03-22 - Completion Date: 2025-02-28 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description LEGO is single center double-blind randomized trial aimed at testing the efficacy of an essential ammino acid (EAA) supplementation in improving the absolute count of peripheral lymphocytes and the tolerance to chemotherapy in patients with advanced gastrointestinal malignancies not candidates to immune check-point inhibitors containing regimens. ### Conditions - Advanced Gastrointestinal Cancers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EAA supplementation - Isocaloric placebo ### Outcomes Primary Outcomes - Exit from lymphopenia Secondary Outcomes - The change in the % of lymphocytes over time - The proportion of patients with G3-G5 toxicity - The percentage of chemotherapy dose administered compared to that expected for the patients. - plasma aminoacids composition chang during treatment ### Location - Facility: IRCCS Policlinico San Matteo, Pavia, N/A, 27100, Italy @@

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