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| # | NCT Number | Study Title | Study URL | Brief Summary |
|---|---|---|---|---|
| 1 | NCT06626477 | Intra-Nasal Mechanical Stimulation (INMEST) As a Potential Treatment Method for Sjogren's Syndrome (SS) | https://clinicaltrials.gov/study/NCT06626477 | The purpose of the study is to investigate the effect and safety of the Walther System delivering INMEST (intranasal mechanical stimulation) on people with Sjogren\'s syndrome. A total of 30 subjects are planned to be enrolled and randomized to either use an active device or a sham device for the first 6 weeks. During the last 6 weeks all subjects will receive active treatment. The treatments are self-administered by the subject at home, three times a week and 10 minutes per nostril. Subjects will: * Use an active or sham device at home 3 times per week for six weeks. * All subjects will then get an active device for use another six weeks. * Visit the clinic every third week for measurements and checkups. * Keep a diary of the treatments and potential problems. |
| 2 | NCT06626386 | Determination of Prostate-specific Antigen in Capillary Blood (PSA-Cap) | https://clinicaltrials.gov/study/NCT06626386 | The aim of the PSA-Cap study is to test the comparability of measurements of total PSA in serum from venipuncture and in serum from capillary blood using anonymized diagnostic blood samples from patients. Furthermore, a stability test of the samples is carried out after storage at room temperature for 24, 72/96 and 168 hours. Particular attention is paid to the comparability of the measurement results and the influence of the transportation time. |
| 3 | NCT06626295 | Exercise-snacks for Breaking the Sedentary Lifestyle and Improving the Physical Fitness of Obese Adolescents? | https://clinicaltrials.gov/study/NCT06626295 | The management of a person with obesity involves long-term behavioral changes with a balanced diet in both quantity and quality, along with the adoption of a more active lifestyle: increasing physical activities and reducing sedentary behaviors. The school setting has been identified as a favorable environment for interventions aimed at reducing and interrupting the time adolescents spend sitting and preventing the associated negative health consequences. Recently, very short (\< 1 minute) and intense exercises, called 'exercise-snacks,' have been reported to be effective in adults for 1) improving physical fitness over 6 weeks, and 2) improving vascular function and lowering blood glucose levels over a single day. Additionally, in adolescents with diabetes, they have been shown to reduce body fat. This raises the question of whether adding \'exercise-snack\' sessions to a multidimensional care program for hospitalized obese adolescents could further improve their physical fitness in the short and medium term. The objective of this project is to compare the effects of a traditional multidimensional care program with the addition of 'exercise-snacks' to the same care program without \'exercise-snacks\' on the physical fitness, body composition, vascular function, and physical activity and sedentary behaviors of obese children in the short and medium term. Thirty-six obese adolescents will be included. The \'exercise-snack\' group will perform six exercise sessions per day for three weeks in addition to the standard care. The control group will receive only the standard care. Assessments of physical fitness, body composition, vascular health, and questionnaires on physical activity, sedentary behavior, and cognitive restraint will be conducted at the beginning and end of the three-week program, as well as 1 and 3 months after the end of the program. |
| 4 | NCT06626243 | Analysis of RATS, VATS and Open Lung Resections After Neoadjuvant Chemo-immunotherapy in Patients Performed in Five Referred Centers | https://clinicaltrials.gov/study/NCT06626243 | The study is a retrospective observational study. The study is designed to be multicentric and international and it will analyze medical records from selected patients diagnosed with locally advanced and resectable NSCLC who underwent lung resection by robotic, VATS and open approach after receiving neoadjuvant chemo-immunotherapy. There are no risks for the patients, as this is a retrospective data collection. |
| 5 | NCT06626204 | Exploration and Application of Intelligent Difficult Airway Assessment Scheme | https://clinicaltrials.gov/study/NCT06626204 | The study aims to explore the effectiveness of an intelligent difficult airway assessment protocol and its potential in clinical applications. The management of difficult airways is a critical task in anesthesiology, and poor management can lead to severe complications or even death. The American Society of Anesthesiologists defines a difficult airway as one that presents difficulties in mask ventilation or endotracheal intubation. Previous studies have shown that the incidence of difficult airways is not low in patients undergoing general anesthesia, emphasizing the need for optimization of airway management strategies. Preoperative airway assessment is an essential step in preventing complications associated with difficult airways. Currently, the modified Mallampati classification and the Cormack-Lehane grading are two commonly used assessment tools. However, these methods rely on the subjective judgment of clinicians and may have limitations in accuracy and consistency. With the development of artificial intelligence and telemedicine technologies, new assessment methods have become possible, offering more precise measurements and analysis of airway anatomy. This study proposes an intelligent airway assessment system that combines phonation modulation and tongue position adjustment, aiming to improve the accuracy and reliability of assessments. The system uses deep learning algorithms to analyze oral images of subjects to predict airway difficulty. The study will also explore the correlation of this system with traditional assessment methods and establish a predictive model for difficult airways. As a country with a large population, China has a significant demand for medical and health resources, especially in the fields of surgery and anesthesia. The diversity of China\'s population may affect airway structure, thereby influencing airway management strategies. Therefore, conducting such research in China has important clinical significance and social value. |
| 6 | NCT06626178 | Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases. | https://clinicaltrials.gov/study/NCT06626178 | The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues. |
| 7 | NCT06626165 | Association Between Effectiveness of Mirikizumab and Ulcerative Colitis Patients With High Neutrophilic Infiltration in Epithelium of the Colonic Mucosa | https://clinicaltrials.gov/study/NCT06626165 | The goal of this study is to confirm that Mirikizumab therapy may provide clinical, endoscopic, and histopathologic improvements in patients with moderate to severe UC refractory to maintenance therapy when high neutrophilic infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2) on endoscopic biopsy is found. |
| 8 | NCT06626152 | Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial | https://clinicaltrials.gov/study/NCT06626152 | Background Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression (LLD), a condition that usually decreases a person's quality of life and is associated with other risks like physical frailty and dementia. A common feature of more severe LLD is psychomotor slowing, where a person's ability to think and move are impaired. For example, they might not be able to walk or process information as quickly, and they might have problems with their working memory. Psychomotor slowing in LLD might be the result of a problem with the way a person's body produces or responds to the neurotransmitter dopamine. The drug Levodopa (L-DOPA), which can replace missing dopamine in the brain, has been used to treat to treat Parkinson's disease for many decades, and it might also affect psychomotor slowing in LLD. Methods In this study, participants are adults aged 60 years or older with moderate to severe major depression. Participants undergo the "L-DOPA challenge"-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week. Before and after a participant completes the L-DOPA challenge, the study team assesses their depressive symptoms and psychomotor function. After the L-DOPA challenge, if a participant still shows signs of moderate or severe depression, they receive an antidepressant for 12 weeks. Aims The first aim of this study is to test the feasibility of the L-DOPA challenge-that is, whether most of the 50 participants recruited for this study will complete the L-DOPA challenge. For example, participants might have to withdraw if they can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's side effects, or if their depressive symptoms get significantly worse. Our hypothesis is that 80% of the participants will complete the L-DOPA challenge. The second aim of the study is to see if L-DOPA affects participants' depressive symptoms, processing speed, and working memory. Our hypothesis is that L-DOPA response, measured as an improvement in gait speed, is associated with a decrease in depressive symptoms and an increase in processing speed and working memory. |
| 9 | NCT06626113 | Transduction of Sympathetic Neural Activity in Human Obesity Without Hypertension | https://clinicaltrials.gov/study/NCT06626113 | In addition to chronically elevated MSNA, there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to MSNA (1, 2, 13, 36-38). To study this phenomenon, we quantify vascular sensitivity to MSNA using an innovative, moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity (MSNA), (10, 11, 34, 37). This approach is termed 'sympathetic-vascular transduction (SVT).' We will examine the hypothesis that SVT is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress. Oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension, obesity, and insulin resistance. Oxidative stress can be safely reduced via intravenous infusion of ascorbic acid (Vit C) (4, 28). Therefore, we will use a randomized, double-blinded, placebo-controlled approach to test the hypothesis that elevated SVT will be attenuated by suppression of oxidative stress via ascorbic acid I.V. infusion compared with saline I.V. infusion (placebo) in obese adults with insulin resistance. Our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for CVD in obesity and insulin resistance. |
| 10 | NCT06626087 | A Prototype Artificial Intelligence Algorithm Versus Liver Imaging Reporting and Data System (LI-RADS) Criteria in Diagnosing Hepatocellular Carcinoma on Computed Tomography: a Randomized Trial | https://clinicaltrials.gov/study/NCT06626087 | This study aims to prospective validate this AI algorithm in comparison with the current standard of radiological reporting in a randomized manner in the at-risk population undergoing triphasic contrast CT. This research project is totally independent and separated from the actual clinical reporting of the CT scan by the duty radiologist. The primary study outcome is to compare the diagnostic performance of the prototype AI algorithm versus LI-RADS criteria in determining HCC on CT in the at-risk population. |
| 11 | NCT06625996 | Examining the Effectiveness of Carbohydrate Loading as a Nursing Intervention in Enhanced Recovery After Surgery | https://clinicaltrials.gov/study/NCT06625996 | The concept of Enhanced Recovery After Surgery (ERAS) protocols has revolutionized perioperative care by promoting a series of evidence-based practices aimed at reducing surgical stress and improving patient outcomes. Among these practices, preoperative carbohydrate loading has emerged as a significant intervention designed to mitigate the adverse metabolic effects of surgery |
| 12 | NCT06625892 | Related Factors and Outcome of Kinesiophobia and the Effects of Multidimensional Intervention in Cardiac Surgery Patients | https://clinicaltrials.gov/study/NCT06625892 | The primary objective of this two-year research project is to investigate the status of activity fear, its related factors, and prognosis in cardiac surgery patients in the first year. Subsequently, the study aims to develop a comprehensive intervention strategy combining exercise with cognitive-behavioral approaches tailored for cardiac surgery patients and assess the effectiveness of this intervention on activity fear, prognosis, and quality of life in the second year. The study uses a convenient sampling method, focusing on patients undergoing cardiac surgery in the cardiac surgery ward of the Central Medical Center. The first-year research adopts a descriptive, correlational, and repeated-measures design, while the second-year research employs an experimental design. Participants are randomly assigned to either the experimental or control group. The experimental group undergoes a 12-week multidimensional interventions, while the control group receives no intervention. Data are collected through structured questionnaires. Data collection occurs at discharge, two weeks post-discharge, six weeks, 12 weeks, and 24 weeks. |
| 13 | NCT06625749 | Evaluate the Safety and Effectiveness of the AccuraSee™ IOPCL for Secondary Implantation in the Capsular Bag to Improve Near and/or Intermediate Vision Following Previous Cataract Surgery | https://clinicaltrials.gov/study/NCT06625749 | This is a study to evaluate the safety and effectiveness of the AccuraSee™ intraocular pseudophakic capsular lens (IOPCL) to improve near and/or intermediate vision following previous cataract surgery. |
| 14 | NCT06625697 | Mindfulness Training and Respiration Biosignal Feedback - Study 1 | https://clinicaltrials.gov/study/NCT06625697 | The goal of this research is to develop a new breathing feature on the meditation app, Equa, to help young adults who are distressed, understand their physiological responses and mindfulness skill development during meditation. Our main aims are to build an algorithm that can use respiration signals (i.e., breathing) to: * Give feedback about how participant physiology is changing during guided lessons on the meditation app, Equa * Measure how much participant mindfulness skills are improving Participants will: * Complete a survey about demographics, their thoughts and feelings before and after the mindfulness meditation program * Complete 14 smartphone guided mindfulness meditation training units while physiological measures are being recorded * Complete a few brief questionnaires before and after mindfulness practices to understand potential changes in their mindfulness skills |
| 15 | NCT06625541 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy Volunteers | https://clinicaltrials.gov/study/NCT06625541 | The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers. |
| 16 | NCT06625424 | Effect of Short Sprint Interval Training With Active Recovery as Compared to Passive Recovery on Anaerobic Capacity in Non-athletic Population | https://clinicaltrials.gov/study/NCT06625424 | Short Sprint Interval Training (SSIT) is a modified form of Sprint Interval Training (SIT) defined as "small bouts of supramaximal exercise with recovery periods between them to increase peak oxygen uptake in spite of having a less amount of exercise volume". SSIT was developed so that non- athletic population could also perform a training which was originally designed for athletes to increase anaerobic capacity. The benefit of this type of exercise is that it is time efficient and yields the result in short amount of time as compared to other type of exercises due to its vigorous nature. Moreover this sort of training is mostly performed in lab setting rather than on field, therefore the aim of this study is to determine the effect of short sprint interval training in a field with active recovery as compared to passive recovery on anaerobic capacity in non-athletic population. |
| 17 | NCT06625411 | An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Active Thyroid Eye Disease (TED) | https://clinicaltrials.gov/study/NCT06625411 | This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with active Thyroid Eye Disease (TED). |
| 18 | NCT06625398 | An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED) | https://clinicaltrials.gov/study/NCT06625398 | This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic Thyroid Eye Disease (TED). |
| 19 | NCT06625346 | Clinical Response of EXTOR (Amlodipine/Valsartan) in Newly Diagnosed Hypertensive Patients. | https://clinicaltrials.gov/study/NCT06625346 | The American College of Cardiology/American Heart Association hypertension guidelines recommend treatment initiation with dual antihypertensive therapy in adults with stage 2 hypertension (corresponding to grade 1 and 2 in the ESH classification) and an average BP \>20/10 mm Hg above target. Amlodipine and valsartan are two of the most commonly prescribed medications for the treatment of hypertension (high blood pressure). In Pakistan multiple studies were conducted on Hypertension and use of Single Pill Combination in uncontrolled Hypertension. However, no study was conducted to assess the role of Single Pill Combination (SPC) like Amlodipine and Valsartan in newly diagnosed hypertension and to assess their quality of life by patients' satisfaction with their medication after managing the hypertension with the SPC. |
| 20 | NCT06625281 | Effects of Epleys Maneuver Versus Semont-Plus Maneuver Combined with Brandt-Daroff Exercises on Dizziness and Quality of Life in Benign Paroxysmal Positional Vertigo | https://clinicaltrials.gov/study/NCT06625281 | Vestibular hypofunction can result in symptoms consisting of dizziness, imbalance, and/or oscillopsia, gaze and gait instability, and impaired navigation and spatial orientation; thus, may negatively impact an individual\'s quality of life, and ability to perform activities of daily living. Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder which occurs with changing of the positions lying down, rolling over, climbing stairs, or looking up and down. The typical symptoms include dizziness, loss of balance, nystagmus, and nausea, limiting the daily activities of life and functional capacity. Much research has been done to rule out the prime treatment for posterior canal-BPPV using vestibular rehabilitation therapy (VRT), Canalith repositioning maneuvers (CRM), and habituation exercises, but scarce literature renders the combination of maneuvers and exercises. The current study will be used to determine and compare the effects of Epley\'s maneuver Versus the Semont-Plus maneuver combined with Brandt-Daroff exercises on Dizziness and Quality of life in participants with pc-Benign paroxysmal positional vertigo. The participants having clinically diagnosed Posterior canal Benign paroxysmal positional vertigo (BPPV) will be selected in this study. The outcome measure will be the Dizziness Handicap Inventory (DHI) to assess the Dizziness in participants and Vestibular activities and the participation measure (VAP) will assess the Quality of life. For such a randomized control trial a sample of 40 participants will be taken with 20 participants in each group will be included in the study. One group will undergo Epley's Maneuver and Brandt-daroff exercises and the second group will receive Semont-plus maneuver and Brandt-daroff exercises. Scores will be taken again after intervention. The study will be conducted over 1 year at Fauji Foundation Hospital and Foundation University Islamabad. Participants of interest would be approached and explained about the research. Informed written consent will be taken first. Recruited participants will be allocated to either of the groups through a convenient sampling method. All outcome measurements would be performed first at baseline and then after the 6 weeks intervention period.. |
| 21 | NCT06625268 | Rapid Point-of-care Bacteriuria and Microbial Susceptibility for Women With Suspected Uncomplicated Urinary Tract Infections: Diagnostic Accuracy in General Practice. | https://clinicaltrials.gov/study/NCT06625268 | In this study, adult women presenting at their general practitioner with a likely bladder infection (with symptoms like a burning sensation when urinating, pain in the lower abdomen, and frequent or urgent need to urinate) will be invited. After informed consent, women provide a urine sample, which is tested using a new system called the PA-100-AST (from the manufacturer Sysmex). This point-of-care test showed first evidence to be able to quickly detect the presence of bacteria commonly responsible for bladder infections. If bacteria are found, the test also checks which antibiotics may work best to treat the infection. Additionally, a sample of the urine is sent to a lab for a traditional culture test, which is considered the most accurate method. The goal of this study is to compare the accuracy of the PA-100-AST system to the lab-based test to see how well it works in general practice. |
| 22 | NCT06625255 | Promoting Family Resilience: Tier 1 Strength-based Parent Education Program to Promote Child and Family Resilience | https://clinicaltrials.gov/study/NCT06625255 | Health inequalities, social isolation, and family adversity impact a child's development. Play is the context for children\'s development in all areas. A parent\'s ability to support children at play while being playful contributes to their psychological adjustment. The proposed tier 1, strengths-based educational program for parents of children aged 2 to 5 years with and without disabilities combines elements of a play-based approach and tips on effective parenting to support children's development by equipping parents with knowledge and empowering them to become change agents in their children's lives. |
| 23 | NCT06625216 | Severe Asthma Network Italy | https://clinicaltrials.gov/study/NCT06625216 | The goal of this registry is collecting data of severe asthma patients, recruited by specialized centers, in a real life setting, homogeneously placed on a database management system to follow them over the time. The information recorded will provide: 1. The collection of homogeneous clinical, functional and biologic data of patients with severe asthma in a real life setting. 2. The evaluation of adherence to treatment in real life. 3. The clinical eligibility of patients treated with biologics. 4. The evaluation of patients' clinical response to each treatment. 5. The monitoring of tolerability and safety. 6. The long-term follow up of patients with severe asthma. |
| 24 | NCT06625203 | A Non-interventional, International, Multicentre Clinical Research Study to Build the Largest Collection of Multimodal Data (Including Clinical Data, Imaging Data and Omics Data) in Oncology | https://clinicaltrials.gov/study/NCT06625203 | Cancer is amongst the leading causes of disease-related morbidity and mortality. A major challenge in cancer treatment is the development of biology-informed, personalised treatment strategies. Recent advances in artificial intelligence (AI) and next-generation sequencing (NGS) technologies have shed further insights into disease biology and treatment pathways, thus identifying new, precision medicine-based therapeutic opportunities. The biological mechanisms leading to cancer development and progression arise from complex and plastic networks of dysregulated cellular programs involving many signalling pathways and effector molecules. Cancer cells alter their surrounding environment via cell-cell interactions with non-tumor cells or by secreting cytokines, chemokines and other factors. This reprogramming of the tumour microenvironment (TME) is critical for cancer progression, invasion, and metastasis. Moreover, there are increasing studies that show that both innate and adaptive immune cell types contribute to tumorigenesis and treatment resistance when present within the TME. Understanding the crosstalk between cancer cells and the surrounding TME will inform on mechanisms of sensitivity and resistance to treatment, including immunotherapy (IO) and targeted therapies. Spatially resolved-Omics is an emerging field that characterises cell types by gene/protein expressions within their spatial context in the tissue organisation. Recent high profile spatial transcriptomics studies have uncovered specific cell identities that define the surrounding TME. The MOSAIC study, a collaborative initiative across industry and top oncology hospitals, proposes to go way beyond current cancer molecular profiling projects by combining the generation and analysis of multiple data modalities (3 essential mandatory modalities: Clinical Data, Hematoxylin and Eosin (H\&E) microscopic image, Spatial transcriptomics; up to 3 high priority data modalities depending on technical feasibility and sample size: bulk Ribonucleic Acid Sequencing (RNAseq), bulk Whole Exome Sequencing (WES), Single-cell transcriptomics; and potentially other optional data modalities and follow-up experiments such as single-cell omics, immunohistochemistry and spatial proteomics or other molecular profiling of proteins and molecules) on a minimum of 2,000 tumour samples across a different cancer indications. This will generate broad molecular and cellular profiling data of the tumour and its microenvironment from cancer patients, integrated with clinical data, at an unprecedented scale and resolution. This study will enroll patients diagnosed with one of the eligible cancer indications and for which a formalin fixed paraffin embedded (FFPE) tumor sample from already performed biopsy and/or surgical resection is available within their local pathology archive or their affiliate centers archives. The MOSAIC study expects to have a strong impact for patients in terms of new targeted therapeutic drug discovery, identification of patient subgroups requiring either specific treatment or broader clinical care and identification of novel treatment response and resistance mechanisms. |
| 25 | NCT06625099 | Investigation of the Optimum PEEP Mechanical Power Relationship | https://clinicaltrials.gov/study/NCT06625099 | The aim of this study is to compare the effects of standard and optimum positive end expiratory pressures on mechanical power during laparoscopic surgeries. |
| 26 | NCT06624917 | Assessment of Oncological Safety, Quality of Life, and Environmental Impact of the Green Breast Surgery Protocol | https://clinicaltrials.gov/study/NCT06624917 | Breast Cancer (BC) is the primary oncological diagnosis in women, with the annual incidence expected to exceed 3 million new cases by 2040 due to population growth and aging. During the COVID-19 pandemic, novel methods were adopted worldwide to provide continuous patient care, including telehealth, fast-track protocols such as awake surgery in breast cancer. These innovative techniques allowed for improved access to care, and additionally reduced emissions with environmental impact, better resource utilization, and improved continuity of care, but their impact post-pandemic era has not been investigated. A current issue is the environmental impact of hospitals, particularly operating rooms, as it has been analysed that 25-30% of hospital waste comes from these areas. A Breast Green Surgery protocol (BuGS protocol) has been designed to reduce Breast Surgery Impact of care, evaluating for the synergistic effect of different procedure for the first time on classic Clincal Outcome, Patients' Reported Outcome Measure (PROM), and Environment Related Outcome Measure (EROM) in breast cancer surgery. Main hypothesis is that BuGs protocol will provide a significant reduction in carbon footprint of care (EROM) without impacting clinical outcome and PROMs. |
| 27 | NCT06624904 | Losartan and Social Processing | https://clinicaltrials.gov/study/NCT06624904 | This study explores the effects of single-dose losartan (50mg) versus placebo on social processing in healthy volunteers. |
| 28 | NCT06624826 | Visual Performance of an Extended Depth of Focus IOL in an Emmetropic or Monovision Modality | https://clinicaltrials.gov/study/NCT06624826 | Comparison of the visual performance of a refractive extended depth of focus intraocular lens in an emmetropic or monovision modality |
| 29 | NCT06624813 | Partial Prostatectomy for Prostate Cancer | https://clinicaltrials.gov/study/NCT06624813 | A phase 2 study investigation of safety and feasibility of partial prostatectomy for localized prostate cancer of intermediate risk at ICESP. It will be included 50 patients that have coincident findings of prostate cancer site on prostate biopsy and a suspicious area in the magnetic resonance imaging of the prostate (PIRADS 3, 4 or 5). |
| 30 | NCT06624735 | Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital | https://clinicaltrials.gov/study/NCT06624735 | Asthma is considered the most common chronic childhood disease and mainly affects children resident in urban areas. Asthma has been designated a serious public health problem due to the increase in its prevalence over the last two decades and the associated high health service costs in admissions and hospitalizations The cause of asthma is not yet completely understood, and there is no consensus about its etiology. A vast body of research emphasizes the role of genetic and environmental factors in the appearance of asthma, and a great deal of interest has recently emerged concerning the relationship between psychosocial factors and asthma morbidity Behavioural problems in children are generally described as "internalizing", which includes "anxiety, depressive, and somatic symptoms" or "externalizing", which includes "oppositional, hyperactive conduct". Both internalizing and externalizing problems can be experienced by healthy children with abnormal and "borderline" personality disorder, the latter referring to a mental illness marked by an ongoing pattern of varying moods, self-image, and behaviour |
| 31 | NCT06624618 | Rapid Molecular Diagnosis of Sepsis in the Intensive Care Unit | https://clinicaltrials.gov/study/NCT06624618 | Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture. |
| 32 | NCT06624527 | Cognitive Behavior Therapy for Children With Attention Deficit Hyperactivity Disorder | https://clinicaltrials.gov/study/NCT06624527 | The aim of this study was planned to determine the changes that cognitive behavior therapy-based psycho-education against the negativities brought by the disease in the long term of children diagnosed with Attention Deficit Hyperactivity Disorder will create changes in the child's quality of life, anxiety and depression status and disease symptoms. As a result of this study, if cognitive behavior-based psycho-education has a positive effect on anxiety, depression and quality of life of children with Attention Deficit Hyperactivity Disorder, it is thought to contribute positively to the development of the disease for the sick child and parents by organizing psycho-education programs with the training to be given to child health nurses. |
| 33 | NCT06624488 | The Relationship Between Brain Injury Biomarkers in Cerebrospinal Fluid and Blood of Patients After Cardiac Arrest and Prognosis. | https://clinicaltrials.gov/study/NCT06624488 | This study is a single-center, prospective, observational study. After successful cardiopulmonary resuscitation for patients with cardiac arrest, they will be transferred to the emergency intensive care unit for further standardized targeted temperature management. When evaluating that the patient meets the indications for lumbar puncture and there are no contraindications for lumbar puncture, lumbar puncture examinations will be completed immediately after return of spontaneous circulation (ROSC), at 24 hours of hypothermia, at 72 hours of hypothermia, and after rewarming. Routine cerebrospinal fluid examinations such as cerebrospinal fluid routine, cerebrospinal fluid biochemistry, and cerebrospinal fluid lactate will be sent for inspection. At the same time, 6 ml of cerebrospinal fluid will be retained and stored in a refrigerator at -80°C. After sample collection is completed, enzyme-linked immunosorbent assay (ELISA) will be used to detect markers such as NSE, HCH-L1, NFL, tau, MBP, GFAP, and S100β. While performing the lumbar puncture examination, peripheral blood will be collected. After centrifugation for 10 minutes (4000 revolutions), serum will be retained and stored in a refrigerator at -80°C to complete the examination of the above markers. After 3 months, the patient\'s neurological function prognosis will be followed up according to the Pittsburgh Cerebral Performance Category (CPC) scale. |
| 34 | NCT06624462 | Effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness - The Meta Care Clinic | https://clinicaltrials.gov/study/NCT06624462 | This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness |
| 35 | NCT06624397 | Evaluation of a New Program for Carers of People with Anorexia Nervosa | https://clinicaltrials.gov/study/NCT06624397 | CAREFREE is a 12-session Carer's Programme for carers of adults with moderate to severe Anorexia Nervosa. This programme was developed to provide carers with an opportunity to develop an understanding of Anorexia from a Biopsychosocial framework, taking into account the complex array of biological, psychological and social/environmental factors associated with the development and maintenance of this disorder. The CAREFREE programme is unique in its focus on providing a framework for understanding AN from a Schema -Compassion Focused framework, incorporating psychoeducation in regard to both Anorexia Nervosa and Carer Burnout. The programme has a relational focus, with an emphasis on improving emotional fluency, family communication skills and self-other compassion. The CAREFREE programme is open to carers from across Scotland and runs online. Outcomes (including carer and patient quality of life, family communication, patient motivation to change) will be analysed and published at the end of the 24-month period. One of the key benefits of this programme is that as it is a cross-regional-NHS project. |
| 36 | NCT06624371 | Atovaquone Combined with Radiation in Children with Malignant Brain Tumors | https://clinicaltrials.gov/study/NCT06624371 | The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma/diffuse midline glioma/diffuse intrinsic pontine glioma (pHGG/DMG/DIPG). The secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of RT and before progression. |
| 37 | NCT06624293 | Access BNP Clinical Enrollment Study | https://clinicaltrials.gov/study/NCT06624293 | The goal of this study is to collect blood from subjects with a suspicion of either new onset or worsened heart failure to be used for testing studies for a new product to aid in the diagnosis of heart failure. |
| 38 | NCT06624241 | Effectiveness of SRP+ Lipo-curcumin Gel for the Treatment of Stage III Periodontitis. | https://clinicaltrials.gov/study/NCT06624241 | The aim of the present study is to clinically and radiographically compare the effectivness of Scaling and Root Plannig (SRP) in association with lipo-curcumin gel (LC) respect SRP+ lipo-gel (L), SRP+ discharged (D) gel and SRP alone. This study will be designed as a randomized clinical trial of 12-month duration. A total of 40 patients will be recruited and randomly equally distributed into 4 groups: an experimental group treated with SRP + LC, a first control group treated with SRP + L, a second control group treated with SRP+D and a third control group SRP alone. Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following SRP, experimental and control sites will be randomly chosen. The test sites will be t filled with a Lipo-Curcumin gel and sealed with cyanoacrylate. In the first control group the defects will be be filled with a Lipo gel and sealed with cyanoacrylate. In the second control sites he pocket defect will be filled with a discharged gel and sealed with cyanoacrylate, in the third control group SRP alone will be performed. Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing. |
| 39 | NCT06624176 | ShotBlocker During Intramuscular Injection Randomized Control Trial | https://clinicaltrials.gov/study/NCT06624176 | The objective of this trial is to evaluate the effect of Bionix ShotBlocker on pain of injection of the first Hepatitis B vaccine in healthy newborns. ShotBlocker is a pain reducing tool used in babies, children, and adults for injections. Swaddling during the injection and administration of oral sucrose prior to the injection are established standards of care for painful procedures in neonates. The investigators hypothesize that the use of ShotBlocker in addition to swaddling and oral sucrose administration will lessen the pain response. |
| 40 | NCT06624163 | Evaluation of Patient Coach Support for Older Adults With Obesity | https://clinicaltrials.gov/study/NCT06624163 | The purpose of the present pilot is to evaluate the outcomes of adding a patient coach to support the Optimal Health Weight and Lifestyle (OHWL) Clinic plan developed by PI Dewar, specifically to address barriers and facilitators of adherence to the plan. This will be accomplished via a coach who is not embedded in clinic care and is supported by pilot research funds. Evaluation of the coach activities, conducted by research personnel, will include compiling data from the electronic health record, a short set of patient report and performance measures, and qualitative interviews. |
| 41 | NCT06624150 | tDCS and Cognitive Training for Restrictive Eating Disorders | https://clinicaltrials.gov/study/NCT06624150 | This study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit. |
| 42 | NCT06624098 | Early Transjugular Intrahepatic Portosystemic Shunt for Advanced Hepatocellular Carcinoma | https://clinicaltrials.gov/study/NCT06624098 | Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension. Studies have proven that early transjugular intrahepatic portosystemic shunt (TIPS) with 72 hours after acute variceal bleeding is effective. |
| 43 | NCT06623864 | Significant Activities in the Integrated Person-centered Care Model | https://clinicaltrials.gov/study/NCT06623864 | The increasing life expectancy and global aging population necessitate changes in long-term gerontological services based on Person-Centred Care approaches. This study aims to improve Person-Centred Care in geriatric centers through meaningful activities and the role of occupational therapists and direct care professionals in developing these activities. A descriptive cross-sectional quasi-experimental design was proposed, with 10 participants. |
| 44 | NCT06623851 | Digital Versus Conventional Impression on Discomfort and Dental Anxiety Among Preschoolers | https://clinicaltrials.gov/study/NCT06623851 | Background: Taking alginate impressions for preschoolers is challenging and might be disturbing for them. Therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression. Objectives: The present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning. Materials and methods: The study will be a randomized, controlled clinical trial, parallel design. A total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University. Participants will be allocated into 2 groups. Children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. Patients' discomfort will be evaluated by a modified VAS index supported with emojis. Dental anxiety will be evaluated using Facial Image Scale (FIS). Gag reflex will be assessed by Gag Severity Index (GSI). Child's behavior towards the impression technique in the 2 groups will be evaluated using Venham's Behavior rating scale. Time taken to complete the procedures will be recorded using a digital stopwatch. |
| 45 | NCT06623838 | An Evolutionarily Informed Conceptualization of Personality Pathology | https://clinicaltrials.gov/study/NCT06623838 | The purpose of this study is to explore the reliability of a new evolutionarily-informed model for conceptualizing personality pathology. In a preliminary phase prior to the present study we investigated reliability by comparing how therapist pairs conceptualized and assessed the same patient and how therapists and patients assessed the acceptability of the model. In this new study we want to confirm that the validity data initially collected are valid across cultures and nations. Therefore, psychology students (n=110) from 5 countries (China, Italy, Poland, Spain, United States) will participate in a specific training on the model and then apply the model on transcripts of the first two sessions and on assessment reports and two supervisors will evaluate the inter-rater reliability and acceptability in using the model on the same patients. |
| 46 | NCT06623799 | Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study | https://clinicaltrials.gov/study/NCT06623799 | This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes. |
| 47 | NCT06623747 | Low Energy Availability and Recovery from Resistance Exercise | https://clinicaltrials.gov/study/NCT06623747 | This research project will determine how restricting Calories to lose weight affects your ability to recover between weightlifting exercise sessions. |
| 48 | NCT06623565 | Extensive Resection of Malignant Brain Tumors Using Advanced Imaging Techniques | https://clinicaltrials.gov/study/NCT06623565 | Rationale: Patients with IDH-wildtype glioblastoma or grade IV IDH-mutant astrocytoma have a very poor prognosis despite standard treatment consisting of surgery, radiotherapy, and chemotherapy. Diffuse infiltration of the brain by the tumor is thought to be one of the main causes of this therapy-resistance. In order to improve the surgical treatment, tumor regions with lower infiltration percentages need to be identified and resected during surgery, a so-called supramarginal resection. Currently, pre-operative T1 contrast enhanced weighted (T1c) MRI is used to identify the tumor for resection. We recently found the combination of apparent diffusion coefficient MRI and O-(2-\[ 18F\]fluoroethyl-)-L-tyrosine positron emission tomography (ADC/FET) to be significantly more accurate than T1c MRI alone in the detection of tumor infiltration. This makes ADC/FET a suitable candidate to guide supramarginal resection. Since FET PET is not as accessible and widely available as MRI, identification of an MRI based alternative could result in a more widespread implementation. Amide proton transfer chemical exchange saturation transfer (APT-CEST) MRI is a novel potential alternative for FET PET, since both measures are related to protein content. Objective: In this project we aim to develop a safe and effective technique for ADC/FET guided resection of IDH-wildtype glioblastoma and grade IV IDH-mutant astrocytoma. The safety concerns neurological deficits and time to start of adjuvant therapy, while the effectiveness is aimed at the extent of resection. Our secondary aim is to evaluate the diagnostic accuracy of APT-CEST MRI and to assess whether APT-CEST MRI can serve as an alternative for FET PET for the detection of tumor infiltration. Study design: prospective observational intervention study Study population: 30 patients with clinical and radiological diagnosis of an untreated high grade glioma (suspected for glioblastoma (IDH wildtype) or grade IV astrocytoma (IDH mutant)), who are eligible for a supramarginal surgical resection and adjuvant treatment according two neurosurgeons in consensus and who are in relatively good condition (Karnofsky Performance Score (KPS) ≥70). Intervention (if applicable): supramarginal ADC/FET-guided resection. To make sure that the standard treatment is always guaranteed, T1c MRI abnormalities will be included in the surgical target. Main study parameters/endpoints: the main study endpoint is the optimization of ADC/FET-guided resection. Volumetric and percentual extent of resection, as measured with MRI and PET imaging, combined with surgery-induced morbidity will be used as outcome parameters. The secondary study parameters will be the histopathology-based diagnostic accuracy of APT-CEST MRI in comparison with FET PET, cognitive performance over time and progression free survival. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: participants will undergo pre- and postoperative MRI scanning. This is also part of regular clinical care, except there are additional MRI sequences including APT CEST in the pre-operative and pre-radiotherapy MRI. There are no risks associated with MRI acquisition after MRI safety screening. Participants will furthermore undergo a pre- and postoperative FET PET. The risks associated with PET scanning are limited, and the radiation burden will remain below 10 mSv (ICRP62 category intermediate risk (level IIb)). During surgery, biopsies are performed from areas that will be resected, so these biopsies will not introduce any extra risk. A potential benefit is the possibility of the removal of more tumor tissue. A potential risk is the additional removal of healthy brain tissue with the risk of neurological damage, which is controlled by pre- and intraoperative techniques such as visualization of white matter tracts and mapping (both asleep and awake) of critical functions such as language and control of strength. |
| 49 | NCT06623526 | Evaluate the PK Interactions of YHR2402 Monotherapy and YHR2402 and YHR2403 Co-Administration in Healthy Volunteers | https://clinicaltrials.gov/study/NCT06623526 | An open-label, randomized, single-dose, crossover study to evaluate the pharmacokinetic interactions and safety after co-administration of YHR2402 and YHR2403 compared to the administration of YHR2402 independently in healthy subjects |
| 50 | NCT06623500 | Iodine Nutrition Status and Clinical Characteristics of Thyroid Cancer | https://clinicaltrials.gov/study/NCT06623500 | The effect of iodine nutritional status on thyroid cancer has been controversial for many years. We designed a prospective cohort study that recruiting patients in different iodine areas who underwent thyroid cancer surgery in branch hospitals from 2012 to 2019，and follow up their clinical outcomes. We aimed to analyse the relationship between regional iodine nutrition level and pathological types, clinical features, and prognosis of thyroid cancer. |
| 51 | NCT06623487 | The Application Value of 68Ga-grazytracer PET in Immunotherapy for Stage III Non-small-cell Lung Cancer | https://clinicaltrials.gov/study/NCT06623487 | Neoadjuvant immunotherapy can significantly improve the pathological complete response (pCR) and major pathological response (MPR) rates in resectable stage III non-small cell lung cancer (NSCLC), and extend the event-free survival (EFS). However, the current means for evaluating its efficacy are limited. This study aims to utilize the convenient and non-invasive 68Ga-grazytracer PET imaging to detect the aggregation of CD8+ T cells in target lesions after neoadjuvant immunotherapy for stage III NSCLC, and to assess its value in efficacy monitoring, providing valuable information for clinical treatment decisions. |
| 52 | NCT06623474 | Correlation Study of Lipid Metabolites as Markers of Hepatocellular Carcinoma | https://clinicaltrials.gov/study/NCT06623474 | As one of the common malignant tumors in China, primary liver cancer, whose incidence rate and mortality rate are always in the top five, is seriously threatening the health of our people. Therefore, early diagnosis and treatment of primary liver cancer are of great significance. In recent years, the incidence of primary liver cancer, which is caused by hepatic steatosis or metabolic dysfunction-related liver disease, is increasing year by year, and it has become one of the fastest rising causes in some developed countries. More and more studies have also confirmed that the levels of different kinds of lipids and their metabolites are correlated with the development of hepatocellular carcinoma. In this study, we performed qualitative and quantitative analyses of various common lipid metabolites in plasma and liver cancer tissues of hepatic resection patients with hepatocellular carcinoma, collected tumor-related pathological data from the patients, and investigated the correlation between the lipid metabolites and the development of hepatocellular carcinoma, in order to provide a new idea for the early diagnosis and treatment of primary hepatocellular carcinoma, as well as for screening of hepatocellular carcinoma markers. |
| 53 | NCT06623396 | A Study of Mesothelin-Targeted CAR T-Cell Therapy in People With Esophagogastric Cancer | https://clinicaltrials.gov/study/NCT06623396 | Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory at Memorial Sloan Kettering to be changed (modified) to become MSLN-targeted CAR T cells, the CAR T-cell therapy that participants will receive during the study. Participant study therapy will take about 3-4 weeks. |
| 54 | NCT06623318 | IV Ensure in Patients Receiving OPAT | https://clinicaltrials.gov/study/NCT06623318 | The purpose of remote therapeutic monitoring is to provide oversight and evaluation of patients receiving IV medications in the home setting post-acute. The goal is to improve patient outcomes and decrease re-admission rates for related diagnoses due to poor adherence. Remote therapeutic monitoring provides data used in the determination of dates, times, and duration of doses administered in the home setting to support real-time intervention by dedicated care managers to support improved adherence with prescribed dosing regiments. The objectives of the study are to: 1. Determine adherence rates for IV medications administered in the home. 2. Assess re-admission against adherence rates. |
| 55 | NCT06623123 | Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies | https://clinicaltrials.gov/study/NCT06623123 | A study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service. Three separate questionnaires will be used to collect this data from patients at regular time intervals. |
| 56 | NCT06622954 | Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients | https://clinicaltrials.gov/study/NCT06622954 | The goal of this clinical trial is to compare a dietary intervention with a regular diet in patients with early breast cancer undergoing anthracycline based chemotherapy. The main question it aims to answer is: What are the effects of a short-term diet with 30% caloric and 70% protein restriction (PCR) on cardiotoxicity induced by anthracycline treatment in women with newly diagnosed invasive breast cancer. Researchers will compare the control group with dietary intervention group to see if cardiotoxicity -measured by concentrations of high-sensitivity troponin T (hsTnT) levels- will be different between these two groups. |
| 57 | NCT06622915 | Cardiac Performance Evaluation in Children With Steroid Dependent vs Steroid Resistant Nephrotic Syndrome | https://clinicaltrials.gov/study/NCT06622915 | nephrotic syndrome (NS) is one of the most common pediatric kidney diseases There is an increased incidence of heart disease in patients with primary nephrotic syndrome (PNS) compared to the normal population Conventional Echocardiography is usually utilized to diagnose myocardial dysfunction. Tissue Doppler imaging is a non-invasive cardiac imaging technique which measures the velocity of the longitudinal motion of the mitral annulus, tricuspid annulus and the basal part of interventricular septum |
| 58 | NCT06622798 | Exploratory Study on the Correlation Between HRD Score and PARPi Efficacy Based on Chinese Ovarian Cancer Patients | https://clinicaltrials.gov/study/NCT06622798 | This study plans to retrospectively include 470 initial surgical specimens from 470 patients with epithelial ovarian, fallopian tube or primary peritoneal cancers who were treated with PARPi maintenance therapy in the hospital from 2018.01 to 2024.01. All patients included would be scored by the proprietary HRD ADx-GSS® algorithm with the detecting results of the three genomic statuses including heterozygous omission (LOH), telomere allelic imbalance (TAI), and large-segment translocation (LST). Finally, the correlation between the HRD scores and the prognosis of Chinese ovarian cancer patients and the efficacy of using PARPi as maintenance treatment would be explored. |
| 59 | NCT06622759 | The Use of a Porcine Collagen Matrix for the Prevention of Buccal Bone Wall During Implant Placement in the Aesthetic Zone. | https://clinicaltrials.gov/study/NCT06622759 | Aim: To provide a comparative assessment of the clinical and radiographic effect of porcine collagen matrix when placed buccally at the time of single implant placement in the aesthetic zone vs autogenous connective tissue graft in terms of buccal bone resorption and soft tissue augmentation 6 months post operative. Histological assessment and patient reported outcomes were reported |
| 60 | NCT06622733 | Attitude Towards the Concept of CS on Demand | https://clinicaltrials.gov/study/NCT06622733 | Caesarean section (CS) is a surgical procedure performed to facilitate delivery of the baby through an incision made on the mother's abdomen. Ideally, it is recommended in situations where normal vaginal delivery (VD) can pose risks to either the mother baby or both . In the western world women have only one or two children, while in the East or the Middle East, women are culturally coerced into having many children. Thus, they are more prone to multiple Cesarean deliveries in their lifetime \[1.2\]. ThisAccording to the World Health Organization (WHO), since 1985, the acceptable percentage of worldwide C-sections has been 10-15% of all deliveries \[3\]. One of the most critical findings of the American Center for Disease Control and Prevention found that the Cesarean delivery rate has increased from 20.7% in 1995 to 31.6% in 2016 \[4 \]. It is important to mention that Cesarean deliveries are life-saving procedures when there are obstetrical indications.(5.6) Cesarean delivery indications include fetal malpresentation, multiple pregnancies, chorioamnionitis, arrested labour, oligohydramnios, cord prolapse, cephalo-pelvic disorders, and medical diseases such as eclampsia and HELPP (hemolysis, elevated liver enzymes, and low platelets) syndrome .the number of patients undergoing Cesarean delivery for non-obstetric reasons has rapidly increased. This could be due to many factors influencing the patients' decisions, including possible fetal outcomes concerning beliefs in some cultures and the convenience of patients and obstetricians(7) .cesarean section on demand allows a woman to choose a cesarean section without a medical reason, based solely on her personal preference Five themes that reflected the reasons for elective cesarian birth without medical indication were identified: (1) fear of vaginal birth process, (2) concerns about future sexual life, (3) need for humanized birth, (4) personal reasons, and (5) decision-making process.(8) raising the awareness of providers about the appropriate indications for CS and the importance of advocating for vaginal delivery among eligible women - including those with a previous CScan trigger practice changes that may reduce the incidence of non-medically indicated caesarean delivery |
| 61 | NCT06622681 | Integrative Adolescence Research Programme (IARP) | https://clinicaltrials.gov/study/NCT06622681 | This study aims to understand child health during adolescence. We will examine the role of lifestyle (e.g. physical activity), growth trajectories and other environmental factors that can influence the development of phenotypes in adolescence which confer risk for later physical and mental disorders. With this study, we will develop a deeper understanding of adolescent health and well-being and their main determinants in the local Singaporean context, identify levers for early interventions to mitigate challenges to adolescent health and well-being and enhance protective factors for adolescents to do well in life, contribute to society and maximize their potential. |
| 62 | NCT06622629 | Nature Based Therapy With Mindful Walks in Urban Coastal Settings for Metabolic Syndrome - Barcelona (Spain) | https://clinicaltrials.gov/study/NCT06622629 | The main objective of the NATURE-MET-B (Barcelona) study is to analyze the effects of a Nature-based Therapy (NbT) on the biopsychological resilience of a group of sedentary patients with metabolic syndrome (MetS) and little contact with nature, through changes in: i) health-related quality of life and ii) allostatic load. The secondary objective is to provide data on the environmental, social, and economic aspects of the intervention in order to refine specific prevention programs and establish programs that include NbTas a secondary preventive measure in healthcare for MetS. Analogous to NATURE-MET-B, two similar NbT studies will be carried out in Padua (Italy) and Salzburg (Austria) for the secondary prevention of MetS. These are not multicenter studies but three comparable studies with the same inclusion and exclusion criteria for MetS patients in all study locations. Only the types of landscape and natural exposure sites differ: Barcelona-Coastal Urban, Padua-Urban Green, Salzburg-Mountainous Rural. |
| 63 | NCT06622538 | Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients: ORION Trial | https://clinicaltrials.gov/study/NCT06622538 | This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia. |
| 64 | NCT06622525 | Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with Heatstroke | https://clinicaltrials.gov/study/NCT06622525 | This study protocol aims to prevent the need for renal replacement therapy in patients with rhabdomyolysis secondary to heatstroke. It is based on previous studies showing that bicarbonate infusion reduces renal failure in similar contexts. The intervention will be conducted at the General Hospital of Mexicali during the summer, targeting the prevention of renal failure and reducing the necessity for renal replacement therapy. |
| 65 | NCT06622512 | Two Standardized Radial Pressure Wave Techniques Versus Pain-Site Guided Therapy in Patients With Knee Osteoarthritis. | https://clinicaltrials.gov/study/NCT06622512 | The goal of this clinical trial is to evaluate and compare the effectiveness of radial pressure wave therapy (RPWT) applied at different anatomical sites in patients with knee osteoarthritis (OA) over a follow-up of four months. The main questions it aims to answer are: How effective is the application of RPWT on the medial and lateral interarticular lines in patients with knee OA? Are standardized RPWT application techniques on interarticular lines superior to the traditional application technique on the points of greatest pain in patients with knee OA? Researchers will compare the effectiveness of two standardized application techniques on interarticular lines to decrease pain and improve function in patients with knee OA. Participants will receive three sessions of RPWT on the most painful knee as a result of knee OA. |
| 66 | NCT06622486 | First-in-human Trial of EGL-001 in Patients with Selected Advanced And/or Metastatic Solid Tumors | https://clinicaltrials.gov/study/NCT06622486 | This multicenter, open-label, first-in-human, Phase 1/2 study consists of a Part 1 (Phase 1) open-label dose escalation of EGL-001 administered as a single agent and in combination with an anti-PD(L)-1 treatment, followed by a Part 2 (Phase 2) open-label dose expansion of EGL-001 administered at the RP2D in patients with recurrent and/or metastatic solid tumors as monotherapy and/or combination therapy with anti-PD(L)-1. |
| 67 | NCT06622395 | Telepsychiatry in Children: Diagnostic Evaluation of Autism Spectrum Disorder | https://clinicaltrials.gov/study/NCT06622395 | Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder recognized as a major national cause in 2012. The French Autism Plan 2018-2022 emphasizes early diagnosis and intervention for better cognitive and behavioral outcomes. The COVID-19 pandemic complicates the use of the ADOS-2 diagnostic tool due to mask-wearing and distancing requirements. To address this, the Brief Observation Symptoms of Autism (BOSA) has been adapted for remote assessment. The BOSA, translated into French, is recommended alongside the Autism Diagnostic Interview -Revised (ADI-R) for complementary diagnostic algorithms. No similar projects have been undertaken in France or Canada. |
| 68 | NCT06622382 | BEAM for Weight Loss - a Pilot Study | https://clinicaltrials.gov/study/NCT06622382 | Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies. |
| 69 | NCT06622369 | The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision | https://clinicaltrials.gov/study/NCT06622369 | The aim of this study is to investigate the effect of virtual reality and cartoons and games on the anxiety, fear and post-procedural pain levels of children aged 7-12 years who will undergo circumcision. The population of the study will consist of children aged 7-12 years who are planned to undergo circumcision in the pediatric urology clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between September 2024 and September 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians and themselves agree to participate in the study. Descriptive Characteristics Form, Vital Symptom Form, Child Fear Scale, Child Anxiety Scale-Disposition (CAS-D) and Child Fear Scale will be used to collect the data. |
| 70 | NCT06622161 | Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support | https://clinicaltrials.gov/study/NCT06622161 | Babies admitted in the NICU (neonatal intensive care unit) frequently need supplemental oxygen to keep their oxygen saturation (SpO2) in target range (TR). Hypoxia and hyperoxia episodes should be avoided while working toward this goal. Preterm babies are particularly vulnerable to abnormal oxygen levels, and adverse effects of hyperoxia and oxygen toxicity may result in retinopathy of prematurity and bronchopulmonary dysplasia. Similarly, mortality may rise due to hypoxic events. In routine practice, the SpO2 target is usually achieved by manual adjustment of FiO2 (fraction of inspired oxygen), but it usually does not accomplish the desired SpO2 target, leading to episodes of hyperoxia and hypoxia and increased risk of complications. A study was conducted in multiple centers involving extremely preterm babies, the results of which depicted that the babies on manual control of FiO2 spent only 48% of their time with SpO2 in the target range, 16% below the target range, and 36% above it. The compliance of the SpO2 target range was also variable in these centers. There is a need to improve compliance by using automated oxygen control systems. At the Aga Khan University Hospital (AKUH) investigators have included SLE 6000 (SLE, Croydon, UK) ventilators in their NICU (neonatal intensive care unit) which have automated oxygen control device "Oxygenie" that continuously adjusts FiO2 (fraction of inspired oxygen) of the patient to keep SpO2 in the target range, avoiding abnormal oxygen levels. This also reduces the workload on staff and improves patient care. Investigators usually put preterm babies on these ventilators so that SpO2 can be kept most of the time in the target range. When the OxyGenie and SpO2 monitoring are added to the SLE 6000 ventilator, it becomes possible to accurately regulate and deliver closed loop oxygen to preterm infants. This automated oxygen control system limits episodes of both hypoxia and hyperoxia by using the VDL 1.1 algorithm that uses an adaptive Proportional-Integral-Derivative (PID) algorithm to control the FiO2 adjustments in response to changes in SpO2. This keeps SpO2 within a target range (TR) which user selects. A randomized crossover trial comparing two devices for automated oxygen control in preterm infants included the SLE 6000 ventilator as one of its devices. |
| 71 | NCT06622044 | Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia | https://clinicaltrials.gov/study/NCT06622044 | This is a single-center, randomized controlled clinical trial to compare the effectiveness of vision therapy and prism wearing for the treatment of small-angle acute acquired concomitant esotropia. |
| 72 | NCT06622031 | TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT | https://clinicaltrials.gov/study/NCT06622031 | Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT. |
| 73 | NCT06621823 | Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies | https://clinicaltrials.gov/study/NCT06621823 | The assessment of lymph node status is of crucial importance in gynaecological malignancies. Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Systematic extensive lymphadenectomies are often performed for staging, diagnosis of skip metastases and to define the radiation field when radiotherapy treatments are required. Nevertheless, these can lead to significant short-term and long-term lymphatic complications, which are difficult to justify if the lymph nodes are free from metastasis. To avoid unnecessary comprehensive procedures in early-stage cancers, evaluation of the sentinel lymph node has acquired a valuable role even if limitations are still present (rate of frozen section false negative, "empty packets" and mapping failure). The introduction of an intra-operative non-invasive imaging technique capable of describing the presence and characteristics of lymph nodes could help in (1) eliminating the risk of empty packet, (2) orienting the intraoperative decision while avoiding the drawbacks of frozen section (time and resources, partial destruction of the tissue material), (3) orientate the pathological section if frozen section is used. To date, technological advancements have paved the way for enhanced intra-operative assessment of cancerous organs and lesions. Over the past decade, the evolution of robotic surgery combined with advancements in image-guided surgery techniques has led to the introduction of ultrasound probes designed specifically for intraoperative ultrasound during robotic surgery (RIOUS). Apart from the conventional rigid laparoscopic probes, which can be inserted through an accessory trocar, there are robotic probes tailored to fit device arms, and drop-in flexible probes that are becoming increasingly relevant in the scientific panorama. Notably, the latter drop-in probes feature a rigid segment designed for compatibility with robotic graspers, leveraging the dexterity and rotational manoeuvrability inherent to robotic surgery. Such probes, already proven effective in evaluating liver and kidney lesions as well as tumour margins, hold promise for intraoperative lymph node assessments due to the possibility of reaching difficult anatomical spaces thanks to the robotic-assisted movements |
| 74 | NCT06621810 | Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults | https://clinicaltrials.gov/study/NCT06621810 | The goal of this study is to develop supportive diagnostic artificial intelligence algorithms to distinguish melanoma from nevi or other benign pigmented skin lesions, especially in younger patients (below the age of 30). The main goals it aims to achieve are: * development of an algorithm based on dermatoscopic images, targeting skin cancer screening in vulnerable populations * development of another algorithm based on histological images, intended to be used by pathologists on lesions that are still suspicious of melanoma after dermatologic assessment * implementation of explainability methods to enable the user to better comprehend the systems' decisions, avoid biases and increase trust in these applications There is no additional time commitment for the study participants for this study, as the data used in this project will be collected in routine clinical practice anyway. |
| 75 | NCT06621706 | Ultrasound Assessment of Gastric Volume in Diabetic Versus Non-Diabetic Term Pregnant Women Undergoing Cesarean Section | https://clinicaltrials.gov/study/NCT06621706 | The aim of the work to compare estimated gastric volumes through ultrasound in fasting diabetic and non-diabetic pregnant women scheduled for caesarean section. |
| 76 | NCT06621576 | Safety and Tolerability of Epicardial Circular RNA-HM2002 Injection in CABG for Ischemic Heart Failure | https://clinicaltrials.gov/study/NCT06621576 | This exploratory, single-center, open-label clinical trial assesses the safety, tolerability, and potential efficacy of a single 5 mg dose of HM2002 injection administered via multiple-point epicardial injections for treating ischemic heart failure. Three patients aged 18-80 undergoing elective coronary artery bypass grafting (CABG) surgery will participate. Using a sentinel dosing approach, the first subject will receive HM2002, followed by a 14-day safety observation before dosing the remaining participants. If any serious adverse events or dose-limiting toxicities occur in the first subject, a Safety Review Committee will evaluate the safety data to determine whether to continue or terminate the trial. |
| 77 | NCT06621550 | Effect of High-Intensity Interval Training Exercise on Cognitive Function of Young Adults | https://clinicaltrials.gov/study/NCT06621550 | To explore the sustainability of the acute effect of High Intensity Interval Training (HIIT) on executive function in young adults. |
| 78 | NCT06621459 | Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29) | https://clinicaltrials.gov/study/NCT06621459 | Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence. However, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2). CDK4/6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer. Given the results in advanced lines, CDK4/6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant. The MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone. It is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%. Real-world data are needed to better understand the management and toxicity of this treatment. |
| 79 | NCT06621381 | Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder | https://clinicaltrials.gov/study/NCT06621381 | The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. It is a non-randomised open label evaluation where children 6-12 years with OCD who are patients at the Child and Adolescent Psychiatry (CAP) at Uppsala University Hospital will be rectruited together with their legal guardians. The treatment will be delivered by trained therapists in regular outpatient care. The main question the study aims to answer is: What are the preliminary treatment effects of concentrated exposure and response prevention with regards to OCD-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement? Participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format). Outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up. |
| 80 | NCT06621368 | Effect of Two Years of Resistance Training on Health Status in Postmenopausal Women: Longitudinal Study Active Aging. | https://clinicaltrials.gov/study/NCT06621368 | Aging is a natural process of the life cycle that can result in morphological, neuromuscular, metabolic, physiological, cognitive and behavioral changes that can compromise quality of life, autonomy, self-esteem, health and life expectancy, especially in the elderly. On the other hand, resistance training (RT) has been widely recommended for the elderly population, due to the numerous health benefits it brings, such as increased strength and muscle mass, reduced body fat, increased bone mineral content and density, and improved cardiometabolic profile, among others. However, the effectiveness of RT in attenuating or reversing the deleterious effects of aging has been analyzed by studies conducted, in most cases, over relatively short periods, i.e., eight to 24 weeks. Considering that recent investigations have demonstrated a wide variation in the adaptive responses to RT in this population, it is likely that many of these responses are time-dependent. Additionally, the influence of important mediators and moderators in this process, especially training intensity and volume, dietary habits, the presence or absence of diseases and degenerative processes that cause disability, and the use of polypharmaceuticals, has not yet been well established. Therefore, based on the Active Aging Longitudinal Study, a research project initiated in 2012, it is intend to analyze whether or not RT practice can produce positive and lasting adaptive responses on muscle strength, body composition, functional fitness, cognition, cardiometabolic biomarkers, and cardiac function in postmenopausal women, based on a randomized controlled clinical trial over a long period of time (two years). In addition, mediation and moderation analyses will be used to understand the real impact of RT on the outcomes to be analyzed. |
| 81 | NCT06621277 | JUMP_START - Optimization of Care for Young Cancer Patients with Gastrointestinal Tumors | https://clinicaltrials.gov/study/NCT06621277 | JUMP_START aims to assess the needs of individuals aged ≤ 50 years with gastrointestinal (GI) tumors and implement a tailored support and counseling program at the University Hospital Heidelberg and the National Center for Tumor Diseases (NCT). In phase 1A, 12-15 individuals aged ≤ 50 years with GI tumors will be interviewed via telephone using semi-structured interviews to obstain a detailed understanding of the life situation, the burdens, and the care situation within the structures of the NCT Heidelberg. In phase 1B, the care networks of young patients with GI tumors beyond the NCT, including the analysis of changes and important access routes/possible gatekeepers, will be explored using so-called ego-centered network analyses, In comparison with patients who received a GI tumor diagnosis after the age of 50. In response to the results of phase 1A and 1B, the care services for young patients with GI tumors will be optimized, and tailored counseling programs will be developed in phase 2. These project phases will be accompanied by Quality of Life assessments using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires. |
| 82 | NCT06621212 | Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML | https://clinicaltrials.gov/study/NCT06621212 | The purpose of this prospective, single-center, single-arm, exploratory study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 20 R/R AML patients who are expected to receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment. |
| 83 | NCT06621199 | Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML | https://clinicaltrials.gov/study/NCT06621199 | This is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS). |
| 84 | NCT06621056 | A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype | https://clinicaltrials.gov/study/NCT06621056 | Acute asthma exacerbations are an important public health problem and a major cause of disease progression and healthcare burden for people with asthma. Frequent acute exacerbations are likely to be a distinct asthma phenotype. Further research is needed to identify risk factors for frequent acute exacerbations, but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes. Moreover, most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma, whereas a certain proportion of non-severe asthmatics may also experience frequent acute exacerbations, the risk factors of which remain to be further evaluated. The main objectives of this project are to compare the baseline clinical, inflammatory, pathophysiological, comorbidities, environmental pollutants and meteorological exposure characteristics of patients with frequent acute exacerbations and those with non-frequent acute exacerbations irrespective of asthma severity, and to develop a disease prediction model for frequent acute exacerbations; and to develop a cohort of patients with frequent acute exacerbations of asthma, observe their prognosis and response to treatment, and search for prognostic factors associated with them. The successful implementation of this study will help in the early identification of patients with frequent acute exacerbations, clarify the factors associated with poor prognosis in this group of patients, and thus provide an individualized plan for the treatment and prevention of this type of patients, which is of great significance in achieving good asthma control, reducing the burden of disease, decreasing the cost of healthcare, and saving clinical healthcare resources and costs. |
| 85 | NCT06620952 | Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study | https://clinicaltrials.gov/study/NCT06620952 | Posterior fossa surgery represents on of the most demanding procedure in neurosurgery. Retrosygmoid (RS), key-hole retrosygmoid (KR) and cerebellar hemispheric (CH) are the most common approaches used to access in this area. Despite they are not technically difficult to perform, these approaches can be burdened by postoperative cerebrospinal fluid (CSF) leakage, both at short and long-term follow-up, with an high risk of meningitis. Many techniques were employed to avoid this risk, but it can still be estimated between 2% and 11% according to literature1-4. Spena et al. reported a CSF leakage rate of 6.8% in a previous experience5. As a consequence, newer efforts are necessaries to avoid this potentially lethal complication. By this explorative study, we want to retrospectively analyzed our experience with a newer technique of bone closure, called O'Ring, in patients subdued to posterior fossa surgery by RS, KR and CH approaches, focusing on postoperative CSF leakage (primary objective), wound complications and subcutaneous CSF collections (secondary objectives). |
| 86 | NCT06620770 | Impact of the Therapeutic Education Program "Living With a Chronic Inflammatory Disease Under Biotherapy" on Patient Compliance and Quality of Life | https://clinicaltrials.gov/study/NCT06620770 | Patient therapeutic education programs have been shown to be effective in many specialties, allowing "Improving biological and psychological parameters, allowing patients to improve their health knowledge, therapeutic adherence and sense of personal effectiveness." Several studies have shown that patient knowledge, adherence and satisfaction are better after attending a therapeutic education program. This multidisciplinary program is presented and offered to all patients with chronic disease treated by subcutaneous biotherapy, followed by dermatologists, rheumatologists and gastroenterologists of the Lorient hospital. The study aims to demonstrate the benefit of the Patient Therapeutic Education program at GHBS Lorient "living with a chronic inflammatory disease under biotherapy" on treatment adherence, as well as the positive impact on quality of life. |
| 87 | NCT06620705 | Left Bundle Branch Area Pacing or Biventricular Pacing in AF and Left Ventricular Dysfunction | https://clinicaltrials.gov/study/NCT06620705 | It is unknown whether left bundle branch area pacing (LBBAP) or biventricular pacing best prevents or reverses left ventricular (LV) adverse remodelling in patients with atrial fibrillation (AF) who require ventricular pacing or CRT. This randomized non-inferiority cross-over trial will compare left ventricular end-systolic volume change and secondary endpoints between LBBAP and biventricular pacing in patients with AF and LV dysfunction. |
| 88 | NCT06620679 | Mapping the Effect of (neuro)inflammation on Stress Sensitivity in the Brain of Healthy Men | https://clinicaltrials.gov/study/NCT06620679 | The goal of this interventional study is to determine the effects of inflammation on stress responses in the brain of healthy men. In order to achieve this goal, participants are injected with an inflammation-inducing agent, then observed inside a brain scanner. |
| 89 | NCT06620627 | Prospective Collection of Samples to Enable the Development of Natera Screening Assay for Early Cancer Detection | https://clinicaltrials.gov/study/NCT06620627 | The PROCEED-CRC study will prospectively collect blood samples from participants who are at average risk of colorectal cancer (CRC). Samples will be used for research use and the development of a blood-based CRC screening test. |
| 90 | NCT06620601 | Digital Technology for Sleep and Homelessness | https://clinicaltrials.gov/study/NCT06620601 | In Canada, 35,000 people are experiencing homelessness on any night. Compared to the general population, people experiencing homelessness (PEH) sleep less and experience increased daytime fatigue. A common sleep disorder and treatable cause of morbidity and low quality of life is sleep apnea. High prevalence of chronic comorbid disorders of sleep apnea in PEH suggest high prevalence of sleep apnea, but the rate of sleep apnea treatment in PEH is very low. Also, in PEH, individual and systemic barriers lead to a high rate of underdiagnosed and untreated sleep apnea. Mortality is higher in PEH than the general population, and sleep apnea remains a potential silent cause of morbidity and low quality of life in PEH. Our goal is to diagnose and treat sleep apnea in people living in shelters and to examine the effect of patient-centered treatment on their quality of life. |
| 91 | NCT06620588 | PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional | https://clinicaltrials.gov/study/NCT06620588 | Study plan to conduct a pilot interventional study to evaluate the impact of a prehabilitation program on physical function and clinical outcomes. The prehabilitation program will include preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training for patients with MIP\<100 cmH2O. Currently, Singapore General Hospital offers the "Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE)" program, targeting frail patients undergoing major surgery. The primary outcome of the study is the change in physical function, measured by handgrip strength (HGS), from baseline to 3 days before surgery. Secondary outcomes include changes in the 6-minute walk test (6MWT), maximal inspiratory pressure (MIP), and sit-to-stand (STS) parameters from baseline to 3 days before surgery and 4-5 weeks postoperatively. Additionally, study will also assess postoperative complications (using the Comprehensive Complication Index), postoperative morbidity (using the Postoperative Morbidity Survey), length of hospital stay (LOS), and Health-Related Quality of Life (HRQoL) outcomes. |
| 92 | NCT06620549 | Feasibility of Nurse-performed Gastric Ultrasound After Surgery | https://clinicaltrials.gov/study/NCT06620549 | Gastric ultrasound is a quick and non-invasive tool to evaluate gastric content. Emptying of gastric content can be affected after abdominal surgery leading to the inability of tolerating oral foods. Gastric content can be assessed by gastric ultrasound and nurses were recently trained to do so in healthy volunteers; however, feasibility of nurse-performed gastric ultrasound after major abdominal surgery is not investigated yet. This study aims to investigate the feasibility of nurse-performed gastric point-of-care ultrasound after major gastro-intestinal surgery. |
| 93 | NCT06620523 | Prevent Cardiac Surgery Associated AKI Trial | https://clinicaltrials.gov/study/NCT06620523 | Prevent CSA-AKI (Cardiac Surgery Associated Acute Kidney Injury) trial is a double blinded randomized controlled trial, 242 patients undergoing elective cardiopulmonary bypass surgery (CPB)will either receive a placebo or daily 1200 mg of Co enzyme Q10 (CoQ10) and 1000 mg of Glutathione (GSH), the first dose will be given the day before surgery and continues while admitted up to 1 week. Blood and urine samples will be collected. Adverse events related to the study drugs will be collected. |
| 94 | NCT06620471 | This is a Prospective Observational Study Assessing the Variation of Impedance Across the Different Tissues to Locate and Block Nerves When Preforming an Axillary Peripheral Nerve Block. the Results Would Enhance Precision of Needle Placement and Increase the Success Rate of the Block. | https://clinicaltrials.gov/study/NCT06620471 | Impedance can have an impact on nerve block during loco-regional anesthesia, particularly when using techniques such as nerve stimulation or ultrasound guidance to locate and block specific nerves. Impedance refers to the resistance to electrical current flow within tissue, and it can affect the ability to stimulate nerves or visualize them using ultrasound. The aim of this research is to assess the impedance across different tissue type during an axillary peripheral nerve block (skin, fat, fascia, muscle, nerve). The results of this study would help clinicians performing nerve block to enhance the precision of needle placement, thus increase the success rate of nerve block and reduce adverse events such as intraneural or intravascular injections. |
| 95 | NCT06620419 | Clinical Study of External Electrical Stimulation for Male Incontinence | https://clinicaltrials.gov/study/NCT06620419 | The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy. |
| 96 | NCT06620055 | Development of an Artificial Intelligence Model for Optimising Therapy in Gliomas Gliomas | https://clinicaltrials.gov/study/NCT06620055 | Artificial intelligence (AI) undoubtedly represents the main tool currently available in the definition of complex algorithms and its use in the medical field is becoming increasingly strategic.As reported in the literature, it is increasingly difficult to find new therapeutic strategies for neoplasms, especially neurological ones. Molecular characterisation is therefore increasingly essential, as is the use of new predictive methods. With this in mind, the aim of this study is to assess, by means of AI algorithms applied to genomic data, in what percentage molecular alterations are susceptible to potential drug therapies, compared to the literature data that does not consider AI algorithms for this purpose. |
| 97 | NCT06620016 | Circulating microRNAs in Small Testicular Masses and Retroperitoneal Post-chemotherapy Residual Masses. | https://clinicaltrials.gov/study/NCT06620016 | The purpose of this study is to evaluate the diagnostic performance of circulating microRNAs in detecting the presence of germ cell cancer in patients with small testicular mass or retroperitoneal post-chemotherapy residual mass and suitable for testis sparing surgery and retroperitoneal lymph node dissection, respectively. |
| 98 | NCT06619808 | Hyperbaric Oxygen Therapy for Metabolic Dysfunction-associated Steatotic Liver Diseases | https://clinicaltrials.gov/study/NCT06619808 | The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) works to treat Metabolic Dysfunction-associated Steatotic Liver Diseases (MASLD). The main questions it aims to answer are: Does HBOT decreases the fat content and fibrosis state of liver in adult MASLD patients? Does HBOT improves the liver function and metabolic condition in adult MASLD patients? Participants will: Receive HBOT for 20 times in 1 month or recerive regular drug; Visit the clinic for checkups and tests at the starting, ending of the therapy and 6 month after the therapy. |
| 99 | NCT06619730 | Brain Function Monitoring During Surgery | https://clinicaltrials.gov/study/NCT06619730 | The purpose of this research is to gather information on the effectiveness of the Sedline Brain Function Monitor, and its use in this study to determine whether monitoring the brain activity during anesthesia will improve recovery, including earlier discharge and less side effects. Furthermore, the study team wants to determine whether males and females respond to anesthetics in a similar manner with and without brain monitoring. |
| 100 | NCT06619626 | Alveolar Recruitment in Obese Patients in Major Gynaecological Cancer Surgery | https://clinicaltrials.gov/study/NCT06619626 | In this study, the investigators planned to evaluate the effect of alveolar recruitment strategy primarily on postoperative pulmonary complications in obese patients undergoing lung protective ventilation in major open gynaecooncological surgeries. Our other aim was to evaluate perioperative haemodynamics, respiratory mechanics, hospital \&amp; inpatient length of stay. |