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## Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit? - NCT ID: NCT06341959 - Study ID: GerodentPLUS1 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-12-30 - Lead Sponsor: University Ghent ### Study Description There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older). ### Conditions - Oral Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Oral screening ### Outcomes Primary Outcomes - Contacted a dentist Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt - NCT ID: NCT06341946 - Study ID: Soh-Med-24-02-05MD - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2025-11 - Lead Sponsor: Sohag University ### Study Description The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV). ### Conditions - Hydrocephalus - Shunt Malfunction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Endoscopic third ventriculostomy ### Outcomes Primary Outcomes - Glasgow Coma Scale (GCS) - visual analogue scale( VAS ) - visual acuity Secondary Outcomes - radiological CT brain and or MRI brain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Risk Factors for AKI in Patients Undergoing VATS for Pulmonary Resection - NCT ID: NCT06341933 - Study ID: 2024-BÇEK/41 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital ### Study Description This study aims to investigate the potential factors contributing to the development of Acute Kidney Injury (AKI) in patients undergoing pulmonary resection with Video Assisted Thoracoscopic Surgery (VATS) for lung malignancy. The study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics.The research will be conducted at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital. The study will involve patients who have given informed consent and will undergo VATS with standard anaesthesia monitoring. Anaesthesia management will follow our routine protocol in our clinic.Patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-GFH) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. The patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed.The preoperative routine blood values, demographic data (age, gender, height, weight, and BMI), ASA physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. Intraoperative urine output and haemodynamic parameters will also be monitored. Routine blood gas analysis, blood urea nitrogen (BUN), glomerular filtration rate (GFR), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-GFH. Patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications. ### Conditions - Acute Kidney Injury - Surgery - Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Duration of Surgery - Volume of Fluid in Surgery - Blood Loss ### Outcomes Primary Outcomes - Glomerular Filtration Rate - Serum Creatinine - Amount of Urine Secondary Outcomes ### Location - Facility: Ankara Atatürk Sanatorium Training and Research Hospital, Ankara, Keçiören, 06290, Turkey @@
## BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery - NCT ID: NCT06341920 - Study ID: RS198 - 332551 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-01 - Lead Sponsor: University of Hull ### Study Description To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery. ### Conditions - Orthopedic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Experimental: BoneFit intervention - Placebo Comparator: Control ### Outcomes Primary Outcomes - Recruitment - Adherence and attendance - Acceptability Secondary Outcomes - Physical fitness - Length of stay - Readmission rates - Overall quality of life - Knee or hip specific pain, function and quality of life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC - NCT ID: NCT06341907 - Study ID: SAHoWMU-CR2024-07-107 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University ### Study Description The goal of this clinical trial is as follows:(1) Establish a clinical technical system for ctDNA dynamic monitoring of MRD in postoperative EOC patients, providing a new technical means for postoperative recurrence prevention and monitoring of EOC patients.(2) Establish a clinical technical system for adjuvant treatment of postoperative recurrence prevention for EOC patients with conventional protocols combined with personalized vaccines, so as to provide a new treatment method for postoperative recurrence prevention for EOC patients, with a view to obtaining a better survival prognosis.(3) To establish and improve the prediction process of Neoantigen for ovarian cancer and the in vitro evaluation system of the effectiveness of neoantigen vaccine, achieve independent innovation of tumor neoantigen vaccine treatment technology, and cultivate a group of technical forces to master the development of modern tumor vaccine drugs.(4) The new technology system has been promoted and applied in 5 hospitals in the province. ### Conditions - Epithelial Ovarian Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Neoantigen polypeptide vaccine ### Outcomes Primary Outcomes - ORR - PFS - OS - CA 125 Secondary Outcomes - Safety Index ### Location - Facility: Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China @@
## Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer - NCT ID: NCT06341894 - Study ID: OBU-II-BC-126 - Status: RECRUITING - Start Date: 2023-11-17 - Completion Date: 2029-06 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer. ### Conditions - Early Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dalpiciclib - Endocrine therapy ### Outcomes Primary Outcomes - invasive Disease-free Survival (iDFS) Secondary Outcomes - Disease-free Survival (DFS) - AEs and SAEs ### Location - Facility: The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, N/A, China @@
## Understanding the Need and Feasibility of Transitional Care Training Program Among Family Caregivers of Geriatric Stroke Survivors in Pakistan - NCT ID: NCT06341881 - Study ID: KMU/DIR/CTU/2024/006 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2025-01 - Lead Sponsor: Khyber Medical University Peshawar ### Study Description The main intention of the study is to understand the need and feasibility of transitional care training program among family caregivers of geriatric stroke survivors in Pakistan ### Conditions - Stroke - Stroke, Ischemic - Stroke Hemorrhagic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Transitional Care Training Program ### Outcomes Primary Outcomes - Physical care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire - Psychological care measured via Training Evaluation Assessment Checklist (TEAC) Questionnaire - Social Care measured via Training Evaluation Assessment Checklist (TEAC) - Training Need Assessment - Training Program Development Secondary Outcomes ### Location - Facility: Khyber Medical University, Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan @@
## Dynamic Muscular Electrical Stimulation Following Anterior Cruciate Ligament Reconstruction in Military Academy Cadets - NCT ID: NCT06341868 - Study ID: KACH.2023.0067 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-09-01 - Lead Sponsor: Keller Army Community Hospital ### Study Description The goal of this clinical trial is to examine the effects of 12 weeks of post-operative use of a novel wearable electrical stimulation knee sleeve device (KneeStim) on post-operative biomechanical function (gait). Participants will be United States Military Academy cadets aged 17-27 years. The main questions it aims to answer are:* Examine the effects of KneeStim wear on cadets' post-operative gait* Examine changes in site-specific skeletal muscle mass* Examine the changes in patient-reported outcomes* Assess time to return to full duty* Compare Bioelectrical Impedance Analysis (BIA) measurements to Magnetic Resonance Imaging (MRI) measurements (total thigh volume)* Determine the concurrent criterion validity of the KneeStim device compared to gold- standard metrics (3D Motion Capture)Participants will undergo body composition analysis, MRI, strength testing, standard of care rehabilitation, gait analysis, and complete surveys. Participants will wear the KneeStim during their standard of care rehabilitation visits for the first 5 weeks post-operative, and throughout daily tasks from 6-12 weeks.Researchers will compare a control group (standard of care + KneeStim controlled low intensity) to an experimental group (standard of care + KneeStim flexible intensity) to assess the aims previously mentioned.. ### Conditions - Anterior Cruciate Ligament Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - KneeStim ### Outcomes Primary Outcomes - Change in gait post-operatively assessed by the KneeStimTM Device Secondary Outcomes - change in gait post-operatively assessed by 3D Motion capture - change in gait post-operatively assessed by force plate instrumented treadmill - change in muscle volume assessed by MRI - ACL graft healing assessed by MRI - Change in isometric muscle strength assessed by CSMi HUMAC NORM - Change in skeletal muscle mass assessed by bioelectrical impedance analysis (SECA BIA) - Change in lean body mass assessed by bioelectrical impedance analysis (SECA BIA) - Change in fat mass assessed by bioelectrical impedance analysis (SECA BIA) - Change in knee pain and function assessed by the Knee Injury and Osteoarthritis Score (KOOS) - Change in knee pain and function assessed by the International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) - Change in knee pain assessed by the Patient-Reported Outcome Measure Information System (PROMIS-29) - Change in knee function assessed with the Single Assessment Numeric Evaluation Method (SANE) - Change in knee function assessed by the Marx Activity Rating Scale (MARS) - Impact of ACL surgery on overall quality of life assessed by the Anterior Cruciate Ligament-Quality of Life (ACL-QOL) - Change of running gait function from the patients' perspective assessed by the University of Wisconsin Running Injury and Recovery Index (UWRI) - Change of knee pain from the patients' perspective assessed by the Visual Analog Scale (VAS) - Time to return to full duty ### Location - Facility: Keller Army Community Hospital, West Point, New York, 10996, United States @@
## Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer - NCT ID: NCT06341855 - Study ID: 23K294001 - Status: RECRUITING - Start Date: 2024-01-25 - Completion Date: 2026-01-30 - Lead Sponsor: The First Hospital of Jilin University ### Study Description Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma. ### Conditions - Endometrial Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - MRD-ctDNA ### Outcomes Primary Outcomes - monitoring recurrence and evaluating prognosis - Treatment benefit Secondary Outcomes ### Location - Facility: the 1st hospital of Jilin University, Chang Chun, Jilin, N/A, China @@
## Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity - NCT ID: NCT06341842 - Study ID: EudraCT 2022-003377-28 - Status: RECRUITING - Start Date: 2023-10-19 - Completion Date: 2025-04-19 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dapagliflozin 10mg Tab ### Outcomes Primary Outcomes - Assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up. Secondary Outcomes - Difference in severe, moderate and mild asymptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ and with or without the use of any of ACEi, angiotensin receptor blockers, or b-blockers - Difference in symptomatic CTRCD between the two groups during 18 months according to the background therapy with AC with or without TZ (subgroup analysis) - Change from baseline in end diastolic and systolic left ventricular volumes and in left atrial volume during 18 months - Change from baseline of at least of one grade of diastolic disfunction (according to ESC guidelines during 18 months. - Change in plasma levels of the bio-humoral marker NT-pro-BNP between baseline and follow-up - Change in plasma levels of the bio-humoral marker hsTNI between baseline and follow-up - Change in plasma levels of the bio-humoral marker CKD-EPI eGFR between baseline and follow-up - Change in plasma levels of the bio-humoral marker hsCRP between baseline and follow-up ### Location - Facility: Fondazione IRCCS Policlinico San Matteo, Pavia, N/A, 27100, Italy @@
## Visuospatial and Affective Abilities in Parkinson Disease - NCT ID: NCT06341829 - Study ID: PRISM1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-17 - Completion Date: 2026-02-28 - Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo" ### Study Description The aim of the study is to investigate whether prismatic adaptation (AP), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). ### Conditions - Parkinson Disease - Alexithymia - Visuospatial/Perceptual Abilities ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Prismatic adaptation ### Outcomes Primary Outcomes - Improve visuospatial skills; - Modulate alexithymia; - Investigation of brain activity; Secondary Outcomes - Improve the quality of life with PDQ-39 questionnaire ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Treatment According to Venous Excess Ultrasound Score in Patients With Heart Failure - NCT ID: NCT06341816 - Study ID: VEXUS2 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-12-01 - Lead Sponsor: Inonu University ### Study Description Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy (1). Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality. With the increase in the severity of the disease and rapid advances in the treatment of heart failure, these patients are frequently hospitalized and monitored in intensive care. (2) Five years after diagnosis, mortality can be up to 67%. Additionally, it is known that patients with heart failure are hospitalized on average once a year after diagnosis. (3) In a multicenter study, it constituted 14% of 3000 cardiac patients admitted to intensive care units. Additionally, due to longer ICU stays, these patients accounted for 33% of total inpatient days. An increasing number of heart failure patients require intensive care due to respiratory failure, regardless of left ventricular ejection fraction. Heart failure accounts for approximately one-third of patient days in intensive care units, and this burden is increasing. This shows that attention should be paid to the quality of care for patients requiring critical care. (2) Multidisciplinary programs have been implemented to deal with the high prevalence. However, the optimal follow-up frequency is unknown. Therefore, some tools are needed to improve patient prognosis (3).Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker whose values in both urine and plasma have been associated with acute kidney injury (AKI). Although NGAL is an early specific biomarker for AKI, it has not yet come into routine use, but is frequently used in clinical and experimental studies (4).Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. ### Conditions - Heart Failure - Acute Kidney Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VEXUS score - NGAL ### Outcomes Primary Outcomes - acute kidney injury - mortality Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalized Transcranial Magnetic Stimulation Treatment for Depression - NCT ID: NCT06341803 - Study ID: DSRB 2023/00397 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Institute of Mental Health, Singapore ### Study Description This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression.Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot.All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations.Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach).Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days.All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up.The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Individually Neuronavigated accelerated intermittent theta burst stimulation with Magpro X100 ### Outcomes Primary Outcomes - Montgomery-Åsberg Depression Rating Scale (MADRS) Secondary Outcomes - Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-16) - Montreal Cognitive Assessment (MoCA), - EuroQol- 5 Dimension (EQ-5D) - Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) ### Location - Facility: Institute of Mental Health, Singapore, N/A, N/A, Singapore @@
## Effect of Consumption of Millet Diet in Patients With NAFLD - NCT ID: NCT06341790 - Study ID: NAFLD-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2026-07-05 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description With NAFLD fast rising its ranks in becoming a major non communicable disease in India and across the globe, this study aims at primary prevention of the condition. NAFLD is a spectrum of diseases characterised by the deposition of fat within hepatocytes and is a precursor of liver inflammation. Global estimates peg the prevalence to be around 30 to 40%, but there are not many studies which have documented the prevalence in India. With the epidemiological transition, the cases of NAFLD are also on a rise as metabolic syndrome is an important risk factor.It is apparent that the westernized way of our lifestyle especially the junk food culture comprising of super portions of loads of calories, sugars and salts is the main driver of this nutritional pandemic. The traditional diets in India were rich in fruits and vegetables, low in simple carbohydrates and high in fibre. Cereals are the main source of calories in any diet, forming the base of the food pyramid. Managing our cereals from being refined to the more complex ones being rich in fibre, protein and good quality fat could be a major player in the whole game of dietary modifications not just therapeutically but also prophylactically. Hence our therapeutic focus should be in increasing the consumption of cereals that are not only high in fibre, low in carbohydrates but also that have the potential to modulate the intestinal bacterial ecology to a more favourable type thus helping in intensifying the effects of overall dietary modifications.Gut microbiota is currently explored for its role in NAFLD and there are gaps in knowledge which preclude having therapeutic strategies through its modulation. Millets, which were once considered to be poor man's diet are now becoming a part of the plate more frequently, especially for its unique nutritive content, with increased fiber, low carbohydrates, high protein and good quality fats. The processing methods may alter glycemic responses. Thus, the present study is proposed to look into the effect of millet based diets in reduction of hepatic steatosis and the resultant alterations in the gut microbiota . ### Conditions - NAFLD ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - jowar based products ### Outcomes Primary Outcomes - Assessment of hepatic steatosis in NAFLD patients Secondary Outcomes - Assessment of blood sugar - Assessment of lipid function - Assessment of liver transaminases - Assessment of body composition - Assessment of Gut Microbiota ### Location - Facility: ILBS, New Delhi, N/A, 110070, India @@
## Multisensory Telerehabilitation for Visual Field Defects - NCT ID: NCT06341777 - Study ID: 25M621 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements. ### Conditions - Visual Field Defect Following Cerebrovascular Accident - Hemianopia - Brain Injuries ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Audio-visual training (AVT) telerehabilitation ### Outcomes Primary Outcomes - Change from baseline in Accuracy on the EF Task - Change from baseline in Response Times (RTs) on the EF Task - Change from baseline in Accuracy on the Triangle Task - Change from baseline in RTs on the Triangle Task - Change from baseline in RTs on the Numbers Task - Change from baseline in omissions on the Bell Test (only children) - Change from baseline in RTs on the Bell Test (only children) - Change from baseline in Accuracy on the Small Faces Test (only children) - Change from baseline in RTs on the Small Faces Test (only children) Secondary Outcomes - Change from baseline in Daily Living Dependent on Vision Questionnaire (total score) - Change from baseline in the Reading test (reading time) - Change from baseline in the Hamilton Anxiety Scale (total score; only adults) - Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults) - Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children) - Change from baseline in the Children Depression Inventory (CDI; total score; only children) - Change from baseline in the visual field size (only adults) - Change from baseline in the amplitude of Visual Evoked Potentials (VEPs) - Change from baseline in the latency of Visual Evoked Potentials (VEPs) - Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus - Change from baseline in the connectivity of the Superior Longitudinal Fasciculus - Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus - Change from baseline in the connectivity of the Optic Radiations - Change from baseline in the connectivity of the Optic Tracts ### Location - Facility: Istituto Auxologico Italiano IRCCS, Milan, Lombardia, 20122, Italy @@
## Neo-adjuvant Chemo and Immunotherapy in The Pre-operAtive Treatment of Locally Advanced cholangIOcarciNoma - NCT ID: NCT06341764 - Study ID: CITATION - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2025-09 - Lead Sponsor: National Cancer Institute, Naples ### Study Description Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery. ### Conditions - Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Durvalumab 1120 mg - Durvalumab 1500 mg - Tremelimumab i.v. at 300 mg - Cisplatin (CDDP) 25 mg/mq i.v - Gemcitabine (GEM) 1000 mg/mq i.v. ### Outcomes Primary Outcomes - Recurrence rate of CCA Secondary Outcomes - Rate of R0 resections - Radiologic responses - Pathologic responses - Toxicity assessed - PFS - OS ### Location - Facility: Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale, Napoli, Italia, 80131, Italy @@
## Psychological Treatment for Persistent Fatigue - NCT ID: NCT06341751 - Study ID: 2024-00393-01 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2025-04 - Lead Sponsor: Karolinska Institutet ### Study Description This is a non-randomized pilot study to investigate the feasibility and acceptability of a transdiagnostic psychological intervention for primary care patients in Region Stockholm, Sweden, who suffer from persistent and disabling fatigue. ### Conditions - Fatigue - Fatigue Syndrome, Chronic - Exhaustion; Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Psychological treatment for persistent fatigue ### Outcomes Primary Outcomes - Treatment adherence and completion - Treatment credibility - Patient satisfaction - Working alliance - Negative effects of treatment - Open-ended questions regarding treatment content and presentation Secondary Outcomes - Feasibility of study inclusion procedures and data-collection - Fatigue severity, primary self-rated symptom outcome - Problems concentrating - Reduced physical activity - Reduced motivation - Depressive symptoms - Somatic symptoms - General anxiety - Insomnia - Perceived Stress - Burnout - Self-rated health - Cognitive and behavioral responses to symptoms - General self-efficacy - Functional disability - Work and Social Adjustment ### Location - Facility: Gustavsberg University Primary Care Clinic, Stockholm, N/A, 134 40, Sweden @@
## The Efficacy of Digital Educational Interventions on Parental HPV Knowledge and Attitude, and Their Children's Vaccination Rates - NCT ID: NCT06341738 - Study ID: 421/215/404.102.28/VI/2023 - Status: COMPLETED - Start Date: 2023-07-05 - Completion Date: 2024-02-29 - Lead Sponsor: Kaohsiung Medical University ### Study Description The goal of this clinical trial is to examine in the parental HPV knowledge and attitude, and their children's completion rates in Indonesia. The main question\[s\] it aims to answer are:* Is the digital educational intervention in improving parent's HPV knowledge in the intervention group compared to the control group?* Is the digital educational intervention in improving parent's attitude toward HPV vaccine in the intervention group compared to the control group?* Is the digital educational intervention more effective in increasing children's HPV vaccine completion rates in the intervention group compared to the control group?Participants in intervention group will:* watch a 8 minutes video in front of class at once.* after video education intervention, in 2 weeks, participants received 2 reminder messages before first and second vaccination event, respectively.Participants in control group will:• Receive usual announcement regarding vaccine by staff ### Conditions - Health Services Research ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Video education about HPV and HPV vaccine - Electronic reminder messages - Usual Information Service ### Outcomes Primary Outcomes - Human Papillomavirus Knowledge Scale (HPV-KS) - Attitude towards HPV vaccine scale by Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) - Vaccine completion rate Secondary Outcomes ### Location - Facility: Elementary school, Ngawi, East Java, 63271, Indonesia @@
## EUS Role in Non-metastatic Pancreatic Adenocarcinoma Lymph Nodes Staging - NCT ID: NCT06341725 - Study ID: LinfoK EUS 2016 - Status: TERMINATED - Start Date: 2018-02-15 - Completion Date: 2018-09-11 - Lead Sponsor: Paolo Giorgio Arcidiacono, MD ### Study Description Aim of the study will be to investigate if Endoscopic Ultrasound (EUS) with elastography can be purposed between the routine staging examinations in patients with pancreatic adenocarcinoma without distant metastasis for the staging of lymph nodes status ("N" in TNM classification)* in RESECTABLE pancreatic cancer the investigators will evaluate the concordance with EUS elastography and histological findings of lymph nodes obtained during surgery, in order to assess the sensibility, specificity and the positive and negative predictive value of EUS with elastography, the disease-free survival, the percentage of metastatic patients and the overall survival (in patients with or without metastatic lymph nodes).* in "BORDERLINE resectable" and UNRESECTABLE non-metastatic ("advanced" locally") disease, the investigators will evaluate if the malignant lymph nodes samples during EUS with elastography and fine needle aspiration (FNA) will be related to a decreased survival.Secondary aim will be to register the prognosis (in terms of survival) of the patients with para-aortic and mediastinal pathological lymph nodes (related to a decreases survival in some series in literature) ### Conditions - Pancreatic Adenocarcinoma - Lymph Node Metastasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - malignant lymph nodes ### Outcomes Primary Outcomes - CONCORDANCE (PERCENTAGE) of pathological lymph nodes at EUS with elastography and surgical pathology report - OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence - OVERALL SURVIVAL (MONTHS) in metastatic lymph node presence Secondary Outcomes - OVERALL SURVIVAL (MONTHS) ### Location - Facility: IRCCS San Raffaele Hospital, Milan, N/A, N/A, Italy @@
## Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma - NCT ID: NCT06341712 - Study ID: CLIN-60000-461 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-13 - Completion Date: 2028-06-15 - Lead Sponsor: Ipsen ### Study Description The participants of this study will be children, adolescents, and young adults with residual osteosarcoma, which cannot be removed completely through surgery.Participants will have achieved a partial response or stable disease at the end of conventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells make immature bone cells, known as osteoid.Osteosarcoma is very rare, but it is the most common type of bone cancer in children and teens. It is most common in teens and young adults.In this study, participants will receive either cabozantinib and best supportive care or the best supportive care alone. Best supportive care will be provided at the investigator's discretion and according to institutional guidelines.It includes antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including radiotherapy), etc. but does not include tumor specific therapy.Cabozantinib will be taken by mouth (orally), as a tablet, once a day. Cabozantinib will be provided to participants who tolerate it for as long as their disease does not progress. Participants in the study receiving best supportive care alone may switch to treatment with cabozantinib and best supportive care if their disease progresses and if other eligibility criteria are met.Participants may withdraw consent to participate at any time.The estimated duration of the study for participants is 24 months, however a participant could remain in the study longer if demonstrating treatment benefit. ### Conditions - Osteosarcoma - Osteosarcoma in Children - Osteosarcoma in Adolescents and Young Adults ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cabozantinib - Best Supportive Care (BSC) - Best Supportive Care (BSC) ### Outcomes Primary Outcomes - Progression-free Survival (PFS) assessed by Blinded Independent Radiology Committee (BIRC) Secondary Outcomes - Progression-free survival (PFS) rate assessed by BIRC - Objective response rate (ORR) assessed by BIRC - Disease control rate (DCR) assessed by BIRC - PFS assessed by investigator - PFS rate assessed by investigator - ORR assessed by investigator - DCR assessed by investigator - Overall survival (OS) - 1-year overall survival rate - Percentage of participants with Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs). - Area Under Curve (AUC) at steady state. - Average concentration (Cavg) at steady state - Minimum concentration (Cmin) at steady state - Maximal concentration (Cmax) at steady state - Acceptability and palatability in children and adolescents assessed using a horizontal visual assessment scale. - Change from baseline in score for all Paediatric QoL Inventory (PedsQL) Scales including Generic Core Scales and Cancer Modules. - Change from baseline in European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (EORTC QLQ-C30) for adult participants ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of the Steroid Hormone Milieu in Obese Patients - NCT ID: NCT06341699 - Study ID: 05C308 - Status: RECRUITING - Start Date: 2023-05-16 - Completion Date: 2024-12-31 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis. ### Conditions - Obesity, Morbid ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Association of androgen milieu with the severity of obesity - Association of cortisol milieu with the severity of obesity - Algorithm fo CV risk in obesity Secondary Outcomes - Prevalence of hypogonadism in morbid obesity - Prevalence of patients with morbid obesity unresponsive to overnight suppression test - Enrichment in rare HH variants in obese patients with central hypogonadism - Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing ### Location - Facility: Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo, Oggebbio, Verbania, 28824, Italy @@
## Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection - NCT ID: NCT06341686 - Study ID: 75471023.2.0000.0082 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-05 - Completion Date: 2025-05 - Lead Sponsor: Hospital do Rim e Hipertensão ### Study Description The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. In contrast, preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses. It is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations. ### Conditions - CMV Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Letermovir 480 MG - Ganciclovir ### Outcomes Primary Outcomes - Incidence of CMV syndrome or disease Secondary Outcomes - Incidence of patients with plasma CMV DNAemia > 200 IU - Incidence of patients with CMV infection/syndrome/disease ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of TTNS on Bladder Symptoms Among People With MS, A RCT - NCT ID: NCT06341673 - Study ID: IRB-2023-O3-442 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2024-06-30 - Lead Sponsor: Hawra Al-Dandan ### Study Description Background: Neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis (MS). Recent studies showed that bladder storage symptoms are predominant among MS with a pooled prevalence of frequency at 73.45% followed by urgency at 63.87%. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment to manage bladder storage symptoms; however, the effectiveness of TTNS is based on a small number of studies with the absence of high-quality evidence. This study aims to investigate the effectiveness of TTNS on bladder storage symptoms compared with sham TTNS among people with MS.Methods: The investigators will use a randomised sham controlled double blind study to explore the effectiveness of TTNS in the treatment of bladder storage symptoms in MS. the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to standardize the conduct and reporting of the current protocol. The recruitment plan is twofold: 1) Open recruitment for people with MS through King Fahd Hospital of the University communication channels; 2) people with any type of MS attending their routine appointments in MS clinic at King Fahd Hospital of the University, Al Khobar. The investigators will investigate the effectiveness of TTNS compared to sham TTNS on bladder storage symptoms and the effect on quality of life using ICIQ-OAB, ICIQ 3-day bladder diary, ICIQ-LUTS qol, and PSQI. Participant's perception of change post intervention will be evaluated using GPE. Outcomes will be measured at 0, 6 weeks and at 6 months post intervention. A sample size of 72 patients (36 in each group) is required to achieve 90% power with two-tailed tests at an alpha level of 0.05.Conclusion: Multiple sclerosis is a long-term condition, and self-management is important. TTNS provide a safe, non-invasive intervention that can be administered at home. Should the trial determine that TTNS is effective compared to sham TTNS, the investigators will plan to integrate TTNS into standard clinical care pathways in MS. ### Conditions - Overactive Bladder Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Active Transcutaneous Electrical Nerve Stimulation (TENS) - Sham Transcutaneous Electrical Nerve Stimulation (TENS) ### Outcomes Primary Outcomes - The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB) - 3- day Bladder diary - Urinary sensation scale. Secondary Outcomes - The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol) - Pittsburgh Sleep Quality Index (PSQI)-item 6 - Global Perceived Effect (GPE) Scale ### Location - Facility: King Fahd Hospital of the University, Khobar, Eastern Providence, N/A, Saudi Arabia @@
## To Evaluate the Safety and Tolerability of Carbognilumab Combined With Chemotherapy as the First-line Treatment for Patients With KEAP1 Mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer (NSCLC) - NCT ID: NCT06341660 - Study ID: CROC202313 - Status: RECRUITING - Start Date: 2023-05-25 - Completion Date: 2025-07 - Lead Sponsor: Guangzhou Institute of Respiratory Disease ### Study Description To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as first-line treatment in patients with KeAP1-mutated advanced or postoperative recurrent non-small cell lung cancer. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - cadonilimab ### Outcomes Primary Outcomes - Safety assessments and ORR Secondary Outcomes ### Location - Facility: The First Affiliated Hospital of Guangzhou Medical University, Guangdong, Guangzhou, 510000, China @@
## Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201 - NCT ID: NCT06341647 - Study ID: AB-201-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-08-31 - Completion Date: 2029-02 - Lead Sponsor: GC Cell Corporation ### Study Description This clinical trial will enroll subjects with HER2+ solid tumors and is conducted in two phases, which are phase 1a and phase 1b. The primary objective of phase 1 is to determine the safety and tolerability of AB-201 in subjects with advanced HER2+ solid tumors. ### Conditions - Breast Cancer - Gastric Cancer - Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - AB-201 - Cyclophosphamide - Fludarabine ### Outcomes Primary Outcomes - Incidence, severity, seriousness, and dose relationship of Adverse Events [Safety & Tolerability] - Determination of Recommended Phase 2 Dose (RP2D) Secondary Outcomes - To determine the preliminary efficacy, by the objective response rate (ORR) per the Response Evaluation Criteria for Solid Tumors (RECIST) v1.1, of AB-201 in subjects with advanced HER2+ solid tumors ### Location - Facility: Peter MacCallum Cancer Centre, Melbourne, Victoria, 3000, Australia @@
## Surveillance of Suicide Ideation in Adolescents (VISIA) - NCT ID: NCT06341634 - Study ID: VISIA - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-06 - Completion Date: 2024-11-24 - Lead Sponsor: Servicio Gallego de Salud ### Study Description The goal of this observational study is to validate an AI algorithm's capability to differentiate the population with suicidal ideation from a control population using various multimodal variables, including voice analysis, facial emotions, natural language, and proteomics data.The primary research question it aims to answer is:Is it possible to identify suicidal ideation and suicide risk in adolescents early and non-intrusively using multimodal data analysis through digital instruments equipped with artificial intelligence?Participants in this study will be asked to:Complete psychometric instruments to establish a gold standard for detecting suicide risk and suicidal ideation.Provide voice recordings, facial emotion data, and linguistic content in natural and specific contexts.Participate in salivary proteomics data collection.This study compares three distinct groups:Ideation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation.General Population: Adolescents without known psychological or psychiatric pathology of the same age and gender, without suicidal ideation.Researchers will compare these groups to determine if the AI algorithm is effective in differentiating individuals with suicidal ideation (Group 1) from both a clinical control group (Group 2) and a general population control group (Group 3) using the collected multimodal data. The study aims to assess the algorithm's ability to identify early signs of suicide risk in these distinct participant populations. ### Conditions - Suicide - Distress, Emotional - Adolescent Behavior - Healthy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Strengths and Difficulties Questionnaire (SDQ) - Mood and Feelings Questionnaire (MFQ) - Paykel Suicide Scale (PSS) - Facial microexpressions, voice and linguistic content analysis - Proteomic and stress level analysis Secondary Outcomes - Millon Adolescent Clinical Inventory - II (MACI-II) - Problematic Internet Use Scale in Adolescents (EUPI-A) - European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q) ### Location - Facility: Servizo Galego de Saúde, Santiago De Compostela, A Coruña, 15703, Spain @@
## Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib - NCT ID: NCT06341621 - Study ID: SCHBCC-N071 - Status: RECRUITING - Start Date: 2024-04-02 - Completion Date: 2029-01-01 - Lead Sponsor: Fudan University ### Study Description This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 3-year abemaciclib without chemo - treatment of physician's choice ### Outcomes Primary Outcomes - Invasive disease free survival Secondary Outcomes - disease free survival - distant disease free survival - overall survival - Time Frame: 5 years] 5. adverse effects adverse effects ### Location - Facility: Zhimin Cancer Shao, Shanghai, N/A, 200032, China @@
## Improving Access to Opioid Use Disorder Treatment Among Marginalized Patients With a Tailored Telehealth Intervention - NCT ID: NCT06341608 - Study ID: K23DA057528 - Status: RECRUITING - Start Date: 2023-12-08 - Completion Date: 2028-04 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this pilot trial is to develop and test a telehealth intervention for OUD care delivery and refine measurement strategies.The specific aims are to: 1) identify components of an effective telehealth intervention and barriers to implementation, 2) partner with an advisory board of OUD treatment stakeholders from different settings to develop a telehealth intervention for OUD treatment with buprenorphine, and 3) conduct a pilot trial of the telehealth intervention for OUD treatment.The investigators will enroll 60 patients, 30 individuals who are currently enrolled in in-person OUD treatment with buprenorphine, with a treatment episode duration of 1-3 months, and 30 individuals who are not currently receiving OUD treatment but approved for treatment intake at buprenorphine clinic by an OUD treatment clinician, to receive the telehealth for OUD care delivery intervention. The investigators will measure clinical, implementation, and patient satisfaction outcomes. ### Conditions - Opioid Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Telehealth for opioid use disorder treatment delivery ### Outcomes Primary Outcomes - Treatment Engagement Secondary Outcomes - Days of medication for OUD - Opioid and non-opioid substance use - Feasibility of intervention - Acceptability - Fidelity - Patient satisfaction ### Location - Facility: University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States @@
## Concurrent Chemoradiotherapy Combined With Sintilimab as Neoadjuvant Therapy for GC Patients With PALM - NCT ID: NCT06341595 - Study ID: 123322 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description This trial is a prospective, single arm, single center, phase II clinical study aimed at subjects with advanced gastric cancer and para aortic lymph node metastasis, exploring the feasibility and safety of Sintilimab Injection combined with synchronous chemo-radiotherapy as neoadjuvant therapy.Patients will receive sintilimab Injection (200mg iv q3w d1) combined with concurrent radiotherapy and chemotherapy. The chemotherapy regimen will use oxaliplatin 130mg/m2+S-1 40mg/m2 bid d1-14. Radiotherapy is performed using intraperitoneal radiation therapy, once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy (60-66 Gy for lymph node lesions). Radiation therapy starts from the second cycle of Sintilimab Injection combined with chemotherapy. The subjects underwent imaging evaluation after completing 4 cycles of combination chemotherapy and radiation therapy with Sintilimab Injection. Evaluated as a surgical subject (surgical conditions: imaging evaluation of enlarged lymph nodes adjacent to the abdominal aorta with PR or no significant activity), radical surgery will be performed within 4 weeks after the last study drug treatment. After surgery, the researcher will determine the necessity of adjuvant treatment and develop an adjuvant treatment plan based on the subject's condition. Subjects evaluated as inoperable will have their best follow-up treatment plan determined by the researcher. ### Conditions - Gastric Cancer - Gastric Cancer Metastatic to Regional Lymph Nodes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Sintilimab - Extraperitoneal radiation therapy - Oxaliplatin - S-1 ### Outcomes Primary Outcomes - Recurrence free survival (RFS) Secondary Outcomes - R0 resection rate - Objective response rate (ORR) - Major pathological response rate (MPR) - Overall survival (OS) - Adverse reactions ### Location - Facility: Jiangsu Province Hospital, Nanjing, Jiangsu, 210029, China @@
## Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort - NCT ID: NCT06341582 - Study ID: 2023-10-14 - Status: RECRUITING - Start Date: 2023-12-11 - Completion Date: 2025-11 - Lead Sponsor: Guangzhou Women and Children's Medical Center ### Study Description The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc. ### Conditions - Neonatal Jaundice - Neonatal Hyperbilirubinemia - Hemolysis Neonatal ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - End-tidal carbon monoxide-corrected (ETCOc) ### Outcomes Primary Outcomes - The incidence of hemolytic hyperbilirubinemia within 14 days of life (DOL) Secondary Outcomes - The incidence of neonatal hyperbilirubinemia within 14 days of life (DOL) - The incidence of hemolytic diseases of newborns within 14 days of life (DOL) ### Location - Facility: Dongguan Maternity and Child Healthcare Hospital, Dongguan, Guangdong, 523700, China @@
## Physical Therapy Students: Well-being - NCT ID: NCT06341569 - Study ID: 11/07.03.2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-10-30 - Lead Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara ### Study Description This study aims to explore various psychosocial aspects and the potential benefits of respiratory techniques for physical therapy students. ### Conditions - Anxiety State - Motivation - Life Stress - Sleep, Inadequate ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: SCREENING ### Interventions - Respiratory breathing techniques group ### Outcomes Primary Outcomes - Assessing intrinsic and extrinsic motivation levels among physical therapy students. - Assessing the happiness levels of the students participating in the study. - Assessing the positive and negative emotional states of the students participating in the study. - Assessing the well-being of the students participating in the study. - Assessing the overall life satisfaction levels of the students participating in the study. - Assessing the subjective happiness levels of the students participating in the study. - Assessing the sleep quality of the students participating in the study. - Assessing the worry and anxiety levels of the students participating in the study. - Assessing the effects of the respiratory techniques program on the intrinsic and extrinsic motivation levels of the students participating in the study. - Assessing the effects of the respiratory techniques program on the happiness levels of the students participating in the study. - Assessing the effects of the respiratory techniques program on the students' positive and negative emotional states. - Assessing the effects of the respiratory techniques program on the students' well-being. - Assessing the effects of the respiratory techniques program on the overall life satisfaction levels of the students participating in the study. - Assessing the effects of the respiratory techniques program on the subjective happiness levels of the students participating in the study. - Assessing the effects of the respiratory techniques program on the quality of sleep of the students participating in the study. - Assessing the effects of the respiratory techniques program on the worry and anxiety levels of the students participating in the study. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma - NCT ID: NCT06341556 - Study ID: iNHL-03 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2028-06 - Lead Sponsor: Fudan University ### Study Description This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy ### Conditions - Mantle Cell Lymphoma - Maintenance Therapy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Zanubrutinib ### Outcomes Primary Outcomes - 2-year progression-free survival (PFS) Secondary Outcomes - 2-year event-free survival (EFS) - overall survival - Hematology and non hematology toxicity - Quality of life questionnaire ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## Quantiferon CMV to Identify Treatment Need For Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT) - NCT ID: NCT06341543 - Study ID: QUANTIFOT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2026-06-15 - Lead Sponsor: University Hospital, Grenoble ### Study Description ContextCytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.Most of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and/or disease, and who ill benefit the most from antiviral therapy.As CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).Aim of the studyThe aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.MethodsParticipation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU/mL.The QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.In the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).The participants will be sampled:* 5 to 12 days after QF-CMV sampling (V2) ;* 7 to 14 days days after V2 (V3 - between D12 and D26) ;* 7 to 14 days days after V3 (V4 - between D19 and D40) .EndpointsThe primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:* Blood CMV viral load \>10,000 IU/mL \[4 log\];* And/or increase in blood viral load ≥0.5 log IU/mL with CV otherwise \>5000 IU/mL;* And/or the onset of CMV disease.The secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity). ### Conditions - Cytomegalovirus Infections - Heart Transplantation - Kidney Transplantation - Lung Transplantation - Liver Transplantation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Quantiferon CMV (assay that determine the presence of CMV-specific T lymphocytes). - Communication of the result of the QF-CMV to the clinician in charge ### Outcomes Primary Outcomes - proportion of participants with CMV viral load (>10,000 IU/mL, or increase ≥0.5 log IU/mL) - proportion of participants with CMV disease Secondary Outcomes - proportion of participants with antiviral-associated anemia - proportion of participants with antiviral-associated leucopenia - proportion of participants with antiviral-associated thrombopenia - proportion of participants with antiviral-associated tubulotoxicity (hypokaliemia) - antiviral-associated kidney failure (creatininemia) ### Location - Facility: Olivier EPAULARD, Grenoble, Isere, 38043, France @@
## Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer - NCT ID: NCT06341530 - Study ID: SURPASS-1 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2025-12-31 - Lead Sponsor: The First Affiliated Hospital of Zhengzhou University ### Study Description In recent years, with the emergence and clinical application of anti-angiogenesis therapy, the therapeutic effect of patients has been significantly improved while ensuring that the adverse reactions of patients do not increase. Anti-angiogenic therapy can improve the hypoxia state of tumor tissue, normalize blood vessels, relieve immune suppression in tumor microenvironment, increase the degree of infiltration of immune cells, and fully activate immune cells to achieve the effect of tumor immunity. Previous studies have shown that penpulimab injection combined with anlotinib in the treatment of NSCLC can induce the normalization of tumor blood vessels and reshape the tumor immunosuppressive microenvironment, and the combination of the two can have synergistic effects.This study intends to treat patients with advanced non-small cell lung cancer (NSCLC) confirmed by pathology with the combination of anlotinib and penpulimab injection, and observe the efficacy and safety of anlotinib and penpulimab injection in the first and second lines of NSCLC. This study is expected to provide a reference for the treatment strategy of advanced non-small cell lung cancer patients, and has important clinical value for the treatment of advanced lung cancer. ### Conditions - Non-small Cell Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - anlotinib combined with penpulimab ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes ### Location - Facility: Zhe Cheng, Zhengzhou, Henan, 450000, China @@
## Brain Circuitry Therapeutics for Schizophrenia - NCT ID: NCT06341517 - Study ID: IRB_in_progress - Status: NOT_YET_RECRUITING - Start Date: 2024-11-05 - Completion Date: 2027-12-12 - Lead Sponsor: Indrit Begue ### Study Description This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia ### Conditions - Schizophrenia; Psychosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iTBS ### Outcomes Primary Outcomes - Brief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12. Secondary Outcomes ### Location - Facility: Indrit Bègue, Geneva, N/A, 1202, Switzerland @@
## Prevention Messages for EGMs: Effects on Behaviours and Cognitions - NCT ID: NCT06341504 - Study ID: ALVMsg2023 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-09 - Lead Sponsor: Benjamin Galipeau ### Study Description The goals of this randomized controlled trial are to test the manifold effects of prevention pop-up messages on participants' behaviours, cognitions and affects. This study is conducted among regular EGMs' players (defined as having played EGMs at least once every two weeks for the past 12 months) who are not classified as probable pathological gamblers by the PGSI.After answering a series of short questionnaires by phone, participants are asked to schedule a gambling session which is done in a laboratory on the university's campus. This laboratory replicates a typical bar, and is equipped with real EGMs. Participants are recruited under the false pretense of giving their opinion on the realism of the bar replica, and on the overall feeling of the gambling session in it. They are told that: (a) they are free to gamble as much and for as long as they like; (b) they are allowed to take breaks; (c) gambling is to be done with their own money; (d) the only compensation for participation are the potential winnings made while gambling; (e) net winnings across their whole session are paid, but losses are real. There is only one participant at a time in the laboratory for the gambling session.After having stopped by their own volition (some exceptions apply, see "Detailed Description" for further details), participants are debriefed on the real goals of this study and reimbursed any incurred losses while gambling. They are then be asked to answer another series of questionnaires. ### Conditions - Gambling ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Prevention pop-up messages - Mandatory time limit - Responsible gambling information - Electronic gambling machine (model IGT GL20) - Square terminal ### Outcomes Primary Outcomes - Gambling behaviour (between group) - Gambling session's total duration - Gambling behaviour (between group) - Total time effectively spent gambling - Gambling behaviour (between group) - Number of breaks taken - Gambling behaviour (between group) - Mean breaks' duration - Gambling behaviour (between group) - Total breaks duration - Gambling behaviour (between group) - Mean time elapsed between breaks - Gambling behaviour (between group) - Number of different games played - Gambling behaviour (between group) - Money betted (physical) - Gambling behaviour (between group) - Money betted (all) - Gambling behaviour (between group) - Number of bets placed - Gambling behaviour (between group) - Gambling speed - Gambling behaviour (between group) - Gambling intensity (physical) - Gambling behaviour (between group) - Gambling intensity (all) - Perceived self-control while gambling on EGMs (between group) - General level of fun while gambling on EGMs (between group) - Psychological reactance to prevention pop-up messages (between group) - Perceived behavioural effectiveness of prevention pop-up messages (between group) - Change in gambling behaviours (within group) - Money betted (physical) - Change in gambling behaviours (within group) - Total time effectively spent gambling - Change in perceived self-control while gambling on EGMs (within group) - Change in general level of fun while gambling on EGMs (within group) Secondary Outcomes - Perceived realism - Gambling location type most resembling the session in the laboratory - Perceived realism - Session in the laboratory VS gambling on EGMs in a bar/restaurant - Perceived realism - Similarities between session in the laboratory VS gambling on EGMs in a bar/restaurant - Perceived realism - Differences between session in the laboratory VS gambling on EGMs in a bar/restaurant - Perceived realism - What could be done to heighten realism of the session in the laboratory - Perceived realism - Effect of using one own money on realism - Perceived realism - Effect of using one own money on realism (free) - Perceived correspondence between habitual gambling behaviour and gambling behaviour during the session in the laboratory - Perceived correspondence between habitual gambling behaviour and gambling behaviour during the session in the laboratory (free) - Protocol credibility - Protocol credibility (free) - Recruitment potential - Volunteers - Recruitment potential - Recruited - Recruitment potential - Rejected - Recruitment potential - Refusal - Attrition ### Location - Facility: Centre québécois d'excellence pour la prévention et le traitement du jeu, Québec, N/A, G1V 0A6, Canada @@
## The Study of Delay Discounting Among Beneficiaries of the Pé-de-Meia Program - NCT ID: NCT06341491 - Study ID: obs. Delay Discounting - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: Federal Institute of Education, Science and Technology of the State of Mato Grosso ### Study Description The aim of this observational study is to explore how the "Pé-de-Meia" Program, a policy of the Brazilian Federal Government designed to encourage the retention and completion of studies by students from low-income families, affects both the students' tendency towards delay discounting and their academic performance. The study seeks to answer the following questions:How does the "Pé-de-Meia" Program affect the students' propensity for delay discounting? Is there a relationship between the level of delay discounting among students, their academic performance, and school attendance? Participants in the study, high school students enrolled in the "Pé-de-Meia" Program, will undergo assessments to measure their level of delay discounting. The academic performance and school attendance of the participants will be monitored and analyzed in relation to their propensity for delay discounting ### Conditions - Delay Discounting ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pé-de-Meia Program ### Outcomes Primary Outcomes - Delay discounting - Academic performance - grades - School attendance Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Investigator Grant (IG) 2022 27746 - NCT ID: NCT06341478 - Study ID: IG-2022-27746 - Status: RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-03-15 - Lead Sponsor: IRCCS San Raffaele ### Study Description Background:Muscle-invasive bladder cancer (MIBC) is a systemic disease as \>40% of patients (pts) ultimately develop recurrence after radical cystectomy (RC). For pts who cannot receive or refuse cisplatin-based chemotherapy there is no standard-of-care neoadjuvant therapy. Single-agent pembrolizumab, given neoadjuvantly in patients with T2-4N0M0 MIBC, documented a 42% pathologic complete response-rate (ypT0N0) in a previous AIRC-supported trial (PURE-01, NCT02736266; PMID: 30343614). However, there is a huge proportion of pts who do not benefit from single-agent immunotherapy. Antibody-drug conjugates (ADC) represent the next wave of MIBC treatment revolution. An umbrella of various neoadjuvant therapies including the ADC Sacituzumab govitecan (SG), SG plus pembrolizumab, and chemoimmunotherapy combination has been established to improve our knowledge on MIBC biology and to improve the outcomes.Hypothesis:By developing a robust biomarker program associated with therapeutic benefit of novel therapies or their combinations, along with an imaging biomarker development, the investigators will be able to identify suitable tumor characteristics for personalizing perioperative therapies in MIBC, coupled with the possibility to predict the pathological response to treatment.Aims:The project is aimed at characterizing the tumor and microenvironment characteristics of muscle-invasive bladder cancer, with a special focus on their changes induced by various neoadjuvant therapies preceding radical cystectomy.The investigators will aim to evaluate the tumor and immune profile on matched pre- vs post-therapy samples and noninvasively monitor the response to treatment with the use of radiological assessments.Experimental design:The investigators will access tumor samples from matched pre-therapy (transurethral resection of the bladder tumor) and post-therapy (radical cystectomy) surgical interventions. They will also analyze the imaging analyses of combined bladder multiparametric MRI/Fluorodeoxyglucose Positron Emission Tomography (PET) scans pre-post neoadjuvant therapies, and will associate the data with the pathological response to treatment, expanding our previously reported work (PMID: 31882281).Biomarker analyses will include the following: i.) multiplex immunofluorescence assays will allow the investigators defining the immune contexture of tumor lesion; ii.) multiparametric flow cytometry will allow the phenotypic and functional analysis of peripheral blood cells at single cell level; iii.) a whole transcriptome assay will enable investigators to assign specific molecular subtypes to pathological response and outcome, as previously reported (PMID: 33785257; 32165065).Expected results:The investigators will expect to identify the tumor characteristics and immune-profiling enabling them to delineate the selection of patients most suited for certain novel perioperative therapies, thus anticipating the developments in clinical research that are being conducted worldwide in MIBC.The investigators will be also able to develop noninvasive tools for pathological complete response identification, thus enabling them to develop a next-generation of clinical trials aimed at sparing any radical local therapy on the bladder tumor.Impact on cancer:In principle, the present personalized strategy yields the potential to enhance the therapeutic standards achievable with RC alone as well as with single-agent immunotherapy and RC. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - various neoadjuvant therapies ### Outcomes Primary Outcomes - Predictors of immune response to experimental combination therapies in MIBC. - Genomic predictors of response to experimental combination therapies in MIBC. - Transcriptomic predictors of response to experimental combination therapies in MIBC. Secondary Outcomes ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, Mi, 20132, Italy @@
## Investigation of the Effects of Exercise and Kinesiological Taping on Spinal Deformities and Serum Markers in Individuals With Scoliosis - NCT ID: NCT06341465 - Study ID: HÜ- FTR- BD- 3 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-07-04 - Lead Sponsor: Hacettepe University ### Study Description The aim of this study is to investigate the effects of Schroth exercises and kinesiological taping on spinal deformities and serum markers in young adults with scoliosis. The study will include young adults aged 18-21 with scoliosis. A total of 57 participants will be included in the study. Out of 57 participants, 38 have scoliosis, and 19 are healthy. 38 participants will be randomly divided into 2 groups. One group (n=19) will receive only Schroth exercises, and the other group (n=19) will receive both Schroth exercises and kinesiological taping. The laboratory analyses of proteins associated with autophagy (Beclin-1, LC3, and ATG3) and bone-cartilage metabolism (COMP and MMP-3) will be conducted in the Biomedical Engineering Laboratory of our university. Trunk rotation will be assessed using the Adams Forward Bend Test with scoliometer, quality of life will be evaluated with the SRS-22 Quality of Life questionnaire and Quality of life profile for spinal deformities questionnaire, perception of deformity will be measured using the Walter Reed Visual Assessment Scale, and Cobb angles will be evaluated from anterior-posterior X-ray images. ### Conditions - Scoliosis - Scoliosis Idiopathic - Musculoskeletal Deformity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Just Exercise - Exercise - Taping ### Outcomes Primary Outcomes - Trunk rotation - Cobb angles - Serum markers Secondary Outcomes - Quality of life with scoliosis people - Body image assessment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Individualized Sodium Management Versus Standard Treatment in Hemodialysis - NCT ID: NCT06341452 - Study ID: HD-NaM-01-EU - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Fresenius Medical Care Deutschland GmbH ### Study Description The SODIAH study is designed with the aim to assess the impact of isonatremic dialysis on interdialytic weight gain, fluid status, intradialytic hemodynamic stability, and incidence of intradialytic morbid events in dialysis patients. The study will be comparing the Na management option on the 6008 HD dialysis machines with the same machine without the Na management option turned on. Relevant performance and clinical data will be collected as well as information on patients' quality of life and wellbeing. ### Conditions - End Stage Renal Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Hemodialysis or Hemodiafiltration either with sodium zero-diffusive treatment or standard treatment without sodium-control ### Outcomes Primary Outcomes - Interdialytic weight gain - Intradialytic hemodynamic stability - Intradialytic hemodynamic stability - Intradialytic morbid events - Fluid status - Fluid status Secondary Outcomes - PRO: Thirst feeling - PRO: Thirst feeling - PRO: Fatigue - PRO: Hypotensive episodes - PRO: HRQOL - PRO: Health status ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Efficacy of Mouthrinses Based on Chlorhexidine 0.12% and CITROX® - NCT ID: NCT06341439 - Study ID: Prot. 001_2023 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-02-18 - Completion Date: 2024-03-30 - Lead Sponsor: University of L'Aquila ### Study Description The goal of the following clinical trial is to compare the efficacy of a product based on chlorhexidine 0.12% and CITROX and the same product without CITROX in the healing phenomena that occur after non-surgical periodontal therapy. The main questions it aims to answer are:* Is the response to periodontal therapy better if mouthwash containing Citrox is used?* What is the patients' perception?Participants, divided into 2 groups, are asked to use either one or the other mouthwash for 14 days after non-surgical periodontal therapy. ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mouthwash with chlorhexidine 0,12% and CITROX - Mouthwash with chlorhexidine 0,12% ### Outcomes Primary Outcomes - Probing Depth (PD) - Gingival Index (GI) - Plaque Index (PI) - Full mouth plaque score (FMPS) - Full mouth bleeding score (FMBS) Secondary Outcomes - Patient Reported Outcome Measure (PROMS) ### Location - Facility: University of L'Aquila, division of periodontology, L'Aquila, N/A, 67100, Italy @@
## Psilocybin-Assisted Psychotherapy for Treatment-Resistant Depression: Comparing One Versus Two Doses of Psilocybin - NCT ID: NCT06341426 - Study ID: 23-5872 - Status: RECRUITING - Start Date: 2024-02-05 - Completion Date: 2028-08-01 - Lead Sponsor: University Health Network, Toronto ### Study Description The purpose of this study is to see if one or two doses of psilocybin is more effective in relieving depressive symptoms in patients with treatment-resistant depression (TRD). Researchers also want to know if a second dose of psilocybin is safe and well-tolerated. This study will see if psilocybin is effective, safe, and well-tolerated by tracking changes in depressive symptoms, suicidality, and side effects. This study will also see if a second dose of psilocybin has an effect on quality of life, functioning, cognition (thinking, reasoning, remembering), and how long depressive symptoms improve (or worsen) after psilocybin is administered. ### Conditions - Major Depressive Disorder - Depression - Treatment-Resistant Depression - Mood Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single Psychedelic Dose Psilocybin - Two Psychedelic Doses Psilocybin ### Outcomes Primary Outcomes - Antidepressant Efficacy Secondary Outcomes - Self-Reported Depression Symptoms - Anxiety Symptoms - Self-Reported Quality of Life - Subjective Functioning - Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) - Cognitive Dysfunction - Psychomotor Performance - Phonemic Word Fluency - Psychomotor Speed, Visual search, and Attention - Verbal Learning and Memory - Working Memory, Attention and Executive Function - Effort-Based Decision Making ### Location - Facility: Toronto Western Hospital, Toronto, Ontario, M5T 2S8, Canada @@
## Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder - NCT ID: NCT06341413 - Study ID: 2023-1281 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2024-10 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The goal of this clinical trial is to characterize the role of sleep, emotion processing, and daily affect in post-traumatic stress disorder (PTSD) and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth.Participants will attend 4 study visits:* A clinical and trauma assessment visit* A testing day that may include cognitive testing, surveys, and an MRI.* An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition* An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition ### Conditions - Post Traumatic Stress Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SmartSleep device ### Outcomes Primary Outcomes - Change in Emotional Regulation - arousal - Change in Emotional Regulation - recall - Change in Slow-wave Activity (SWA) Secondary Outcomes - Change in Positive and Negative Affect Schedule (PANAS) ### Location - Facility: University of Wisconsin, Madison, Wisconsin, 53705, United States @@
## RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients - NCT ID: NCT06341400 - Study ID: 2024-KY-030-01 - Status: RECRUITING - Start Date: 2024-05-20 - Completion Date: 2027-05-01 - Lead Sponsor: Zhujiang Hospital ### Study Description A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy. ### Conditions - Bladder Cancer - Muscle-Invasive Bladder Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - DisitamabVedotinForIicction Toripalimab ### Outcomes Primary Outcomes - PcR Secondary Outcomes ### Location - Facility: Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Volatolomic and Proteomic Profile for Early Diagnosis of Lung Cancer - NCT ID: NCT06341387 - Study ID: R178522-ieo1906 - Status: RECRUITING - Start Date: 2023-05-05 - Completion Date: 2024-07-31 - Lead Sponsor: European Institute of Oncology ### Study Description The goal of this prospective, case-control study is to discover the specific "omics" biomarkers of early stage of lung cancer using the non-invasive samples (breath, urine and serum) in a total of 200 subjects (100 healthy controls and 100 lung cancer patient). The main questions it aims to answer are:* Which are the "omics" biomarkers that characterize the early stage of lung cancer?* How to Translate Laboratory Data into Clinical Data?For each participant we will collected the breath, urine and blood samples. In lung cancer patients group the samples will be sample before lung cancer resection. The samples of Breath, urine and serum will be analysed using different type of analysis: eNose and the Gas Chromatography combined with Ion Mass Spectrometry (GC/IMS). Moreover, Serum will be analyzed by mass-spectrometry-based proteomics. The purpose of these analyses will be to find biomarkers capable of distinguishing the early-stage of lung cancer from the healthy group. Followup will be performed to evaluate the possible change of the volatolomic and proteomic profile. ### Conditions - Lung Cancer - Non-small Cell Lung Cancer Stage I - Non-small Cell Lung Cancer Stage II - Lung Cancer Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breath, urine and blood analysis ### Outcomes Primary Outcomes - Comparison of the proteomic and volatolomic signature in samples of respiratory exhalation, serum, and urine from patients with lung cancer (stage I/II) and healthy individuals at high risk. Secondary Outcomes - Omics-Data intagration. ### Location - Facility: Europen insitute of Oncology- Division of Thoracic Surgery, Milan, N/A, 20141, Italy @@
## Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients - NCT ID: NCT06341374 - Study ID: 2023/5079 - Status: RECRUITING - Start Date: 2023-11-06 - Completion Date: 2024-09-30 - Lead Sponsor: Parc Taulí Hospital Universitari ### Study Description Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response. ### Conditions - Apnea, Obstructive Sleep - SARS CoV 2 Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Influvac Tetra ### Outcomes Primary Outcomes - Immunological study: cytokines. Secondary Outcomes - Innate cells: monocytes, classical dendritic cells and Natural Killer cells. - Epigenetic modification. - Diagnostic of obstructive sleep apnea in selected cohort ### Location - Facility: Hospital Universitari Parc Tauli, Sabadell, Barcelona, 08208, Spain @@
## OCT-based Machine Learning FFR for Predicting Post-PCI FFR - NCT ID: NCT06341361 - Study ID: OCT-FFR - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-10-15 - Lead Sponsor: Yonsei University ### Study Description This study aims to compare the diagnostic accuracy of the fractional flow reserve (FFR) model derived by machine learning based on optical coherence tomography (OCT) exam after coronary artery stent implantation with the wire-based FFR. ### Conditions - Tomography, Optical Coherence - Fractional Flow Reserve, Myocardial ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - OCT-based machine learning FFR ### Outcomes Primary Outcomes - Correlation of OCT-based machine learning FFR compared to wire-based FFR Secondary Outcomes - Diagnostic performance of OCT-based machine learning FFR compared to wire-based FFR - Diagnostic performance of OCT-based machine learning FFR according to the coronary artery (LAD, LCx or RCA) compared to wire-based FFR ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of Case Management for Patients With Rheumatoid Arthritis in Taiwan - NCT ID: NCT06341348 - Study ID: Dalin Tzuchi Hospital - Status: COMPLETED - Start Date: 2016-01-01 - Completion Date: 2018-12-31 - Lead Sponsor: Dalin Tzu Chi General Hospital ### Study Description Case management (CM) has been recommended as a way of inspiring measurable changes in individual behaviors and improving clinical outcomes for patients with chronic diseases. However, data on its effectiveness for Taiwanese patients with rheumatoid arthritis (RA) are limited. This study aimed to determine the long-term effectiveness of CM that focused on nurses' role among Taiwanese RA patients.A quasi-experimental pre-post test, control-group study with purposive sampling recruited RA patients from a hospital in Taiwan during 2016-2017. CM program was composed of health education sessions and follow-up telephone consultations over a six-month period. A review of medical records and structured questionnaires yielded data about patient demographics and disease characteristics, and included Chinese version of the Arthritis Self-Efficacy Scale and the Taiwanese Depression Questionnaire. A comparison of the long-term effectiveness of the CM program was made using generalized estimating equation.This evidence-based study may be beneficial to characterize the long-term effectiveness of CM for Taiwanese patients with RA, and may be a reference for healthcare providers in facilitating the provision of appropriate interventions to improve the adaptation processes and clinical outcomes for them. ### Conditions - Case Management - Rheumatoid Arthritis - Effectiveness ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Case management ### Outcomes Primary Outcomes - Depressive symptoms - Self-efficacy level - Sexual dysfunctionform-14 - DAS28 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma - NCT ID: NCT06341335 - Study ID: AK109-301 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2027-07 - Lead Sponsor: Akeso ### Study Description This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy. ### Conditions - Gastric and Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - cadonilimab - pulocimab - paclitaxel - placebo ### Outcomes Primary Outcomes - Progression-free survival (PFS) assessed by blinded independent central review (BICR) - Overall survival (OS) Secondary Outcomes - Progression-free survival (PFS) assessed by investigator - Objective Response Rate (ORR) - Duration of Response (DoR) - Disease control rate (DCR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Using Behavioural and Cultural Insights to Increase Colorectal Cancer Home-testing in Croatia - NCT ID: NCT06341322 - Study ID: ERC0003996 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-07 - Lead Sponsor: Veerle Snijders ### Study Description Colorectal cancer (CRC) is one of the leading causes of death in Croatia. An average of 3600 cases are diagnosed and an average of 2100 people die from the disease every year. Since 2007, Croatia has invited every man and woman aged 50-74 to participate in the home testing screening programme every two years. Currently only around 36% of the invited request the test-kit and 25% complete the home testing procedure, far below the target of 40-60%.The Croatian Institute of Public Health with technical support from World Health Organization (WHO) Regional Office for Europe is undertaking a mixed-methods research study with the aim to increase the completion of colorectal cancer home testing and improve our knowledge of the barriers and drivers to do so. The study has a quantitative and a qualitative component:1. Quantitative: testing the introduction of a reminder letter to encourage people to respond to the initial invite to participate in the CRC home test program and test which elements of a reminder letter improve response rates. The quantitative component consists of a four-arm reminder letter randomized controlled trial (RCT) comparing no letter, standard letter, behaviorally informed letter, and behaviorally informed letter sent with a home testing kit to investigate the effectiveness of reminders in increasing uptake of home-testing for colorectal cancer. Recruitment and data collection for the reminder letter trial will be conducted utilizing the routine screening process and routinely collected screening data.2. Qualitative: conducting in-depth interviews with people from the target population who did or did not respond to the CRC invite letter and reminder to better understand the barriers and drivers to participation.The qualitative component consists of 24 in-depth interviews (IDIs) conducted with members of the target population to identify barriers and drivers to completing colorectal cancer screening home-testing. Data collection for IDIs will be face-to-face, using discussion guides, and will be audio recorded. The audio-recordings will then be analyzed using a rapid analysis approach based on by the modified Capability-Opportunity-Motivation-Behavior (COM-B) framework. ### Conditions - Colorectal Cancer - Behavior Change ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Standard letter - Behaviorally informed letter - Home testing colorectal cancer kit ### Outcomes Primary Outcomes - Home test kit ordered - Completed colorectal cancer screening Secondary Outcomes - Opted out - Qualitative feedback ### Location - Facility: Croatian Institute of Public Health, Zagreb, N/A, N/A, Croatia @@
## Exploratory Study of Irinotecan Liposomes in Maintenance Therapy of Metastatic Colorectal Cancer - NCT ID: NCT06341309 - Study ID: CSPC-DEY-CRC-K09 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-08-01 - Lead Sponsor: West China Hospital ### Study Description To evaluate the progression-free survival (PFS1), objective response rate (ORR), disease control rate (DCR), progression-free survival from first-line treatment initiation (PFS2), overall survival (OS), and safety of irinotecan liposome combined with bevacizumab in patients with advanced metastatic colorectal cancer. ### Conditions - Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Irinotecan Liposome - Bevacizumab ### Outcomes Primary Outcomes - Progression free survival -1 Secondary Outcomes - Progression free survival -2 - Objective response rate - Disease control rate - Overall survival - Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phase II Study of Irinotecan Liposomes in First-line Treatment of Metastatic Colorectal Cancer - NCT ID: NCT06341296 - Study ID: CSPC-DEY-CRC-K07 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: West China Hospital ### Study Description To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients. ### Conditions - Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Irinotecan Liposome - 5-FU - LV - Bevacizumab ### Outcomes Primary Outcomes - Objective response rate Secondary Outcomes - Disease control rate - Progression free survival - Overall survival - Percentage of patients undergoing surgery. - R0 resection - Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Retrospective Real-world Study of Abemaciclib Tablets Based on HIS System in HR+ Breast Cancer Patients - NCT ID: NCT06341283 - Study ID: BCOOS2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-07-01 - Lead Sponsor: The Affiliated Hospital of Qingdao University ### Study Description The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive breast cancer. ### Conditions - Breast Cancer - Neoplasms - Breast Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Abemaciclib and Letrozole/Anastrozole - Letrozole or Anastrozole - Abemaciclib and Fulvestrant - Fulvestrant ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Objective Remission Rate - Disease Control Rate - Toxicity rate - Cost-utility analysis ### Location - Facility: Clinical Research Center, Qingdao, Shandong, N/A, China @@
## Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy - NCT ID: NCT06341270 - Study ID: 2024HX1564 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2026-12-20 - Lead Sponsor: West China Hospital ### Study Description The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy ### Conditions - Liver Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcutaneous electrical acupoint stimulation - sham transcutaneous electrical acupoint stimulation ### Outcomes Primary Outcomes - The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24 hours after surgery Secondary Outcomes - The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 48 and 72 hours after surgery - The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24, 48 and 72 hours after surgery - Pain scores of movement-evoked pain at postoperative 24,48 and 72 hours - Pain scores of pain at rest at 24, 48 and 72 hours postoperatively - The cumulative morphine consumption at 24, 48, and 72 hours postoperatively - The incidence of postoperative nausea and vomiting during the first 24,48,72 hours - The incidence of a composite of postoperative pulmonary complications during hospitalization - Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery - Time of Bowel function recovery - Length of hospital stay - The postoperative sleep quality score - The anxiety and depression scores - The incidence of chronic postsurgical pain (CPSP) ### Location - Facility: West China Hospital, Chengdu, Sichuan, 610041, China @@
## Efficacy and Toxicity of SCART - NCT ID: NCT06341257 - Study ID: VGHTCCTC_SCART001 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2029-12-31 - Lead Sponsor: Taichung Veterans General Hospital ### Study Description This study is expected to enroll patients for a period of five years, with a total of 30 participants. It is a prospective observational study involving cancer patients with tumors having a longest diameter greater than or equal to 5 cm. Systemic drug therapy may be administered concurrently. The following inclusion criteria must be met for participation in the study: age greater than or equal to 18 years, Eastern Cooperative Oncology Group (ECOG) score ≤ 2, pathological confirmation of cancer diagnosis, tumor with a maximum diameter greater than or equal to 5 cm, one or more lesions, not suitable for surgery, patient has provided informed consent, patient receives SCART, and reproductive-age women must agree to take adequate contraceptive measures during the study and for six months after discontinuation of medication. The patient will receive a dose of 21 Gy in 3 fractions, with the dose maintained at 5 Gy per fraction for the entire tumor gross target volume (GTV) boundary. For certain patients, an additional two fractions of 5 Gy each were added using Stereotactic Body Radiotherapy (SBRT), resulting in a total dose of 5 Gy × 5 for the GTV boundary. ### Conditions - Tumor Size Greater Than or Equal to 5 cm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Stereotactic Central/Core Ablative Radiation Therapy (SCART) ### Outcomes Primary Outcomes - Local Control (LC) - Progression-Free Survival (PFS) Secondary Outcomes ### Location - Facility: Taichung Veterans General Hospital, Taichung, N/A, 407, Taiwan @@
## Air Stacking Technique Efficacy on Peak of Expiratory Flow and Cough Peak Flow in Non-cardiac Thoracic Surgery - NCT ID: NCT06341244 - Study ID: UNIFESP - Status: COMPLETED - Start Date: 2019-08-20 - Completion Date: 2022-12-15 - Lead Sponsor: Universidade Cidade de Sao Paulo ### Study Description After thoracic surgical intervention, patients often feel intense pain with respiratory movements reduction making coughing less effective. The air stacking improves peak of expiratory flow (PEF) and cough peak flow (CPF) in neuro myopathies, thus raising the hypothesis that may also be effective in patients undergoing thoracic surgeries. Objectives: To evaluate the effectiveness, safety and feasibility of air stacking on postoperative PEF and CPF in patients undergoing thoracic surgeries. Methods: Patients undergoing thoracic surgery underwent air stacking on 3th PO. Dyspnea, pain, SpO2, maximum inspirational pressure (MIP), maximum expiratory pressure (MEP), PEF and CPF were evaluated in pre and postoperatory. ### Conditions - Postoperative Care ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Air Stacking Technique ### Outcomes Primary Outcomes - Peak of expiratory flow (PEF) - Cough peak flow (CPF) Secondary Outcomes - Maximum Inspiratory Pressure ( MIP) - Maximun Expiratory Pressure (MEP) ### Location - Facility: Luciana Chiavegato, São Paulo, N/A, 04115000, Brazil @@
## Personalized Anticoagulant Therapy for Pulmonary Thromboembolism - NCT ID: NCT06341231 - Study ID: 202400248 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2027-12-31 - Lead Sponsor: Xiangya Hospital of Central South University ### Study Description The goal of this prospective observational study is to explore the influencing factors of the efficacy and safety of anticoagulant therapy for pulmonary thromboembolism in special populations with older age, renal insufficiency or co-existing malignancy, and establish a predictive model to guide clinical practice. The main questions it aims to answer are:* To analyze the influencing factors of the efficacy and safety of anticoagulant therapy for specific populations with pulmonary thromboembolism (PTE) in the real world (such as the elderly, those with impaired kidney function, and individuals with malignant tumors).* Whether we can use machine-learning models to predict bleeding events and VTE recurrence in special populations following anticoagulant therapy in the real world? Participants will receive diagnostic and therapeutic measures for pulmonary thromboembolism in accordance with clinical guidelines, including anticoagulant therapy. Some patients need to have peripheral blood samples collected at the time of enrollment and 3 months after anticoagulant therapy. ### Conditions - Pulmonary Thromboembolisms - Anticoagulants; Increased ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Major bleeding - Clinically relevant non-major bleeding - Recurrent VTE Secondary Outcomes - All-cause mortality ### Location - Facility: Xiangya Hospital, Changsha, Hunan, 410008, China @@
## The Effect Of Simulation-Supported Pediatric CPR Training Based On CRM On Knowledge, Attitude, And Performance - NCT ID: NCT06341218 - Study ID: 21-5T/3 - Status: COMPLETED - Start Date: 2021-02-25 - Completion Date: 2023-11-15 - Lead Sponsor: Zonguldak Bulent Ecevit University ### Study Description Crew Resource Management is a training system that aims to use all available resources effectively and increase safety by improving technical knowledge and skills as well as non-technical skills in risky tasks such as CPR. In safe critical patient management, the healthcare team should have interpersonal skills such as communication, stress management, teamwork, and leadership, cognitive skills such as situational awareness, task completion, planning, monitoring the situation, and rapid response to critical incidents, in addition to technical skills. To improve outcomes after pediatric cardiac arrest, many systems have been developed for performance measurement and quality improvement initiatives of the healthcare team. However, studies are needed to evaluate the effects of these systems. This study was planned to evaluate the effectiveness of simulation-supported pediatric cardiopulmonary resuscitation training based on team resource management on knowledge, attitude, and performance of the healthcare team in the pediatric intensive care unit. ### Conditions - Cardiopulmonary Resuscitation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Pediatric Cardiopulmonary Resuscitation Training Based On Team Resource Management ### Outcomes Primary Outcomes - Socio-demographic data of the healthcare team - Pediatric KPR knowledge level - Pediatric KPR team attitude level - Pediatric KPR team performance level Secondary Outcomes ### Location - Facility: Ege University, İzmir, Bornova, 35100, Turkey @@
## Personalized Rituximab Treatment Based on Artificial Intelligence in Membranous Nephropathy (iRITUX) - NCT ID: NCT06341205 - Study ID: 22-APN-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2031-09-30 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Membranous nephropathy is an autoimmune disease affecting the kidney, and the most common cause of nephrotic syndrome in non-diabetic Caucasian adults. The course of this disease is highly variable from one individual to another, ranging from spontaneous remission to progressive chronic kidney disease.The identification of autoantibodies - e.g., the phospholipase A2 receptor type 1 (PLA2R1) - has promoted the use of immunosuppressive drugs such as rituximab which is now a safe and effective first-line treatment for the management of membranous nephropathy. However, up to 40% of patients do not respond to a first course of rituximab treatment. In nephrotic patients, due to urinary drug loss, rituximab blood level is lower than in other autoimmune diseases treated with rituximab without proteinuria. This high urinary drug loss decreases the drug exposure, potentially explaining why rituximab regimen with low dose infusions (375 mg/m2) did not demonstrate efficacy after month-6 compared to a non-immunosuppressive antiproteinuric treatment in a previous study. In contrast, a regimen of two 1-g infusions two weeks apart was associated with a significantly greater remission rate after 6 months.Recently, the investigators have shown that after two 1-g rituximab infusions, the rituximab blood level 3 months after the first rituximab infusion, was correlated with the likelihood of remission after 6 and 12 months of the rituximab treatment. Patients with positive rituximab blood level 3 months after treatment had a higher chance of remission at month-6 and at month-12 than patients with an undetectable rituximab level at month-3.Nowadays, machine learning algorithms are increasingly used in medicine, especially in pharmacology, to predict the exposure to a drug, the initial dose to administer or the interval between two infusions.The objective of this study is to use a machine learning algorithm predicting the risk of having an undetectable residual level of rituximab 3 months after treatment, in order to propose a personalized treatment management with early additional doses of rituximab for the patients at risk. ### Conditions - Membranous Nephropathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - RiTUXimab Injection ### Outcomes Primary Outcomes - Clinical remission (complete or partial) after 6 months of rituximab initiation Secondary Outcomes - Complete clinical remission after 12 months of rituximab initiation - Partial clinical remission after 12 months of rituximab initiation - Immunological remission: anti-PLA2R1 depletion - Change in urine protein/creatinine ratio (UPCR) - Change in serum creatinine - Change in renal function - Change in the immunological status of the disease - Appearance of anti-drug antibodies after rituximab treatment - Rituximab underdosed patients - Serious adverse events - Adaptation of symptomatic treatment - Model improvement through machine learning - Effect of rituximab on immune profiles ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06341192 - Study ID: ChangGungMH ALL SB DB - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-10-31 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are:* What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL) reconstruction versus double-bundle ACL reconstruction combined with ALL reconstruction?* How do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates?Participants will:* Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations* Be randomly assigned to either: * Single-bundle ACL + ALL reconstruction * Double-bundle ACL + ALL reconstruction* Receive the assigned surgical procedure* Participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 yearResearchers will compare the single-bundle ACL + ALL group and the double-bundle ACL + ALL group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower ACL re-tear rates. ### Conditions - Anterior Cruciate Ligament Injuries - Anterior Cruciate Ligament Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Single-bundle ACL combined anterolateral ligament reconstruction - Double-bundle ACL combined anterolateral ligament reconstruction ### Outcomes Primary Outcomes - Patient-reported outcome measures (PROMs) - Patient-reported outcome measures (PROMs) - Patient-reported outcome measures (PROMs) - Knee ligament stability: - Knee ligament stability clinical evaluation - Knee ligament stability clinical evaluation - Knee ligament stability clinical evaluation - Functional performance and return to sport - Functional performance and return to sport - Imaging - Imaging Secondary Outcomes ### Location - Facility: Chang Gung memorial hospital, Taoyuan, N/A, 333, Taiwan @@
## Effect of Sleep Extension on Overweight and Learning in Children - NCT ID: NCT06341179 - Study ID: M2S - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-12-31 - Lead Sponsor: University of Copenhagen ### Study Description More2Sleep is a randomized, controlled, parallel trial with two groups (sleep extension vs control) including 300 school-aged children (6-9 years) who are mildly overweight or obese and habitually sleep for ≤ 9 h/night. Data will be collected before and after a 3-month sleep extension intervention, and after a 6-month follow-up (at months 0, 3, and 9). The collection of data is mainly related to the main study. However, some optional examinations will be conducted on a first come, first serve basis, consisting of substudy-I (metabolic mechanisms, n=60) and substudy-II (learning mechanisms, n=150).The primary objective is to assess the effects of sleep extension by \~45 min/night, achieved by going to bed 60-90 min earlier, on adiposity and learning ability in school-aged children who are overweight or obese, and sleep less than recommended for their age. ### Conditions - Sleep Duration - Child Obesity - Child Development - Child Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sleep extension ### Outcomes Primary Outcomes - BMI Z-score - Learning ability: skill learning - Learning ability: Explicit memory Secondary Outcomes - Body fat percent - Total fat mass (FM) - Total lean mass (LM) - Bone mineral content (BMC) - Bone mineral density (BMD) - Dietary energy intake - Dietary protein, carbohydrate, fiber, and fat intakes - Subjective hunger - Physical activity (PA) time: total PA and MVPA - Resting metabolic rate (RMR) - Thermic effect of food (TEF) - Weight - Height - Total energy expenditure (TEE) - Fasting and postprandial glucose concentration - Fasting and postprandial insulin concentration - Fasting and postprandial total, HDL and LDL cholesterol concentrations - Fasting and postprandial triglyceride concentration - Fasting and postprandial C-reactive protein concentration - Fasting and postprandial tumor necrosis factor alpha concentration - Fasting and postprandial ghrelin concentration - Fasting and postprandial leptin concentration - Fasting and postprandial glucagon like peptide 1 concentration - Fasting and postprandial peptide YY concentration - Fasting and postprandial cholecystokinin concentration - Fasting and postprandial interleukin 6 concentration - Cognitive functions: processing speed - Cognitive functions: Sustained attention - Cognitive functions: Spatial working memory - Cognitive functions: Inhibitory control - Cognitive functions: Cognitive flexibility - School performance: mathematics performance - School performance: reading comprehension - Neurophysiological Measurement 1 - ERP Amplitude - Neurophysiological Measurement 2 - Cortical activity during skill learning - Neurophysiological Measurement 3 - Muscle activity during skill learning - Neurophysiological Measurement 4 - corticocortical functional connectivity - Neurophysiological Measurement 5 - corticomuscular connectivity ### Location - Facility: University of Copenhagen, Copenhagen, N/A, 1958, Denmark @@
## Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse - NCT ID: NCT06341166 - Study ID: CCM1959 - Status: RECRUITING - Start Date: 2023-06-19 - Completion Date: 2025-06-19 - Lead Sponsor: Centro Cardiologico Monzino ### Study Description This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP. ### Conditions - Mitral Valve Prolapse ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prediction of fibrosis by CMR Secondary Outcomes - Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve ### Location - Facility: Centro Cardiologico Monzino, Milan, N/A, 20131, Italy @@
## The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips - NCT ID: NCT06341153 - Study ID: SelcukUni2542 - Status: COMPLETED - Start Date: 2022-07-15 - Completion Date: 2023-11-15 - Lead Sponsor: Sibel Küçükoğlu ### Study Description The study aimed to investigate the effects of breast milk sniffing and breast milk tasting and sniffing on sucking success and early feeding cues in term newborns who were started to breastfeed for the first time. ### Conditions - Breastfeeding - Odors, Body - Newborn; Vitality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breast Milk Odor Stimulation - Stimulation of Breast Milk Smell and Taste ### Outcomes Primary Outcomes - Introductory Information Form - Early Feeding Tips Scale - Breastfeeding Identification and Assessment Scale (LATCH) - Early Feeding Tips Scale - Breastfeeding Identification and Assessment Scale (LATCH) - Early Feeding Tips Scale - Breastfeeding Identification and Assessment Scale (LATCH) Secondary Outcomes ### Location - Facility: Selcuk University, Konya, Selcuklu, 42100, Turkey @@
## The Effect of Breastfeeding Support on Exclusive Breastfeeding, Occurrence of Breast Problems and Breastfeeding Self-Efficacy - NCT ID: NCT06341140 - Study ID: secil koken - Status: COMPLETED - Start Date: 2021-08-01 - Completion Date: 2023-02-06 - Lead Sponsor: Celal Bayar University ### Study Description The aim of the study is to determine the effect of individual breastfeeding support on the lactation process. The research is a randomized controlled experimental study. The sample of the study consisted of pregnant women who applied to the Obstetrics Polyclinic of a university hospital (intervention=51, control=51). In the study, individual breastfeeding education was given to the intervention group during the antenatal period, and a training booklet was given to the control group. In the postpartum period, home visits and phone follow-ups were carried out for both groups between the fifth day and the sixth month. The effect of breastfeeding counseling on the lactation process; The duration of exclusive breastfeeding, breast problems and breastfeeding success was evaluated with. The data of the study were collected using the Pregnant, Postpartum-Newborn Information Form, Breastfeeding Questionnaire, Breast Problems Diagnosis Form, LATCH Breastfeeding Diagnostic Tool and Breastfeeding Self-Efficacy Scale. ### Conditions - Breastfeeding - Breastfeeding, Exclusive ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Breastfeeding support and Booklet containing information about breastfeeding - Booklet containing information about breastfeeding ### Outcomes Primary Outcomes - Situation of mothers feeding their babies exclusively with breast milk - Mothers experiencing breast problems - Determination of mothers' breastfeeding self-efficacy Secondary Outcomes ### Location - Facility: Manisa Celal Bayar University, Manisa, N/A, N/A, Turkey @@
## Fluoxetine in KCNC1-related Disorder - NCT ID: NCT06341127 - Study ID: 2023-01 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-17 - Completion Date: 2025-12-31 - Lead Sponsor: Holland Bloorview Kids Rehabilitation Hospital ### Study Description This is a single patient study of oral powdered fluoxetine to target developmental outcomes in a child with KCNC1-related disorder. This trial will be conducted at Holland Bloorview Kids Rehabilitation Hospital over 32 to 42 weeks, using a quasi experimental ABA phase design (placebo-fluoxetine-placebo) with randomized and blinded active treatment start and stop moments. ### Conditions - KCNC1 Related Disorder - Genetic Disease - Rare Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Fluoxetine ### Outcomes Primary Outcomes - Motor development - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Secondary Outcomes - Adaptive skills - Cognitive skills - Family priority outcome targets - Clinical Global Impression- Improvement Scale (CGI-I) ### Location - Facility: Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, M5G1R8, Canada @@
## A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors - NCT ID: NCT06341114 - Study ID: BAT-8008-1308-001-CR - Status: NOT_YET_RECRUITING - Start Date: 2024-04-12 - Completion Date: 2026-07-28 - Lead Sponsor: Bio-Thera Solutions ### Study Description The study, led by Zhejiang Cancer Hospital and sponsored by Bio-Thera Solutions, Ltd., is an exploratory multicenter, open-label phase Ib-II clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the combination of BAT8008 with BAT1308 in patients with advanced solid tumors.This study aims to explore the safety, tolerability, and pharmacokinetic characteristics of BAT8008 combined with BAT1308 in patients with advanced solid tumors, determine the maximum tolerated dose (MTD), provide recommended doses and reasonable dosing regimens for subsequent clinical studies, and preliminarily evaluate the antitumor efficacy.The study is divided into two stages. The first stage will use a "3+3" dose escalation design to explore the safety and tolerability of the investigational drugs. In the second stage, based on the preliminary safety and efficacy results from the first stage, appropriate doses and tumor types will be selected for expansion studies within the safety dose range to further investigate the safety and clinical efficacy of BAT8008+BAT1308 and provide evidence for subsequent clinical studies. ### Conditions - Advanced Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BAT8008 injection - BAT1308 injection ### Outcomes Primary Outcomes - Dose-limiting toxicity (DLT) - vital signs - Physical examination - Adverse events - Clinical laboratory tests - Clinical auxiliary tests - Objective response rate (ORR) - Duration of Response(DOR) - Disease Control Rate (DCR) - Progression Free Survival(PFS) - Overall Survival(OS) Secondary Outcomes - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic - Pharmacokinetic ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Timely Recovery After Subclinical Heart Failure - NCT ID: NCT06341101 - Study ID: 2022-503135-33-00 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-03-01 - Lead Sponsor: Academisch Ziekenhuis Maastricht ### Study Description The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on:1. Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;2. The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);3. Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);4. Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years.Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure. ### Conditions - Heart Failure - Diastolic Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Perindopril ### Outcomes Primary Outcomes - No left Ventricular Hypertrophy - No concentric remodeling - No impaired systolic function - Normal diastolic function Secondary Outcomes ### Location - Facility: AZMaastricht, Maastricht, Limburg, 6202AZ, Netherlands @@
## Evaluation of Anatomical Results and Sexual Functions After Unilateral and Bilateral Laparoscopic Suture Sacro-hysteropexy Operations - NCT ID: NCT06341088 - Study ID: B.30.2.ATA.0.01.00/132 - Status: RECRUITING - Start Date: 2024-04-05 - Completion Date: 2024-10-05 - Lead Sponsor: Ataturk University ### Study Description The study was planned as prospective and randomized. For the study, patients will be randomized into two groups as unilateral and bilateral suture sacro-hysteropexy operations. ### Conditions - Pelvic Organ Prolapse ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - unilateral suture sacro-hysteropexy - bilateral suture sacro-hysteropexy ### Outcomes Primary Outcomes - anatomical success of the operations Secondary Outcomes - evaluation of the sexual functions of the patients ### Location - Facility: Atatürk University, Erzurum, Palandöken, N/A, Turkey @@
## Real-World Study of Magnetic Resonance-guided Laser Interstitial Thermal Therapy for Drug-resistant Epilepsy - NCT ID: NCT06341075 - Study ID: KY2024-053-02 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-14 - Completion Date: 2026-03-14 - Lead Sponsor: Beijing Tiantan Hospital ### Study Description The goal of the real-world study is to evaluate the long-term seizure control outcomes, postoperative complications, long term impact on cognitive, memory function outcomes, quality-of-life measures, and healthcare resource utilization of magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) on patients with drug-resistant epilepsy (DRE). ### Conditions - Drug Resistant Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) ### Outcomes Primary Outcomes - Seizure-freedom rate Secondary Outcomes - Seizure frequency reduction - ILAE classification of outcome - Seizure severity - Rate of mild complications - Cognitive function evaluation - Memory function evaluation - The quality of life - Length of hospital stay - Rate of reoperations - Rate of antiepileptic drug reduction or withdrawn ### Location - Facility: Beijing Tiantan Hospital, Beijing, Beijing, 100070, China @@
## The Application of Contrast-enhanced Ultrasound in Acute Kidney Injury in ICU - NCT ID: NCT06341062 - Study ID: M2024078 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-06-30 - Lead Sponsor: Peking University Third Hospital ### Study Description The goal of this study is to quantitatively assess renal microcirculation changes by contrast-enhanced ultrasound and to obtain systemic hemodynamic information by ultrasound Doppler at the same time, to analyze the relationship between renal microcirculation changes and systemic hemodynamic changes, and to explore its predictive value in renal function recovery in patients with critical acute kidney injury. The main questions it aims to answer are:1. To explore the quantitative parameters of contrast-enhanced ultrasound which can reflect the changes of renal microcirculation.2. To explore the relationship between renal microcirculation and systemic hemodynamics.3. To explore the value of renal microflow changes quantitatively evaluated by contrast-enhanced ultrasound in predicting renal function recovery. ### Conditions - Intensive Care Unit - Acute Kidney Injury - Ultrasound ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Renal microcirculation quantitatively assessed by Contrast-enhanced ultrasound ### Outcomes Primary Outcomes - Serum creatinine values and/or urine output Secondary Outcomes ### Location - Facility: Department of Ultrasound Diagnosis, Peking University Third Hospital, Beijing, Beijing, N/A, China @@
## Effect of Three Different Postcesarean Analgesic Techniques on QbsQor-10 Score: Prospective, Randomized Trial - NCT ID: NCT06341049 - Study ID: 2024-03/14 - Status: RECRUITING - Start Date: 2024-03-12 - Completion Date: 2025-09-12 - Lead Sponsor: Ataturk University ### Study Description The aim of this study is to evaluate the effects of three different postsesarean analgesia techniques, including instillation of local anesthetic into the peritoneum with infiltration into all layers of the anterior abdominal wall, intrathecal morphine injection with local anesthetic, and quadrotus lumborum type 1 block, on the postoperative recovery of women using the ObsQoR-10 score.. ### Conditions - Postoperative Recovery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intraperitoneal local anasthetic application + local anesthetic wound infiltration - Intrathecal morphine application - Quadratus lumborum block tip 1 application ### Outcomes Primary Outcomes - obstetric quality of recovery-10 (ObsQoR-10) scores of parturient at the 24th and 48th postoperative hours Secondary Outcomes ### Location - Facility: Ataturk University, Erzurum, Palandoken, N/A, Turkey @@
## Aetiology And Outcome Of Children With Thrombocytosis Admitted to Assiut University Children Hospital - NCT ID: NCT06341036 - Study ID: Thrombocytosis in Children - Status: NOT_YET_RECRUITING - Start Date: 2024-07-15 - Completion Date: 2026-03-03 - Lead Sponsor: Assiut University ### Study Description The primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children. ### Conditions - Thrombocytosis in Children ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Aetiology And Outcome Of children with Thrombocytosis admitted to Assiut University children hospital Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Functional Balance Intervention in Multiple Sclerosis - NCT ID: NCT06341023 - Study ID: 2023-1430 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-14 - Completion Date: 2027-01-09 - Lead Sponsor: University of Illinois at Chicago ### Study Description This project involves two sub-parts:Study 1: Effect of lab-based Functional Balance Intervention (FBI) for physical and cognitive symptoms of Multiple Sclerosis.Study 2: Feasibility of home-based FBI for physical and cognitive symptoms of Multiple Sclerosis.Each study involves a 2-arm, Phase-1, randomized controlled clinical trial to evaluate the effect of FBI on physical, cognitive function, and daily living among people with MS (PwMS). Study 1 is conducted in a lab setting, while Study 2 is conducted at home with additional safety measures. A total of 150 people with multiple sclerosis will be recruited and telephone screened, with an expected enrollment of 120 (60 per phase). After in-person screening, 96 eligible participants (48 per phase) will undergo pre-training assessment and randomization into FBI or Stretching groups. Training sessions will occur twice a week for four months. Anticipating a 15-17% attrition rate, the target sample size is 80 (40 per phase) for completion of the study. Post-training assessments will be conducted after four months to evaluate FBI's impact on physical and cognitive functions. This evidence-based protocol, previously successful with neurological and older adult populations, intends to provide a low-cost, safe, and effective intervention for PwMS in clinical and community settings, including rural areas. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Functional Balance Intervention - Stretching ### Outcomes Primary Outcomes - Change in physical function - Change in cognitive function - Change in dual task balance performance - Change in dual task gait performance - Change in measured community mobility - Change in self-reported community mobility - Change in self-reported quality of Life Secondary Outcomes - Change in walking performance - Change in walking speed - Change in balance confidence - Change in functional independence ### Location - Facility: University of Illinois at Chicago, Chicago, Illinois, 60612, United States @@
## The Role of Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis - NCT ID: NCT06341010 - Study ID: The Role of Angiojet Rheolytic - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-09-01 - Lead Sponsor: Abdelrahman Ibrahim Sayed Mohamed Abdalla ### Study Description The aim of this study is to evaluate the efficacy and safety of rheolytic thrombectomy in restoring venous patency DVT, periprocedural complications and development of PTS after tratment of iliofemoral DVT. ### Conditions - Iliofemoral Deep Vein Thrombosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Angiojet Rheolytic Thrombectomy in The Management of Iliofemoral Deep Venous Thrombosis ### Outcomes Primary Outcomes - Technical success Secondary Outcomes - Incidence of PTS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis. - NCT ID: NCT06340997 - Study ID: Mitral Stenosis - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2027-08-01 - Lead Sponsor: Assiut University ### Study Description • Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications. ### Conditions - Mitral Stenosis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Transesophageal echocardiography ### Outcomes Primary Outcomes - Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients with Mitral Stenosis. Secondary Outcomes - Prevention of left atrial appendage thrombus. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast - NCT ID: NCT06340984 - Study ID: sICAM-1 in acne vulgaris - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-02 - Lead Sponsor: South Valley University ### Study Description The aim of this study is to:1. Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group2. Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity3. Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris ### Conditions - Acne Vulgaris ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Montelukast 10 Mg Oral Tablet ### Outcomes Primary Outcomes - Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris (moderate -severe ) - Montelukast in treatment of acne vulgaris patients Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Air Pollution and Pregnancy - NCT ID: NCT06340971 - Study ID: 331247 - Status: RECRUITING - Start Date: 2024-09-01 - Completion Date: 2029-08-31 - Lead Sponsor: Queen Mary University of London ### Study Description We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth.We aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact. ### Conditions - Premature Birth ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Policy ### Outcomes Primary Outcomes - Machine learning model to predict the risk of preterm birth and adverse birth outcomes Secondary Outcomes - Machine learning model to predict how air quality increases the risk of preterm birth and adverse birth outcomes ### Location - Facility: Tina Chowdhury, London, N/A, E14NS, United Kingdom @@
## A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder - NCT ID: NCT06340958 - Study ID: CLE100-MDD-202 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-01-10 - Lead Sponsor: Clexio Biosciences Ltd. ### Study Description The study is a Phase 2, double-blind, randomized, placebo-controlled study in Major Depressive Disorder (MDD) participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 (oral esketamine) for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants. ### Conditions - Adjunctive Treatment of Major Depressive Disorder (MDD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CLE-100 - Placebo ### Outcomes Primary Outcomes - Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score Secondary Outcomes - Change from Baseline in the Clinical Global Impression - Severity (CGI-S) - Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score - Safety Outcomes: Assessment of the safety and tolerability of CLE-100 compared to placebo ### Location - Facility: Clinical Site 105, Lauderhill, Florida, 33319, United States @@
## The Outcomes of Ultrasound-guided Thermal Ablation for Benign Thyroid Nodules - NCT ID: NCT06340945 - Study ID: S2023-761-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-12-31 - Lead Sponsor: Chinese PLA General Hospital ### Study Description 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablationfor the treatment of benign thyroid nodules;2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of benign thyroid nodules ### Conditions - Thyroid Nodules ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ultrasound-guided thermal ablation ### Outcomes Primary Outcomes - volume reduction rate - rate of nodule regrowth Secondary Outcomes - rate of complications - cosmetic score - symptom score - vital volume - total volume ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Opioid Avoidance Protocol for ACL Reconstruction - NCT ID: NCT06340932 - Study ID: CRS-119 (Pro00077191) - Status: NOT_YET_RECRUITING - Start Date: 2024-03-28 - Completion Date: 2024-10-01 - Lead Sponsor: Matthew Varacallo ### Study Description This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for ACLR postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change.The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in MME from POD0-7 after ACLR compared to the current standard of care pain management protocol.Secondary objectives are to:* evaluate the effects of an opioid avoidance protocol on the daily average NRS pain scores from POD0-7* evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7* evaluate the ability to recover opioid free through 7, 30, and 60 days* evaluate the QoR-15 scores on POD2* assess the number of opioid prescriptions required by patients in the 60 day recover period* assess KOOS pain and symptom scales at 8 weeks post-operatively between groups. ### Conditions - ACL Tear - Post Operative Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Iovera - Celecoxib - Acetaminophen - Oxycodone - Tramadol - Bupivacaine Hydrochloride - Acetaminophen 500Mg Cap ### Outcomes Primary Outcomes - Opioid consumption from POD0-POD7 Secondary Outcomes - Average daily pain (NRS) - Average daily worst pain (NRS) - KOOS Pain Subscale Score - Quality of Recovery-15 - Pittsburgh Rehabilitation Participation Scale Score ### Location - Facility: Penn Highlands Dubois, DuBois, Pennsylvania, 15801, United States @@
## Hearing Aid Algorithms for Sudden Sounds - NCT ID: NCT06340919 - Study ID: 1406014978-241 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-21 - Completion Date: 2025-05-31 - Lead Sponsor: Purdue University ### Study Description This study explores the impact of hearing aid settings for managing sudden sounds on speech comprehension and recall in individuals with hearing loss. Participants will undergo a comprehensive audiological evaluation, case history, and cognitive assessments. Subsequently, they will participate in listening experiments designed to measure sentence recognition, storage, and retrieval under various sudden sound reduction conditions recorded through a hearing aid. The experiment will be complemented by subjective preference ratings to identify participant comfort and listening clarity associated with different sudden sound reduction settings. ### Conditions - Hearing Loss ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Sudden Sound Reduction Setting ### Outcomes Primary Outcomes - Speech recognition - Recall - Preference Secondary Outcomes ### Location - Facility: Purdue University, West Lafayette, Indiana, 47907, United States @@
## Electroacupuncture in Symptom Management After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - NCT ID: NCT06340906 - Study ID: 4573 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-01-30 - Lead Sponsor: University of California, Irvine ### Study Description The investigators are conducting this research study is to evaluate the feasibility (recruitment, compliance, safety, and acceptance) of using electroacupuncture (EA) to manage complex symptoms such as pain, nausea/vomiting, diarrhea, and insomnia in patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. Additionally, the investigators are aiming to determine the effectiveness of EA in reducing these symptoms, and to examine how EA impacts important biomarkers, or proteins in the blood, that can be used as indicators or signs of these symptoms. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Electroacupuncture ### Outcomes Primary Outcomes - Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Patients Recruited - Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Patient Recruitment Rate - Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Reasons for Abstaining from Participation - Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Recruitment Duration - Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Number of Completed Electroacupuncture Sessions - Feasibility in utilizing an EA for patients who have undergone Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy - Proportion of Completed Electroacupuncture Sessions Secondary Outcomes - Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30 - Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - EORTC QLQ-C30 - Efficacy of EA in managing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3 - Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Symptoms - FACT-Cog version 3 ### Location - Facility: UCI Health Susan Samueli Integrative Health Institute, Irvine, California, 92697, United States @@
## Exercise Training in Children With Communication Impairments - NCT ID: NCT06340893 - Study ID: 76117 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-31 - Lead Sponsor: Marquette University ### Study Description This clinical trial study has two goals. The first goal is to establish fitness levels, participation in physical activities, and fine/gross motor abilities for children with development language disorder (DLD). DLD occurs in 1/13 children and children with DLD often have poorer fine/gross motor skills than those with typical development. The second goal is to determine whether physical exercise helps children with DLD and typical development to learn better and improve fitness and fine/gross motor abilities more than participating in restful play activities.All children (DLD and typically developing) will undergo communication, fine/gross motor and fitness testing. Children will be randomly assigned to participate in an exercise program (n =20) or to a restful play program (n = 20). Both programs will take place 3x/week for 6 weeks and children will only participate in one of the two programs.Children in the exercise program will do activities to train cardiovascular fitness, agility, balance, strength, and endurance while children in the restful play condition will do things like play with legos and color.Researchers will compare changes in learning tasks and fitness levels for children (DLD and typically developing) who participated in the exercise program vs. restful play program. ### Conditions - Developmental Language Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Exercise - Restful Play ### Outcomes Primary Outcomes - Changes to cognitive-linguistic performance: Word learning accuracy (% correct) - Changes to cognitive-linguistic performance: Reaction time on the Serial Reaction Time task (milliseconds) Secondary Outcomes - Fitness: Maximum oxygen consumption (VO2 max) (ml/kg/min) - Motor Performance (scaled scores) - Enjoyment of Intervention ### Location - Facility: Marquette U, Milwaukee, Wisconsin, 53201, United States @@
## Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided. - NCT ID: NCT06340880 - Study ID: SAPB - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-05 - Lead Sponsor: Menoufia University ### Study Description This prospective, double-blinded randomized controlled trial aims to compare the efficacy of the serratus anterior plane block (SAPB) ultrasound guided versus anatomical landmark guided for gynecomastia surgery. And to detect if the anatomical landmark technique is inferior or not to the ultrasound guided technique. We hypothesize that anatomical landmark guided SAPB is not inferior to ultrasound guided SAPB. ### Conditions - Serratus Anterior Plane Block ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Serratus anterior plane block ### Outcomes Primary Outcomes - visual numerical rating score (NRS) Secondary Outcomes - first call of analgesia - incidence of complications - patient satisfaction ### Location - Facility: Menoufia University Hospitals, Shibīn Al Kawm, Menoufia, N/A, Egypt @@
## Intraoral Scanner With and Without Orthodontic Brackets - NCT ID: NCT06340867 - Study ID: 30723 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-04-01 - Lead Sponsor: Cairo University ### Study Description this study aim to evaluate the effect of two different intraoral scanners on the scanning Quality and Time in Patients With/Without Orthodontic Brackets ### Conditions - Intra-oral Scanner - Adolescent Behavior ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CEREC primescan intra-oral scanner ### Outcomes Primary Outcomes - The effect of the different scanning techniques on the scanning quality and time Secondary Outcomes - The effect of the bracket presence on the scanning quality ### Location - Facility: Faculty of Dentistry, Cairo university, Cairo, N/A, N/A, Egypt @@
## A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes - NCT ID: NCT06340854 - Study ID: NN1436-7724 - Status: RECRUITING - Start Date: 2024-04-19 - Completion Date: 2025-06-20 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study compares insulin icodec, a new insulin taken once a week, to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 2 diabetes. Participants will either get insulin icodec or insulin glargine. Which treatment participants get is decided by chance. Insulin icodec is the new medicine being tested, while insulin glargine is already approved and can be prescribed by doctors. Participants will get one injection of insulin icodec once a week, or one injection of insulin glargine once a day, depending on the treatment group participants are assigned into. Participants will use a pen with a small needle to inject the medicine under participants skin into participants thigh, upper arm or stomach.The study will last for about 9 months, but participants will only be taking the study medicine for 6 months. ### Conditions - Diabetes, Type 2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Insulin icodec - Insulin glargine ### Outcomes Primary Outcomes - Change in glycated hemoglobin (HbA1c) Secondary Outcomes - Change in time in range 3.9-10.0 millimoles per litre (mmol/L) (70-180 milligrams per decilitre (mg/dL)) - Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire status version) total treatment satisfaction - Number of severe hypoglycaemic episodes (level 3) - Number of clinically significant hypoglycaemic episodes (level 2) (less than (<) 3.0 millimoles per litre (mmol/L) (54 mg/dL), confirmed by blood glucose (BG) meter) - Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL),confirmed by BG meter) or severe hypoglycaemic episodes (level 3) - Time spent < 3.0 mmol/L (54 mg/dL) - Change in time spent > 10.0 mmol/L (180 mg/dL) - Mean weekly insulin dose - Change in body weight ### Location - Facility: Advanced Investigative Medicine, Inc., Hawthorne, California, 90250, United States @@
## LEMURS SSI: Evaluation of Behavioral Incentives - NCT ID: NCT06340841 - Study ID: LEMURS SSI 24 - Status: RECRUITING - Start Date: 2024-02-12 - Completion Date: 2028-05-31 - Lead Sponsor: University of Vermont ### Study Description The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities. ### Conditions - Incentives ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Personal Incentives - Personal Restorative Incentives - Charity Incentives - Charity Restorative Incentives ### Outcomes Primary Outcomes - Activity Completion Secondary Outcomes - Depression, Anxiety, Stress Scale - 21 - Depression, Anxiety, Stress Scale - 21 - Depression, Anxiety, Stress Scale - 21 - Warwick-Edinburgh Mental Well-being Scale - Oura Ring Sleep Index ### Location - Facility: University of Vermont, Burlington, Vermont, 05405, United States @@
## Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study - NCT ID: NCT06340828 - Study ID: 2023-KY-186-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-07-20 - Lead Sponsor: The Second Hospital of Nanjing Medical University ### Study Description The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are:* The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests.* The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria.* The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes.* The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients.Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment. ### Conditions - Diabetic Gastroparesis - Diabetic Gastropathy - Diabetic Gastroenteropathy - Diabetic Gastroparesis Associated With Type 2 Diabetes Mellitus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Washing Microbiota Transplantation ### Outcomes Primary Outcomes - Gastrointestinal Symptom Rating Scale - Gut Microbiome Sequencing Secondary Outcomes - Gastroparesis Cardinal Symptom Index - Composite Autonomic Symptom Score 31 - Gastrointestinal Motility - Heart Rate Variability - Serum Metabolites ### Location - Facility: The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210000, China @@
## Varian ProBeam Proton Therapy System Clinical Trial (Shandong) - NCT ID: NCT06340815 - Study ID: VAR-2022-02 - Status: COMPLETED - Start Date: 2022-07-20 - Completion Date: 2023-03-10 - Lead Sponsor: Varian, a Siemens Healthineers Company ### Study Description This study is prospective, single-center, single-arm objective performance criteria.This trial will be conducted with a total of 47 subjects enrolled. All of subjects will be treated with radiation therapy using the medical device Varian ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for oncology patients, providing a clinical basis for the medical device registration. ### Conditions - Tumor, Solid ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Radiation: Proton Therapy System (ProBeam) ### Outcomes Primary Outcomes - Effectiveness evaluation: Local tumor control rate at 90 days after the proton radiation treatment completion - Safety evaluation: Incidence of Acute radiation injury - Safety evaluation: Incidence of Adverse Events based on CTCAE 5.0 criteria Secondary Outcomes ### Location - Facility: Sophia Shao, Shanghai, N/A, 230001, China @@
## A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl - NCT ID: NCT06340802 - Study ID: SYG001 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-12 - Lead Sponsor: Synergia Medical ### Study Description This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM. ### Conditions - Drug Resistant Epilepsy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - VNS Treatment ### Outcomes Primary Outcomes - Treatment emergent adverse events - Procedure and/or device related adverse events Secondary Outcomes - Device-related treatment emergent adverse events - Device deficiencies - Procedural Success - Change in seizure frequency - Proportion of responders - Change in seizure severity - Change in quality of life - Changed in mood - Usability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate - NCT ID: NCT06340789 - Study ID: A-BR-110-49 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-04-30 - Lead Sponsor: National Cheng-Kung University Hospital ### Study Description Although antipsychotic is effective for schizophrenia, however, still certain proportion of patients were not responsive to treatment. Treatment resistant schizophrenia (TRS) is accompanied by function decline and heavy burden. In recent decades, the biological mechanism of schizophrenia extended from dopamine theory to the role of glutamate system. This shift could be an alternative pathway to developing the treatment of TRS. Sodium benzoate (SB) could be an option as a glutamatergic agent for the patients with TRS. However, most evidence of SB is for treating patients with schizophrenia and other mental disorders but the evidence for treating patients with TRS is scarce. To predict the treatment response of SB will be an urgent topic in the future. Little is known about the precise medicine for treating patients with TRS. The present project will extend our pilot randomized clinical trial on SB for TRS. A total of 90 patients with TRS will be enrolled from three centers and will be assigned to 8 weeks of treatment with SB or placebo (2:1). A comprehensive battery of potential markers will be employed, including 1H- magnetic resonance spectroscopy (MRS), brain functional connectivity, genotyping, immune biomarkers, cognitive function, and clinical characteristics. The efficacy of SB on TRS will be confirmed in this project. Predictors for treatment response will be identified. Artificial intelligence algorithms will be used for probing the feasibility of precision medicine. ### Conditions - Symptom, Cognitive - Schizophrenia - Schizo Affective Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sodium Benzoate 2gram/day - Placebo ### Outcomes Primary Outcomes - Brain imaging, functional MRI Secondary Outcomes - Clinical psychiatric condition, Positive and Negative Symptoms Scale (PANSS) - Wechsler adult intelligence scales 4th edition (WAIS-IV) - Continuous performance test third edition (CPT-3) - Wisconsin card sorting test (WCST) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With Hysterectomy - NCT ID: NCT06340776 - Study ID: 81321 - Status: COMPLETED - Start Date: 2021-08-15 - Completion Date: 2023-09-28 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description Aim This randomized controlled trial was conducted to evaluate the effect of acupressure application on gastrointestinal functions and pain after abdominal hysterectomy.Materials and methods After undergoing hysterectomy, 39 women were randomised into acupressure (n=19), and control groups (n=20). Women in the acupressure group received acupressure on the mide meridian (ST36), the heart meridian (HT7), large intestine meridian (LI4), intersection of the spleen, liver and kidney meridians 6(SP6) and pericardium meridian (PC6) acupoints 30 min after admission to the clinic, for a period of 15 min, whereas those in the sham group received acupressure on locations 1-1.5 cm away from these points. The control group received standard treatment. The patient information form, Visual analog scale, the Rhodes Index of Nausea, Vomiting and Retching, and daily follow-up form were used for data collection. ### Conditions - Pain Management - Hysterectomy - Vomiting ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Acupressure ### Outcomes Primary Outcomes - the score of nausea, vomiting and retching experiences - gas output and stool formation of the participants - postoperative pain Secondary Outcomes - Systolic Blood pressure - Heart rate - Diastolic blood pressure ### Location - Facility: Yeliz Yildirim Varişoğlu, Istanbul, Beykoz, 34413, Turkey @@
## JETi Hong Kong Post Market Study (PMS) - NCT ID: NCT06340763 - Study ID: ABT-CIP-10466 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-02 - Lead Sponsor: Abbott Medical Devices ### Study Description The JETi Hong Kong PMS is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the lower extremity peripheral vasculature. This is a post-market study that will register approximately 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days after the JETi procedure. ### Conditions - Peripheral Artery Thrombosis - Peripheral Venous Thrombosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - JETi Hydrodynamic Thrombectomy System ### Outcomes Primary Outcomes - For Arterial Subjects: Clot removal grade for each JETi-treated vessel - For Arterial Subjects: Composite of JETi-related major adverse events (MAEs) - For Venous Subjects: Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score (limb basis). - For Venous Subjects: Composite of JETi-related major adverse events (MAEs) Secondary Outcomes ### Location - Facility: Prince of Wales Hospital, Hong Kong, N/A, N/A, Hong Kong @@
## BAFF CAR-T Cells (LMY-920) for Systemic Lupus Erythematosus - NCT ID: NCT06340750 - Study ID: LMY-920-003 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-04-15 - Lead Sponsor: Luminary Therapeutics ### Study Description This phase 1 study seeks to examine the safety and recommended phase 2 dose (RP2D) of BAFF-ligand CAR-T cells (LMY-920) in adult patients with refractory systemic lupus erythematosus (SLE). It is hypothesized that BAFF CAR-T cells will be safe and will improve SLE disease activity scores. ### Conditions - Systemic Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LMY-920 ### Outcomes Primary Outcomes - Safety of the Treatment - Recommended Phase 2 Dose (RP2D) Secondary Outcomes - Efficacy of the Treatment: SELENA-SLEDAI - Efficacy of the Treatment: BILAG - Efficacy of the Treatment: PGA ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas - NCT ID: NCT06340737 - Study ID: IRB-73394 - Status: RECRUITING - Start Date: 2024-03-29 - Completion Date: 2031-04 - Lead Sponsor: Stanford University ### Study Description This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion. ### Conditions - Follicular Lymphoma - Mantle Cell Lymphoma - Hairy Cell Leukemia - Lymphoplasmacytic Lymphoma - Burkitt Lymphoma - Marginal Zone Lymphoma - Waldenstrom Macroglobulinemia ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - CD22CART Infusion ### Outcomes Primary Outcomes - Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort. - Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) - Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL) Secondary Outcomes - Evaluate Progression Free Survival (PFS) - Evaluate Overall Survival (OS) - Evaluate Duration of Response (DOR) - Assess the response rate in adults with relapsed/refractory Hairy cell leukemia (HCL), Lymphoplasmacytic lymphoma (Waldenstrom macroglobulemia) (WM), Burkitt lymphoma (BL), and Marginal Zone lymphoma (MZL). ### Location - Facility: Stanford University, Palo Alto, California, 94304, United States @@
## Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication - NCT ID: NCT06340724 - Study ID: KY20240123-08 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail. ### Conditions - Helicobacter Pylori Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Vonoprazan - Amoxicillin - Banxiaxiexin decotion ### Outcomes Primary Outcomes - Change from Baseline in functional dyspepsia symptoms at 6 weeks - Change in Traditional Chinese Medicine syndromes from Baseline to 6 weeks Secondary Outcomes - Adverse reactions that occur after taking medication - Patients' drug compliance ### Location - Facility: Nanjing First Hospitai, Nanjing, Jiangsu, 210006, China @@
## Study of Suratadenoturev (OBP-301) in Combination With Pembrolizumab in Esophagogastric Adenocarcinoma - NCT ID: NCT06340711 - Study ID: 23-06026219 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description The goal of this study is to learn about of the research study drug, telomelysin (OBP-301), in combination with pembrolizumab in advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The main question it aims to answer is whether this combination is safe and effective in this type of cancer.Participants will receive 5 injections of OBP-301, approximately every 2 weeks. OBP-301 will be injected directly into the tumor during an esophagogastroduodenoscopy (EGD). At the same time as the injection, a tumor biopsy will be taken. Participants will also receive pembrolizumab infusions every 6 weeks until disease progression or for a maximum of two years. Pembrolizumab infusions will occur on different days than OBP-301 injections. ### Conditions - Esophageal Adenocarcinoma - Gastric Adenocarcinoma - Gastroesophageal Junction Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - OBP-301 - Pembrolizumab ### Outcomes Primary Outcomes - Overall response rate as assessed by the RECIST v1.1 - Number of serious adverse events (SAEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 - Number of adverse events (AEs) tabulated by severity and classification per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Secondary Outcomes - Disease control rate (DCR) - Duration of response (DoR) - Overall Survival (OS) - Progression free survival (PFS) ### Location - Facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, 10065, United States @@
## An RCT to Improve HRQoL of HIV+ Mothers and Children - NCT ID: NCT06340698 - Study ID: GRF-11606221 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-02 - Lead Sponsor: City University of Hong Kong ### Study Description The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive children and their HIV positive mothers in China.The main questions it aims to answer are:1. Whether baseline resilience and treatment adherence are associated with the HRQoL;2. Whether the resilience intervention will improve the mediators associated with intervention sessions, such as positive coping and social support, the proximal outcome of resilience factors, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;3. Whether the adherence intervention will improve the mediators associated with intervention sessions, such as adherence information and behavioral skills, the proximal outcome of self-reported adherence, the distal outcome of HRQoL, and dyadic level outcomes such as dyadic coping;4. Whether the enhanced mediators (e.g., positive coping and social support) associated with the resilience-intervention sessions at the end of the intervention will transmit the effect of the resilience intervention on the increases in resilience factors during follow-ups;5. Whether the improved mediators (e.g., adherence information and behavioral skills) associated with the adherence-intervention sessions at the completion of the intervention will transmit the effect of the adherence intervention on the increases in adherence in follow-ups.Participating mother-child dyads in the two intervention arms will receive two sessions of dyadic intervention. Researchers will compare the above-described outcomes between participants in the two intervention arms and the control arm (treatment as usual) to see the effectiveness of the interventions. ### Conditions - HIV - Perinatal HIV Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Resilience intervention - Adherence intervention ### Outcomes Primary Outcomes - Change of health-related quality of life (HRQoL) - Change of depressive and anxiety symptoms - Change of resilience factors - Change of HAART adherence - Change of mediators in the resilience intervention: Perceived stigma - Change of mediators in the resilience intervention: Emotional regulation - Change of mediators in the resilience intervention: Positive coping - Change of mediators in the resilience intervention: Social support - Change of mediators in the resilience intervention: Self-efficacy - Change of mediators in the adherence intervention: Adherence information, motivation, and behavioral skills - Change of mediators in the adherence intervention: Illness perception - Change of mediators in the adherence intervention: Adherence efficacy - Change of mediators in the adherence intervention: Children's medication-taking responsibility Secondary Outcomes - Change of mother-child relationship and interaction: Dyadic coping - Change of mother-child relationship and interaction: Mother-child closeness - Change of mother-child relationship and interaction: Family harmony - Change of mother-child relationship and interaction: Mother-child conflict - Change of mother-child relationship and interaction: Relationship satisfaction ### Location - Facility: Guangxi Center for Disease Prevention and Control, Nanning, Guangxi, 530027, China @@
## Triheptanoin for Children With Primary-Specific Pyruvate Dehydrogenase Complex (PDC) Deficiency - NCT ID: NCT06340685 - Study ID: STUDY23050042 - Status: RECRUITING - Start Date: 2024-05 - Completion Date: 2027-06-30 - Lead Sponsor: Jirair Krikor Bedoyan ### Study Description This is a medical research study to test a medication in patients with a disease called Pyruvate Dehydrogenase Complex (PDC) Deficiency. The medication is triheptanoin, which is currently FDA approved for the treatment of Long-Chain Fatty Acid Oxidation Disorders. Previous research suggests that triheptanoin may also be effective in the treatment PDC Deficiency. This study will investigate the safety and efficacy (how well it works) of triheptanoin in patients with PDC Deficiency. ### Conditions - Pyruvate Dehydrogenase Complex Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Triheptanoin ### Outcomes Primary Outcomes - Number of participants who report side-effects related to gastrointestinal (GI) distress - Normalization of biochemical markers of disease (lactate) - Normalization of biochemical markers of disease (pyruvate) - Normalization of biochemical markers of disease (β-hydroxybutyrate level) - Normalization of biochemical markers of disease (Alanine/Leucine ratio) - Normalization of biochemical markers of disease (Alanine/Lysine ratio) - Normalization of biochemical markers of disease (Alanine/Proline ratio) - More efficacious seizure control - More efficacious metabolic control - More efficacious disease control Secondary Outcomes - Improved quality of life - Improved long-term maintenance and tolerance of diet - Improved quality of life ### Location - Facility: UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States @@
## The Effect of AR in Patient Pre-operative Education - NCT ID: NCT06340672 - Study ID: STUDY24010034 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-02-01 - Lead Sponsor: University of Pittsburgh ### Study Description The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in older adults undergoing spinal surgery. The main aims of this study are:Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores.Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals.This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices. ### Conditions - Anterior Cervical Discectomy and Fusion - Transforaminal Lumbar Interbody Fusion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Augmented Reality Enhanced Preoperative Counseling - Standard preoperative counseling ### Outcomes Primary Outcomes - Amsterdam Preoperative Anxiety and Information Score (APAIS) survey - Simulator Sickness Questionnaire (SSQ) - Evaluation of the Experience of General Anesthesia (EVAN-G) Survey - Time of preoperatively patient counseling - Degree of knowledge acquisition questionnaire at baseline - Degree of knowledge acquisition questionnaire 2 weeks post-operative - Degree of knowledge acquisition questionnaire 3 months post-operative - Degree of knowledge acquisition questionnaire 6 months post-operative - Participant age - Participant gender - Participant's indication for surgery - Participant education - Participant's past surgeries - Names of pain medications - Doses of pain medications - Prior experience with simulated environments - Patient understanding of surgery at baseline - Patient understanding of surgery 2 weeks post-operative - Patient understanding of surgery 3 months post-operative - Patient understanding of surgery 6 months post-operative - Patient pain level at baseline - Patient pain level 2 weeks post-operatively - Patient pain level 3 months post-operatively - Patient pain level 6 months post-operatively - Confidence in surgeon at baseline - Confidence in surgeon 2 weeks post-operatively - Confidence in surgeon 3 months post-operatively - Confidence in surgeon 6 months post-operatively - Patient preoperative visit satisfaction level - Patient satisfaction level with the surgical explanation at baseline - Patient postoperative visit satisfaction level 2 weeks post-operatively - Patient surgery satisfaction level 2 weeks post-operatively - Patient postoperative visit satisfaction level 3 months post-operatively - Patient surgery visit satisfaction level 3 months post-operatively - Patient postoperative visit satisfaction level 6 months post-operatively - Patient surgery satisfaction level 6 months post-operatively Secondary Outcomes - Patient referral rates - Patient retention rates - Patient preference on the type of pre-operative counseling received for the AR-specific participants ### Location - Facility: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States @@

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