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## A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants - NCT ID: NCT06356259 - Study ID: IMMUNRX-01 - Status: RECRUITING - Start Date: 2023-06-07 - Completion Date: 2025-01-22 - Lead Sponsor: ImmunoRx Pharma Inc. ### Study Description The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics with intravenous(IV) administration of IRX-010 in Healthy Participants. ### Conditions - Healthy Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: BASIC_SCIENCE ### Interventions - IRX-010 - Placebo ### Outcomes Primary Outcomes - Number of participants with Serious Adverse Events - Number of participants with Treatment-Emergent Adverse Events Secondary Outcomes - Pharmacokinetics(PK): Area under Curve(AUC) - Pharmacokinetics(PK): Maximum Concentration (Cmax) - Pharmacokinetics(PK): Half-Life (t½) ### Location - Facility: ICON, Groningen, N/A, 9728, Netherlands @@
## Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association. - NCT ID: NCT06356246 - Study ID: APHP240363 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-08-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Cystic Fibrosis (CF) is a rare hereditary disease with autosomal recessive transmission, affecting 1 in 4700 births in France. Numerous studies have explored the links between oral health and CF, predominantly focusing on a children population. These studies reveal hyposalivation, a risk of dental erosion, an increased prevalence of enamel structural defects, but a reduced prevalence of dental caries in CF children, potentially explained by better oral hygiene. Periodontal disease does not appear to be increased in this population, while the oral quality of life of CF patients has been insufficiently studied.Today, emerging challenges arise due to the increased life expectancy of CF patients, attributed to the rise of modulators such as Kaftrio®, resulting in an adult-majority population in France. The study of periodontal diseases, associated with oral dysbiosis, becomes relevant as they represent bacterial reservoirs that could impact respiratory complications in CF patients.To deepen understanding of the links between oral health and CF, as well as to improve oral health of these patients, it is crucial to update the specific oral profile of this population. A cross-sectional survey using a questionnaire is proposed to include a large number of CF patients in France, aiming for real-life data. This questionnaire is constructed around internationally recognized tools for comparative analysis with normative data. Collaboration with the Patients Association "Vaincre la Mucoviscidose" (VLM) facilitates questionnaire creation, dissemination, and interpretation of results. ### Conditions - Cystic Fibrosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Periodontal Risk Screening Score PESS Secondary Outcomes - Assess the adherence to good oral hygiene practices and dental follow-up in adult CF patients according to French Union for Oral Health (UFSBD) 2021 - Evaluate the risk of dental caries and tooth wear - Assess the oral quality of life - Evaluate oral dryness ### Location - Facility: Marjolaine GOSSET, Ivry-sur-Seine, Ile-de-France, 94270, France @@
## Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy - NCT ID: NCT06356233 - Study ID: FIMBEX - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-12-31 - Lead Sponsor: Fundación Iniciativa para las Neurociencias (FINCE) ### Study Description This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF). ### Conditions - STXBP1 Encephalopathy With Epilepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention will be performed ### Outcomes Primary Outcomes - CSF biomarkers - EEG markers - MRI markers Secondary Outcomes - Clinical phenotype ### Location - Facility: Hospital Ruber Internacional, Madrid, N/A, 28034, Spain @@
## GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health) - NCT ID: NCT06356220 - Study ID: IRB-P00046867 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2026-07 - Lead Sponsor: Boston Children's Hospital ### Study Description We propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. We hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits ### Conditions - Celiac Disease in Children - Nutrition Disorder, Child ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Gluten-Free Diet Education ### Outcomes Primary Outcomes - To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass Secondary Outcomes - To compare the effect of GFFG vs conventional GFD class on diet quality - To compare the effect of GFFG versus conventional GFD on arsenic exposure ### Location - Facility: Boston Children's Hospital, Boston, Massachusetts, 02115, United States @@
## Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study - NCT ID: NCT06356207 - Study ID: 113-2023 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-03 - Lead Sponsor: Azienda Ospedaliera di Bolzano ### Study Description Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study. ### Conditions - Syncope - Pacemaker - Asystole - Neurally Mediated Syncope ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tilt Table Test ### Outcomes Primary Outcomes - SALT (Syncope-Asystole Latency Time) Secondary Outcomes - Recurrence of syncope - Recurrence of syncope ### Location - Facility: Azienda Sanitaria di Bolzano, Bolzano, N/A, 39100, Italy @@
## Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir - NCT ID: NCT06356194 - Study ID: AT-01B-006 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-05-30 - Lead Sponsor: Atea Pharmaceuticals, Inc. ### Study Description Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir ### Conditions - Healthy Volunteer Study ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK - Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. ### Outcomes Primary Outcomes - PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR). - To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) Secondary Outcomes ### Location - Facility: Atea Study Site, Québec, Montreal, N/A, Canada @@
## Training Adaptations With and Without Ventilatory Training Device - NCT ID: NCT06356181 - Study ID: Pro00135143 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-09-01 - Lead Sponsor: University of South Carolina ### Study Description This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Respiratory Maximus Training Device - No Respiratory Training Device ### Outcomes Primary Outcomes - Changes in spirometry - Changes in aerobic capacity - Changes in peak power - Changes in ventilatory threshold - Changes in countermovement jump - Changes in anaerobic capacity - Changes in high-intensity functional training test - Changes in heart rate at ventilatory threshold Secondary Outcomes - Changes in body composition - Changes in sleep quality - Changes in total mood disturbances - Changes in positive mood and emotion - Change in blood lactate responses - Changes in negative mood and emotion ### Location - Facility: University of South Carolina Sport Science Lab, Columbia, South Carolina, 29208, United States @@
## Virtual Reality in End Stage Kidney Disease - NCT ID: NCT06356168 - Study ID: SVR/IVR - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-01-31 - Lead Sponsor: University of Pennsylvania ### Study Description The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks. ### Conditions - End Stage Kidney Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Social Virtual Reality - Individual Virtual Reality ### Outcomes Primary Outcomes - De Jong Gierveld Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer - NCT ID: NCT06356155 - Study ID: UMCC 2023.011 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2027-07 - Lead Sponsor: University of Michigan Rogel Cancer Center ### Study Description This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab. ### Conditions - Urothelial Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Enfortumab vedotin - Pembrolizumab ### Outcomes Primary Outcomes - Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in cisplatin-eligible patients based off pathological response Secondary Outcomes - Assess the safety and toxicity of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in UTUC - Assess whether patients who receive the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy have increased surgical complications. - Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring RECIST v1.1 measurable disease. - Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year recurrence-free survival (RFS). - Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year overall survival (OS). - Estimate the number of patients who are able to complete neoadjuvant combination enfortumab vedotin and pembrolizumab and safely complete definitive surgery. ### Location - Facility: University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109, United States @@
## The Effects of Palmar Cooling on Repeated Sprinting Ability - NCT ID: NCT06356142 - Study ID: UMMC-IRB-2023-317 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-03-01 - Lead Sponsor: University of Mississippi Medical Center ### Study Description Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale. ### Conditions - Exercise Induced Fatigue ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Palmar Cooling - Placebo Palmar Cooling ### Outcomes Primary Outcomes - Participants Sprinting times Secondary Outcomes - Participants Heart Rate Recovery - Participants Rating of Perceived exertion - Participants Reported Delayed Onset Muscle Soreness ### Location - Facility: University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States @@
## Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma - NCT ID: NCT06356129 - Study ID: CA073-1020 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-24 - Completion Date: 2029-11-20 - Lead Sponsor: Celgene ### Study Description The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL). ### Conditions - Large B-cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Golcadomide - Placebo - Rituximab - Cyclophosphamide - Doxorubicin - Vincristine - Prednisone ### Outcomes Primary Outcomes - Progression-free survival (PFS) assessed by the Investigator Secondary Outcomes - Overall survival (OS) - Event-free survival (EFS) - Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC) - Minimal residual disease (MRD) negativity rate - Progression-free survival (PFS) assessed by the IRAC - Objective response (OR) assessed by the Investigator - Complete metabolic response (CMR) assessed by the Investigator - PFS24 assessed by the Investigator 24 months after randomization - Duration of response (DoR) - Second progression-free survival (PFS2) assessed by the Investigator - Relative dose intensity (%) - Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire - Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire - Mean change from baseline in the EORTC QLQ-C30 - Mean change from baseline in the FACT-LymS - Number of participants with Adverse Events (AEs) - Number of participants with treatment-emergent adverse events (TEAEs) - Number of participants with laboratory abnormalities - Number of participants with vital sign abnormalities ### Location - Facility: Local Institution - 0014, Mobile, Alabama, 36604, United States @@
## Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty - NCT ID: NCT06356116 - Study ID: CMUH111-REC3-029 - Status: RECRUITING - Start Date: 2023-11-14 - Completion Date: 2024-12-31 - Lead Sponsor: China Medical University Hospital ### Study Description The causes for total hip arthroplasty (THA) in Taiwan include ischemic necrosis of the femoral head and degenerative osteoarthritis. Contemporary, the surgical approach for total hip replacement mostly adopts the lateral approach. However, the direct anterior approach (DAA) has gained attention gradually due to its characteristics such as muscle preservation, small surgical incision length, and few surgical complications. Nevertheless, literature lacks detailed exploration or long-term follow-up on the recovery of physical functions related to fall occurrence after this type of surgery. It limits the establishment and design of suitable post-operative rehabilitation plans. Therefore, this study aims to explore and follow-up the functional recovery in patients who undergo the DAA for hip replacement using current usual care and new-designed accelerated rehabilitation program. The proposed method involves recruiting 30 patients who will undergo the DAA for total hip replacement, who will receive the current usual care plan; and another 30 patients will receive the accelerated rehabilitation program. The assessments will be conducted before the surgery and at 2, 4, 8, and 12 weeks after the operation, evaluating hip joint function, hip abduction and flexion muscle strength, balance function, and gait performance. The statistical analysis will utilize mixed-model two-factor ANOVA, comparing the preoperative and postoperative recovery of patients undergoing the DAA with different intervention programs and at different time points. The expected outcome of this study is to enhance the understanding of the functional recovery of patients undergoing the DAA for total hip replacement in terms of hip joint function, muscle strength, balance function, and gait performance after surgery. This information will help establish the targeted DAA postoperative treatment plans, which will be practically applied to patients and compared with the current usual care to assess its effectiveness, ultimately contributing to more efficient rehabilitation plans in the future. ### Conditions - Total Hip Arthroplasty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Usual care - Accelerated rehabilitation ### Outcomes Primary Outcomes - Functional recovery questionaire - Maximum muscle strength - Quality of Life questionaire Secondary Outcomes - Balance function - Gait performance - Walking speed ### Location - Facility: China Medical University Hospital, Taichung, N/A, 404, Taiwan @@
## Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula On Undernourished Neurologically Impaired Children - NCT ID: NCT06356103 - Study ID: 0107060 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-07-15 - Lead Sponsor: Alexandria University ### Study Description Purpose: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. It must be recognized and treated as early as possible. This study aimed primarily to compare the efficacy of high-caloric whey-based partially hydrolyzed formula (HC-WPHF) versus standard feeding on the nutritional status reflected by growth parameters and feeding tolerance in undernourished children with neurological impairment (NI). The secondary aim was to compare the change in these parameters after using HC-WPHF for 3 and 6 months. ### Conditions - Nutrition Disorder, Child - Neurologic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - High Caloric Whey-Based Partially Hydrolyzed Formula - nutritional feeding according to ESPGHAN guidelines ### Outcomes Primary Outcomes - To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI). - To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in centimeter in undernourished children with neurological impairment (NI). - To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the body mass index (BMI) in children with neurological impairment (NI). - To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in centimeter in undernourished children with neurological impairment (NI) Secondary Outcomes - To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI) for 3 and 6 months - To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months - To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus on the body mass index in undernourished children with neurological impairment (NI) for 3 and 6 months - To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months ### Location - Facility: Alexandria University Children Hospital, Alexandria, N/A, 23445, Egypt @@
## SPACE: a Parent-based Treatment for Pediatric OCD - NCT ID: NCT06356090 - Study ID: 2023.0322 - NL84369.018.23 - Status: RECRUITING - Start Date: 2023-11-23 - Completion Date: 2025-03-31 - Lead Sponsor: Chaim Huijser ### Study Description This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment. ### Conditions - Obsessive-Compulsive Disorder - Obsessive-Compulsive Disorder in Children - Obsessive-Compulsive Disorder in Adolescence - Anxiety Disorders and Symptoms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Supportive Parenting for Anxious Childhood Emotions (SPACE) ### Outcomes Primary Outcomes - (Change in) OCD severity - (Change in) family accommodation (parent report) - (Change in) Family accommodation (child report) - Daily (change in) OCD symptoms - Daily (change in) family accommodation Secondary Outcomes - Symptoms of child anxiety - Symptoms of child depression - Symptoms of autism - Quality of life (parent-report) - Quality of life (child-report) - Clinical impression of outcome - Treatment progress - Session experience - Treatment adherence ### Location - Facility: Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry), Amsterdam, N/A, N/A, Netherlands @@
## Evaluation of the Satisfaction of a Hypertensive Population in Their Use of the Aktiia 24/7 Blood Pressure Monitor - NCT ID: NCT06356077 - Study ID: OBPM_HTN2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-12 - Lead Sponsor: Aktiia SA ### Study Description OBPM_HTN2024 study was designed by AKTIIA SA to evaluate how a hypertensive population, reflective of the United States and encompassing a range of phenotypes, perceives the Aktiia 24/7 device (Aktiia G1) during their first 3 months of use. ### Conditions - Hypertension ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Preferences of subjects regarding the method to monitor their blood pressure between Aktiia Bracelet, Home Blood Pressure Monitor, or Ambulatory Blood Pressure Monitor - Frequency of Aktiia app use - Frequency of use of Aktiia device as compared to previously use other blood pressure monitors Secondary Outcomes - Evaluation of subject's experience in using the Aktiia App - Evaluation of the most valuable data on the Aktiia Mobile App by subjects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei - NCT ID: NCT06356064 - Study ID: E2-23-3834 - Status: COMPLETED - Start Date: 2023-05-15 - Completion Date: 2024-01-15 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up. ### Conditions - Spur, Heel ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Extracorporeal shock wave therapy ### Outcomes Primary Outcomes - Visual Analog Scale - Functional Foot Index Secondary Outcomes - Radiographic assesment, epin size ### Location - Facility: Özge TEZEN, Ankara, N/A, N/A, Turkey @@
## Cardiovascular Disease Risk in Children With Type 1 Diabetes Mellitus - NCT ID: NCT06356051 - Study ID: Gbuyukyilmaz - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2023-09-01 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description Epicardial fat thickness, carotid intima-media thickness, and augmentation index from arterial stiffness indicators are increased in children with T1DM compared to the healthy control group. These results support the idea that children with T1DM present significant changes in important subclinical indicators for the development of cardiovascular disease. ### Conditions - Type 1 Diabetes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Echocardiography ### Outcomes Primary Outcomes - Epicardial fat thickness Secondary Outcomes - carotid intima-media thickness - arterial stiffness parameters such as pulse wave velocity, augmentation index ### Location - Facility: Ankara Bilkent City Hospital, Ankara, N/A, N/A, Turkey @@
## Phrenic Nerve Infiltration: Pulmonary Expansion and Pain Control - NCT ID: NCT06356038 - Study ID: Prot. n. 76 SA/2022 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-03-09 - Completion Date: 2025-01-02 - Lead Sponsor: Azienda Ospedaliera "Sant'Andrea" ### Study Description Between January 2021-2023, 65 consecutive patients at risk for PAL (defined in accordance to "2019 Society of Thoracic Surgery score-criteria of PAL") underwent lung resection (lobectomy or sublobar resection) for malignancy. 5 patients were lost. The remaining have been assigned with a 1:2 randomization into: group A (22 patients), received intra-operative phrenic nerve infiltration with Ropivacaine 10 mg/ml in the peri-neurotic fat on the pericardium and group B (38 patients), did not receive infiltration. Data on hemidiaphragm elevation, air leaks, pain at 24 and 72 hours post-surgery, shoulder pain, length of hospital stay, length of chest tube permanence, were retrospectively collected and compared.The aim of the study is to investigate the effect of intra-operative phrenic nerve infiltration with long acting anesthetic in patients at high risk for PAL, improving pulmonary expansion after surgery, and reducing air leaks, while controlling post-operative pain. ### Conditions - Prolonged Air Leak - Post-operative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intra-operative phrenic nerve infiltration ### Outcomes Primary Outcomes - rate of pulmonary expansion due by phrenic nerve intra-operative local anaesthetic infiltration Secondary Outcomes - rate of post-operative pain control after intra-operative phrenic nerve infiltration with local anaesthetic ### Location - Facility: Azienda Ospedaliera "Sant'Andrea", Roma, N/A, N/A, Italy @@
## Botulinum Toxin Injection in the UES for R-CPD - NCT ID: NCT06356025 - Study ID: 52082 - Status: NOT_YET_RECRUITING - Start Date: 2024-07 - Completion Date: 2027-07 - Lead Sponsor: AZ Delta ### Study Description The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label. ### Conditions - Retrograde Cricopharyngeus Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - botulinum toxin type A - Sodium Chloride 0.9% Inj ### Outcomes Primary Outcomes - Change of at least 50% of 'inability to belch' using the symptom questionnaire at week 12. Secondary Outcomes - Change in associated gastrointestinal symptoms: abdominal bloating/discomfort - Change in associated gastrointestinal symptoms: abdominal/chest pain - Change in associated gastrointestinal symptoms: flatulence - Change in associated gastrointestinal symptoms: gurgling noises from the chest/lower neck - Change of at least 50% of 'inability to belch' during long term follow-up at week 20, and at 48 weeks. - Overall treatment effect (OTE) - Overall symptom severity (OSS) - EuroQol-5D (EQ-5D) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated With Imiquimod - NCT ID: NCT06356012 - Study ID: 71163523.1.0000.5437 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2028-12-31 - Lead Sponsor: Barretos Cancer Hospital ### Study Description The goal of this clinical trial is to identify the immunophenotypic profile of the local immune response, the cervicovaginal microenvironment and the microbiological profile of women with CIN 3 treated with imiquimod. Participants will be divided in 3 groups: CIN 3 who will use 16 doses of imiquimod in the uterine cervix, applied twice a week and will be treated with LEEP procedure; 2) patients with CIN 3 who will undergo standard treatment with LEEP procedure; 3) patients with negative cytology and HPV (human papillomavirus) test. Blood and cervicovaginal lavage collections will be performed at different times, for comparisons between cellular response profiles to imiquimod during treatment and baseline levels in healthy patients. ### Conditions - HSIL, High-Grade Squamous Intraepithelial Lesions - Vaginal Microbiome - Biomarkers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Imiquimod - Loop Electrosurgical Excision Procedure ### Outcomes Primary Outcomes - Number of participants with histological regression of High-grade squamous intraepithelial lesion (HSIL) Secondary Outcomes - Identification of immune response in vaginal and plasma collection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Levari Exp.20: 2D - Partial Feedback - NCT ID: NCT06355999 - Study ID: 2007p000646-F - Status: COMPLETED - Start Date: 2021-05-01 - Completion Date: 2021-06-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Suppose that observers are trying to classify a spot on the skin as normal or abnormal and suppose that the two attributes that are important are the color and shape of the spot. The investigators have found that perceptual decisions of this short are shaped by the prevalence of the target abnormality and by the feedback that observers (Os) receive. If abnormal spots are rare (low prevalence), Os will tend to become more conservative about calling spots abnormal. In this experiment, Os see items defined by color and shape. They are looking for one combination (bumpy green). Bumpy green targets can be common (50% prevalence) or rare (10%). Os in one group will get feedback about their responses based on color. The other group will receive feedback based on shape. The investigators will look for effects of prevalence and of the type of feedback. The goal is to better understand perceptual decisions in settings like clinical evaluation of skin lesions. ### Conditions - Form Perception - Color Perception - Decision Making ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Feedback ### Outcomes Primary Outcomes - Participant naming of visual stimuli Secondary Outcomes ### Location - Facility: Visual Attention Lab / Brigham and Women's Hospital, Boston, Massachusetts, 02215, United States @@
## Computerized Decision Support to Prevent Stroke in Atrial Fibrillation - NCT ID: NCT06355986 - Study ID: 39039039AFL4016 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-07-30 - Lead Sponsor: Brigham and Women's Hospital ### Study Description Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management. ### Conditions - Atrial Fibrillation - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Alert-based computerized decision support ### Outcomes Primary Outcomes - Frequency of prescription of anticoagulation at 90 days in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation for stroke prevention at the time of study enrollment - Frequency of major bleeding at 6 months from enrollment. Secondary Outcomes - Frequency of failure to prescribe anticoagulation because of perceived risk of bleeding in high-risk AF patients in the outpatient setting who are not being prescribed anticoagulation at the time of study enrollment and are assigned to the alert group - Frequency of a composite of major adverse cardiovascular events, defined as cerebrovascular accident, systemic embolism, any MI, symptomatic VTE, or all-cause mortality at 6 months from enrollment ### Location - Facility: St. Elizabeth Health, Edgewood, Kentucky, 41017, United States @@
## A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment - NCT ID: NCT06355973 - Study ID: 2024-01-061 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-12-31 - Lead Sponsor: MinYoung Kim, MD, PhD ### Study Description This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.It is for the prevention and treatment of dementia in the future. randomized, Pilot Study. ### Conditions - Patients With Mild Cognitive Impairment (MCI) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Using tablets and workbooks cognitive function. - self-programming of physical function training. ### Outcomes Primary Outcomes - Montreal Cognitive Assessment (MoCA) Secondary Outcomes - Korean-Mini Mental Status Examination (K-MMSE) - Clinical Dementia Rating (CDR) - Clinical Global Impressions of Change (CGIC) - Instrumental Activities of Daily Living (I-ADL) - Berg Balance Scale (BBS) - Geriatric Quality of Life-Dementia (GQOL-D) - Geriatric Depression Scale (GDSd) - Global Deterioration Scale (GDS) - Electroencephalography ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Dexmedetomidine on Oxygenation and Lung Mechanics - NCT ID: NCT06355960 - Study ID: 2024-853 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-05-01 - Lead Sponsor: Cairo University ### Study Description Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation ### Conditions - Drug Use - Dexmedetomidine ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - GROUP Dexmedetomidine - GROUP B - GROUP C ### Outcomes Primary Outcomes - Oxygenation by the end study Secondary Outcomes - Intraoperative dynamic lung compliance - Intraoperative static lung compliance - Physiological dead space ### Location - Facility: Cairo university, Cairo, N/A, 11562, Egypt @@
## Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement - NCT ID: NCT06355947 - Study ID: 103-7445B - Status: COMPLETED - Start Date: 2015-12-07 - Completion Date: 2018-07-31 - Lead Sponsor: Chang Gung University ### Study Description Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability. ### Conditions - Parkinson Disease(PD) ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive cycling training - Cognitive treadmill training ### Outcomes Primary Outcomes - Walking Speed - Step Length - Step Time - Power Spectral Density (PSD) - Task Accuracy - Reaction Time - Balance Performance Secondary Outcomes - Double Support Time - Single Support Time - Swing Time - Stance Time - Cadence - Heart rate ### Location - Facility: Chang Gung University, Taoyuan, N/A, 333, Taiwan @@
## OverTTuRe: Characteristics, Treatment Patterns and Outcomes of Patients With ATTR Amyloidosis - NCT ID: NCT06355934 - Study ID: D8450R00004 - Status: RECRUITING - Start Date: 2023-08-21 - Completion Date: 2026-09-30 - Lead Sponsor: AstraZeneca ### Study Description The overall aim of this observational study is to generate real-world evidence on the pre- and post-diagnosis disease journeys, including baseline characteristics, treatment patterns and selected clinical, economic, and humanistic outcomes (for example Health Related Quality of Life (HRQoL), Neuropathy impairment score, activities of daily living (ADL) assessments) in patients with ATTR amyloidosis, and to better understand how the disease is presented. ### Conditions - ATTR Amyloidosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Health Care Resource Utilization (HCRU) - Outpatient visits - Health Care Resource Utilization (HCRU) - Outpatient visits by specialty - Health Care Resource Utilization (HCRU) - Emergency department visits - Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay - Health Care Resource Utilization (HCRU) - Hospitalizations - Health Care Resource Utilization (HCRU) - Health care cost - Cardiac transplant - All cause mortality - Liver transplant - Heart Failure Hospitalization - New ATTR amyloidosis clinical manifestation - Hospitalization (any cause) - Neuropathy Impairment Score (NIS) - Neuropathy Impairment Score Lower Limbs (NIS-LL) - Neuropathy Impairment Score +7 (NIS+7) - Neuropathy Impairment Score modified +7 (mNIS+7) - Neuropathy symptoms and change (NCS) score - PND (Polyneuropathy Disability) - Other relevant clinical measurement of ATTR amyloidosis functional status - Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QoL-DN) Score Secondary Outcomes - Health Care Resource Utilization (HCRU) - Outpatient visits - Health Care Resource Utilization (HCRU) - Outpatient visits by specialty - Health Care Resource Utilization (HCRU) - Emergency department visits - Health Care Resource Utilization (HCRU) - Hospitalizations, length of stay - Health Care Resource Utilization (HCRU) - Hospitalizations - Health Care Resource Utilization (HCRU) - Health care cost ### Location - Facility: Research Site, Eden Prairie, Minnesota, 55344, United States @@
## A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors - NCT ID: NCT06355921 - Study ID: RFAdesmoid - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-05-01 - Lead Sponsor: Blokhin's Russian Cancer Research Center ### Study Description This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months. ### Conditions - Desmoid Tumor - Desmoid Fibromatosis - Desmoid ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - radiofrequency ablation ### Outcomes Primary Outcomes - Comparison of safety assessment. Secondary Outcomes - Overall Response Rate - Duration of responce - Comparison of tumor necrosis based on MRI/CT ### Location - Facility: Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO), Moscow, MO, 115522, Russian Federation @@
## IL13Rα2 CAR-T for Patients With r/r Glioma - NCT ID: NCT06355908 - Study ID: TT002 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2027-05-01 - Lead Sponsor: Yang Zhang ### Study Description This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma. ### Conditions - Glioma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - IL13Rα2 CAR-T ### Outcomes Primary Outcomes - Safety of IL13Rα2 CAR-T Secondary Outcomes - Overall Response Rate (ORR) - Duration of Response (DOR) - Progression Free Survival (PFS) - Overall Survival (OS) - Overall Survival (OS) at 6 months (OS6) - Overall Survival (OS) at 12 months (OS12) - The levels of IL13Rα2 CAR-T cell and IL13Rα2 CAR in the CSF and peripheral blood - The levels of cytokines in the CSF and peripheral blood ### Location - Facility: Beijing Tiantan Hospital, Beijing, N/A, N/A, China @@
## Liver Volume Variation Effect on SBRT Planning and Delivery for Upper Abdominal Malignancies - NCT ID: NCT06355895 - Study ID: HCC 23-104 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: University of Pittsburgh ### Study Description Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT. ### Conditions - Upper Abdominal Malignancies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Standardized high-carbohydrate meal ### Outcomes Primary Outcomes - Diurnal Difference in Liver Volumes Secondary Outcomes - Difference in total liver volume - Percentage diurnal difference in liver mean dose at V5 Gy - Percentage diurnal difference in liver mean dose at V15Gy - Difference in liver mean dose at V15 Gy - Difference in liver dose at V15 Gy ### Location - Facility: UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States @@
## Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia - NCT ID: NCT06355882 - Study ID: LCOSDental - Status: RECRUITING - Start Date: 2023-08-08 - Completion Date: 2024-12-01 - Lead Sponsor: University of Sao Paulo General Hospital ### Study Description Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed ### Conditions - Low Cardiac Output Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Anesthetic infiltration ### Outcomes Primary Outcomes - Amount ventricular and supraventricular arrhythmia Secondary Outcomes ### Location - Facility: Instituto do Coração HCFMUSP, São Paulo, N/A, 05403000, Brazil @@
## Repeatability of Gait Deviations in Children With Cerebral Palsy - NCT ID: NCT06355869 - Study ID: s65337 - Status: COMPLETED - Start Date: 2021-08-17 - Completion Date: 2023-05-31 - Lead Sponsor: Universitaire Ziekenhuizen KU Leuven ### Study Description Three-dimensional gait analysis (3DGA) is the 'gold standard' for measurement and description of gait. Gait variability can arise from intrinsic and extrinsic factors and may vary between walking conditions. This study aimed to define the inter-trial (intrinsic) and inter-session (extrinsic) repeatability in gait analysis data of children with CP who were walking in four conditions, namely barefoot or with ankle-foot orthosis, and overground or treadmill. ### Conditions - Spastic Cerebral Palsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - repeated 3D gait-analysis ### Outcomes Primary Outcomes - The standard error of measurement (SEM) of the continuous kinematic gait waveforms - The intra-class correlation (ICC) of the gait indices - The standard error of measurement (SEM) of the continuous kinetic gait waveforms - The standard error of measurement (SEM) of the gait indices Secondary Outcomes ### Location - Facility: UZ Leuven, Leuven, Vlaams-Brabant, 3000, Belgium @@
## Efficacy/ Safety of DNN.22.17.036 in Male Patients With Pattern Hair Loss - NCT ID: NCT06355856 - Study ID: ACH-PNT-04(01/22) - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-05 - Lead Sponsor: Ache Laboratorios Farmaceuticos S.A. ### Study Description Evaluation of the efficacy and safety of DNN.22.17.036 versus 10573048700 in the treatment of male pattern hair loss. ### Conditions - Alopecia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - DNN.22.17.036 - 10573048700 ### Outcomes Primary Outcomes - Percentage variation of hairs in the hair loss phase Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Clinical Applications of Integrated PET/MR and PET/CT in the Diagnosis and Treatment of Prostate Cancer. - NCT ID: NCT06355843 - Study ID: SXY - Status: SUSPENDED - Start Date: 2022-04-28 - Completion Date: 2027-03-31 - Lead Sponsor: The First Affiliated Hospital of Anhui Medical University ### Study Description The goal of this study type: observational study (prospective study) is to study prostate cancer occurrence and recurrence, to specifically identify and localize tumor foci at the molecular level at an early stage, to evaluate the prognosis of patients, and to accurately stage not only intermediate- and high-risk prostate cancer patients with a primary diagnosis, but also detect recurrent foci in patients with biochemical recurrence, to restage those who have developed metastases, to assess tumor load, and to ultimately assist in determining the personalized treatment plans. The main question it aims to answer is whether 68Ga-PSMA PET/CT (PET/MR) examination is beneficial for assessing the* Accurate staging of patients with intermediate- and high-risk prostate cancer at first diagnosis;* Detecting recurrent lesions in patients with recurrent tumors for re-staging;* Assessment of tumor load;* Assessment of patient prognosis. Participants will sign an informed consent form, undergo 68Ga-PSMA PET/CT (PET/MR) before surgery or biopsy, and have regular follow-up after obtaining pathological results of surgical resection or puncture biopsy, 6 weeks after surgery or biopsy, and then every 3 months; the follow-up will include: blood PSA, whole-body bone imaging, etc. ### Conditions - Prostate Cancer - Pet-ct ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-PSMA ### Outcomes Primary Outcomes - Measuring the value of 68Ga-PSMA PET/MRI in the diagnosis and staging of primary prostate cancer and comparing it with mp-MRI and PET/CT - Exploring whether 68Ga-PSMA PET/MRI can be used as a method for diagnostic efficacy Secondary Outcomes ### Location - Facility: First affiliated hospital of anhui university, Hefei, Anhui, 230032, China @@
## Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study - NCT ID: NCT06355830 - Study ID: RETimaging4iAMD - Status: RECRUITING - Start Date: 2019-01-02 - Completion Date: 2026-06 - Lead Sponsor: Universidade Nova de Lisboa ### Study Description Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.Primary outcome: Identifying imaging predictors of iAMD progression. ### Conditions - Age-Related Macular Degeneration ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Orthoptic assessment (Outcome measure) ### Outcomes Primary Outcomes - Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline - Change in Drusen morphology from baseline - Change in Subfoveal drusen area from baseline - Change in other drusen area from baseline - Change in Drusen reflectivity from baseline - Change in other Drusen homogeneity from baseline - Change in ellipsoid zone disruption from baseline - Change in Drusen homogeneity from baseline - Change in hyperreflective foci from baseline - Change in hyperreflective foci location (within 500-μm disc area) from baseline - Change in hyperreflective foci association to drusen from baseline - Progression to Moderate Vision Loss - Geographic Atrophy (GA) Growth Rate Secondary Outcomes - Progression to Advanced AMD according to international classification/grading system ### Location - Facility: Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE, Lisbon, N/A, 1150-199, Portugal @@
## Distraction Techniques in Periocular Anesthesia: Tapping vs Vibration - NCT ID: NCT06355817 - Study ID: HS25941 - Status: COMPLETED - Start Date: 2023-09-21 - Completion Date: 2024-03-19 - Lead Sponsor: University of Manitoba ### Study Description To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections. ### Conditions - Anesthetics, Local - Blepharoplasty - Age-Related Ptosis - Adult - Humans - Lidocaine - Ophthalmologic Surgical Procedure - Vibration - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Vibration - Tapping ### Outcomes Primary Outcomes - Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia Secondary Outcomes - Difference in Pain Reduction ### Location - Facility: Misericordia Health Centre, Winnipeg, Manitoba, R3C 1A2, Canada @@
## Lifestyle Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis - NCT ID: NCT06355804 - Study ID: STUDY2023-1565 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-04-22 - Lead Sponsor: University of Illinois at Chicago ### Study Description The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a control condition (i.e., waitlist control) in persons newly diagnosed with MS (disease duration ≤ 2 years).Specific Aim 1: To evaluate the changes in self-report and device-measured physical activity after the 16-week remotely delivered physical activity behavior change intervention compared with a control condition (i.e., waitlist control) in persons who have diagnosed with MS within the past two years. The investigators hypothesize that the 16-week behavior change intervention will yield greater improvements in physical activity levels than the control condition immediately after the intervention.Specific Aim 2: To investigate the efficacy of the 16-week, remotely delivered physical activity behavior change intervention compared with the control condition for improvements in fatigue, depression, anxiety, and QoL in persons newly diagnosed with MS. The investigators hypothesize that there will be beneficial effects on the symptoms and QoL outcomes immediately after the physical activity intervention compared with minimal changes in the control condition. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Physical activity condition - Waitlist condition ### Outcomes Primary Outcomes - Physical Activity Behavior - Physical Activity Behavior - Physical Activity Level (Light physical activity) - Physical Activity Level (Moderate-to-vigorous physical activity) - Physical Activity Level (Daily step count) Secondary Outcomes - Health-related quality of Life - Health-related Quality of Life - Fatigue Severity - Depressive Symptoms - Anxiety ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Stability Study - NCT ID: NCT06355791 - Study ID: PDPROJ-4-TP-001-23 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-15 - Completion Date: 2025-09-30 - Lead Sponsor: Spinal Simplicity LLC ### Study Description The studied indication is degenerative conditions of the lumbar spine resulting in back pain with lower extremity symptoms and neurogenic claudication.The purpose of this study is to evaluate the effectiveness and safety of instrumented posterior arthrodesis using the Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft material in patients with degenerative conditions of the lumbar spine resulting in chronic low back pain with lower extremity symptoms and concurrent neurogenic claudication. ### Conditions - Lumbar Spinal Stenosis - Spondylolisthesis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Minuteman G5 ### Outcomes Primary Outcomes - NRS Back and Leg - ODI - PROMIS 29 2.0 Secondary Outcomes - 12 Month Fusion Assessment ### Location - Facility: Kansas University Medical Center, Kansas City, Kansas, 66160, United States @@
## Adversity, Brain and Opioid Use Study - NCT ID: NCT06355778 - Study ID: HUM00234185 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2028-04 - Lead Sponsor: University of Michigan ### Study Description The way people process and remember information may be related to adverse childhood experiences and Opioid Use Disorder symptoms. The purpose of this project is to examine brain function and performance during learning and memory tasks in adults. The study will compare measures of learning and memory across three groups of participants: those with an Opioid Use Disorder (OUD) that take buprenorphine for opioid replacement therapy, adults without an Opioid Use Disorder taking buprenorphine, and healthy adults that do not have an Opioid Use Disorder and are not taking buprenorphine. ### Conditions - Opioid Use Disorder - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Magnetic Resonance Imaging (MRI) - Computer Tasks ### Outcomes Primary Outcomes - Differences in Blood Oxygen Level Dependent (BOLD) signal in the hippocampus - Differences in Hippocampal (Hpc) volume - Differences in hippocampal circuit connectivity - Differences in performance - Differences in performance - Differences in threat reactivity measured via skin conductance response (SCR) - Differences in threat reactivity measured via skin conductance response (SCR) Secondary Outcomes ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Citicoline & Antioxidants in Glaucoma - NCT ID: NCT06355765 - Study ID: CITIZ_001 - Status: COMPLETED - Start Date: 2022-01-10 - Completion Date: 2022-12-10 - Lead Sponsor: University of Naples ### Study Description To evaluate the long-term effects of oral citicoline, vitamins A, B, C and E, and blackcurrant therapy in patients with primary open-angle glaucoma (POAG) using optical coherence tomography (OCT), OCT angiography (OCTA) and microperimetry parameters. ### Conditions - Glaucoma, Open-Angle ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Citicoline blackcurrant supplement ### Outcomes Primary Outcomes - Evaluation of Ganglionar cells complex (GCC) Secondary Outcomes - Evaluation of Retinal nerve fiber layer (RNFL) ### Location - Facility: University of Naples Federico II, NAples, N/A, 80131, Italy @@
## Biomarkers of Pain and Stress Perception and Dry Needling Technique Application - NCT ID: NCT06355752 - Study ID: 0018-N-23 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2024-07-15 - Lead Sponsor: University of Alcala ### Study Description The use of the dry needling technique has become widespread in recent years for the treatment of musculoskeletal pain. Although dry needling has been shown to be effective in the treatment of shoulder pain, elbow pain, headache, etc., we do not yet have a clear understanding of the mechanisms of action that justify its beneficial effects.In this study, we propose to analyse the biochemical markers of pain generated by the application of a dry needling technique on the lumbar musculature in patients with mechanical lumbar pain of non-specific origin.The aim of this study will be to evaluate the effects of dry needling technique on the plasmatic concentration of biochemical markers.Furthermore, the test subjects will be randomly distributed into two groups.An experimental group where the subjects will receive a real dry needling technique.Another group will be treated with a sham technique. ### Conditions - Low Back Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Dry needling of lumbar iliocostalis muscle - Sham dry needling lumbar iliocostalis muscle ### Outcomes Primary Outcomes - Extracting Blood Samples and Obtaining Serum/Plasma Secondary Outcomes ### Location - Facility: Centro Investigación Fisioterapia y Dolor, Alcalá De Henares, Madrid, 28805, Spain @@
## CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+ - NCT ID: NCT06355739 - Study ID: BIC-19GG, BIC-2019,BIC-2219 - Status: RECRUITING - Start Date: 2024-02-01 - Completion Date: 2027-01-15 - Lead Sponsor: Zhu Xiaofan ### Study Description To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children ### Conditions - B Lymphocytic Leukemia - B Lymphoblastic Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CAR T cell injection ### Outcomes Primary Outcomes - Overall survival and event-free survival Secondary Outcomes - Overall remission rate - Adverse events ### Location - Facility: Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, 300020, China @@
## Efficacy of Plasma Exchange Therapy vs Standard Medical Therapy in Severe Alcoholic Hepatitis With High Discriminant Function - NCT ID: NCT06355726 - Study ID: ILBS-Alcoholic Hepatitis-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-02-28 - Lead Sponsor: Institute of Liver and Biliary Sciences, India ### Study Description Alcoholic hepatitis, the most florid form of alcoholic liver disease, has a very high short-term mortality of up to 50% and no specific therapies are available other than steroids. Steroids also only show a limited utility in improving the short-term survival and boast no evidence of any long-term benefits. Additionally, only a small proportion of patients with alcoholic hepatitis are eligible to receive steroids. Thus, a large number of patients are either not eligible or do not respond to steroids and this group outnumbers those who do respond to steroids, leaving us without any specific therapeutic options for a majority of these individuals.\[1\] Even liver transplantation is not feasible in most cases due to the presence of sepsis or recent alcohol consumption and many ethical and logistic issues are involved despite the documented safety and survival benefits of early liver transplantation in patients with severe alcoholic hepatitis (SAH) not responding to medical management.\[2,8\] Therefore, newer, more effective, and nontransplant therapeutic options for managing severe alcoholic hepatitis are needed. TPE is expected to be an effective and well-tolerated bridge therapy in patients with severe alcoholic hepatitis of moderate severity not improving on SMT and without immediate prospects for liver transplantation. ### Conditions - Alcoholic Hepatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Plasma Exchange - Standard Medical Treatment ### Outcomes Primary Outcomes - Liver transplant free survival at 28 days, 90 days and 180 days. Secondary Outcomes - Change in total bilirubin and INR as measured by Discriminant Functions - Number of patients with change in Model for End Stage Liver Disease (MELD) - Number of patients with change in CTP - Number of patients with change in LSM,SSM - Mortality in both groups - clinical improvement in the form of jaundice as measured by total bilirubin - clinical improvement in the form of hepatic encephalopathy as measured by west haven criteria - clinical improvement in the form of ascites as measured by ICA criteria. - Frequency of decompensation events on follow up period - Adverse events during plasma exchange ### Location - Facility: Institute of Liver & Biliary Sciences (ILBS), New Delhi, Delhi, 110070, India @@
## Improvement of Symptoms After Removal of the Essure® Contraceptive Implant - NCT ID: NCT06355713 - Study ID: 69HCL23_0899 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2036-06-01 - Lead Sponsor: Hospices Civils de Lyon ### Study Description ESSURE® is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age. These implants are inserted into the fallopian tubes by hysteroscopy. Marketed in 2002, ESSURE® contraceptive implants were withdrawn from the French market in 2017 (and worldwide in 2017 and 2018) following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms. Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation. This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group, 198,000 French women have these implants and only 30,000 of them, or 15%, have been explanted, knowing that explantation of ESSURE® implants is recommended only in symptomatic patients. A large number of these patients, presenting symptoms, have not yet been treated for an explant.The physiopathological mechanism(s) is (are) not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory and/or allergic and/or autoimmune phenomena.Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients, determine the most appropriate surgical techniques, and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers. From a surgical point of view, there is a real risk of fracture of implants whatever the type of intervention performed: study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation. From a biological point of view, the dosage of the metallic elements constituting ESSURE® implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body. Analysis of pro-inflammatory cytokines, micro-RNAs (miRNA), quantitative analysis of inflammatory pathway messenger ribonucleic acid (mRNAs) (NanoString technology) and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms. This study responds to a significant request from patient associations. ### Conditions - Implant Complication - Contraceptive Device; Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Magnetic resonance imaging- Positron Emission Tomography (MRI-PET) examination - blood sample - urine collection - Collection of a lock of hair - questionnaire ### Outcomes Primary Outcomes - Percentage of patients with improvement in symptoms Percentage of patients with improvement in symptoms Secondary Outcomes - Percentage of patients with improvement in symptoms - Short Form 12 (SF-12) score - Fibromyalgia Impact Questionnaire (FIQ) score - Hospital Anxiety and Depression scale (HADS) score - Multidimensional Fatigue Inventory (MFI)-20 score - Visual analog scale (VAS) score - Questionnaire Douleur St-Antoine (QDSA) score - Female Sexual Function Index (FSFI) score - Higham questionnaires - visual analog scale (VAS) score - Duration of the procedure - Complications - characterization of the mechanical behavior of the implant - determination of the associated mechanical stress levels determination of the associated mechanical stress levels - quantification of the factors influencing these levels of mechanical stress - thermal resistance - risk of degradation - Concentrations of titanium constituting the Essure® implant - Concentrations of nickel constituting the Essure® implant - Concentrations of chromium constituting the Essure® implant - Concentrations of tin constituting the Essure® implant - Concentrations of platinum constituting the Essure® implant - Concentrations of iridium constituting the Essure® implant - Concentrations of molybdenum constituting the Essure® implant - Concentrations of manganese constituting the Essure® implant - Concentrations of tungsten constituting the Essure® implant - Concentrations of silver constituting the Essure® implant - Concentrations of iron constituting the Essure® implant - concentration of pro-inflammatory cytokines - expression profile of miRNAs - activated T lymphocyte profile - analysis of inflammatory pathway mRNAs - Percentage of detection of Human Leukocyte Antigen - Functional brain functions ### Location - Facility: CHU de Angers, Angers, N/A, 49933, France @@
## Hepatocellular Carcinoma Liver Organoids - NCT ID: NCT06355700 - Study ID: 5476 - Status: RECRUITING - Start Date: 2023-06-15 - Completion Date: 2025-03 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description The goal of this interventional study is to create hepatocellular carcinoma organoids from liver bioptic samples of individuals with hepatocellular carcinoma. The main questions it aims to answer are:* the feasibility of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells* the molecular pattern of the organoid tumor microenvironment* the in vitro therapeutic response of hepatocellular carcinoma organoids ### Conditions - Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Liver biopsy ### Outcomes Primary Outcomes - Success rate of hepatocellular carcinoma organoids integrated with host gut microbiota and peripheral blood mononuclear cells Secondary Outcomes - Analysis of hepatocellular carcinoma organoid transcriptome distribution within a reference set from The Cancer Genome Atlas - Evaluation of the concordance of somatic genetic mutations between the organoid and the original tumor - Correlation between gut microbiota community profiling and growth rate of hepatocellular carcinoma organoids - Treatment response evaluation in vitro ### Location - Facility: Fondazione Policlinico Agostino Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Melatonin in Obese Patients in Laparoscopic Cholecystectomy - NCT ID: NCT06355687 - Study ID: FMASU MD304/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Ain Shams University ### Study Description Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Melatonin - Vitamin Supplement ### Outcomes Primary Outcomes - Postoperative Pain. Secondary Outcomes - Postoperative Pain. - Analgesics usage. - Postoperative nausea and vomiting. - Recovery time. - Number of participants with hemodynamic instability. - Number of participants with hemodynamic instability. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Adolescent Mother and Breastfeeding Education - NCT ID: NCT06355674 - Study ID: HRÜ/23.21.12 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-10-15 - Lead Sponsor: Adiyaman University ### Study Description In low-income and developing countries, 30% of adolescents marry before the age of 18, and 14% marry before the age of 15. Additionally, adolescents between the ages of 15 and 19 are often coerced into marriage or sexual relationships with partners older than themselves. 10% of adolescents under the age of 15 in the world are forced to have sexual intercourse and as a result, unwanted teenage pregnancies occur. In high-income countries like Latin America, there is a high prevalence of adolescent non-marital pregnancies. When considering the fertility, health, and social outcomes of adolescence, it emerges as a significant issue. Adolescent motherhood carries numerous adverse effects from both demographic and social perspectives.In pregnancies occurring during adolescence, both maternal and infant mortality rates are two to three times higher compared to pregnancies at later ages. Many infant and child deaths occur due to preventable causes. Breastfeeding is a significant factor in reducing infant and child mortality. Since infants born to adolescent mothers are at higher risk of death and illness, breastfeeding these infants becomes even more important. However, one of the significant challenges adolescent mothers face during the postpartum period is initiating and maintaining lactation. Research has shown that maternal age plays a significant role in initiating and sustaining breastfeeding, with a strong positive correlation between maternal age and duration of breastfeeding. This study was designed as a randomized controlled trial to examine the effect of breastfeeding education provided to adolescent mothers on maternal breastfeeding self-efficacy, mother-infant attachment, and infant anthropometric measurements. ### Conditions - Adolescent Mother ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Breastfeeding education provided with Lactation Simulation Model ### Outcomes Primary Outcomes - Postnatal Breastfeeding Self-Efficacy Scale-Short Form - Maternal-Infant Attachment Scale Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections - NCT ID: NCT06355661 - Study ID: HP/231102/PA/URTI - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-06-01 - Lead Sponsor: Vedic Lifesciences Pvt. Ltd. ### Study Description The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days ### Conditions - Upper Respiratory Tract Infections ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule - MCC: 400 mg (± 10%) per Capsule ### Outcomes Primary Outcomes - To evaluate the effect of investigational products on participant's severity of common cold like symptoms Secondary Outcomes - To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms - To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms - To evaluate the effect of investigational products on Percentage of population with minimal important difference of ≥ 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study) - To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale. - To evaluate the effect of investigational products on Percentage population with fever during the study. - To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life ### Location - Facility: Biswas health care & Diagnostic Centre, Nainital, Uttaranchal, N/A, India @@
## Advanced Clinical Practitioners in the ED - NCT ID: NCT06355648 - Study ID: IRAS 337181 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2025-03-01 - Lead Sponsor: King's College London ### Study Description No patient data is involved in the study. This study is designed to understand better how Emergency Care Advanced Clinical Practitioners (EC-ACPs) work in emergency departments (EDs). The main research question is:1) What is the EC-ACP's perception of assimilation into emergency care teams, what tensions are created due to the role, and what system adaptations are required to facilitate integration?With secondary aims :1. What are the common organisational factors that affect the implementation of the EC-ACP workforce, and what recommendations can be made to improve Trust-wide implementation?2. How are EC-ACPs deployed in two contrasting emergency departments, what differences can be identified in their Work-As-Done (WAD), and how does this compare to the Work-As-Imagined (WAI) of the role?Participants will all be staff members who work in the hospital. Patient data is not being collected or processed. This is a mixed-method study using two approaches to collect data:1. Observation of the EC-ACPs at work - noting how they interact with colleagues and how they are deployed in the ED.2. Interviews with various staff who work with the EC-ACPs clinically or in various managerial or director roles.BackgroundIn the UK, a health care role has been developed called Advanced Clinical Practitioners (ACPs). ACPs work in various clinical settings, but this study focuses on those in Emergency Care. While non-medical practitioners have worked in Emergency Departments (EDs) for over 20 years, the ACP role is relatively new. Most ACPs in ED are from a nursing or paramedical background, but they can also be from other allied health professions like physiotherapy. After the base qualification, ACPs undertake a three-year master\'s degree with clinical portfolios. Once qualified, the goal is to create clinicians who work alongside doctors, seeing, treating, and discharging patients. Unlike previous practitioner roles, EC-ACPs treat the whole spectrum of ED patients, from minor injuries and illnesses to the sickest patients needing the highest level of care.These roles were heavily supported by local and political desires to create blended workforces to meet increasing patient demands. The problem with implementing ACP roles is that initially, little consultation was held with stakeholders in EDs. This has resulted in various trade-offs. For example, trainee doctors often feel displaced by trainee ACPs seeking to learn the same or similar skills.Previous research on advanced roles in ED has focused on direct clinical comparisons between doctors and practitioners. Researchers have investigated which professional (doctors vs. nurse practitioners) triages patients quickest or who is more accurate at interpreting X-rays. There are several problems with these approaches. The first is that they can create a professional rivalry. The second problem is that these approaches oversimplify what is a more complex system of care. ### Conditions - Healthy Volunteers ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Narrative data - Narrative data Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Application and Monitoring of Vasoactive and Inotrope Drugs - NCT ID: NCT06355635 - Study ID: JohannesGUVA - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2024-11-01 - Lead Sponsor: Johannes Gutenberg University Mainz ### Study Description The investigators aimed to establish current practice of application and monitoring of vasoactive and inotrope Drugs in non-cardiac surgery patients. ### Conditions - Hemodynamic Instability ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Choice and Monitoring ### Outcomes Primary Outcomes - current practice of correct application and monitoring of vasoactive and inotrope Drugs Secondary Outcomes ### Location - Facility: Department of Anaesthesiology;, Mainz, Rhineland-Palatinate, D55131, Germany @@
## Prevalence and Characterization of Pain in RASopathies - NCT ID: NCT06355622 - Study ID: 3717 - Status: RECRUITING - Start Date: 2021-01-27 - Completion Date: 2024-06-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description RASopathies are a group of syndromes caused by variants in genes belonging to the RAS/MAPK pathway. Pain is a neglected topic in RASopathies but it is frequently complained by affected individuals. ### Conditions - RASopathy - Costello Syndrome - Cardio-Facio-Cutaneous Syndrome - Noonan Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Characterization of pain ### Outcomes Primary Outcomes - Prevalence of pain in verbal patients with RASopathies - Prevalence of Pain in no-communitating patients with RASopathies Secondary Outcomes - Characterization of pain in RASopathies ### Location - Facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS, Roma, N/A, 00168, Italy @@
## Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW - NCT ID: NCT06355609 - Study ID: DZ2023EI004-RW - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2027-12-30 - Lead Sponsor: Hunan Province Tumor Hospital ### Study Description This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive 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 - sunvozertinib in combination with Anlotinib ### Outcomes Primary Outcomes - Progression-free survival (PFS) Secondary Outcomes - Objective Response Rate (ORR) - Overall survival (OS) - Duration of Response (DoR) - Adverse events (AEs) according to CTCAE 5.0 ### Location - Facility: Hunan Cancer Hospital, Changsha, Hunan, 410013, China @@
## Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills - NCT ID: NCT06355596 - Study ID: 20IC6361 - Status: COMPLETED - Start Date: 2022-03-11 - Completion Date: 2022-04-08 - Lead Sponsor: Imperial College London ### Study Description The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?Participants in this study will:Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks. ### Conditions - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Virtual teaching ### Outcomes Primary Outcomes - McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score - European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score Secondary Outcomes - SURG-TLX score - Heart rate - Pupil metrics ### Location - Facility: St Mary's Hospital, London, N/A, W2 1NY, United Kingdom @@
## Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant (MAST) Trial - NCT ID: NCT06355583 - Study ID: C/42/2022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2027-05-01 - Lead Sponsor: Imperial College London ### Study Description The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant.The main questions it aims to answer are:* Tolerability and acceptability of intestinal microbiota transplantation (IMT) versus placebo (as assessed via patient perspective questionnaires* Changes in gut microbiome diversity across all timepoints* Markers of general health, infective/microbiological and haematological outcomes including, days of fever, admission to intensive care unit, survival, non-relapsed mortality, and incidence of graft-versus-host disease across all time points measured.Participants will be asked at their routine follow up visits to,* Provide stool, urine and blood samples at the scheduled study visits* Complete questionnaires at selected visits* Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant (+/-3 days)Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity. ### Conditions - Acute Lymphoblastic Leukaemia - Acute Leukemia of Ambiguous Lineage - Chronic Myeloid Leukemia - Chronic Myelomonocytic Leukemia - Myelodysplastic Syndrome - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - EBX-102 - Placebo ### Outcomes Primary Outcomes - Change in gut microbiota diversity using Inverse Simpsons Index Secondary Outcomes - Gut Microbiome Diversity - Alpha diversity - Alpha Diversity - Chao1 Index - Alpha Diversity - Shannon Index - Alpha Diversity - Faiths Phylogenetic Diversity (Faiths PD) - Beta Diversity - Aitchison Distance - Gut Microbiome Taxonomic Composition - Markers of general health - ITU Admission - Quality of life EQ-5D-5L - Quality of Life EORTC-QLQ-C30 - Infective Haematological Outcomes - Fever Occurrence - Infective Haematological Outcomes - Fever CTCAE Grade - Infective Haematological Outcomes - Infection - Infective Haematological Outcomes - Multi drug Resistant Bacterial Colonisation (MDROs) - Infective Haematological Outcomes - Antibiotic Use - Markers of General Health - Severity of Mucositis - Markers of General Health -Occurrence of Severe Acute Kidney Injury (AKI) - Markers of General Health - Occurrence of Severe liver dysfunction - Markers of general health - Use of Parenteral Nutrition - Neutrophil and platelet engraftment data - Recovery of T-cell Chimaerisms, - Haematological Outcomes - Non-relapsed mortality - Haematological Outcomes - Occurrence Graft vs Host Disease - Haematological Outcomes - Severity of graft vs Host Disease - Overall Survival - Graft-versus disease-free relapse-free survival ### Location - Facility: University Hospitals Birmingham NHS Foundation Trust, Birmingham, England, B15 2WB, United Kingdom @@
## Delirium After Cardiac Surgery in Intensive Care Units - NCT ID: NCT06355570 - Study ID: 331314 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2025-03-20 - Lead Sponsor: Imperial College Healthcare NHS Trust ### Study Description STUDY SUMMARYSTUDY DESIGN The study will be conducted over twelve months in the Cardiac Intensive Care Unit (ICU) at Hammersmith Hospital, Imperial College Healthcare NHS Trust (ICHT). This study is a mixed methods research design that includes the collection of data through qualitative interviews, quality-of-life questionnaires and patients' medical records.AIMS* Determine the incidence of ICU delirium in ICHT following cardiac surgery* Explore the compliance of outcome measures that diagnose ICU delirium* Implement a family-focused sensory stimulation programme in the ICU* Evaluate its useability and potential impact on patients, families and ICU staffSTUDY POPULATION 30 study participants (12 patients, 12 family members/friends and 6 ICU nurses)ELIGIBILITY Study eligibility criteria are specific for each care group (patients, family members/friends and ICU nurses).DURATION 12 months at Hammersmith Hospital, ICHT ### Conditions - Intensive Care Unit Delirium - Cardiac Surgery - Post Operative Delirium ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Personal Pictures - Family Videos - Family Videos - Intervention as required ### Outcomes Primary Outcomes - Feasibility of implementing the study intervention Secondary Outcomes - Practicalities of introducing the study intervention - Acceptability of implementing the study intervention - Short-term delirium outcomes post-ICU discharge ### Location - Facility: Imperial College Healthcare NHS Trust, London, N/A, W12 0HS, United Kingdom @@
## Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE - NCT ID: NCT06355557 - Study ID: DSRB 2023/00640 - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2025-01 - Lead Sponsor: Tan Tock Seng Hospital ### Study Description The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor. ### Conditions - Ultrasound ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - AI enabled ultrasound system for self-directed learning - Simulator for self-directed learning - traditional with human instructors ### Outcomes Primary Outcomes - Improvement in image acquisition and structure identification at the end of 3 months. Secondary Outcomes ### Location - Facility: Tan Tock Seng Hospital, Singapore, N/A, 319581, Singapore @@
## Individual Factors Related to Chronic Low-grade Inflammation and Cardiometabolic Disease Risk - NCT ID: NCT06355544 - Study ID: PINEAPPL2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-06-30 - Lead Sponsor: Integrative Phenomics ### Study Description The goal of this observational study is to learn about low-grade inflammation in healthy individuals and individuals with overweight or obesity.The main questions it aims to answer are:* Whether it is possible to predict low-grade inflammation* What are the medical, biological, and lifestyle variables related to low-grade inflammation?Participants will be asked to:1. Attend a general medical visit to collect vital signs, anthropometric measurements, and collect blood samples.2. Complete questionnaires and collect a stool sample at home. ### Conditions - Overweight - Obesity - Metabolic Syndrome - Healthy - Low-grade Inflammation - Normal Weight Adults - Risk Factor, Cardiovascular - Hypertension - Hypercholesterolemia - Abdominal Obesity - Metabolically Healthy Controls ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Low-grade inflammation Secondary Outcomes - Gut microbiome metabolites - Fasting glucose - Stool microbiome composition - Stool microbiome functional pathways - Systolic blood pressure - Resting heart rate - Serum glycated hemoglobin (HbA1c) - Diastolic blood pressure - Height - Waist circumference - Neck circumference - Hip circumference - Body fat mass - Water body mass - Lean body mass - Serum fasting low-density lipoprotein - Fasting serum high-density lipoprotein - Fasting total serum cholesterol - Consumption of dietary macronutrients - Consumption of dietary micronutrients - Consumption of dietary metabolites - Food item consumption - Food group consumption - Body weight - Serum Alanine Transaminase (ALT) - Serum Aspartate Aminotransferase (ALT) - Serum gamma-glutamyl transferase (GGT) - Fasting serum triglycerides - Fasting serum uric acid - Fasting serum creatinine - Fasting serum insulin - Blood hemoglobin - Blood hematocrit - Red blood cells - Red blood cell volume - Hemoglobin relative red blood cell size - Mean cell hemoglobin (MCH) - Blood platelets - White blood cells - Perceived quality of life - Eating behavior - Physical activity - Stool consistency - Stress - Deprivation - Sleep - Sleep apnea ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP) - NCT ID: NCT06355531 - Study ID: FNP223-CT-2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-11 - Lead Sponsor: Ferrer Internacional S.A. ### Study Description PROSPER trial is a trial to assess the efficacy of FNP-223 in slowing disease progression in participants with PSP as measured by the PSP Rating Scale (PSPRS) over 52 weeks and to assess the safety and tolerability of FNP-223 for 52 weeks in participants with PSP. ### Conditions - Progressive Supranuclear Palsy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - FNP-223 - Placebo ### Outcomes Primary Outcomes - Change From Baseline to Week 52 in the PSPRS Outcome - Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) - Number of Participants Experiencing Serious Adverse Events (SAEs) Secondary Outcomes - Change From Baseline to Week 52 in Clinical Global Impression of Severity Scale (CGI-S) - Change From Baseline to Week 52 Participant Global Impression of Severity Scale (PGI-S) - Change From Baseline to Week 52 in Caregiver Global Impression of Severity Scale (CaGI-S) - Slope of Decline in PSPRS - Change From Baseline to Week 52 in Individual Subitems of PSPRS - Change From Baseline to Week 52 in Schwab and England Activities of Daily Living Scale - Change From Baseline to Week 52 in PSP Clinical Deficits Scale (PSP-CDS) - Change From Baseline to Week 52 in Montreal Cognitive Assessment (MoCA) - Change From Baseline to Week 52 in PSP Quality of Life Scale (PSP-QoL) - Pharmacokinetic characterization of FNP-223 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pre-operative Immuno-Nutrition in Radical Cystectomy - NCT ID: NCT06355518 - Study ID: INu-RC - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-09 - Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia ### Study Description This study will evaluate the effect of preoperative oral immunonutrition on postoperative complications in patients undergoing radical cystectomy for bladder cancer. Patients receiving preoperative immunonutrition will be compared to controls receiving a standard high-calorie, high-protein oral nutritional supplement. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Immunonutrition - Standard Oral Nutritional Supplement ### Outcomes Primary Outcomes - 30-day complications Secondary Outcomes - 30-day severe complications - 90-day severe complications - 30-day and 90-day infectious complications - 30-day and 90-day occurrence of other medical conditions - Time to recovery of bowel function - Time to postoperative mobilization - Muscular strength modifications - Weight modifications - Biochemical nutritional indexes modifications - Need of blood transfusions - Length of stay - Readmission rate - 30-day and 90-day mortality - Compliance - Tolerability (gastrointestinal symptoms related to nutritional supplement) ### Location - Facility: IRCCS Ospedale San Raffaele, Milan, N/A, 20132, Italy @@
## Process of Emergence and Implementation of Advanced Practice Nursing in France - NCT ID: NCT06355505 - Study ID: PREPS-21-0098 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-03-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Longitudinal, observational research with a mixed quantitative (by questionnaires) and qualitative (by interviews and observations) approach, multidisciplinary, among Advanced Practice Nurses (APNs) already graduated and 3 consecutive classes of advanced practice students who will be followed annually during their implementation as APN until the last year of the study. The questionnaires will focus on APN scope of practice evolution, economical analysis and geographical distribution of APN. The ethnographical approach will assess APN settlements and relation with healthcare colleagues and patients. ### Conditions - Nurse's Role ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Factors influencing the effective implementation of advanced practice nursing in France in primary care and health facilities Secondary Outcomes - Mapping of APNs in France with socio-demographic data - Definition by the APN of its role and missions - Implementation and dissemination of the APN practice in the territory according to the context of practice (community care, hospital) - Identification of potential impact dimensions of Advanced Practice Nursing ### Location - Facility: Beaujon hospital, Clichy, N/A, 92110, France @@
## Virtual Reality Distraction in Pediatric Patients. - NCT ID: NCT06355492 - Study ID: 2090/10/30 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-07 - Lead Sponsor: Tanta University ### Study Description The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients. ### Conditions - Virtual Reality - Distraction - Infiltration Anesthesia - Pediatric Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Virtual reality goggles (VR ) - regular screen ### Outcomes Primary Outcomes - Assessment of pain during virtual reality distraction Secondary Outcomes ### Location - Facility: Rokia Abdelrhman Saad Elfaramawy, Tanta, El-Gharbia, 31527, Egypt @@
## A Study to Evaluate the Efficacy and Safety of OsrHSA in Patients of Hepatic Cirrhosis With Hypoalbuminemia - NCT ID: NCT06355479 - Study ID: HY1001-2022-P3 - Status: COMPLETED - Start Date: 2023-04-10 - Completion Date: 2023-12-12 - Lead Sponsor: Healthgen Biotechnology Corp. ### Study Description The goal of this clinical trial is to evaluate the efficacy of OsrHSA works to treat hypoalbuminemia in hepatic cirrhosis patients. It will also learn about the safety and immunogenicity of OsrHSA. The main question it aims to answer is whether OsrHSA is effective in elevating the serum albumin level of cirrhotic patients with hypoalbuminemia.Researchers will compare OsrHSA to the positive comparator, plasma-derived HSA (pHSA) to see if OsrHSA presents as non-inferior to pHSA in the indication of hypoalbuminemia in hepatic cirrhosis patients.Participants will be randomized in a 1:1 ratio to receive OsrHSA or HpHSA (20g IV qd) for up to 14 days, following an EOT visit. Follow-up visits will be taken on EOT+7d, EOT+14d, and EOT+30d, respectively. ### Conditions - Hypoalbuminemia - Hepatic Cirrhosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - OsrHSA - Plasbumin®-20 ### Outcomes Primary Outcomes - To evaluate the efficacy of OsrHSA on elevating the serum albumin level. Secondary Outcomes - To estimate the time to reach 35 g/L or more in serum albumin - To estimate the change from baseline in serum albumin - To estimate the change from baseline in colloid osmotic pressure - To estimate the change from baseline in body weight - To estimate the change from baseline in abdominal circumference, and ascites severity - To estimate the change from baseline in ascites severity ### Location - Facility: Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing, N/A, China @@
## Tunneled Hemodialysis Catheters as Permanent Vascular Access: Evaluating One-year Patency Rate and Affecting Factors - NCT ID: NCT06355466 - Study ID: 51-112334 - Status: COMPLETED - Start Date: 2022-01-09 - Completion Date: 2023-08-28 - Lead Sponsor: Golestan University of Medical sciences ### Study Description In this prospective cross-sectional study, patients with ESRD unfit for AVF/AVG were scheduled for a right or left trans-jugular tunneled catheter placement. All patients were asked about their catheters' function one year after its implantation and the presumed affecting factors on catheters' patency were evaluated. ### Conditions - Vascular Access Devices ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - one year patency rate of hemodialysis catheters Secondary Outcomes - one year patency rate of hemodialysis catheters in age subgroups - one year patency rate of hemodialysis catheters in diabetic patients - one year patency rate of hemodialysis catheters in hypertensive patients - one year patency rate of hemodialysis catheters in patients on antiplatelet drugs - one year patency rate of hemodialysis catheters in sex subgroups ### Location - Facility: Golestan University of Medical Sciences, faculty of medicine, Gorgan, Golestan, 4918936316, Iran, Islamic Republic of @@
## Evaluation of the Goldcrest Patch Performance - NCT ID: NCT06355453 - Study ID: 2023-090-MIC-GES - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2024-12-31 - Lead Sponsor: GE Healthcare ### Study Description The Novii Patch is an accessory to the Novii+ Pod that connects directly to the Novii+ Pod and contains the surface electrodes that attach to the abdomen.The primary objective is to collect Data on Skin Integrity and Patch Adhesion Quality From the Patch After 18 Hours of Wear. The secondary objective is to evaluate fetal monitoring on adult pregnant females greater than 32 weeks gestation and non-pregnant females to collect data on electrical fetal, maternal, and uterine activity. ### Conditions - Fetal Monitoring ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Goldcrest Patch and Three Patch Coupons - Goldcrest Patch and Novii Patch ### Outcomes Primary Outcomes - Primary Objective - Primary Objective Secondary Outcomes - Secondary Objective - Secondary Objective ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China - NCT ID: NCT06355440 - Study ID: 2312288-16 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-06-30 - Lead Sponsor: Fudan University ### Study Description The goal of this pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.The main questions it aims to answer are:* Is the intervention feasible and acceptable among participants?* Does the intervention enhance participants' cost-related health literacy?* Does the intervention reduce participants' financial toxicity?Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.Participants will receive comprehensive information support, including:* Strategies on patient-physician costs discussion* Skills for inquiring and tracking treatment-related costs* Basic knowledge about health insurance* Guidance on accessing and applying for financial assistance* Suggestions for returning to normal life and work* Strategies for holding a financial-related family meeting ### Conditions - Breast Neoplasm Female - Financial Toxicity - Financial Navigation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Financial Navigation - Usual Care ### Outcomes Primary Outcomes - Eligibility rate - Consent rate - Retention rate - Adherence rate - Patient-reported satisfaction - Qualitative assessment of the intervention Secondary Outcomes - Cost-related health literacy - Financial toxicity - Material domain of financial toxicity - Behavioral domain of financial toxicity ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, 200032, China @@
## The Effect of [18F] F-FAPI PET-CT on Management in Patients With Proximal Cholangiocarcinoma - NCT ID: NCT06355427 - Study ID: 2023-507938-24-00 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2028-02-01 - Lead Sponsor: Mara Veenstra, MD ### Study Description BackgroundBile duct cancer (cholangiocarcinoma) represents the second most common type of hepatobiliary cancer worldwide with an incidence of 0.35 to 2 per 100.000 annually. Currently, surgical resection is the only curative option. However, patients are not eligible for surgery if the tumor cannot be resected or the cancer has spread. For this group of patients, palliative chemotherapy is the most suited treatment option. To find out if a patient is suited for surgery, CT and MRI are performed. These imaging techniques, however, struggle to correctly identify small cancer spreads that are smaller than 1 cm. Therefore, cancer that has already spread can be found during surgery. In these cases, the tumor cannot be removed and the surgery therefore has not been of any benefit for the patient. These surgeries could be avoided by implementing a diagnostic tool with significantly higher accuracy than those currently used. Single center studies have shown that fibroblast activation protein inhibitor (FAPI) PET-CT is a very promising technique for determining metastases in tumors with prominent desmoplastic reactions, like cholangiocarcinoma. The investigators predict that implementation of preoperative FAPI PET-CT could prevent futile surgery for at least half of patients in whom intra-operative metastasized disease is found using the current work-up.Patient populationPatients ≥18 years with potentially curable proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma) who are planned to undergo surgery based on imaging using CT thorax/abdomen and MRI of the upper abdomen. Exclusion criteria are previous abdominal surgery or chemotherapy, known pregnancy or lactation and indication for FDG PET-CT.Participation in this studyParticipation would mean to undergo FAPI PET-CT prior to the scheduled surgery. This will take up about half a day of the participant's time. Afterwards, participants receive questionnaires about quality of life and use of healthcare services over a period of six months in order for the researchers to be able to calculate the cost-effectiveness of additional FAPI PET-CT.Risks and benefits of participationPatients may benefit directly from \[18F\]F-FAPI PET-CT by allowing for more targeted treatment, possibly avoiding futile surgery and receiving chemotherapy or best clinical support instead, minimizing treatment delay. Avoiding futile surgery will also prevent patients from being exposed to the risks and discomfort associated with surgery: hospital stay, possibility of intraoperative or postoperative complications, postoperative pain and recovery, and mortality.Potential risks and burdens associated with this study are an extra hospital visit and a time burden of approximately half a day. Risks associated with administering FAPI are (re)bleed and infection. Both risks have a minimal probability of onset and can usually easily be treated. As \[18F\]F-FAPI is a sub-pharmacologically micro-dosed diagnostic tracer, the risk of allergic reactions is expected to be minimal and no tissue damage is expected. The burden associated with undergoing a PET-CT may be laying still for a certain time, and possible experience of claustrophobia. Possible metastases of the cancer will have to be confirmed when suspicious findings are seen on FAPI PET-CT. This could mean that participants will have to undergo additional testing such as imaging (CT or MRI) or biopsy. Undergoing FAPI PET-CT prior to surgery will result in a surgical delay when compared with the current clinical practice. The investigators do not expect this delay to influence the patient's prognosis. Follow-up will result in a time burden for patients to answer questionnaires on a two-weekly or monthly basis. ### Conditions - Cholangiocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - [18F]F-FAPI PET-CT ### Outcomes Primary Outcomes - Diagnostic accuracy of [18F]F-FAPI PET-CT Secondary Outcomes - Change of treatment - Cost-effectiveness - Number of additional significant findings using [18F]F-FAPI PET-CT - Number of times nuclear medicine specialists' [18F]F-FAPI PET-CT conclusions differed from one another - Number of lesions found on [18F]F-FAPI PET-CT - Number of days between [18F]F-FAPI PET-CT and exploratory surgery - Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 - Number of participants in which dynamic [18F]F-FAPI PET-CT followed by conventional [18F]F-FAPI PET-CT was able to distinguish benign lesions from malignant lesions - Change in volume of interest (cm3) using dynamic [18F]F-FAPI PET-CT - Difference in SUVmax between dynamic and conventional [18F]F-FAPI PET-CT - Difference in SUVmean between dynamic and conventional [18F]F-FAPI PET-CT - Difference in transport rate (k1 to k2) on dynamic [18F]F-FAPI PET-CT between participants with malignant lesions and particpants with benign lesions ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Psilocybin in Chronic Low Back Pain and Depression - NCT ID: NCT06355414 - Study ID: IRB00385932 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-08-30 - Lead Sponsor: Johns Hopkins University ### Study Description This study seeks to provide insight on psilocybin's effects on mechanisms of chronic pain among patients with co-morbid chronic low back pain and depression (CLBP+D).Participants will receive either a single high-dose of psilocybin (25mg absolute dose) or methylphenidate (40mg absolute dose). Participants will be asked to complete assessments of pain, depressive symptoms, and more general questionnaires regarding the participants experiences during the experimental sessions and the associated enduring effects. ### Conditions - Chronic Low-back Pain - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Psilocybin - Methylphenidate ### Outcomes Primary Outcomes - Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) - Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) - Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) - Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) Secondary Outcomes - Changes in positive affect as assessed by discrete positive affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) - Changes in negative affect as assessed by discrete negative affect items and averaged over 7-day periods of Ecological Momentary Assessment (EMA) - Changes in Pain Catastrophizing as assessed by the Pain Catastrophizing Scale and averaged over 7-day periods of Ecological Momentary Assessment (EMA) - Changes in Positive Affective Pain Inhibition (Quantitative Sensory Testing) ### Location - Facility: Johns Hopkins University School of Medicine, Baltimore, Maryland, 21224, United States @@
## Maintenance Hormonal Therapy and DLBCL - NCT ID: NCT06355401 - Study ID: Soh-Med-24-03--06PD - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2029-03 - Lead Sponsor: Sohag University ### Study Description the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy and/or radiotherapy in patients with DLDCL ### Conditions - Diffuse Large B Cell Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tamoxifen 20mg ### Outcomes Primary Outcomes - disease free survival - overall survival Secondary Outcomes - side effects ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## TRAnscutaneous vaGUS Nerve Stimulation in Patients With Chronic Heart Failure - NCT ID: NCT06355388 - Study ID: TRAGUSHF - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2027-05-01 - Lead Sponsor: Fondazione Toscana Gabriele Monasterio ### Study Description To verify the efficacy of transcutaneous vagus nerve stimulation (tVNS) on and autonomic balance in patients with chronic heart failure and reduced (HFrEF) or mildly reduced (HFmrEF) left ventricular ejection fraction. The study hypothesis is that tVNS increases baroreflex gain, with consequent benefits on sympathovagal balance (at short- and mid-term), and on quality of life and bio-humoral parameters (at mid-term). ### Conditions - Heart Failure - Heart Failure With Reduced Ejection Fraction - Heart Failure With Midrange Ejection Fraction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Active tVNS - Sham tVNS ### Outcomes Primary Outcomes - Mean change in baroreflex gain (ms/mmHg) - Mean change in baroreflex gain (ms/mmHg) Secondary Outcomes ### Location - Facility: Michele Emdin, Pisa, Pi, 56120, Italy @@
## Exercise in Pregnancy and Risk of Postpartum Depression - NCT ID: NCT06355375 - Study ID: 02.24 - Status: RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-12-01 - Lead Sponsor: Federico II University ### Study Description The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day ### Conditions - Depression - Pregnancy Related ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - exercise in pregnancy ### Outcomes Primary Outcomes - edinburgh depression scale Secondary Outcomes - Postpartum depression - preterm birth ### Location - Facility: Gabriele Saccone, Naples, N/A, 80100, Italy @@
## Association of Intraoperative Hemodynamic Characteristics to Postoperative Complications and Mortality - NCT ID: NCT06355362 - Study ID: HeCoMo - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-06-30 - Lead Sponsor: Kliniken Essen-Mitte ### Study Description Worldwide, about 400 million major surgeries are performed annually. The scarce data available in the literature still suggest high postoperative morbidity and mortality, even in Europe. Data of the World Health Organization on causes of death suggest that death after surgery would be the number three cause of mortality if it were considered a separate cause of death. However, there is little structured or high-quality data on postoperative mortality in the literature.The aim of this study project is to collect data on postoperative complications and mortalities worldwide and to establish a Perioperative Outcome Study Platform on this topic.In the first study of this platform, we aim to investigate the association of hemodynamic characteristics with postoperative complications and mortality. It is a prospective, multi-center study.In addition, the investigators aim to collect data on the structural characteristics of the study sites and, for each patient, characteristics of quality of perioperative care in order to analyze associations with hemodynamic characteristics and postoperative complications and mortalities. ### Conditions - High-risk Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of postoperative complications - Incidence of postoperative mortalities Secondary Outcomes - Implementation rate of preoperative factors impacting postoperative outcome - Intraoperative hemodynamic characteristics - Postoperative haemodynamic characteristics - Co-morbidities of patients - Transfusion of blood components and administration of coagulation factors - Score of the physical/pathological activity status of the patients - Clinical frailty scale - Characteristics of perioperative care, time in perioperative units and the hospital - Characteristics of provision of anesthesia and type of pain therapy - Implementation rate of items perioperatively impacting outcome within an Enhanced-Recovery-After-Surgery pathway description ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## To Evaluate the Safety and PK Characteristics in Healthy Volunteers - NCT ID: NCT06355349 - Study ID: JW22101 - Status: COMPLETED - Start Date: 2023-04-28 - Completion Date: 2023-07-17 - Lead Sponsor: JW Pharmaceutical ### Study Description The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0101 and C2101 and administration of JW0102 in healthy volunteers under fasting conditions ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: OTHER ### Interventions - Reference Drug or Test Drug ### Outcomes Primary Outcomes - AUCt - Cmax Secondary Outcomes ### Location - Facility: Clinical Trial Center, Jeonbuk National University Hospital, Jeonju, N/A, N/A, Korea, Republic of @@
## Real World Prostate Cancer Registry - NCT ID: NCT06355336 - Study ID: CCA/IRN-24-001 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2034-03-18 - Lead Sponsor: Cincinnati Cancer Advisors ### Study Description Prostate cancer is the most common cancer diagnosed in men in the USA with 268,490 cases diagnosed in 2022 constituting 27% of male cancers and 34,500 deaths (11%) occurred in same year.1 Prostate cancer is a very heterogeneous disease that has different presentations, molecular and pathological features, stages, and disease biology. The treatment options are dependent on the disease stage, its features, and the patient's condition and preferences. The disease outcome also varies significantly due to the previous heterogeneity of the features in addition to other social determinants of health.Therefore, it is critical to obtain real-world data that reflects the actual patterns of prostate cancer presentation, work up, management, and outcome. Real World Prostate Cancer Registry (RWPCR) aims at compiling real world data from patients presented with prostate cancer in the tristate area. The data collection will be prospective and longitudinal including patients' demographics and disease characteristics, work up, management, and outcome. ### Conditions - Prostate Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To determine practice patterns for prostate cancer in the region. Secondary Outcomes - To determine progression free survival and overall survival of patients. - Prevalence of long term complications of prostate cancer treatment. ### Location - Facility: Cincinnati Cancer Advisors, Cincinnati, Ohio, 45212, United States @@
## Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France - NCT ID: NCT06355323 - Study ID: PT22020 - Status: RECRUITING - Start Date: 2022-11-28 - Completion Date: 2025-11-28 - Lead Sponsor: CHU de Reims ### Study Description Primary humoral immunodeficiency (PHID), such as common variable immunodefiency, are the most common symptomatic primary immunodeficiency in adults, in France. Patients are more prone to infections (particularly bacterial upper and lower respiratory tract infections), auto-immunity and atopic manifestations. Morbidity and mortality in PHID are mainly linked to the presence of bronchiectasis, which can lead to infections and to chronic respiratory failure. However, bronchiectasis in these patients can be asymptomatic for a long time. There is no known predictive factors to identify patients more susceptible to develop bronchiectasis and notably, there was no link between the number of previous infectious episodes and bronchiectasis. A marked IgM deficiency and switched memory B cell deficiency might be associated with bronchiectasis.Thoracic CT-scan is recommended at PHID diagnosis but there is no guideline for follow-up, thus leading to bronchiectasis being under-diagnosis or leading to delayed diagnosis ### Conditions - Primary Immunodeficiency - Common Variable Immunodeficiency - Igg Subclass Deficiency - Selective IgM Deficiency ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Blood test - chest CT scan ### Outcomes Primary Outcomes - Thoracic CTscan Secondary Outcomes - Pulmonary Function Test - Pulmonary Function Test - Pulmonary Function Test - Pulmonary Function Test - Pulmonary Function Test - Pulmonary Function Test - 6 minutes walking test - 6 minutes walking test - 6 minutes walking test - 6 minutes walking test - Quality of life questionnaires - Quality of life questionnaires - Immunophenotyping - Biochemical factors : desmosine seric concentration ### Location - Facility: Damien JOLLY, Reims, N/A, N/A, France @@
## Mechanisms of SGLT2 Inhibition in Pediatric Steatotic Liver Disease - NCT ID: NCT06355310 - Study ID: IRB 2023-6429 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2028-12-31 - Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago ### Study Description This study is a randomized, double-blind, placebo-controlled trial specifically designed to evaluate the preliminary feasibility, initial efficacy and safety of SGLT2 inhibitors for treating NAFLD in adolescents with obesity. ### Conditions - Non-Alcoholic Fatty Liver Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Empagliflozin 10 MG - Placebo Oral Tablet ### Outcomes Primary Outcomes - Hepatic Fat Secondary Outcomes - Body mass index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Educational Intervention Related to Pelvic Floor Care in Females in Sport: ACTITUD - NCT ID: NCT06355297 - Study ID: 124CER19. - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-04-09 - Completion Date: 2024-06-20 - Lead Sponsor: University of the Balearic Islands ### Study Description Pelvic floor dysfunctions (PFD) are especially prevalent among females who practice and compete in sport. One of the main reason is the great physical effort required to achieve the maximal sports performance. As conservational management, increasing the females' information is an important research line. However, gender stereotypes, embarrassment and normalization among females make it difficult to seek professional care. In this situation, prevention or management of PFD is limited.New technologies could facilitate engaging virtual educational approaches. This study will evaluate the effects of an educational intervention compounded by three sessions (60 min of duration) with one week apart, about PFD, habits related with it, and existing gender stereotypes.To this end, all female who practice and compete in any sport in Spain will be invited to attend an educational online intervention with theoretical-practical content about PFD. As eligibility criteria, participants should train and compete in any sport, and have federative license from regional or national sports federation at the moment of the start of the study. Participants should have at least 16 years old. The investigators expect 400 athletes to fulfill the questionnaires, of which the investigators expect 200 to attend the educational intervention. Before the educational intervention, all females will reply an anonymous questionnaire to inform about their knowledge of PFD, daily practices related to PFD, influencing gender stereotypes and PFD self-reported diagnosis. One month later, this questionnaire will be sent to females (both athletes who attended the educational intervention or not) to describe changes after attending the online educational intervention and compared to those females who did not attend it. The main outcomes will be the level of knowledge about PF, the number of habits potentially related to PFD, and score of gender stereotyped beliefs. As an additional outcome, it will be considered the PFD self-reported symptomatology. ### Conditions - Pelvic Floor Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Education about pelvic floor ### Outcomes Primary Outcomes - Knowledge about pelvic floor - Habits related to pelvic floor dysfunctions Secondary Outcomes - Gender stereotypes beliefs - Occurrence of symptoms related to pelvic floor dysfunctions ### Location - Facility: University of the Balearic Islands, Palma De Mallorca, Balearic Islands, 07122, Spain @@
## Overcontrol and Suicide in PTSD - NCT ID: NCT06355284 - Study ID: D5150-P - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-04-30 - Lead Sponsor: VA Office of Research and Development ### Study Description High standards and self-discipline are prized in military culture, but drawbacks of overcontrol are often ignored. Overcontrol is characterized by over-regulated behavior and cognitive rigidity, driven by an intense need for perfection and control. It is frequently observed in people with obsessive-compulsive (OC) spectrum disorders, especially OC Personality Disorder (OCPD). Their inclination to set high expectations for others can strain social bonds. When grappling with mental health challenges, overcontrolled individuals often do so with limited social support, and as a result, tend to be at greater risk of developing more severe mental health symptoms, or suicidal thoughts and behaviors, over time.New treatments are needed to improve social functioning in these vulnerable Veterans. Adding brain stimulation to psychotherapy is one method that might speed learning of social skills discussed in therapy. However, before this technology can be developed and tested more broadly, the investigators must make sure that the methods used to measure social functioning and related brain circuits are acceptable to most potential patients and can be used consistently.In this pilot project, the investigators aim to recruit trauma-exposed Veterans with overcontrolled traits and study the feasibility and acceptability of:1. Our recruitment strategy and social functioning and mental health symptom assessments2. A three-session, weekly fMRI protocol.3. A three-week online protocol for remote monitoring of social and emotional functioning. ### Conditions - Compulsive Personality Disorder - Stress Disorders, Post-Traumatic ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Functional MRI ### Outcomes Primary Outcomes - Number of potential participants screened per month meeting the overcontrol criterion. - Percentage of sessions completed by participants receiving MRI. - Percentage of remote questionnaires completed. Secondary Outcomes ### Location - Facility: Providence VA Medical Center, Providence, RI, Providence, Rhode Island, 02908-4734, United States @@
## Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery - NCT ID: NCT06355271 - Study ID: 2024-00019 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-09-01 - Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona ### Study Description Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery ### Conditions - Obstetric Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fentanyl 1 - Fentanyl2 - Fentanyl 3 ### Outcomes Primary Outcomes - Patient Controlled Analgesia morphine consumption - obstetric quality of recovery score Secondary Outcomes - Visual Analogue Scale - pruritus - nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity - intraoperative hypotension - intraoperative opioids - satisfaction rate - intraoperative pain ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of the Efficacy of Troxerutin in Preventing Thrombotic Events in COVID-19 Patients - NCT ID: NCT06355258 - Study ID: 20230817LX001 - Status: RECRUITING - Start Date: 2023-09-15 - Completion Date: 2025-03 - Lead Sponsor: Westlake University ### Study Description The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are:* Does troxerutin lower the number of thrombotic events in participants?* What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients.Participants will:* Take troxerutin or a placebo every day for 7 days.* Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests* Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia ### Conditions - COVID 19 Associated Coagulopathy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Troxerutin - Placebo - placebo + low molecular weight heparin - troxerutin + low molecular weight heparin ### Outcomes Primary Outcomes - Overall number of thrombotic events through 28 days - Tolerability of anticoagulation therapy Secondary Outcomes - Time to clinical improvement in patients through 28 days ### Location - Facility: Shaoxing central hospital, Shaoxing, Zhejiang, N/A, China @@
## MEDECA - Markers in Early Detection of Cancer - NCT ID: NCT06355245 - Study ID: 2017/2160-31/1 - Status: RECRUITING - Start Date: 2018-03-01 - Completion Date: 2026-12 - Lead Sponsor: Danderyd Hospital ### Study Description Early diagnosis of cancer is key for improving patient outcomes, but cancers are difficult to diagnose if patients present with unspecific symptoms. The principal objective of the MEDECA (Markers in Early Detection of Cancer) study is to identify a multi-analyte blood test that can detect and map occult cancer within a mixed population of patients presenting with serious but unspecific symptoms. The study will include 1500 patients referred to the Diagnostic Center at Danderyd Hospital (DC DS), a multidisciplinary diagnostic center referral pathway for patients with radiological findings suggestive of metastasis without known primary tumor or suspicion of serious but unspecific symptoms. Blood samples are collected prior to a standardized and extensive cancer diagnostic work-up, including an expanded panel of biochemical analyses and extensive imaging such as computed tomography or magnetic resonance investigations. In collaboration with world-leading international scientists, the blood samples will be analyzed for a panel of novel and established blood biomarkers predictive of an underlying cancer, including markers of neutrophil extracellular traps, circulating tumor DNA, platelet mRNA profiling, affinity-based proteomics and nuclear magnetic resonance metabolomics. The diagnostic accuracy of the blood biomarkers with respect to cancer detection during the diagnostic work-up will be analyzed through machine learning. ### Conditions - Cancer - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sampling ### Outcomes Primary Outcomes - Cancer diagnosis Secondary Outcomes - Other diagnosis - Mortality - Cancer diagnosis ### Location - Facility: Danderyd Hospital, Stockholm, N/A, N/A, Sweden @@
## Covid-19 and Influenza Oral Vaccine Study - NCT ID: NCT06355232 - Study ID: Vaxine-2301 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-21 - Completion Date: 2025-04-21 - Lead Sponsor: Vaxine Pty Ltd ### Study Description The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines. ### Conditions - covid19 Infection - Influenza, Human ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Covid-19 vaccine - Influenza vaccine ### Outcomes Primary Outcomes - SARS-CoV-2 Seroconversion - Influenza Seroconversion - SARS-CoV-2 Seroprotection - Influenza Seroprotection - SARS-CoV-2 Geometric mean titer fold change - Influenza geometric mean titer fold change - Safety assessment 1 - Safety assessment 2 - SARS-CoV-2 infection - Influenza infection Secondary Outcomes - Antibody durability - Seroconversion in participants with and without evidence of past infection - Antibody GMT in participants with and without evidence of past infection - Antibody correlates of protection ### Location - Facility: ARASMI, Adelaide, South Australia, 5042, Australia @@
## Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines - NCT ID: NCT06355219 - Study ID: IRB #19-066 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2010-01-01 - Completion Date: 2024-12-31 - Lead Sponsor: Ali Aminian ### Study Description The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths. ### Conditions - Type 2 Diabetes Mellitus - Obesity - Microvascular Disease - Macrovascular Disease - Major Adverse Cardiovascular Events - Nephropathy - Retinopathy - Heart Failure - All Cause Mortality ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause Mortality Rate Secondary Outcomes - Incidence of MACE - Incidence of Nephropathy - Incidence of Retinopathy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Natural Course and Therapeutic Effect of Recurrent Acute Pancreatitis - NCT ID: NCT06355206 - Study ID: NACRE20230306 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2034-12 - Lead Sponsor: Changhai Hospital ### Study Description The goal of this observational cohort study is to learn about the etiology, natural course, therapeutic effect and outcome of recurrent acute pancreatitis patients. The main question it aims to answer is:Does endoscopic intervention, surgery or conservative treatment reduce the recurrence of acute pancreatitis? What are the risk factors affecting the recurrence of acute pancreatitis?Patients will be closely followed and clinical information will be recorded. ### Conditions - Cohort Study - Recurrent Acute Pancreatitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - endoscopic intervention, surgery or conservative treatment ### Outcomes Primary Outcomes - Recurrence rate of acute pancreatitis Secondary Outcomes - Proportion of patients with different treatment - Characteristics of acute pancreatitis - Proportion of patients wtih pain in RAP patients - Proportion of patients with chronic pancreatitis - Evaluation of quality of life - Evaluation of psychological condition ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Use of Isatidis Root and Forsythia Oral Liquid for the Treatment of Mild Cases of COVID-19: A Trial Clinical Study - NCT ID: NCT06355193 - Study ID: MZhou - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2022-12-31 - Lead Sponsor: Central South University ### Study Description This study has significant implications for research, as it provides a basis for further studies on the antiviral effects of LGLQ Oral Liquid, encouraging more extensive clinical studies in larger populations and diverse age groups to validate these findings. For medical practice, the findings suggest that LGLQ can be considered an alternative treatment option for mild cases of COVID-19, especially in managing symptoms like fatigue, potentially broadening the range of effective treatments available to healthcare practitioners. In terms of policy, the demonstrated efficacy of LGLQ could lead to its inclusion in treatment guidelines for COVID-19 and other viral infections, fostering a more integrated approach combining Western medicine and Traditional Chinese Medicine in the global fight against pandemics. The insights from this study might prompt health policymakers to reassess the potential of herbal formulations in managing and treating infectious diseases and consider them in the development of future healthcare strategies and policies. ### Conditions - Treatment of Mild Cases of COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Langenlianqiao - LianhuaQingWen - placebo control group ### Outcomes Primary Outcomes - Treatment and symptomatic improvement effects of LGLQ Secondary Outcomes ### Location - Facility: Changde Hospital, Changde, Hunan, N/A, China @@
## Esketamine Treatment for Depressive Episodes With Suicidal Ideation in Mood Disorders - NCT ID: NCT06355180 - Study ID: Shoudufazhan2024-1-2122 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-12 - Lead Sponsor: Capital Medical University ### Study Description This study is a multicenter, non-inferiority, randomized, parallel-group, open-label clinical trial aimed at evaluating the effectiveness of esketamine versus modified electroconvulsive therapy (MECT) in treating suicidal ideation during depressive episodes of mood disorders. Additionally, it seeks to explore the potential mechanisms of esketamine's anti-suicidal effects. ### Conditions - Mood Disorders - Suicidal Ideation - Depressive Episode ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Subanesthetic dose intravenous esketamine - Modified electroconvulsive therapy ### Outcomes Primary Outcomes - Suicide remission rate based on the Scale for Suicidal Ideation (SSI) Secondary Outcomes - Quick Inventory of Depressive Symptoms Self Report (QIDS-SR) - Columbia Suicide Severity Rating Scale (CSSR-S) - Montgomery Asberg Depression Rating Scale (MADRS) - Clinical Global Impressions(CGI) - Short Form 12 Health Survey(SF-12) - Sheehan Disability Scale(SDS) - Digital Span Test(DST) - Digit Symbol Substitution Test(DSST) - Perceived Deficit Questionnaire for Depression 5-item(PDQ-D-5) - Young Mania Rating Scale (YMRS) - Clinician Administered Dissociative States Scale(CADSS) - Adverse event ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Oral Intake of Bacopa Monneiri on Vascular Oxidative Stress - NCT ID: NCT06355167 - Study ID: Bacoxy_I - Status: COMPLETED - Start Date: 2022-03-15 - Completion Date: 2022-09-30 - Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain ### Study Description Bacoxy_I study aims to evaluate the efficacy of a standardized Bacopa monnieri extract, Bacopa-400®, on vascular oxidative stress. ### Conditions - Oxidative Stress - Cardiovascular Diseases - Bacopaside II - Bacopa Monnieri - Endothelial Dysfunction - Aquaporin 1 - AQP1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Bacopa monnieri ### Outcomes Primary Outcomes - Ex vivo DCFDA test on red blood cells (RBCs) - Plasma lipid peroxydes - Methemoglobin in red blood cells - Nitrosylated hemoglobin (HbNO) in red blood cells Secondary Outcomes - haemoglobin - haematocrit - Red blood cells count - Sodium - Potassium - Bicarbonate - Total cholesterol - High-Density Lipoprotein (HDL) cholesterol - Low-Density Lipoprotein (LDL) cholesterol - Triglycerides - aspartate aminotransferase (ASAT), (U/L) - alanine aminotransferase (ALAT) (U/L) - gamma-glutamyl-transferase (GGT) level - Creatinine - Glomerular filtration rate ### Location - Facility: Clinique universitaires saint luc, Brussels, N/A, 1200, Belgium @@
## Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial - NCT ID: NCT06355154 - Study ID: 069823- HMO-CTIL - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-02-01 - Lead Sponsor: Hadassah Medical Organization ### Study Description Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT. ### Conditions - Diabetes in Pregnancy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nutritional intervention ### Outcomes Primary Outcomes - Time in range - Time above range Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Oral Structural and Functional Problems in Children With Autism - NCT ID: NCT06355141 - Study ID: E-15189967-050.04-494458 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-11 - Completion Date: 2024-08-12 - Lead Sponsor: Hacettepe University ### Study Description This study aims to examine oral structural and functional problems in children with autism. ### Conditions - Autism Spectrum Disorder - Chewing Problem - Drooling ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - oral assessment ### Outcomes Primary Outcomes - Demographic Information Form - Time to achieve Oromotor skills - Oral structural assessment Secondary Outcomes - Chewing evaluation - Drooling of saliva evaluation - Tongue thrust evaluation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Cross-sectional Study of Ocular Manifestations During the Covid-19 Pandemic in Hubei Province - NCT ID: NCT06355128 - Study ID: 20240307 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-01-01 - Completion Date: 2024-04-30 - Lead Sponsor: Zhongnan Hospital ### Study Description To investigate the clinical features of ocular manifestations during the novel coronavirus pneumonia pandemic in Hubei at the end of 2022 ### Conditions - COVID-19 - Ocular Surface Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NOT ### Outcomes Primary Outcomes - Questionnaire data were collected and statistically analyzed. Secondary Outcomes ### Location - Facility: Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071, China @@
## Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation - NCT ID: NCT06355115 - Study ID: 400/218/K.3/302/2023 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-09-01 - Lead Sponsor: University of Brawijaya ### Study Description The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections.Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations.The main questions it aims to answer are:1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations?2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications?Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections.Participants will:* Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations.* Visit the clinic for follow-ups and tests. ### Conditions - Pacemaker Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Cefazolin 1000 MG Injection ### Outcomes Primary Outcomes - Number of participants with early pocket infection (EPI) - Number of participants with late pocket infection (LPI) - Number of participants with infective endocarditis (IE) - Number of participants who underwent pacemaker revision Secondary Outcomes - Level of C-reactive protein (mg/dl) - Level of procalcitonin (mcg/dl) - Erythrocyte sedimentation rate (ESR) (mm/hour) - Neutrophil-to-leukocyte ratio (NLR) - Neutrophil count (cells/mm3) - Leukocyte count (cells/mm3) ### Location - Facility: RSUD Dr. Saiful Anwar, Malang, Jawa Timur, 65112, Indonesia @@
## The Development of Tinnitus in Patients With SSNHL: Insights From fMRI and Metabolomics - NCT ID: NCT06355102 - Study ID: 2024-SR-116 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-15 - Completion Date: 2026-03-31 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The goal of this clinical trial is to investigate the factors and mechanisms underlying tinnitus generation and chronification in patients with sudden sensorineural hearing loss (SSNHL) . The main questions it aims to answer are:* What are the peripheral and central influencing factors that contribute to tinnitus in patients with SSNHL?* Can serum metabolic biomarkers be identified to predict and monitor tinnitus prognosis in these patients?Participants in this study will include patients with SSNHL and tinnitus, patients with SSNHL without tinnitus, and healthy subjects. They will be asked to undergo a series of assessments, including audiological tests, vestibular function examinations, and functional magnetic resonance imaging (fMRI). Additionally, blood samples will be collected for metabolomics analysis.Investigators will compare the brain functional states and serum metabolite profiles of patients with SSNHL and tinnitus to those without tinnitus. Morever, tinnitus symptom characteristics, audiological outcomes, and brain functional states will be assessed during time. ### Conditions - Sudden Sensorineural Hearing Loss - Tinnitus ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Brain function states - Serum metabolomics Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intestinal Microbiota: Immunity, Recovery and Metabolic Health - NCT ID: NCT06355089 - Study ID: VAR-MIKRO - Status: COMPLETED - Start Date: 2023-01-09 - Completion Date: 2023-09-07 - Lead Sponsor: University of Turku ### Study Description The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Placebo Comparator - Whey protein hydrolysate milk product - Postbiotic and whey protein hydrolysate milk product ### Outcomes Primary Outcomes - Concentrations of inflammatory markers from the blood samples Secondary Outcomes - Gut microbiota composition in feces - Weight of the participant - Waist circumference of the participant - Infections during the intervention - Development of physical fitness - Sleep quality - Recovery - Blood pressure - BMI ### Location - Facility: University of Turku, Turku, N/A, N/A, Finland @@
## New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection - NCT ID: NCT06355076 - Study ID: CSZ03 - Status: RECRUITING - Start Date: 2023-02-05 - Completion Date: 2026-06 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.Participants will:The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group. ### Conditions - Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - New urethral reconstruction ### Outcomes Primary Outcomes - Recovery of urinary incontinence Secondary Outcomes - complication - PSA - recurrence ### Location - Facility: Qilu hospital, Jinan, Shandong, 276600, China @@
## CellFX® nsPFA™ Cardiac Surgery System to Treat Atrial Fibrillation - NCT ID: NCT06355063 - Study ID: NP-PCF-037 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2025-10-31 - Lead Sponsor: Pulse Biosciences, Inc. ### Study Description This feasibility study will be conducted to demonstrate the initial safety and effectiveness of the CellFX® nsPFA™ Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more extensive surgical ablation set in conjunction with concomitant cardiac surgical procedure. ### Conditions - Atrial Fibrillation - Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CellFX® nsPFA™ Cardiac Surgery System ### Outcomes Primary Outcomes - Rate of acute major adverse events (MAEs) - Number of Participants with acute electrical isolation of the bilateral pulmonary veins and left atrial free wall. Secondary Outcomes - Proportion of Participants with one or more SAEs - Number of Participants with Long-Term Technical Success ### Location - Facility: Academic Medical Center, Amsterdam, N/A, N/A, Netherlands @@
## Ultrahypofractionated, Adaptive Radiation Therapy of Prostate Cancer - NCT ID: NCT06355050 - Study ID: UKJ-ultraHART - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2031-09-30 - Lead Sponsor: Jena University Hospital ### Study Description In this prospective, multi-center cohort study, the tolerability and quality of life during ultrahypofractionated radiotherapy (RT) of early stage prostate cancer is surveyed at several institutions in Germany. Radiotherapy is delivered with by an online-adaptive RT device (Varian Ethos), which is able to correct daily variations in anatomy and to adjust the irradiation plan accordingly. A digital patient questionnaire is used to asses quality of life longitudinally. Quality of life (QoL) and toxicity profiles will be correlated with planning parameters and compared to retrospective cohorts of patients who underwent normofractionated RT or moderately hypofractionated RT, respectively. ### Conditions - Prostate Cancer - Adaptive Radiotherapy - Quality of Life ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Toxicity (CTCAE v5.0) - Quality of Life (EPIC 26) Secondary Outcomes - Planning parameters - Dose constraints - Conformity indices - Quality of adaptive planning - PSA-value - Overall survival - Recurrence free survival ### Location - Facility: Department of Radiotherapy and Radiation Oncology, Jena University Hospital, Jena, N/A, N/A, Germany @@
## Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer - NCT ID: NCT06355037 - Study ID: B2024.1.30 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-01-31 - Lead Sponsor: Fudan University ### Study Description This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. ### Conditions - Triple-negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Quercetin - Dasatinib - Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Disease Control Rate (DCR) - Progression Free Survival (PFS) - Safety and treatment-related AEs - Biomarker analysis1 - Biomarker analysis2 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Inosine Reverse Chemo Resistance in Triple Negative Breast Cancer - NCT ID: NCT06355024 - Study ID: A2024.1.30 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-10 - Completion Date: 2025-01-31 - Lead Sponsor: Fudan University ### Study Description This is a Phase II, open-label, single-arm study evaluating the efficacy and safety of combined treatment of Inosine with chemotherapy in mTNBC (triple negative breast cancer) patients who progressed during previous chemotherapy. ### Conditions - Triple-negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Inosine - Taxane/Anthracycline/Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1/platinum ### Outcomes Primary Outcomes - Objective Response Rate (ORR) Secondary Outcomes - Disease Control Rate (DCR) - Progression Free Survival (PFS) - Biomarker analysis1 - Safety and treatment-related AEs ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Total Elbow Replacement in England: Analysis of National Joint Registry and Hospital Episode Statistics Data - NCT ID: NCT06355011 - Study ID: 7016194 - Status: COMPLETED - Start Date: 2024-03-01 - Completion Date: 2024-04-02 - Lead Sponsor: University of Manchester ### Study Description The goal of this observational registry study is to provide detailed descriptions of the patients who are receiving primary total elbow replacement surgery in England. The main questions it aims to answer are:* Who are receiving primary total elbow replacement surgery?* Where and by whom is the total elbow replacement surgery is being performed?* What the current surgical practices for total elbow replacement?Pseudonymous data from the National Joint Registry NJR of all patients with total elbow replacement will be used. ### Conditions - Total Elbow Replacement ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Total Elbow Replacement ### Outcomes Primary Outcomes - The incidence of total elbow replacement (TER) in England Secondary Outcomes - Serious adverse events or re-admissions - Duration of elective wait - Post-operative duration of stay - Surgeon volume - Hospital volume ### Location - Facility: Centre for Epidemiology Versus Arthritis, Centre for Musculoskeletal Research, University of Manchester, Manchester Academic Health Science Centre, Manchester, N/A, M13 9PT, United Kingdom @@
## A Study of an Investigational mRNA-1273.815 COVID-19 Vaccine in Previously Vaccinated Adults - NCT ID: NCT06354998 - Study ID: mRNA-1273-P401 - Status: RECRUITING - Start Date: 2024-04-08 - Completion Date: 2024-06-01 - Lead Sponsor: ModernaTX, Inc. ### Study Description To evaluate immune responses of an Investigational mRNA-1273.815 vaccine against the Omicron subvariant strain (XBB.1.5) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). ### Conditions - SARS-CoV-2 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Investigational mRNA-1273.815 - Licensed Spikevax Vaccine ### Outcomes Primary Outcomes - Geometric Mean of Neutralizing Antibodies (nAbs) Against SARS-CoV-2-specific Strain at Day 15 Secondary Outcomes - Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) of Special Interest (AESIs), and AEs Leading to Withdrawal From the Study - Seroresponse Rate of nAb Against the SARS-CoV-2-specific Strain at Day 15 - Geometric Mean Ratio of nAb Against the SARS-CoV-2-specific Strain for Investigational mRNA-1273.815 Over the Licensed Spikevax Vaccine at Day 15 ### Location - Facility: Paratus Canberra, Canberra, Australian Capital Territory, 2617, Australia @@
## Modafinil and Exercise for Post Stroke Fatigue - NCT ID: NCT06354985 - Study ID: 23-5996 - Status: NOT_YET_RECRUITING - Start Date: 2024-10 - Completion Date: 2027-09 - Lead Sponsor: University Health Network, Toronto ### Study Description A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has two main aims:1. Test if Exercise Program One is better than Exercise Program Two2. Test if Modafinil is better than a Sugar PillAs another aim, the investigators will also look at if combining Modafinil with exercise has any benefits.This study will take place at 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.Participants will be assigned at random (like flipping a coin) to 1 of 4 groups:1. Sugar Pill plus Exercise Program One2. Sugar Pill plus Exercise Program Two3. Modafinil plus Exercise Program One4. Modafinil plus Exercise Program TwoThe treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke. ### Conditions - Stroke - Fatigue - Modafinil - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Modafinil 200mg - Placebo - Exercise Program One - Exercise Program Two ### Outcomes Primary Outcomes - Severity of Fatigue Symptoms Secondary Outcomes - Severity of Fatigue Symptoms - Impact on Quality of Life - Walking Recovery - Leg Strength and Coordination - 3-Day Physical Activity Assessment - Mood and Anxiety - Attention - Cognition - Health Resource Utilization - Quality Adjusted Life Years ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of SASP in the GCF on the Outcomes of Periodontal Regeneration - NCT ID: NCT06354972 - Study ID: SASP Turin - Status: COMPLETED - Start Date: 2022-01-02 - Completion Date: 2024-01-02 - Lead Sponsor: University of Turin, Italy ### Study Description Objectives: To test the impact of clinical inflammation and molecular expression profile (senescence-associated secretory phenotype; SASP) in the gingival crevicular fluid (GCF) on the outcomes of minimally-invasive periodontal regeneration in intra-bony defects.Methods: Sites associated with intrabony defects ≥ 3 mm requiring periodontal regeneration through minimally-invasive surgical technique were included. Pre-operatively, GCF was sampled for inflammatory biomarker analysis related to SASP \[interleukin (IL)-1β, IL-6 and IL-12; matrix-metalloproteinases (MMP)-8 and -9\]. Correlation analyses and logistic regression models were performed to assess the impact of predictors on clinical and radiographic outcomes. ### Conditions - Periodontal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Minimally invasive surgical procedure ### Outcomes Primary Outcomes - Clinical attachment level change - Achievement of composite outcome measure Secondary Outcomes - Radiographic bone level change - Probing pocket depth change ### Location - Facility: CIR Dental School, Turin, N/A, 10126, Italy @@

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