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## Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies - NCT ID: NCT06383572 - Study ID: 2024-0196 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-31 - Completion Date: 2029-04-01 - Lead Sponsor: M.D. Anderson Cancer Center ### Study Description To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS. ### Conditions - Lymphodepleting Chemotherapy - Myeloid Malignancies ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cyclophosphamide - Fludarabine phosphate - Decitabine ### Outcomes Primary Outcomes - Safety and adverse events (AEs) Secondary Outcomes ### Location - Facility: MD Anderson Cancer Center, Houston, Texas, 77030, United States @@
## Safety and Efficacy of XELOX Combined With Sintilimab and Lenvatinib in Advanced AFP-positive Gastric Cancer Patients - NCT ID: NCT06383559 - Study ID: TJMUCH-GI-GC07 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2026-09-01 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description This is a multi-center, prospective, open label phase 2 study evaluating the safety and efficacy of standard first-line chemotherapy XELOX regimen combined with Sintilimab (anti-PD-1 antibody) and Lenvatinib in the treatment of advanced AFP-positive gastric cancer. This study was conducted in the Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Institute and Hospital. Previous phase 1 dose escalation study (TJMUCH-GI-GC002) has demonstrated that such combinational pattern was well tolerated with promising efficacy. In this study, patients with AFP-positive and HER-2-negative advanced gastric cancer who had not received palliative systematic treatment in the past will be enrolled. Patients who met the inclusion criteria were treated with XELOX regimen combined with Sintilimab plus Lenvatinib every 3 weeks until disease progression or intolerable adverse reactions or death. The treatment regimen is XELOX chemotherapy (oxaliplatin 130mg/ m2, d1, capecitabine 850-1250 mg/m2, bid, d1-14, every 3 weeks) in combination with Sintilimab (\>=60kg, 200 mg; \<60kg, 3mg/kg; intravenous infusion, every 3 weeks) plus Lenvatinib (determined from previous phase 1 study, 16mg, orally once a day). Patients received regular and periodic reviews, with imaging evaluations every 6 weeks. Safety will be evaluated by AE and laboratory tests. ### Conditions - Gastric Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lenvatinib and Sintilimab ### Outcomes Primary Outcomes - ORR Secondary Outcomes - OS - PFS ### Location - Facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, N/A, China @@
## Artificial Intelligence-enabled ECG Detection of Congenital Heart Disease in Children: a Novel Diagnostic Tool - NCT ID: NCT06383546 - Study ID: XHEC-C-2024-053-1 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-30 - Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine ### Study Description Congenital heart disease (CHD) is the most common congenital disease in children. The early detection, diagnosis and treatment of CHD in children is of great significance to improve the prognosis and reduce the mortality of children, but the current screening methods have limitations. Electrocardiogram (ECG), as an economical and rapid means of heart disease detection, has a very important value in the auxiliary diagnosis of CHD.Big data and deep learning technologies in artificial intelligence (AI) have shown great potential in the medical field. The advent of the big data era provides rich data resources for the in-depth study of CHD ECG signals in children. The development of deep learning technology, especially the breakthrough in the field of image recognition, provides a strong technical support for the intelligent analysis of electrocardiogram. The particularity of children electrocardiogram requires the development of a special algorithm model. At present, the research on the application of deep learning models to identify children's electrocardiograms is limited, and the training and verification from large data sets are lacking. Based on the Chinese Congenital Heart Disease Collaborative Research Network, this project aims to integrate data and deep learning technology to develop a set of intelligent electrocardiogram assisted diagnosis system (CHD-ECG AI system) suitable for children with CHD, so as to improve the early detection rate of CHD and improve the efficiency of congenital heart disease screening. ### Conditions - Artificial Intelligence - Electrocardiogram - Deep Learning - Congenital Heart Disease in Children - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Large-scale ECG database for children - Artificial intelligence-assisted electrocardiogram model for CHD in Children Secondary Outcomes ### Location - Facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, N/A, China @@
## Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma - NCT ID: NCT06383533 - Study ID: IRB-2023-385 - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-12-31 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description It is a single arm, open-label, phase II cinical trial to evaluate the efficacy and safety of Disitamab Vedotin Plus Cadonilimab in second-line treatment of patients with Advanced or Metastatic Bile Duct Adenocarcinoma ### Conditions - Bile Duct Adenocarcinoma Non-Resectable - HER2 Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Disitamab Vedotin Plus Cadonilimab ### Outcomes Primary Outcomes - Objective response rate(ORR) Secondary Outcomes - Overall survival (OS) - Progression-free survival (PFS) - Disease control rate (DCR) - Incidence of Treatment-Emergent 3/4 Adverse Events ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China @@
## Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma - NCT ID: NCT06383520 - Study ID: XLan-0415 - Status: RECRUITING - Start Date: 2023-09-30 - Completion Date: 2025-12 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens. ### Conditions - Malignant Neoplasm of Liver ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - 68Ga-aGPC3-scFv/Fab ### Outcomes Primary Outcomes - Visual and standardized uptake values assessment of lesions and biodistribution Secondary Outcomes - Radioactivity in the blood and urine samples - Concentration of tumor markers (e.g., APF) in participants' blood - Pathological sections of tumour tissue ### Location - Facility: China, Hubei Province, Wuhan, Hubei, 430022, China @@
## A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors - NCT ID: NCT06383507 - Study ID: CHT101 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2029-04-21 - Lead Sponsor: Zhejiang University ### Study Description This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns. ### Conditions - Metastatic Tumor - Advanced Solid Tumor - Renal Cell Carcinoma - Ovarian Cancer - Cervix Cancer - Head and Neck Squamous Cell Carcinoma - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - CHT101 ### Outcomes Primary Outcomes - Incidence of Adverse events after CD70 UCAR-T cells infusion (Safety and Tolerability) Secondary Outcomes - Disease control rate (DCR) - Objective response rate (ORR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## GMA-TulipTM, i-gelTM and the LMA-SupremeTM (LMA-S) Devices in Airway Management - NCT ID: NCT06383494 - Study ID: IRB-2024-356（IIT） - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-30 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description Patients were randomly assigned to three extraglottic airway (EGA) devices groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded. ### Conditions - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - LMA supreme group - I-gel group - GMA-Tulip ### Outcomes Primary Outcomes - Glottic exposure grading Secondary Outcomes - Peak inspiratory pressures - Pharyngalgia - Bleeding ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, 310022, China @@
## The Effect of Mobile-Based Education on Postoperative Recovery and Quality of Life in Thyroidectomy Patients - NCT ID: NCT06383481 - Study ID: TDK-2024-13362 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-08-22 - Lead Sponsor: Ataturk University ### Study Description Thyroid diseases constitute one of the most common health problems around the world and in our country. In its treatment; Drug therapy, radioactive iodine therapy and surgical treatment can be applied alone or together. Advances in the diagnosis of thyroid diseases have led to an increase in the number of thyroidectomies. When there are no complications after thyroidectomy, patients are discharged from the hospital on the day of surgery or are hospitalized for only a few days. In this context, since technical care is given priority, discharge training remains incomplete.Patients who have had thyroidectomy are discharged within 1-2 days after surgery if no problems occur. For this reason, patient education provided by health professionals and especially nurses may be insufficient. Post-discharge patient education in surgical services can sometimes be ignored, and it is noteworthy that this situation is not given importance due to the busy nature of surgical services. Although short hospital stays after surgery are beneficial in many ways, it increases the need for patient education.In this study, a mobile application that covers the entire perioperative process and includes education will be developed for patients undergoing thyroidectomy. This developed mobile application aims to manage post-operative problems such as neck pain and discomfort and voice changes experienced by patients, and to improve post-operative recovery, voice quality and, accordingly, quality of life. In this context, it is believed that even in cases where patients cannot access health care professionals, their educational needs will be met, problem management will be provided with applications for the problems they experience, and accordingly, their post-operative recovery, voice and quality of life will increase, starting from the hospital before the surgery until the end of the recovery period, including the home care process after discharge.When the literature on the subject is examined, studies involving education in patients with thyroidectomy are limited. However, no studies have been found on mobile health applications that include training to reduce neck pain and discomfort experienced by thyroidectomy patients, ensure postoperative recovery, and improve voice quality and quality of life. ### Conditions - Thyroid Diseases - Healthy Lifestyle - Thyroid ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Mobile based education ### Outcomes Primary Outcomes - Postoperative Recovery Index (ASII) - SF-36 Quality of Life Scale Secondary Outcomes - Visual Comparison Pain Scale(GKAÖ) - Turkish- Computer System Usability Questionnaire Short Version (TCSUQ- SV) - Neck Pain and Discomfort Scale (BARÖ) - Voice Handicap Index (Voice Handicap Index 10)(VHI10) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis - NCT ID: NCT06383468 - Study ID: AK120-301 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-01-30 - Lead Sponsor: Akeso ### Study Description This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. ### Conditions - Atopic Dermatitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - AK120 ### Outcomes Primary Outcomes - Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 Secondary Outcomes - Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA ### Location - Facility: Beijing Friendship Hospital Capital Medical University, Beijing, Beijing, N/A, China @@
## Effects of Smoking on Clinical and Microbiological Response in Individuals With Periodontitis - NCT ID: NCT06383455 - Study ID: Observational - Status: COMPLETED - Start Date: 2018-09-15 - Completion Date: 2019-03-01 - Lead Sponsor: Trakya University ### Study Description This study aimed to compare the distribution of subgingival periodontal pathogens following non-surgical periodontal therapy in smoking and non-smoking people with periodontitis. The main question it aims to answer is:- Does smoking affect the results of non-surgical periodontal treatment on subgingival flora in participants with periodontal disease?Researchers performed non-surgical periodontal therapy on 48 participants with stage III/IV periodontitis and recorded clinical measurements. They obtained subgingival plaque samples from periodontal pockets at the onset and after four weeks of treatment, determining the level of periodontopathogens using a polymerase chain reaction-based method. ### Conditions - Periodontitis - Smoking Habit - Subgingival Plaque ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Non-surgical periodontal therapy ### Outcomes Primary Outcomes - Change in levels of periodontopathogens in subgingival plaque after non-surgical periodontal therapy in smokers and non-smokers with stage 3/4 periodontitis Secondary Outcomes - Change in clinical attachment level (CAL) - Change in probing depth (PD) - Change in gingival index (GI) scores - Change in plaque index (PI) scores - Change in Bleeding on Probing (BOP) ### Location - Facility: Trakya University, Edirne, N/A, 22030, Turkey @@
## HIIT on Overweight Middle-aged Adults - NCT ID: NCT06383442 - Study ID: N202103041 - Status: COMPLETED - Start Date: 2021-05-25 - Completion Date: 2023-11-22 - Lead Sponsor: Taipei Medical University ### Study Description 36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss. ### Conditions - Overweight or Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - L-HIIT - M-HIIT ### Outcomes Primary Outcomes - Aerobic Capacity Test - Aerobic Capacity Test - Anti-fatigue performance - skinfold thickness - Body composition_body fat Secondary Outcomes - Glucose - Triglycerides - low-density lipoprotein (LDL) - high-density lipoprotein (HDL) - creatine kinase (CK) level - C-reactive protein (CRP) - tumor necrosis factor (TNF)-R1 - TNF-R2 ### Location - Facility: Taipei Medical University, Taipei, N/A, 110, Taiwan @@
## Relation Between Forward Head Posture and Incidence of Headache in Obese Adults - NCT ID: NCT06383429 - Study ID: P.T-WH-10/2023-521 - Status: COMPLETED - Start Date: 2024-01-01 - Completion Date: 2024-04-15 - Lead Sponsor: Ahram Canadian University ### Study Description Cross sectional study to detect relation between forward head posture and headache. We will take information from the patient about:* Detailed history of patient* Forward head posture by using mobile application* Headache disability index ### Conditions - Obese - Headache - Neck Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - forward head posture by using mobile application. And patients will fill out headache disability index. ### Outcomes Primary Outcomes - forward head posture - BMI - headache disability index Secondary Outcomes ### Location - Facility: Ababa physical therapy center, Banī Suwayf, Beni- Suaf, 2711860, Egypt @@
## Incidence of Headache and Its Effect on Quality of Life in Geriatric Patients With Chronic Neck Pain - NCT ID: NCT06383416 - Study ID: P.T-INT-10/2023-522 - Status: COMPLETED - Start Date: 2024-01-21 - Completion Date: 2024-04-20 - Lead Sponsor: Ahram Canadian University ### Study Description cross sectional study to detect the incidence of headache and its effect on quality of life in geriatric patients with chronic neck pain. Patients will fill out quality of life questionnaire and headache disability index. We will take information from the patients about:* The frequency of headache occurrence.* Visual analogue scale of chronic neck pain. Main measures: chronic neck pain will be assessed by visual analogue scale. Patients will fill out quality of life questionnaire and headache disability index. ### Conditions - Geriatric Patients With Neck Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neck pain by VAS ### Outcomes Primary Outcomes - Visual analogue scale - headache disability index - SF-36 quality of life questionare Secondary Outcomes ### Location - Facility: Ababa physical therapy center, Banī Suwayf, N/A, 2711860, Egypt @@
## A Study of Elafibranor in Adults With Primary Biliary Cholangitis and Inadequate Response or Intolerance to Ursodeoxycholic Acid. - NCT ID: NCT06383403 - Study ID: CLIN-60190-463 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2026-12-21 - Lead Sponsor: Ipsen ### Study Description The participants in this study will have confirmed PBC with inadequate response or intolerance to Ursodeoxycholic acid (UDCA), which is a medication used in the management and treatment of cholestatic liver disease.Primary biliary cholangitis is a slowly progressive disease characterised by damage of the bile ducts in the liver, leading to a build-up of bile acids which causes further damage. The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms.Many patients with PBC may require a liver transplant or may die if the disease progresses and a liver transplant is not done. This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment).The main aim of this study is to determine if elafibranor is better than placebo in reducing ALP levels to a normal value. High ALP levels in the blood can indicate liver disease.There will be three periods in this study: A screening period (up to 8 weeks) to assess whether the participant can take part; a treatment period (up to 52 weeks) where eligible participants will be grouped as per their blood ALP levels and randomly assigned to either receive elafibranor or placebo, and a follow-up period (4 weeks) where participants' health will be monitored.Participants will be twice as likely to receive elafibranor than placebo (2:1 ratio).Participants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), ultrasound examinations (a noninvasive test that passes a probe over skin to look at the bladder, urinary tract, and liver), and Fibroscan® examinations (a noninvasive test that passes a probe on skin to measure stiffness of the liver).They will also be asked to fill in questionnaires. Each participant will be in this study for up to 64 weeks (15 months). ### Conditions - Primary Biliary Cholangitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Elafibranor - Placebo ### Outcomes Primary Outcomes - Percentage of participants with normalisation of Alkaline Phosphate (ALP) Levels Secondary Outcomes - Percentage of participants with normalisation of ALP Levels - Change from baseline in ALP levels - Percentage of participants with normalisation of ALP Levels and ≥15% decrease from Baseline - Percentage of participants with ≥40% decrease from Baseline in ALP Levels - Percentage of participants with ALP <0.5 × Upper Limit of Normal (ULN) - Changes from baseline in Total Bilirubin (TB) Levels - Percentage of participants with TB <0.7 × ULN - Percentage of participants with normalisation of ALP and TB <0.7 × ULN - Percentage of participants with normalisation of TB and ALP Levels - Percentage of participants with complete biochemical response - Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score - Percentage of participants with moderate to severe pruritus at baseline (i.e. score ≥4) with a clinically meaningful response in PBC Worst Itch NRS - Change from baseline in 5-D itch score - Change from baseline in Patient Global Impression of Severity (PGI-S) scores - Patient Global Impression of Change (PGI-C) scores - Change from baseline in PBC-40 Quality of Life (QoL) scores - Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a scores - Percentage of participants experiencing Treatment- Emergent Adverse Events (TEAEs), treatment- related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs). - Percentage of participants developing clinically significant changes in physical examination - Percentage of participants developing clinically significant changes in vital signs - Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) Readings - Percentage of participants developing clinically significant changes in laboratory parameters ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES) - NCT ID: NCT06383390 - Study ID: 18584 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-02 - Lead Sponsor: Eli Lilly and Company ### Study Description The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Retatrutide - Placebo ### Outcomes Primary Outcomes - Time to First Occurrence of Composite Endpoints - Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), ≥ 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death Secondary Outcomes - Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3) - Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF - Time to Occurrence of All-Cause Death - Time to First Occurrence of composite endpoint of ≥ 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death - Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR ≥30 mg/g (0.03 mg/mg) at baseline ### Location - Facility: Central Research Associates, Birmingham, Alabama, 35205, United States @@
## Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation - NCT ID: NCT06383377 - Study ID: Pre-market parallel study - Status: RECRUITING - Start Date: 2024-04-26 - Completion Date: 2030-03-31 - Lead Sponsor: Wishbone SA ### Study Description This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket. ### Conditions - Bone Regeneration - Safety Issues ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tooth extraction and bone graft procedure ### Outcomes Primary Outcomes - Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. Secondary Outcomes - Assessment of the bone density at implant placement. - Evaluation of the implant primary stability. - Assessment of the implant osteointegration after implant placement - Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement - Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness - Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. - Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. - Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. ### Location - Facility: Clinique de la Source DentalMe, Louvain-la-Neuve, Brabant Wallon, 1348, Belgium @@
## The Effect of a Medication Coordinator on the Quality of Patients Medication Treatment - NCT ID: NCT06383364 - Study ID: SHS-Pharm - 1 - 2024 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-01 - Completion Date: 2025-06-01 - Lead Sponsor: University of Southern Denmark ### Study Description To examine the effect of a Medication Coordinator, who facilitates medication reviews in close collaboration with patients using My Medication Plan to reduce the risk of post-hospital inappropriate medication usage. ### Conditions - Medication Administered in Error ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Medication Coordinator ### Outcomes Primary Outcomes - Reduction of potentially inappropriate medication according to Potentially Inappropriate Medication List Secondary Outcomes - Evaluation of patients experiences quality of life with the EQ-5D and EQ-VAS. - Evaluation of patients experienced quality of life with visual analogue scale (VAS). - Evaluation of patients experienced treatment burden with the questionnaire Multimorbidity treatment burden questionnaire (MTBQ). - Evaluation of patients experienced medication burden with visual analogue scale (VAS). - Patient readmission 30 days after hospital discharge - Patient contact to the ward 30 days after hospital discharge ### Location - Facility: Sygehus Sønderjylland, Aabenraa, Southern Denmark, 6200, Denmark @@
## Patients' Illness Perception of Peri-implant Diseases. A Cross-sectional Study - NCT ID: NCT06383351 - Study ID: BQ001 - Status: RECRUITING - Start Date: 2024-04-16 - Completion Date: 2024-05 - Lead Sponsor: University of Siena ### Study Description Despite extensive research on periodontitis, little attention has been given to the symptoms and perception of peri-implant diseases and their impact on oral health-related quality of life. The study aims to assess patient perception of these diseases and their impact on quality of life through a cross-sectional observational study. Patients will be recruited from the Unit of Periodontics at "Le Scotte" University Hospital and will undergo diagnosis followed by questionnaire assessments. No follow-up visits are planned, and validated questionnaires will be administered to evaluate perception and impact on quality of life. Study procedures will include recording biometric peri-implant parameters and administering questionnaires such as the Brief Illness Perception Questionnaire (BIPQ) and Oral Health Impact Profile-14 (OHIP-14). ### Conditions - Peri-implant Mucositis - Perception - Survey - Questionnaires - Peri-Implantitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Assessment of patient's perception of their peri-implant disease through the Brief Illness Perception Questionnaire (Brief IPQ) - Assessment of peri-implant disease's impact on the oral health-related quality of life through the Oral Health Impact Profile 14. Secondary Outcomes ### Location - Facility: AOUS, Siena, N/A, 53100, Italy @@
## A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma. - NCT ID: NCT06383338 - Study ID: PEGASUS - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-05 - Lead Sponsor: Murdoch Childrens Research Institute ### Study Description PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.The study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine. ### Conditions - Hodgkin Lymphoma - Non Hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Omeprazole - Dextromethorphan ### Outcomes Primary Outcomes - Proportion of patients who consent to study and complete baseline and at least two longitudinal timepoints with successful measurement of probe drug MR (Metabolic ratio) Secondary Outcomes - Percentage of participants completing all required longitudinal blood sampling - Proportion of participants with successful detection of probe drug overall and at each sampling timepoint - Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint - The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA]) - Percentage of participants experiencing an adverse event (AE) during probe drug administration - Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints - Proportion of participants with disease staging and biomarkers of extent of disease - Proportion of participants with a systemic inflammatory state - Proportion of participants taking medications involving the CYP P450 pathway - Participant demographic information - Proportion of participants with other environmental factors - Longitudinal inflammatory profile of participants with Hodgkin or non-Hodgkin Lymphoma as measured by a panel including serum levels of procalcitonin, c-reactive protein and cytokine analysis. ### Location - Facility: Peter MacCallum Cancer Centre, Melbourne, Victoria, 3000, Australia @@
## Livertoxcicity in Acute Leukemia Patients During Chemotherapy Treatment - NCT ID: NCT06383325 - Study ID: Livertoxcicity in AL - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2025-08-01 - Lead Sponsor: Assiut University ### Study Description Detection of hepatotoxcicity in acute leukemia and study the outcome of acute leukemia patients that suffer from hepatic toxiciyt ### Conditions - Liver Toxicity, Chemically-Induced ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Chemotherapy ### Outcomes Primary Outcomes - Detection of hepatotoxcicity in acute leukemia during chemotherapy treatment Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Magnetic Reflexologic Insoles for Primary Dysmenorrhea - NCT ID: NCT06383312 - Study ID: E-10840098-772.02-4248 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2024-09 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description In the study, easy-to-access and easy-to-use reflexologic magnetic insoles were used in women with primary dysmenorrhea who did not want to receive medical treatment; In addition to reducing symptoms such as pain, nausea, dizziness, fainting, vomiting, weakness, constipation/acute gastroenteritis, it is aimed to increase individuals' participation in daily life activities and increase their quality of life by increasing their emotional state. ### Conditions - Primary Dysmenorrhea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Reflexologic Magnetic Insole Group - Orthopedic Insole Group ### Outcomes Primary Outcomes - McGill Pain Questionnaire-Short Form: - Menstruation Attitude Questionnaire - Menstruation Symptom Questionnaire - Visual Analogue Scale (VAS) Secondary Outcomes ### Location - Facility: Istanbul Medipol University, Istanbul, N/A, 34815, Turkey @@
## The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index - NCT ID: NCT06383299 - Study ID: AnkaraYbuMNC - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2021-08-01 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was "Calgary Sleep Apnea Quality of Life Index" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index. ### Conditions - Obstruvtive Sleep Apnea Syndrome (OSAS) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Calgary Sleep Apnea Quality of Life İndex (C-SAQLI) - Short Form 36 - Epworth Sleepiness Scale Secondary Outcomes ### Location - Facility: Ankara Yildirim Beyazıt University, Ankara, N/A, N/A, Turkey @@
## The Relationship Between Physical Activity Levels and Anxiety, Depression, Stress of Disabled Athletes - NCT ID: NCT06383286 - Study ID: AnkaraYBUfby - Status: COMPLETED - Start Date: 2020-12-01 - Completion Date: 2022-03-01 - Lead Sponsor: Ankara Yildirim Beyazıt University ### Study Description It is aimed to investigate the relationship between anxiety, depression, stress and physical activities of disabled athletes prepared for the paralympic games to be held in Tokyo in 2021, 3 times in total at 2-3 months intervals, and to determine the change over time ### Conditions - Paralympic Athletes ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - State-Trait Anxiety Inventory (STAI) - The Center for Epidemiological Studies Depression Scale (CES-D) - Fatigue Severity Scale - International Physical Activity Questionnaire short form - Perceived Stress Scale (PSS-14) Secondary Outcomes ### Location - Facility: Ankara Yıldırım Beyazıt Univercity, Ankara, N/A, N/A, Turkey @@
## A Study to Evaluate Efficacy and Safety of MELT-300 for Procedural Sedation in Subjects Undergoing Cataract Extraction With Lens Replacement (CELR) - NCT ID: NCT06383273 - Study ID: MELT-3-001 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-01 - Lead Sponsor: Melt Pharmaceuticals ### Study Description The goal of this clinical trial is to learn if MELT-300 works on procedural sedation in adult participants undergoing cataract extraction with lens replacement (CELR). It will also learn about the safety of MELT-300. Researchers will compare MELT-300 to a placebo (a look-alike substance that contains no drug) to see if MELT-300 works on procedural sedation in adult participants undergoing CELR. Researchers will also include a comparator SL midazolam to confirm the benefit of inclusion of ketamine in the combined drug product.The main questions it aims to answer are:1. Does MELT-300 is effective in comparison to placebo on procedural sedation for cataract surgery?2. To determine the effectiveness of MELT-300 compared with midazolam on procedural sedation (to determine the contribution of ketamine component and inform the risk of ketamine in MELT-300)3. To determine the time to achieve preoperative target sedation level with MELT-3004. What medical problems do participants have when taking MELT-300 vs placeboEligible participants will admitted to the study unit on Day 1. Participants will be randomized prior to surgery 4:1:1 to1. MELT-300 (i.e. 1 MELT-300 sublingual tablet which contains 3 mg midazolam and 50 mg of ketamine)2. Midazolam (i.e. 1 matching midazolam sublingual tablet which contains 3 mg midazolam)3. Placebo (i.e. 1 matching placebo sublingual tablet)Participants will receive study medication 30 (± 5) minutes, without food or water, before planned surgery start (defined as instillation of topical ocular anesthetic gel \[i.e.. 3 drops of chloroprocaine hydrochloride ophthalmic gel)\].The effectiveness of MELT-300 will be performed after study medication is administered before surgery, in the course of surgery, and postoperative on Day 1 (end of surgery defined as just prior to drape removal). The safety of MELT-300 will be performed at baseline, in the course of surgery, postoperatively on Day 1, and on Day 3 ± 1 day post dose of study medication. ### Conditions - Cataract ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MELT-300 sublingual tablet - Midalozam sublingual tablet - Placebo sublingual tablet ### Outcomes Primary Outcomes - Percentage of Participants Achieving Successful Procedural Sedation Secondary Outcomes - Percentage of Participants Requiring Rescue Sedation Medication - Percentage of Participants Achieving Preoperative Procedural Sedation Without Need For Rescue Sedation Medication - Percentage of Participants Requiring Rescue Sedation Medication Preoperatively - Percentage of Participants Requiring Rescue Sedation Medication Intraoperatively - Assessment of Sedation Scores in Participants Without Requiring Rescue Sedation Medication - Percentage of Participants Able to Complete the Surgery - Percentage of Participants Able to Complete the Surgery Without Intervention (Other Than Rescue Sedation Medication) - Duration to Achieve Preoperative Target Sedation (RSS level 2 or 3) - Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs) - Percentage of Participants Reporting Adverse Events Special Interest (AESIs) - Mean Change from Baseline in Blood Pressure (mmHg) - Mean Change from Baseline in Heart Rate [beats per minute (bpm)] - Mean Change from Baseline in Respiratory Rate (breath per minute) - Mean Change from Baseline in Body Temperature (degrees Fahrenheit) - Mean Change from Baseline in Pulse Oximetry (%) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessing the Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Undiagnosed Young Adults:A Cross Sectional Study - NCT ID: NCT06383260 - Study ID: 009-0001-7719-1189 - Status: COMPLETED - Start Date: 2023-07-01 - Completion Date: 2023-09-01 - Lead Sponsor: Jinnah Sindh Medical University ### Study Description To asses the prevalence of Attention deficit hyperactivity disrorder in undiagnosed young adults. ### Conditions - Finding the Prevalence of ADHD in Undiagnosed Young Adults ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Behavioral diagnostic ### Outcomes Primary Outcomes - Assess the prevalence of undiagnosed ADHD in Young adults Secondary Outcomes ### Location - Facility: JSMU, Karachi, Sindh, 75330, Pakistan @@
## The Efficacy of Repetitive Transcranial Magnetic Stimulation With Precision Neuronavigation in Parkinson's Disease - NCT ID: NCT06383247 - Study ID: AMU-PD-multicenter - Status: NOT_YET_RECRUITING - Start Date: 2024-11-01 - Completion Date: 2030-12-31 - Lead Sponsor: Anhui Medical University ### Study Description Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and widely used neuromodulation technology. Small sample studies have shown that rTMS treatment can significantly improve the symptoms of Parkinson's disease(PD) and delay the progression of the disease. In order to further explore the effectiveness of rTMS in the treatment of PD and lay the foundation for its clinical promotion, our research team plans to conduct a randomized double-blind controlled study of rTMS in the treatment of PD in multiple centers across the country. ### Conditions - Parkinson Disease - Transcranial Magenetic Stimualtion - Supplementary Motor Area ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - transcranial magnetic stimulation ### Outcomes Primary Outcomes - Movement Disorder Society- Unified Parkinson's Disease Rating Scale III scores Secondary Outcomes - Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅰ scores - Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅱ scores - Movement Disorder Society- Unified Parkinson's Disease Rating Scale Ⅳ scores ### Location - Facility: Cognitive Neuropsychology Lab Anhui Medical University, Hefei, Anhui, 230032, China @@
## REduced Pain After Bariatric Surgery - Sleeve Gastrectomy - NCT ID: NCT06383234 - Study ID: PAR 89/21 - Status: COMPLETED - Start Date: 2022-01-10 - Completion Date: 2023-09-28 - Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico ### Study Description This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo). ### Conditions - Pain - Postoperative Pain - Acute Pain - Analgesia - Bariatric Surgery Candidate - Anesthesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LG-TAP block with local anesthetic - LG-TAP block with saline solution - Port site infiltration ### Outcomes Primary Outcomes - Pain Score Secondary Outcomes - Morphine Consumption - Toradol Consumption - Nausea and/or vomiting - Lenght of Hospital Stay - Time to walking - Time to first flatus - Surgical Complication ### Location - Facility: Fondazione Policlinico Universitario Campus Bio-medico, Rome, N/A, 00128, Italy @@
## Study of the Intervention Effect of Stepped-care Models on Depression Symptoms During Pregnancy. - NCT ID: NCT06383221 - Study ID: 83244570 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-20 - Completion Date: 2026-03-10 - Lead Sponsor: Fangbiao Tao ### Study Description In this study, pregnant women were screened and managed for depression in three time windows: early pregnancy, mid-pregnancy, and late pregnancy. Pregnant women who screened positive for depression during pregnancy were dynamically enrolled in the study and stratified into randomized groups based on gestation period (early/mid/late) and randomly assigned to the intervention and control groups on a 1:1 basis. Pregnant women in the intervention group attended a three-week "mental fitness boot camp" and were assessed at 3 weeks, and if they still screened positive for depression, they were offered 4 times one-on-one counseling sessions by the obstetrician. The control group received routine care. ### Conditions - Perinatal Depression - Stepped Care ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - "Mental Fitness Boot Camp - Advanced Counseling" Step-by-Step Care ### Outcomes Primary Outcomes - Edinburgh Postnatal Depression Scale Secondary Outcomes - Generalized Anxiety Disorder - World Health Organization Five-item Well-Being Index ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Cardiovascular-Renal Adverse Prognosis Assessment System for Coronary Heart Disease With Chronic Kidney Disease Based on Metabolomics - NCT ID: NCT06383208 - Study ID: 2024-ZF-13 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-31 - Lead Sponsor: China-Japan Friendship Hospital ### Study Description Coronary heart disease (CHD) combined with chronic kidney disease (CKD) affects a substantial portion of the population and carries a significant disease burden, often leading to poor outcomes. Despite efforts to strictly control traditional risk factors, the efficacy in improving outcomes for patients with both CHD and CKD has been limited. Recent advancements in lipid metabolism research have identified new lipid metabolites associated with the occurrence and prognosis of CHD and CKD. Our preliminary trial has shown that levels of certain lipid metabolites, such as Cer(18:1/16:0), HexCer(18:1/16:0), and PI(18:0/18:1), are notably elevated in patients with CHD and reduced kidney function compared to those with relatively normal kidney function. This suggests that dysregulation of these non-traditional lipid metabolites may contribute to residual risk for adverse outcomes in these patients.Furthermore, the emerging concept of "cardiovascular-kidney-metabolic syndrome" and the availability of new treatment options highlight the urgent need for a risk stratification tool tailored to modern management strategies and treatment goals to guide preventive measures effectively. To address this, we propose to conduct a prospective cohort study focusing on CHD combined with CKD. This study aims to comprehensively understand the clinical characteristics, diagnosis, treatment status, and cardiovascular-kidney prognosis in these patients. Through advanced metabolomics analysis, we seek to identify lipid metabolism profiles and non-traditional lipid metabolites associated with the progression of coronary artery disease in CHD-CKD patients. Leveraging clinical databases and metabolomics data, we will develop a robust risk prediction model for adverse cardiovascular-kidney outcomes, providing valuable guidance for clinical diagnosis, treatment decisions, and ultimately improving patient prognosis. ### Conditions - Chronic Kidney Diseases - Coronary Heart Disease - Lipid Metabolism Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lipid metabolomics ### Outcomes Primary Outcomes - Incidence of cardiovascular adverse events - Incidence of Renal composite endpoint event Secondary Outcomes - Incidence of All-cause mortality - Incidence of Repeat revascularization - Incidence of bleeding ### Location - Facility: China-Japan Friendship Hospital, Beijing, Beijing, N/A, China @@
## The Reliability and Validity of the Ankylosing Spondylitis Performance Index (ASPI) in Enthesitis-Related Arthritis - NCT ID: NCT06383195 - Study ID: SBA 24/189 - Status: RECRUITING - Start Date: 2024-03-21 - Completion Date: 2026-03-20 - Lead Sponsor: Hacettepe University ### Study Description This study assesses the test-retest reliability, construct validity, and minimal detectable change of the Ankylosing Spondylitis Performance Index (ASPI) in assessing the physical function of patients with Enthesitis-related arthritis (ERA). ### Conditions - Enthesitis Related Arthritis - Enthesitis Related Arthritis, Juvenile ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Ankylosing Spondylitis Performance Index (ASPI) Secondary Outcomes - Childhood Health Assessment Questionnaire (CHAQ) - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - Bath Ankylosing Spondylitis Functional Index (BASFI) - Bath Ankylosing Spondylitis Metrology Index (BASMI) - Modified Paediatric Mini Mental Scale (MPMMS) ### Location - Facility: Hacettepe University, Ankara, N/A, N/A, Turkey @@
## Change in Serum Biomarkers After Endovascular Treatment for Acute Anterior Circulation Large Vessel Occlusion - NCT ID: NCT06383182 - Study ID: Y (2024) 054 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-07 - Completion Date: 2026-12-30 - Lead Sponsor: General Hospital of Shenyang Military Region ### Study Description Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO , but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays. ### Conditions - Ischemic Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - endovascular treatment ### Outcomes Primary Outcomes - Dynamic changes in serum biomarkers after endovascular treatment Secondary Outcomes - favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2 - excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1 - distribution of modified Rankin Scale (mRS) score - early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS) - changes in National Institute of Health stroke scale (NIHSS) - symptomatic intracranial hemorrhage (sICH) - occurence of new stroke or other vascular events ### Location - Facility: General Hospital of Northern Theater Command, ShenYang, N/A, 110840, China @@
## Impact of External Drainage of the Lumbar Cistern in Patients With Hydrocephalus Following Meningioma Surgery and Its Influence on Patient Satisfaction - NCT ID: NCT06383169 - Study ID: wanglizhong - Status: COMPLETED - Start Date: 2019-05-01 - Completion Date: 2022-05-30 - Lead Sponsor: First Hospital of Zhangjiakou City ### Study Description This study aims to investigate the effect of external lumbar cistern drainage in preventing postoperative hydrocephalus in patients who have undergone meningioma surgery and its impact on patient satisfaction. ### Conditions - Investigate the Effect of External Lumbar Cistern Drainage in Preventing Postoperative Hydrocephalus in Patients Who Have Undergone Meningioma Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Comparison of general clinical data - Comparison of the response rate - Comparison of GCS scores and intracranial pressure - Comparison of KPS scores and satisfaction Secondary Outcomes ### Location - Facility: First Hospital of Zhangjiakou City, Zhangjiakou, N/A, N/A, China @@
## The Use of Lung US, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT : A Comparative Study - NCT ID: NCT06383156 - Study ID: MD157/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-17 - Completion Date: 2024-10-01 - Lead Sponsor: Ain Shams University ### Study Description The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries. ### Conditions - Endotracheal Tube Wrongly Placed During Anesthetic Procedure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Double lumen endotracheal tube ### Outcomes Primary Outcomes - the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope Secondary Outcomes - sensitivity and accuracy in confirming the position of the LDLT. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Promoting Diagnosis and Management of AL in Italy (ProDigALIty) - NCT ID: NCT06383143 - Study ID: AC-020-IT - Status: RECRUITING - Start Date: 2023-05-01 - Completion Date: 2025-05-01 - Lead Sponsor: IRCCS Policlinico S. Matteo ### Study Description We plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical/clinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis ### Conditions - AL Amyloidosis - Smoldering Multiple Myeloma - Monoclonal Gammopathy of Undetermined Significance ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - no intervention ### Outcomes Primary Outcomes - Assess proportion of patients with newly diagnosed AL identified through the biomarker-based screening of at-risk patient - Assess the proportion of patients with deep haematological response after frontline therapy (best response evaluation) in the new enhanced, contemporary, real-world series of AL patients enrolled during the study. - 3. Identify associations of clonal light chain features with different clinical features at baseline. Secondary Outcomes - Description of the baseline characteristics and 6-months outcome, as well as the time to AL development for patients with AL identified through the biomarker-based screening - Description of the baseline characteristics of MGUS/SMM patients with abnormal FLCR - Identification of clinical and biological correlates of hematological response - To verify whether implementing a dedicated pipeline for referral of AL patients to the National Referral Center will increase the proportion of patients from spoke centers - Identification of associations of clonal light chain features with event-free survival - Validation of existing algorithms for predicting AL amyloidosis status ### Location - Facility: Azienda Ospedaliera Policlinico Consorziale, Bari, N/A, N/A, Italy @@
## London Asthma Diagnostics Study - NCT ID: NCT06383130 - Study ID: 24SM8792 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-07 - Lead Sponsor: Imperial College London ### Study Description The goal of this trial is to learn if the addition of oscillometry with reversibility testing increases diagnostic accuracy in adult asthma diagnosis, when added to current standard of care tests: spirometry with reversibility testing and Fractional Exhaled Nitric Oxide (FeNO). The main question it aims to answer is:- Does oscillometry with reversibility testing increase diagnostic accuracy in detection of asthma in adults when added to spirometry with reversibility and FeNO?Researchers will evaluate the diagnostic accuracy of this approach with the reference standard, which is a clinically adjudicated diagnosis of asthma by two respiratory clinicians based on history and investigation results.Participants will* Undergo oscillometry testing alongside their routine asthma investigations within their scheduled clinic visit* Optionally participate in our sub-studies on new breath and nasal swab tests for asthma* Optionally participate in our qualitative substudy on patients views and attitudes to asthma testing and oscillometry ### Conditions - Asthma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Oscillometry with reversibility testing - Breath volatile testing - Nasal eosinophil peroxidase - Handheld capnometry ### Outcomes Primary Outcomes - To evaluate the diagnostic accuracy (sensitivity, specificity) of a combination of oscillometry ± reversibility, spirometry ± reversibility and FeNO Secondary Outcomes - To conduct an analysis comparing the diagnostic accuracy of (i) oscillometry ± reversibility with spirometry ± reversibility, (ii) spirometry±reversibility with FeNO and (iii) oscillometry ±reversibility and FeNO - To compare the concordance of positive and negative test results for (i) oscillometry±reversibility, (ii) spirometry ±reversibility and (iii) Fractional Exhaled Nitric Oxide (FeNO) - To collect data on (i) testing time, (ii) testing burden, (iii) general feasibility of implementation of the asthma diagnostic tests ### Location - Facility: Imperial College Healthcare NHS Trust, London, N/A, W2 1PG, United Kingdom @@
## Understanding Effects of Calcium on the Gut-Bone Axis - NCT ID: NCT06383117 - Study ID: UL1TR002378 - Status: COMPLETED - Start Date: 2023-10-17 - Completion Date: 2024-02-23 - Lead Sponsor: University of Georgia ### Study Description The study team is inviting 13 healthy people to complete a study to explore how calcium affects hormones and bones after eating. Participants will be asked to complete two study visits within eight weeks. Before each visit, participants will be asked to not eat or drink (except water) for 9 hours. At each visit, participants will eat the same meal provided by the research team. Along with their meal, they will take a pill - in one session, this will be a calcium supplement, and in the other, a placebo (a pill with no calcium), but they won't know which one they are taking at which session. A phlebotomist will draw blood before the meal and pill, then again several times after eating. Blood draws will take place over three hours. During that time, participants will complete questionnaires about health, diet, and physical activity.Blood will be analyzed to check on various health indicators, like bone health markers and certain hormones, to see how they change after the meal. The difference in these health indicators between the calcium and placebo sessions will help the study team understand the impact of calcium on health after eating. This could help increase knowledge of the impact of calcium on hormones and bone health. ### Conditions - Healthy - Adult - Calcium - Bone Resorption - Endocrine; Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Calcium carbonate - Placebo Control ### Outcomes Primary Outcomes - Difference in GIP (gastric inhibitory peptide) area under the curve between calcium and placebo - Difference in GLP-1 (glucagon-like peptide 1) area under the curve between calcium and placebo Secondary Outcomes - Difference in CTX (carboxy-terminal collagen crosslinks) area under the curve between calcium and placebo - Difference in P1NP (N-terminal propeptide) area under the curve between calcium and placebo ### Location - Facility: University of Georgia Clinical and Translational Research Unit, Athens, Georgia, 30606, United States @@
## Myofascial Techniques and Proprioceptive Neuromuscular Facilitation in Patients With Systemic Lupus Erythematosus. - NCT ID: NCT06383104 - Study ID: MyoLupus - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2024-06-26 - Lead Sponsor: Universidad Católica San Antonio de Murcia ### Study Description Introduction. Systemic lupus erythematosus is an autoimmune disease. The musculoskeletal system is affected in 90% of patients. The most common manifestations are myalgias, arthralgias and arthritis.Objective. To analyse the efficacy of an intervention using myofascial techniques and proprioceptive neuromuscular facilitation in patients with systemic lupus erythematosus.Methods. Randomised clinical study with 20 patients with systemic lupus erythematosus, randomised to an experimental and control group. The intervention will last 4 weeks, with a periodicity of 2 weekly sessions of 50 minutes each. The intervention of the experimental group will consist of a protocol using myofascial and proprioceptive neuromuscular facilitation techniques.Expected results. Improvement of knee and ankle pain intensity, functional capacity, basic mobility skills, strength, balance, agility and fatigue. ### Conditions - System; Lupus Erythematosus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Intervention ### Outcomes Primary Outcomes - Change from baseline joint pain after treatment and at 4 weeks Secondary Outcomes - Change from baseline functional capacity after treatment and at 4 weeks - Change from baseline functionality after treatment and at 4 weeks - Change from baseline joint pain after treatment and at 4 weeks ### Location - Facility: Universidad Católica San Antonio, Murcia, Murcia, N/A, 30107, Spain @@
## Impact of Manual Therapy on Laryngeal Function Following Total Thyroidectomy - NCT ID: NCT06383091 - Study ID: IRB00380938 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2026-12 - Lead Sponsor: Johns Hopkins University ### Study Description In this clinical trial, the investigators are seeking to learn if a course of voice therapy, including neck massage, stretches and pain science education in addition to voice exercise and scar massage will effectively treatment patient complaints of swallowing or voice changes after total thyroidectomy as compared to voice exercise and scar massage alone.The main questions it aims to answer are:Will neck massage, stretches and pain science education reduce patient complaints of swallowing changes after total thyroidectomy?Will neck massage, stretches and pain science education reduce patient complaints of voice changes after total thyroidectomy?Will neck massage, stretches and pain science education reduce patient complaints of scar tethering and quality changes after total thyroidectomy?Will neck massage, stretches and pain science education improve quality of life after total thyroidectomy?Participants will:Participate in 4 visits with the participant's endocrine/laryngology surgeon. One prior and 3 after surgery for endoscopic evaluation and tests.Participate in 5 Speech-Language Pathology Sessions for intervention exercises and tests. One prior and 4 after surgery.Complete a journal of the participant's Home Exercise Practice ### Conditions - Total Thyroidectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Anterior Neck Manual Therapy - Pain Neuroscience Education - Neck Stretches - Scar massage - Voice Exercises - Placebo Anterior Neck Manual Therapy - Placebo Pain Neuroscience Education - Placebo Neck Stretches ### Outcomes Primary Outcomes - Acoustic measures of voice clarity - Acoustic measures of speaking voice pitch - Acoustic measures of speaking voice quality subjectively - Swallowing Quality of Life as assessed by the Eating Assessment Tool - 10 - Laryngeal sensation - Scar Tethering Distance - Scar Quality as assessed by The Patient and Observer Scar Assessment Scale - Voice Quality of Life as measures by the Voice Related Quality of Life - 10 Secondary Outcomes - Adverse Effects in the Experimental Group ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer - NCT ID: NCT06383078 - Study ID: MA-PC-II-012 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-20 - Completion Date: 2027-12-30 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer. ### Conditions - Efficacy and Safety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HR070803 - Oxaliplatin - Tegafur - Folinic acid - 5-Fluorouracil ### Outcomes Primary Outcomes - 1-year Disease-free survival rate Secondary Outcomes - Overall survival (OS) - Disease-free survival（DFS） ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Respiratory Physiotherapy in Type 2 Diabetes and Bariatric Surgery - NCT ID: NCT06383065 - Study ID: YDU/2020/76-1007 - Status: COMPLETED - Start Date: 2020-02-01 - Completion Date: 2022-01-30 - Lead Sponsor: Near East University, Turkey ### Study Description The aim of this study is to investigate the early effects of Inspiratory Muscle Training (IMT) applied before and after bariatric surgery on respiratory function, respiratory muscle strength and functional capacity in individuals with type 2 diabetes.The study will be conducted with 40 individuals with type 2 diabetes aged between 25-65. Individuals will be randomly assigned to the IMT (trained at 30% of maximum inspiratory pressure with an IMT threshold device) and control group. As measurement parameters, a 6-minute walk test for functional capacity, a spirometry test for respiratory function, and a portable device (Cosmed Pony FX Desktop Spirometer, USA) will be used for respiratory muscle strength. Hand grip strength will be measured with a Baseline dynamometer. All measurements will be repeated on the first day before surgery and on the fourth day before discharge after surgery. ### Conditions - Type 2 Diabetes - Bariatric Surgery Candidate ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - IMT Group ### Outcomes Primary Outcomes - Respiratory Muscle Strength - Respiratory Function - Functional Capacity: The 6-minute walk test - Hand Grip Strength Secondary Outcomes ### Location - Facility: Near East University, Nicosia, N/A, N/A, Cyprus @@
## A Phase 1/2 Study of 177Lu-NYM032 Injection in mCRPC - NCT ID: NCT06383052 - Study ID: NYM032Z01 - Status: RECRUITING - Start Date: 2024-04-30 - Completion Date: 2024-11-30 - Lead Sponsor: Norroy Bioscience Co., LTD ### Study Description 177Lu-NYM032 injection is a radioligand therapeutic agent that targets prostate specific membrane antigen (PSMA)-expressing prostate tumors. NYM032 is a small molecular with strong affinity for PSMA. ### Conditions - Metastatic Castration-resistant Prostate Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 177Lu-NYM032 injection ### Outcomes Primary Outcomes - Number of Patients With Dose Limiting Toxicity (DLT) - Maximum Tolerated Dose (MTD) Secondary Outcomes ### Location - Facility: Affliated Hospital of Jiangnan University, Wuxi, N/A, 214000, China @@
## Transcranial Direct Current Stimulation and Balance - NCT ID: NCT06383039 - Study ID: ZSoy - Status: COMPLETED - Start Date: 2022-05-16 - Completion Date: 2023-05-13 - Lead Sponsor: Zeynep Soy ### Study Description Postural control is an adaptive sensorimotor process involving continuous integration of sensory information from three channels. These; visual, somatosensory (proprioceptive) and vestibular senses. The study will be carried out at Istanbul Medipol University. 30 healthy individuals between the ages of 18-25 will be included. To each individual Anodal-supplementary motor area tDCS, Anodal-cerebellar tDCS, Sham tDCS applications will be cross-applied. tDCS application will take 20 minutes and each individual will receive 3 sessions in total. There will be a 72-hour rest period between sessions. Individuals assessed with Demographic Information Form for demographic information, Wii-Fit and Balance Error Scoring System for Static Balance Evaluation, Star Balance Test and Timed Get Up and Go Test for Dynamic Balance Assessment. The aim of this study is to investigate the effect of transcranial direct current stimulation applied on the supplementary motor area and cerebellum on static and dynamic balance in healthy individuals. ### Conditions - Balance ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - Transcranial Direct Current Stimulation ### Outcomes Primary Outcomes - Demographic Information Form - Wii-Fit - balance error scoring system - star excursion balance test - Time Up & Go Test Secondary Outcomes ### Location - Facility: Istanbul Medipol University, Istanbul, Beykoz, N/A, Turkey @@
## Transgender and Gender-Diverse Breast Cancer Screening Pilot - NCT ID: NCT06383026 - Study ID: PRO00047199 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2028-02 - Lead Sponsor: Medical College of Wisconsin ### Study Description This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening. ### Conditions - Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Breast Cancer Screening - Survey/Interview - Focus Group ### Outcomes Primary Outcomes - Callback and Biopsy Rates after Breast Cancer Screening - Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons - Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening Secondary Outcomes ### Location - Facility: Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States @@
## Phase II Study of BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers - NCT ID: NCT06383013 - Study ID: BB-101-BBCBB1A - Status: RECRUITING - Start Date: 2024-02-29 - Completion Date: 2028-12-31 - Lead Sponsor: Blue Blood Biotech Corp. ### Study Description This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer. ### Conditions - Diabetic Foot Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - BB-101 ### Outcomes Primary Outcomes - Efficacy Evaluation Secondary Outcomes - Safety Evaluation - Secondary Efficacy Evaluation ### Location - Facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare, Taipei, N/A, N/A, Taiwan @@
## Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes - NCT ID: NCT06383000 - Study ID: BLZ2024MOH - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-12-31 - Lead Sponsor: BLZ Technology (Wuhan) Co.,Ltd ### Study Description The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic surgeries for more than 60 minutes with planned invasive blood pressure and pulse oximeter monitoring.Researchers will compare blood pressure data derived from MOH200 to the invasive blood pressure (IBP) data to see if the MOH200 is effective to measure the blood pressure of a surgical person. Also, researchers will compare pulse rate data drived from MOH200 to that from the pulse oximeter to see if the MOH200 is effective to measure the pulse rate of a surgical person.Participants will be asked to be applied with MOH200 monitoring while IBP monitoring and pulse oximeter are applied. And after 30 minutes of the surgery, researchers will monitor the adverse effects occurred on the skin of participants to assess the safety of MOH200. ### Conditions - General Anesthesia - Blood Pressure - Pulse Rate - Arterial Line ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Continuous Non -invasive Blood Pressure Measurement from MOH200 - Invasive Blood Pressure Measurement from Arterial Line - Pulse Rate Measurement from MOH200 - Pulse Rate Measurement from Pulse Oximeter Secondary Outcomes - The Occurrence of Pressure Pores ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of the Comparative Effectiveness of Deucravacitinib in Adults With Plaque Psoriasis in Japan (RePhlect) - NCT ID: NCT06382987 - Study ID: IM011-1124 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2029-12-31 - Lead Sponsor: Bristol-Myers Squibb ### Study Description This is a prospective, observational, real-world study of adult participants in Japan with physician-reported diagnosis of plaque psoriasis treated with deucravacitinib or apremilast. ### Conditions - Plaque Psoriasis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Deucravacitinib - Apremilast ### Outcomes Primary Outcomes - Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib. - Number of participants who achieved Physician's Global Assessment (PGA) of 0/1 from baseline to follow-up - Number of participants who achieved Absolute Psoriasis Area and Severity Index (aPASI) of ≤2 from baseline to follow-up - Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0 /1 from baseline to follow-up - Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) Secondary Outcomes - Change in percent Body Surface Area (BSA) involved affected by plaque psoriasis from baseline to follow up in participants treated with deucravacitinib or apremilast - Number of participants who achieved Dermatology Life Quality Index (DLQI) of 0/1 from baseline to follow-up - Participant duration of treatment (time difference between date of treatment initiation to date of discontinuation) from baseline to follow-up - Number of participants treated with deucravacitinib with a change in Physician's Global Assessment (PGA) from baseline to follow-up - Number of participants treated with deucravacitinib with a change in Dermatology Life Quality Index (DLQI) from baseline to follow-up - Number of participants achieving a Dermatology Life Quality Index (DLQI) score of ≤5 from baseline to follow-up - Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 75 from baseline to follow-up - Number of participants who achieve a Psoriasis Area Severity Index (PASI) response of 90 from baseline to follow-up - Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤5 from baseline to follow-up - Number of participants who achieve an absolute Psoriasis Area Severity Index (aPASI) score ≤3 from baseline to follow-up - Number of participants who achieve a National Psoriasis Foundation (NPF) Acceptable Body Surface Area response from baseline to follow-up - Number of participants who achieve an absolute scalp-specific Physician's Global Assessment (ss-PGA) of 0/1 from baseline to follow-up - Number of participants who achieve an absolute Physician's Global Assessment-Fingernail (PGA-F) of 0/1 from baseline to follow-up - Number of participants who achieve an absolute Palmoplantar Physician's Global Assessment (pp-PGA) of 0/1 from baseline to follow-up ### Location - Facility: Mebix. Inc., Minato-ku, Tokyo, 1070052, Japan @@
## Evaluation of the Osteoinductivity of Atorvastatin Combined With β-TCP - NCT ID: NCT06382974 - Study ID: 3-3-14 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-03 - Lead Sponsor: Cairo University ### Study Description This case series study aims to evaluate the local effects of Atorvastatin (which belongs to the family of lipid-lowering drugs, known as statins) combined with β-TCP (which is a synthetic osteoconductive bone graft), on the volume of the residual bone defects and on hastening the bone regeneration after radicular jaw cyst enucleation using CBCT-based volumetric analysis to calculate the shrinkage rate of these defects. ### Conditions - Infection - Bone Loss ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Cyst enucleation and bone grafting ### Outcomes Primary Outcomes - Shrinkage Rate Secondary Outcomes - Inflammation ### Location - Facility: Cairo University, Cairo, N/A, N/A, Egypt @@
## Postoperative Dexmedetomidine in Prevention of Postoperative Delirium - NCT ID: NCT06382961 - Study ID: SZUS_231101 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-11 - Completion Date: 2024-04 - Lead Sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd. ### Study Description The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.Participants will undergo routine postoperative care:1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine2. Postoperative visit twice a day for at least seven days ### Conditions - Delirium in Old Age - Anesthesia; Adverse Effect ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dexmedetomidine injection - Sufentanil injection ### Outcomes Primary Outcomes - Incidence of postoperative delirium Secondary Outcomes - Incidence of postoperative nausea and vomiting - incidence of postoperative complications - Pain intensities ### Location - Facility: Kunming Children's Hospital, Kunming, Yunnan, 650100, China @@
## Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. - NCT ID: NCT06382948 - Study ID: MedOPP545 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2028-04 - Lead Sponsor: MedSIR ### Study Description This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated. Patients will be treated with elacestrant, a compound that acts as a selective estrogen receptor degrader, and everolimus (or placebo), a kinase inhibitor indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of elacestrant plus everolimus therapy in patients who have ER-positive/HER2-negative, ESR1-mutated, ABC progressing to endocrine therapy and cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. The efficacy of elacestrant plus everolimus combination will be determined by assessing the period from elacestrant plus everolimus (or placebo) treatment initiation until to the first occurrence of disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason, whichever occurs first, defined as progression free survival.Rigorous eligibility criteria based on specific co-morbidities and clinicopathologic features of their disease have been designed to minimize the risk of patients participating in this study. The anticipated favorable clinical benefits of elacestrant combined with everolimus are projected to outweigh the risks of this treatment. This study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations. ### Conditions - Advanced Breast Cancer - ER-positive Breast Cancer - HER2-negative Breast Cancer - ESR1 Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Everolimus - Elacestrant - Placebo - Auxiliary Medicinal Product - Dexamethasone - Auxiliary Medicinal Product - Luteinizing hormone-releasing hormone (LHRH) analogues ### Outcomes Primary Outcomes - To demonstrate superiority of elacestrant+everolimus vs. elacestrant+placebo in prolonging PFS based on a BIRC in patients with ER[+]/HER2[-], ESR1-mutated, ABC that have previously received ET+CDK4/6i (all patients). Secondary Outcomes - To compare overall survival (OS) between treatment groups, in all patients. - To compare investigator-assessed PFS based on local assessment between treatment groups, in all patients. - To compare objective response rate (ORR) between treatment groups, in all patients. - To compare clinical benefit rate (CBR) between treatment groups, in all patients. - To compare overall time to response (TTR) between treatment groups, in all patients. - To compare duration of response (DoR) between treatment groups, in all patients. - To compare best percentage of change in tumor burden between treatment groups, in all patients. - To describe the changes in health-related quality-of-life (HRQoL) from baseline using the EuroQoL 5 Dimension 5 Level (EQ-5D-5L) scale. - To describe the changes in HRQoL from baseline using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). - To describe the changes in HRQoL from baseline using the EORTC Quality of Life Questionnaire Breast Cancer module (EORTC QLQ-BR45). - To assess adverse events (AEs) between treatment groups in all patients. - To assess adverse events leading to study treatment withdrawal. - To assess adverse events leading to dose modification. - To assess the number of participants with abnormal hematology and/or chemistry values that are related to treatment. - To assess the number of participants with changes on vital signs and/or AEs that are related to treatment. - To assess the number of participants with changes on cardiac function measured by ECG QT Interval Corrected by Fridericia formula (QTcF) that are related to treatment effect . - To assess the number of participants with changes on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that are related to treatment. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Non-surgical Periodontal Treatment of miRNome - NCT ID: NCT06382935 - Study ID: 34-24 - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-10-15 - Lead Sponsor: University of Catania ### Study Description A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid ### Conditions - Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Probin Pocket Depth reduction ### Outcomes Primary Outcomes - Probing Pocket Depth Secondary Outcomes ### Location - Facility: AOU Policlinico G. Rodolico, Catania, N/A, 95124, Italy @@
## Role of Antifungal Prophylaxis in Elderly Patients With Acute Myeloid Leukemia During Consolidation Therapy - NCT ID: NCT06382922 - Study ID: PAPAML022019 - Status: RECRUITING - Start Date: 2023-03-29 - Completion Date: 2025-06-01 - Lead Sponsor: University of Rome Tor Vergata ### Study Description In previous retrospective study (SEIFEM 2016 study) the investigators evaluated the incidence of proven/probable invasive aspergillosis (IA) and the role of mold active primary antifungal prophylaxis (PAP) in a "real life" setting of acute myeloid leukemia (AML )patients receiving intensive consolidation therapy. All cases of proven/probable IA, observed during consolidation chemotherapy in adult and pediatric AML patients between 2011 and 2015, were retrospectively collected in a multicenter study involving 38 Italian hematologic centers. The investigators observed 56 (2.2%) cases of IA \[43 probable (1.7%) and 13 proven (0.5%)\]. The overall mortality rate and the mortality rate attributable to IA (AMR) on day 120 were 16% and 9%, respectively. In multivariate analysis, parameters that influenced the outcome were age ≥60 years and treatment with high doses of cytarabine (HDAC).The investigators also observed that centers involved in this survey had different antifungal policies during the AML consolidation phase. The results from this study show that in a large real-world setting the mold active PAP, with itraconazole or posaconazole, decreases the rate of IA after consolidation course.In SEIFEM 2016 study the investigators demonstrated that the incidence of IA during the AML consolidation is low. However, the mortality is not negligible, mainly in older patients. Further, a sub-analysis in the subset of patients older than 60 years demonstrated that patients who didn't receive mold active prophylaxis had higher incidence of IA than patients who received mold active prophylaxis (15% vs 6%). Therefore, as prophylaxis seems to prevent IA in consolidation, further studies should be performed especially in elderly patients treated with HDAC to confirm our data and to identify the subset of patients who require PAP. ### Conditions - Invasive Aspergillosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the incidence of proven, probable and possible IA in patients enrolled in the study in both groups of patients Secondary Outcomes - overall mortality rate ### Location - Facility: Tor Vergata University, Roma, RM, 00133, Italy @@
## Effect of Probiotic Compound K11T e K11TMax in ASD - NCT ID: NCT06382909 - Study ID: 202302 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2024-03-22 - Completion Date: 2025-04-07 - Lead Sponsor: Deivis de Oliveira guimaraes ### Study Description The research is characterized as a randomized, double-blind clinical trial (phase III) in which administered the probiotic K11-T (with and without added amino acids, fatty acids and vitamins) to children between 3 and 11 years old with Autism Spectrum Disorder - ASD, being subsequently assessed outcomes related to inflammatory markers and neuropsychiatric and sociopedagogical criteria. To this end, the study will create three groups, one of which will be a control group, which will receive a placebo, the other will receive the probiotic without micronutrients and another will receive the probiotic with added nutrients. ### Conditions - Autism Spectrum Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Inflammatory level - Cognitive assessment - Pedagogical assessment ### Outcomes Primary Outcomes - Inflammation biomarker 1 - Inflammation biomarker 2 - Inflammation biomarker 3 - Inflammation biomarker 4 - Inflammation biomarker 5 - Neuropsychological Assessment Secondary Outcomes - Psychiatric Assessment - Psychopedagogical Assessment ### Location - Facility: Gon1 P&D, Vitoria, ES, 29050335, Brazil @@
## Effect of Oliceridine on Rebound Pain - NCT ID: NCT06382896 - Study ID: FirstAHXiamenU-YB-2 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: The First Affiliated Hospital of Xiamen University ### Study Description The purpose of this clinical study was to identify the risk factors for postoperative pain outburst in patients undergoing arthroscopic knee surgery after Oliceridine and nerve block, and to evaluate the effect of oxeridine on early rehabilitation exercise in patients. A total of 320 patients undergoing arthroscopic knee arthroscopy under general anesthesia combined with femoral nerve block were selected to record the time and duration of postoperative pain outbreak, pain degree, age, gender, operation type, previous surgical history and other related risk factors. ### Conditions - Rebound Pain - Arthroscopic Knee Surgery - Oliceridine ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - Time of onset of postoperative rebound pain - The duration of the rebound pain - The degree of the rebound pain - age - sex - Surgical procedure - Previous surgical history Secondary Outcomes - Movement recovery time ### Location - Facility: First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361000, China @@
## Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment - NCT ID: NCT06382883 - Study ID: FINELO2024 - Status: RECRUITING - Start Date: 2024-04-22 - Completion Date: 2026-07-31 - Lead Sponsor: Filha ry ### Study Description The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity.The main questions the trial aims to answer are:* Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA?* Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA?* Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior?Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group.In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group. ### Conditions - Obstructive Sleep Apnea ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Individually tailored lifestyle and physical activity intervention - Individually tailored lifestyle and physical activity intervention combined with enhanced behavioral support -intervention (EBS) ### Outcomes Primary Outcomes - Change in apnea-hypopnea-index (AHI) Secondary Outcomes - Change on sleep apnea symptoms - Change in the mean daily total light physical activity time - Change in the mean daily total moderate to vigorous (MVPA) physical activity time - Change in the mean daily total sedentary time - Change in 6-minute walk distance (6MWD) in meters - Change in hand grip strength in kilograms - Change in waist circumference in centimeters - Change in body weight in kilograms - Change in visceral fat area (VFA) in square centimeters - Change in muscle mass in kilograms - Change in Quality of Life RAND 36-Item Health Survey ### Location - Facility: Central Finland Hospital District, Jyväskylä, N/A, 40620, Finland @@
## Simulation-Based Training for Child Neglect and Abuse - NCT ID: NCT06382870 - Study ID: 107.2023fbu - Status: NOT_YET_RECRUITING - Start Date: 2024-05-29 - Completion Date: 2024-06-29 - Lead Sponsor: Fenerbahce University ### Study Description Child abuse and neglect is a broad structure that includes physical abuse, sexual abuse, emotional abuse and neglect. Child neglect and abuse is one of the primary areas of responsibility of health professionals, which negatively affects child health and threatens public health in the long term. All healthcare professionals are legally obligated to report known or suspected cases of child abuse and neglect. Health professionals, in particular, play an important role in stopping child abuse by assessing children, identifying risk factors, and reporting suspected child maltreatment to authorities. Early diagnosis of a neglected and abused child is important in reducing the recurrence of maltreatment.Regarding the evaluation of child neglect and abuse, healthcare professionals should approach a child who presents with suspicious injuries, thinking that he or she may be abused. The key here is to be aware of the problem. Health professionals should carefully examine children and fulfill their responsibilities by identifying possible clues to abuse and neglect. It is recommended that clues to recognize neglect and abuse be taught within the scope of in-service training for healthcare professionals working in hospitals. ### Conditions - Simulation-based Training ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - education ### Outcomes Primary Outcomes - The awareness level Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition - NCT ID: NCT06382857 - Study ID: 823779-MDF Niger - Status: RECRUITING - Start Date: 2024-05-02 - Completion Date: 2026-02-01 - Lead Sponsor: Epicentre ### Study Description This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission. ### Conditions - Malnutrition, Child ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - MDF - RUTF - RUSF ### Outcomes Primary Outcomes - Programmatic recovery by 12 weeks from admission - Sustained recovery at 24 weeks from admission Secondary Outcomes - Default - Non-response - Time to recovery - For MAM children: Deterioration to SAM - Change in weight gain - Change in weight-for-length Z (WLZ) - Change in length-for-age Z (LAZ) - Change in weight-for-age Z (WAZ) - Change in MUAC - Serious adverse events - Hospitalization - Death - Motor, cognitive, language, social-emotional, and mental health skills - Cost effectiveness - Dietary intake - Adherence - Microbiome profile at enrollment, week 4, program discharge, and study discharge - Plasma proteome profile at enrollment, week 4, program discharge, and study discharge - Environmental enteric dysfunction at enrollment, program discharge, and study discharge - Change of fat mass and fat-free mass at program discharge and study discharge - Micronutrient status at enrollment, program discharge and study discharge - Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only) ### Location - Facility: Epicentre Niger, Maradi, N/A, N/A, Niger @@
## Novel Flow-cytometry Approaches to Improve the Detection of Tumor Cells in CTCL - NCT ID: NCT06382844 - Study ID: PI23/00486 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-12-31 - Lead Sponsor: Instituto de Investigación Biomédica de Salamanca ### Study Description Identification and quantitation of circulating tumor cells in patients with cutaneous T-cell lymphoma -mycosis fungoides (MF)/Sézary syndrome (SS)- are required for diagnosis and precising the actual staging and response to treatment. The current flow cytometry techniques used in clinical laboratories do not correctly allow to compare results in a clinical setting. Furthermore, now we know that the phenotype of tumor cells partially overlaps with that of normal TCD4+ cells, and it is rather heterogeneous. The GENERAL OBJECTIVE of this project is to apply flow-cytometry standardized strategies for rapid, specific, sensitive, and reproducible detection and quantitation of tumor cells in patients with MF/SS. For this purpose, in the first phase of the project we will design an optimal combination of markers to detect tumor cells by spectral flow-cytometry, and then the specificity and analytical sensitivity of the new combination/procedure will be assessed in blood samples -to be later applied to skin samples-, and finally reference databases will be created for the automatic analysis of cytometry data. In a second phase of the project, the developed method will be validated in a multicenter manner, through the demonstration of its practical applicability and clinical utility (speed and precision) in blood samples (and skin, where appropriate) for diagnosis, staging, and treatment monitoring. In parallel, the tumor microenvironment (residual normal immune system) will be explored -by applying the panel designed in the first phase together with additional immune-monitoring panels by flow cytometry-, and its relationship with clinical-biological heterogeneity of the tumor will be analyzed. In the two phases of the project, cytometry data will be compared with the gold standard approach to identify tumor T cells (through the identification of clonal rearrangement by PCR and/or NGS, performed on cell populations previously sorted by flow cytometry). ### Conditions - Cutaneous T-Cell Lymphoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Detection and quantitation of (blood) tumor cells in patients with mycosis fungoides (MF) / Sézary syndrome (SS). ### Outcomes Primary Outcomes - Optimizing Marker Combination for Specific Identification and Quantification of Sézary Cells using Spectral Flow Cytometry Secondary Outcomes ### Location - Facility: Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, N/A, 37007, Spain @@
## Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery - NCT ID: NCT06382831 - Study ID: IndonesiaU240201 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2024-10-01 - Lead Sponsor: Indonesia University ### Study Description Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery ### Conditions - Anesthesia and Analgesia - Anesthesia, Endotracheal ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Dexmedetomidine - Fentanyl ### Outcomes Primary Outcomes - Postoperative nausea and vomiting (PONV) - Pain score - Time to laryngeal mask exertion - Adverse effect Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability - NCT ID: NCT06382818 - Study ID: PROICM 2023-10 PRO - Status: NOT_YET_RECRUITING - Start Date: 2024-04-26 - Completion Date: 2036-04-26 - Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle ### Study Description Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - COHORT A - COHORT B - COHORT C - COHORT D ### Outcomes Primary Outcomes - Rate of patients without any grade 2 or more fibrosis, nor radio-induced sarcoma Secondary Outcomes - Acute toxicity - Late toxicity - Local recurrence rate (LRR) - Relapse-free survival (RFS) rate - Overall survival (OS) rate - Radiation-induced Breast Sarcoma prevalence ### Location - Facility: Institut Du Cancer de Montpellier, Montpellier, N/A, N/A, France @@
## Comparison of the Effects of Kinesio Tape and High-intensity Laser Therapy in Lateral Epicondylitis - NCT ID: NCT06382805 - Study ID: HasanKU_FTR_AA_02 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-11-15 - Lead Sponsor: Hasan Kalyoncu University ### Study Description Lateral epicondylitis is a common upper extremity disease that occurs with tenderness in the lateral epicondyle, the common attachment point of the wrist extensor muscles, and pain during resisted wrist extension. The main purpose of treating lateral epicondylitis is to reduce pain and increase functionality, but there is no accepted standard treatment method. The purpose of this study is to compare the effectiveness of kinesio tape and high intensity laser in the treatment of lateral epicondylitis. ### Conditions - Tennis Elbow - Physical Therapy - Kinesiotaping - Laser ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiotherapy program - Kinesio Tape - High Intensity Laser therapy ### Outcomes Primary Outcomes - Pain Measurement - Hand grip strength - Patient-Rated Tennis Elbow Evaluation Secondary Outcomes - Pain Sensitivity Measurement ### Location - Facility: Hasan Kalyoncu University, Gaziantep, N/A, 27000, Turkey @@
## Osteolysis of Allograft Prosthetic Composite After Shoulder Resection for Tumors - NCT ID: NCT06382792 - Study ID: 2024PI059 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-05-01 - Completion Date: 2024-05-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature). ### Conditions - Shoulder Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - proximal humeral resection for tumor and allograft prosthetic composite reconstruction ### Outcomes Primary Outcomes - Osteolysis (bone stock in cm3) Secondary Outcomes - Constant score - Complications - Revision ### Location - Facility: Central Hopital, Nancy, N/A, 54000, France @@
## Proximal Humerus Reconstruction After Resection for Tumors : Comparison Between Allograft Prosthetic Composite and Cement Sleeve Prosthetic Composite - NCT ID: NCT06382779 - Study ID: 2024PI057 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-04-15 - Completion Date: 2024-05-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis. ### Conditions - Shoulder Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - reverse shoulder arthroplasty ### Outcomes Primary Outcomes - Constant score Secondary Outcomes - complication - mortality - revision ### Location - Facility: CHRU - Centre chirurgical emile galle, Nancy, N/A, 54000, France @@
## Skeletal Muscle Ultrasonography in Detection of Malnutrition - NCT ID: NCT06382766 - Study ID: SMU in malnutrition - Status: NOT_YET_RECRUITING - Start Date: 2025-03 - Completion Date: 2026-03 - Lead Sponsor: Assiut University ### Study Description * To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.* To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools . ### Conditions - Skeletal Muscle Ultrasonography ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Skeletal Muscle Ultrasonography ### Outcomes Primary Outcomes - accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools . Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis - NCT ID: NCT06382753 - Study ID: 20-24-PAR - Status: RECRUITING - Start Date: 2024-04-20 - Completion Date: 2024-06-30 - Lead Sponsor: University of Catania ### Study Description The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development. ### Conditions - Gingivitis - Periodontitis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gingival inflammation ### Outcomes Primary Outcomes - Bleeding on Probing Secondary Outcomes ### Location - Facility: AOU Policlinico G. Rodolico, Catania, N/A, 95124, Italy @@
## Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years - NCT ID: NCT06382740 - Study ID: AOP2097 - Status: RECRUITING - Start Date: 2022-10-01 - Completion Date: 2025-10-01 - Lead Sponsor: Azienda Ospedaliera di Padova ### Study Description Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years. ### Conditions - End Stage Liver DIsease - Liver Transplantation - Old Age ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Liver transplantation ### Outcomes Primary Outcomes - 1 year patient survival Secondary Outcomes - 1 year graft survival - 3 months mortality and morbidity ### Location - Facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova, Padova, N/A, 35128, Italy @@
## CONTINUation of Enteral Nutrition Prior to Extubation Compared to Standard Care - NCT ID: NCT06382727 - Study ID: ER008 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-04 - Lead Sponsor: Emma Ridley ### Study Description Critically ill patients admitted to the Intensive Care Unit (ICU) often need to be connected to a breathing machine (ventilator) and are unable to eat. During this time, liquid nutrition is delivered via a feeding tube to the stomach or bowel (termed enteral nutrition (EN)) to ensure nutrition needs are provided until such time that the patient can eat normally.The delivery of nutrition via EN is frequently interrupted due to procedures and changes in the gastrointestinal system that can cause digestion to be slow. One of the main contributors to EN interruptions is fasting prior to removal of the breathing tube (termed extubation).The practice of pausing EN prior to the removal of the breathing tube is historical and based on evidence for patients who are not within the ICU. There is currently no scientific consensus on whether pausing of EN is necessary, or for how long. Because of this, some clinicians choose to pause EN prior to removal of the breathing tube and some clinicians continue to provide EN.This study is a pilot randomised controlled trial of fasting patients for at least 4 hours prior to removal of the breathing tube compared with not pausing EN. The investigators hypothesise that this will reduce the number of hours of fasting in the 24 hours prior to extubation. ### Conditions - Critical Illness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - EN will be continued up to extubation (EN will not be withheld prior to extubation) ### Outcomes Primary Outcomes - Fasting time (hours) Secondary Outcomes - Reintubation rate - Days alive and free of mechanical ventilation - Commencement of antibiotics - Ratio of oxygen saturation (SpO2)/ fraction of inspired oxygen (FiO2) - ICU length of stay - In-hospital mortality - Nutrition delivery - Recruitment rate - Protocol compliance ### Location - Facility: Gold Coast University Hospital, Southport, Queensland, 4215, Australia @@
## Virtual Museum Visit on Dialysis Symptoms and Anxiety in Hemodialysis Patients - NCT ID: NCT06382714 - Study ID: 2023-12/13 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2024-12-31 - Lead Sponsor: Cumhuriyet University ### Study Description The main purpose of dialysis used in the treatment of end-stage renal failure is; By relieving the patient from uremic symptoms, controlling excess fluid, electrolyte and acid base disorders, improving the well-being of the patients and also improving the quality of life of the patients. In addition to its contribution to the continuation of life, dialysis can significantly affect the biological and physiological balance and normal life order of patients. Some of these effects may be negative on patients. During this process, patients may frequently experience symptoms such as changes in fluid-electrolyte balance, increased fatigue, and weakness, as well as psychopathological conditions such as anxiety. In this context, it is extremely important to handle patients from a holistic perspective and keep their homeostatic balance under control during the hemodialysis process. In addition to pharmacological treatments, many integrative methods are used in the management of symptoms for reasons such as being low in cost, having fewer side effects than pharmacological treatments, and strengthening the immune system. Museum visit, one of these integrative treatment methods, has become an area of art therapy where help is received for various reasons such as coping with the symptoms of chronic diseases, reducing the side effects of medications, preventing mental depression, strengthening healthy behaviors, and avoiding tension and loss of control. In this context, the research was planned as a randomized controlled study investigating the effect of virtual museum tour on dialysis symptom index and anxiety in hemodialysis patients..T.R. The "https://sanalmuze.gov.tr" site belonging to the Ministry of Culture and Tourism will be shown to the patients five times and the virtual museum visit will be made by showing the patient's preferred museum five times among the 53 museums prepared by the General Directorate of Information Technologies of the Ministry of Culture and Tourism, and the Initiative Group, Control It will be compared with its group. Research data; It will be collected using the Patient Information Form, Dialysis Symptom Index and Beck Anxiety Scale (BAI). At the end of the study, the data will be evaluated in the SPSS program. The museum visit applied to the Intervention Group will also be applied to the control group after the study is completed, taking into account the ethical dimension. ### Conditions - DIALYSIS SYMPTOMS AND ANXIETY ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - For the intervention group, a museum visit with virtual reality glasses will be applied. ### Outcomes Primary Outcomes - Dialysis Symptom Index (DSI) - Beck Anxiety Scale (BAI) Secondary Outcomes ### Location - Facility: Mukadder, Mollaoğlu, Sivas, 58140, Turkey @@
## Effect of Aromatherapy on Pain, Anxiety and Satisfaction in Cannulation - NCT ID: NCT06382701 - Study ID: Kayseri - Status: ACTIVE_NOT_RECRUITING - Start Date: 2021-09-06 - Completion Date: 2024-06-30 - Lead Sponsor: TC Erciyes University ### Study Description The most active members of the healthcare professionals responsible for hemodialysis units are nurses, and they have a key role in pain, anxiety and satisfaction management as they are responsible for cannulation. Therefore, complementary and integrated practices need to be implemented based on evidence to strengthen the independent role of nurses in managing pain and anxiety. ### Conditions - Hemodialysis Patients ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - aromatherapy - placebo ### Outcomes Primary Outcomes - Visual Analog Scale (VAS) Secondary Outcomes - State and Trait Anxiety Inventory (STAI) ### Location - Facility: Erciyes University, Melikgazi, Kayseri, 38260, Turkey @@
## IV Administration of ChromaDex's Niagen® as Compared to NAD+ - NCT ID: NCT06382688 - Study ID: 23-08-0010 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-13 - Completion Date: 2024-08-31 - Lead Sponsor: Franklin Health Research ### Study Description This is a 2-part study evaluating the effects of IV administration of NR on healthy adult populations. Study 1 involved all four arms with 37 people. The second study only included the active NR and NAD+ arms to further evaluate tolerability and comfort of the IV. ### Conditions - Healthy Aging ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - NAD+ (nicotinamide adenine dinucleotide) IV - Niagen® (nicotinamide riboside) IV - Niagen® (nicotinamide riboside) oral - Placebo ### Outcomes Primary Outcomes - Blood Pressure - Heart rate - Total NAD measured through dried blood spot testing - Glucose - Insulin Levels - total NAD measured through blood and plasma - Tolerable Infusion Rate Secondary Outcomes - Complete Blood Count - Comprehensive Metabolic Panel - Sleep Scale - Energy Scale ### Location - Facility: Nutraceuticals Research Institute, Franklin, Tennessee, 37067, United States @@
## Clinical Performance of the New Plasma Filter PX2 in TPE Treatments - NCT ID: NCT06382675 - Study ID: TA-PF-01-DE - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: Fresenius Medical Care Deutschland GmbH ### Study Description The plasma filter is applied for a single use in extracorporeal blood purification therapy. The intended purpose is the separation of plasma from blood by filtration, in conditions, which are associated with increased concentration of plasma components where a rapid depletion slows down or stops a pathogenic process.The investigation involves the collection of treatment data of the new Plasma Filter PX2 in combination with the multiFiltrate and multiFiltratePRO in therapeutic plasma exchange (TPE) treatments. The multiFiltrate and multiFiltratePRO are devices for extracorporeal blood purification treatments. No further control treatments will be investigated in this one arm design. The design is considered to be appropriate to reflect daily clinical practice and to contribute to empirical evidence of performance of the new Plasma Filter PX2. No specific treatment schedule is defined by the study protocol. The TPE treatment is performed with the plasma filter PX2 (investigational device) according to clinical practice established in each of the participating centers and are prescribed at the discretion of the treating physician. The participation in the study will have no influence on the treatment plan. The documentation of the treatment includes the therapy up to the tenth (10th) treatment. ### Conditions - Autoimmune Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Therapeutic Plasma Exchange (TPE) with the Plasma Filter PX2 ### Outcomes Primary Outcomes - Analysis of TPE treatments with the Plama Filter PX2 Secondary Outcomes ### Location - Facility: Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Bavaria, 63739, Germany @@
## Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Other Skeletal Muscle Relaxants - NCT ID: NCT06382662 - Study ID: PMDAC-01 - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2025-04-15 - Lead Sponsor: Primus Pharmaceuticals ### Study Description Every participant will receive active study drug and (tone) 1 comparator, in two (2) stages, one after the other. Each drug will be taken one (1) time after a high fat meal. Vital signs and discussion of medications, illness or injury are considered safety assessments and will be discussed at every visit. There will be (four) 4 visits. ### Conditions - Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - metaxalone m640 - Tizanidine ### Outcomes Primary Outcomes - Change from baseline, Standard Deviation of Lateral Position - Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes Secondary Outcomes - Change from baseline of participants' subjective report of drowsiness on a 10-point scale - Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test) - The number of product related adverse events experienced by participants from Visit 1 through Visit 4 ### Location - Facility: Sun Valley Arthritis Center, Peoria, Arizona, 85381, United States @@
## Rivastigmine for Antimuscarinic Delirium - NCT ID: NCT06382649 - Study ID: 202403051 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-07 - Lead Sponsor: Washington University School of Medicine ### Study Description Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine, the standard antidote for AMD, currently has very limited availability in the United States due to an interruption of production.Recent case reports and small observational studies suggest that rivastigmine might be useful in the treatment of AMD, but there is not direct prospective evidence comparing rivastigmine to physostigmine or supportive care. In order to investigate the effectiveness of rivastigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine for antimuscarinic delirium will experience more rapid resolution of agitation and delirium than those treated with placebo. ### Conditions - Anticholinergic Toxicity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Rivastigmine - Placebo ### Outcomes Primary Outcomes - Time to control of agitation and delirium Secondary Outcomes - Duration of agitation and delirium - Total amount of sedatives administered - Use of sedative infusions - Use of physical restraints - Disposition - Time to medical clearance - Oversedation - Intubation - Seizure - Gastrointestinal upset - Bradycardia ### Location - Facility: Washington University School of Medicine, Saint Louis, Missouri, 63110, United States @@
## Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes - NCT ID: NCT06382636 - Study ID: 23-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-31 - Completion Date: 2027-02-28 - Lead Sponsor: The Cleveland Clinic ### Study Description The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions.Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer. ### Conditions - Prenatal Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Standard Care - Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot ### Outcomes Primary Outcomes - Patient activation Secondary Outcomes ### Location - Facility: Neighborhood Family Practice, Cleveland, Ohio, 44102, United States @@
## Efficacies of Different Managements in Patients With Trigger Finger - NCT ID: NCT06382623 - Study ID: 43 - Status: COMPLETED - Start Date: 2022-10-01 - Completion Date: 2023-06-30 - Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital ### Study Description The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger. ### Conditions - Trigger Finger ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The percutaneous A1 pulley release - The peritendinous Betamethasone group ### Outcomes Primary Outcomes - Stage of the disease Secondary Outcomes - Pain intensity - severity of triggering ### Location - Facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, Ankara, N/A, N/A, Turkey @@
## Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations - NCT ID: NCT06382610 - Study ID: 2024-002 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2024-12-15 - Lead Sponsor: University of Redlands ### Study Description Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body. ### Conditions - Sleep ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Melatonin ### Outcomes Primary Outcomes - Salivary melatonin level Secondary Outcomes - Side effects ### Location - Facility: University of Redlands, Redlands, California, 92373, United States @@
## Four Weeks of Nordic Hamstring Exercises Impact the Strength and Balance of the Hamstring Muscle Group - NCT ID: NCT06382597 - Study ID: AWFiS/2024_2_P-GM - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-07-10 - Lead Sponsor: Gdansk University of Physical Education and Sport ### Study Description The aim of the study is to assess the impact of 4 weeks of eccentric Nordic Hamstring Exercise training on changes in the hamstring muscle group, as well as to analyze parameters such as maximum muscle strength of the knee flexors, RFD (rate of force development) and static balance, dynamics for the dominant leg. ### Conditions - Hamstring Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Nordic hamstring exercise ### Outcomes Primary Outcomes - Biodex Balance System Secondary Outcomes - Biodex System ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Treatment With Oral Anticoagulants of Patients With Fractures of the Upper End of the Femur - NCT ID: NCT06382584 - Study ID: IRB_23.09.01 - Status: COMPLETED - Start Date: 2022-01-01 - Completion Date: 2023-06-01 - Lead Sponsor: Centre Hospitalier Universitaire de Nīmes ### Study Description In 2023, oral anticoagulant treatments (anti Xa: apixaban , rivaroxaban, etc.) are tending to replace anti vitamin K treatments in many medical indications. Their prescription is increasing rapidly in the elderly.In this context, the Nimes University Hospital receives a large number of elderly patients who have suffered a fracture of the end of the femur requiring surgery and who are taking anti Xa drugs.To avoid massive intra- and post-operative haemorrhage, surgical management is postponed because of the need to suspend the treatment, allowing a return to near-normal biological haemostasis within a few days. No consensus has been reached on the withdrawal period required to authorise surgery, as the elimination kinetics of the drug are altered in this context (elderly patients, dehydration, hypovolaemia, impaired renal function). A plasma assay (threshold of \<30 to 60 ng/mL) has been proposed without any real justification. This waiting period exposes the elderly to excess mortality. Reversing these treatments by adding coagulation factors would be an attractive alternative, as it would allow surgery to be performed earlier, but this would expose patients to an increased thrombotic risk.Before considering a prospective randomised study (early vs delayed surgery on AOD), we wish to retrospectively analyse data on patients admitted to the Nimes University Hospital on anti Xa and operated on for fracture of the upper end of the femur between 1 January 2022 and 1 June 2023 ### Conditions - Direct Oral Anticoagulants (DOACs) - Femoral Fractures - Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Femoral fracture surgery ### Outcomes Primary Outcomes - Hospital Mortality Secondary Outcomes - Duration of the surgery - Transfusion - Postoperative comorbidities - Hospital stay - Anti Xa assay ### Location - Facility: CHU de NIMES, Nimes, N/A, 30029, France @@
## Factors Associated With Sub - Targeted Therapeutic Dose Of Renin - Angiotensin Blockage Among Chronic Heart Failure With Reduced Ejection Fraction Patients - NCT ID: NCT06382571 - Study ID: 026/66 - Status: COMPLETED - Start Date: 2016-01-01 - Completion Date: 2021-12-31 - Lead Sponsor: Chulalongkorn University ### Study Description Objective: To analyze factors associated with Thai heart failure with reduced ejection fraction patients who received sub-target doses of Angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor-neprilysin inhibitors (ARNIs), and angiotensin receptor blockers (ARBs).Methods: The retrospective cohort study was designed to collect data on Thai heart failure with reduced ejection fraction patients at Out-patient Clinic, Trat Hospital and Phrapokklao Hospital from January 2016 to December 2020. Thirteen factors were analyzed to determine their association with the sub-target group. ### Conditions - Heart Failure With Reduced Ejection Fraction ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Renin-Angiotensin System Inhibitor ### Outcomes Primary Outcomes - factors associated with sub - target dose of ACEIs,ARBs,ARNI Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Validity and Reliability of Sensorimotor Processing Paradigm - NCT ID: NCT06382558 - Study ID: s68470 - Status: RECRUITING - Start Date: 2024-04-10 - Completion Date: 2024-12-31 - Lead Sponsor: KU Leuven ### Study Description Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal assessment for sensory processing, one of the most important sensory functions, does not exists. However, our research team has developed a novel assessment paradigm using the KINARM End-Point robot to assess the level of sensory processing of the upper limb. Within a previous study, the investigators examined the validity within 20 chronic stroke patients and 80 age-matched healthy controls by comparing the novel robotic assessment with a set of existing clinical and robotic assessments for the upper limb. The investigators hypothesize that the stroke patients will show a poorer performance on this novel assessment compared to the healthy controls, that the novel assessment will show better correlation coefficients with other sensory tests compared to motor tests, that the novel assessment can differentiate between different motor subgroups of chronic stroke patients, and that the novel assessment shows good test-retest reliability. ### Conditions - Stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Kinarm: Passive and active discrimination task Secondary Outcomes - Kinarm: Arm position matching task - Kinarm: Visually guided reaching task - Erasmus modified Nottingham sensory assessment - Tactile discrimination test - Tactile functional object recognition - Stereognosis section of the original Nottingham sensory assessment - Wrist position sense test - Perceptual threshold of touch - Fugl-Meyer upper extremity assessment - Action research arm test - Barthel index - Montreal cognitive assessment - Star cancellation test ### Location - Facility: KU Leuven, Leuven, N/A, 3001, Belgium @@
## Post-instrumentation Pain After Use of the Fanta and M3 Pro Gold Systems - NCT ID: NCT06382545 - Study ID: Approval number 36.3.22 - Status: COMPLETED - Start Date: 2021-11-01 - Completion Date: 2022-07-30 - Lead Sponsor: Ahram Canadian University ### Study Description Comparing the intensity of post-operative pain following endodontic treatment of posterior teeth with Fanta (Pepsi gold) (FPG) and M3-pro+ Gold (assorted) (MPG) rotary files. ### Conditions - Endodontic Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Fanta (Pepsi gold) (FPG) - M3-pro+ Gold (assorted) (MPG) ### Outcomes Primary Outcomes - comparing the intensity of post-instrumentation pain Secondary Outcomes ### Location - Facility: Faculty of Oral and Dental medicine, Ahram Canadian University, Giza, N/A, 12573, Egypt @@
## Diagnosis of Depressive Disorder Malinger Using the Niacin Skin Response Test (NSRT) - NCT ID: NCT06382532 - Study ID: AFMMUChina_NSRT - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-05-01 - Lead Sponsor: Air Force Military Medical University, China ### Study Description This study will explore the specific response characteristics of the niacin skin response test in the population with depressive disorder malinger. The investigators expect that depressive disorder malinger can be discriminated by the niacin skin reaction test. ### Conditions - Depressive Disorder - Malingering ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Niacin skin reaction test ### Outcomes Primary Outcomes - Niacin reaction test Secondary Outcomes - Model specificity and sensitivity - The F Scale in Minnesota Multiphasic Personality Inventory ### Location - Facility: Air Force Medical Center, Beijing, Beijing, 100142, China @@
## Thalidomide Therapy for VEOIBD - NCT ID: NCT06382519 - Study ID: Thal in VEOIBD - Status: NOT_YET_RECRUITING - Start Date: 2024-05-15 - Completion Date: 2026-12-31 - Lead Sponsor: Children's Hospital of Fudan University ### Study Description This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease ### Conditions - Inflammatory Bowel Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Thalidomide ### Outcomes Primary Outcomes - endoscopic response rate Secondary Outcomes - clinical response rate - biomarker remission rate - growth development - clinical remission rate with steroid-free - adverse event - treatment persistence ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Hazelnut Flour on Blood Glucose - NCT ID: NCT06382506 - Study ID: 2024/138 - Status: COMPLETED - Start Date: 2024-03-21 - Completion Date: 2024-04-21 - Lead Sponsor: Ege University ### Study Description One of the factors affecting human health is nutrition. The effects of foods on blood glucose are still under investigation. The Glycemic Index (GI), which is associated with many diseases today, is a value that measures the rate at which carbohydrate-containing foods raise blood glucose. It is thought that the loaves of bread produced will be a product with low GI value and can be consumed by celiacs and diabetics. It is aimed to investigate the effect of adding different amounts of hazelnut flour to bread recipes using gluten-free corn flour on blood glucose. ### Conditions - Obesity - Celiac Disease - Blood Glucose - Flour Sensitivity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Consumption of Cornbread with Hazelnut Bread ### Outcomes Primary Outcomes - One loaf of bread was consumed each week and the study will continue for a month. Blood glucose measurements were performed with a glucometer at 0 (fasting), 15, 30, 45, 60, 90, and 120 minutes after each bread consumption. Secondary Outcomes - This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week. ### Location - Facility: Avrasya University, Trabzon, N/A, 61000, Turkey @@
## Tegoprazan-containing Sequential for H. Pylori - NCT ID: NCT06382493 - Study ID: B-2011-648-005 - Status: RECRUITING - Start Date: 2021-02-01 - Completion Date: 2024-12-12 - Lead Sponsor: Seoul National University Bundang Hospital ### Study Description As H. pylori eradication, we prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy ### Conditions - Helicobacter Pylori Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tegoprazan-containing sequential H. pylori eradication therapy ### Outcomes Primary Outcomes - Eradication rate Secondary Outcomes - Adverse events ### Location - Facility: Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of @@
## PROTeIn-rich Meals to Control Glucose - NCT ID: NCT06382480 - Study ID: 90/2023 - Status: RECRUITING - Start Date: 2024-04-12 - Completion Date: 2027-02-28 - Lead Sponsor: German Institute of Human Nutrition ### Study Description The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status. ### Conditions - Overweight - Obesity - Prediabetes - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Diet with specific macronutrient composition. ### Outcomes Primary Outcomes - Mean 24-hour glucose Secondary Outcomes - Measurement of height - Measurement of body weight - Waist and hip circumference / waist to hip ratio - Systolic and diastolic blood pressure - Body fat and lean mass - Energy expenditure and substrate oxidation rates - Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)) - Renal values (creatinine, urea, uric acid) - Intra- und inter-day glycemic variability - Glucose levels in meal tolerance test (MTT) - Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin) - Inflammatory markers and T cell populations analyses - Satiety and hunger scores - Sleep/wake timing and sleep quality - Physical activity - Adipose tissue transcriptome - Gene expression in peripheral blood mononuclear cells (PBMC) - Gut microbiota and microbiome-derived metabolites - Determination of decision behavior ### Location - Facility: Olga Ramich, Potsdam, Potsdam-Rehbrücke, 14558, Germany @@
## Comparison of Remimazolam and Propofol Combination vs. Propofol in IOM - NCT ID: NCT06382467 - Study ID: 2401-136-016 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-06 - Lead Sponsor: Chung-Ang University Gwangmyeong Hospital ### Study Description This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements. ### Conditions - Neurologic Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Remimazolam besylate + propofol MCT - Propofol MCT ### Outcomes Primary Outcomes - Incidence of intraoperative hypotension Secondary Outcomes - Amount and number of inotropic agents - Incidence of participants' intraoperative involuntary movement - scores of neurophysiologic monitoring quality - onset time of study drugs - The administration number of rescue anti-emetic agents - Time-weighted average of intraoperative hypotension - recovery time of study drugs (remimazolam+propofol or propofol) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Upper Extremity Robot-Assisted Therapy in Stroke Patients - NCT ID: NCT06382454 - Study ID: E2-23-5921 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-03-30 - Lead Sponsor: Hacettepe University ### Study Description Upper extremity hemiparesis is one of the most common symptoms after stroke. Robot-assisted therapies have been used as an approach to rehabilitation of upper extremity hemiplegia in recent years. Robot-assisted therapy is an approach to post-stroke rehabilitation that uses robotic devices to provide motor or task-oriented training to patients. When the literature is examined, there are studies showing that robot-assisted therapies are similar or superior to conventional methods. In order to provide the most effective rehabilitation approach in upper extremity robots, it is suggested that it may be more accurate to consider the robotic device as a training platform consisting of various therapeutic techniques and principles, not as a tool alone. A robotic system will be used to overcome the disadvantages of the existing robotic systems in the literature such as not providing support to the patient at the time of need, not providing fluidity in shoulder movements by not taking into account the scapulohumeral rhythm in upper extremity movements, long installation times, and ignoring task-oriented training. The system to be used is a self-aligning exoskeleton system for robot-assisted upper extremity rehabilitation. The system provides safe and versatile rehabilitation at increasing intensity and also allows for objective assessments. The aim of this clinical study was to evaluate the efficacy of robot-assisted upper limb rehabilitation in stroke patients. ### Conditions - Stroke - Upper Extremity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Assist-On Arm Robot Group - Control Group ### Outcomes Primary Outcomes - Modified Ashworth Scale - Fugl-Meyer Assessment Upper Extremity - Action Research Arm Test - Box and Block Test - Nine Hole Peg Test Secondary Outcomes - ACTIVLIM - ABILHAND Assessment - Stroke Impact Scale ### Location - Facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Ankara, Altındağ, Ankara, 06100, Turkey @@
## A Tele-exercise Program for Breast Cancer Survivors - NCT ID: NCT06382441 - Study ID: KC/KE-23-0122/ER-4 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-01 - Completion Date: 2024-05-31 - Lead Sponsor: Hong Kong Baptist University ### Study Description The research protocol outlines a pilot study for a home-based and group-based tele-exercise program designed for breast cancer survivors. The study is a randomized controlled trial (RCT) led by Dr. Yang Gao from Hong Kong Baptist University, with multiple other investigators from Kwong Wah Hospital and the university itself.Breast cancer is identified as the most prevalent cancer among women globally and in Hong Kong. The document states that adjuvant therapies post-surgery, such as radiation and chemotherapy, can have both short-term and long-term side effects, which may affect the survivors' physical and mental health.The study is based on evidence that physical activity levels often decrease after a breast cancer diagnosis and that exercise can mitigate the side effects of treatment, improving health and quality of life. The pilot aims to test the acceptability and feasibility of a 12-week tele-exercise program that combines psychological theories and behaviour change techniques, transitioning from supervised to unsupervised exercise to build sustainable exercise habits.The study will enrol 24 patients, randomly assigning them to an intervention group or an active control group. The intervention group will receive 12 online training sessions plus 4 psychological counselling sessions, whereas the control group will receive educational essays on exercise and health.The training sessions for the intervention group will include various exercises with increasing intensity and duration over the 4 weeks, monitored by a pulse oximeter to ensure exercises are done at the appropriate heart rate. The sessions will be led by qualified coaches, with Dr. Gao overseeing quality control. ### Conditions - Behavior, Health ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - tele-exercise ### Outcomes Primary Outcomes - Acceptability (quantitative) - Acceptability (qualitative) - Recruitment rate - Retention rate - Attendance rate - Compliance rate Secondary Outcomes - Cardiorespiratory fitness - muscle strength - balance - % body fat - skeletal muscle mass - height - Shoulder joint range of motion (ROM) of affected side - Limb circumference and lymphedema - Health-related quality of life - Physical activity level (min/week) ### Location - Facility: Xiong Zhennan, Kowloon Tong, Kowloon, N/A, Hong Kong @@
## The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period - NCT ID: NCT06382428 - Study ID: T-DAYICAN-002 - Status: COMPLETED - Start Date: 2022-12-30 - Completion Date: 2024-01-30 - Lead Sponsor: Izmir Tinaztepe University ### Study Description Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum). ### Conditions - Pelvic Floor Disorders - Postpartum Disorder - Quality of Life - Mothers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Pelvic floor muscle training ### Outcomes Primary Outcomes - Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms - Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms - Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms - Pelvic Floor Distress Inventory-20 to measure the urinary symptoms - Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life - Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life - Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life - Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life - Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles - Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles - Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles - Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles - Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles Secondary Outcomes ### Location - Facility: Yeditepe University, Istanbul, N/A, 34010, Turkey @@
## Organ/Space Surgical Site Infection and Recurrence and Survival in Rectal Cancer Surgery - NCT ID: NCT06382415 - Study ID: VINCat_PDO_2 - Status: COMPLETED - Start Date: 2011-01-01 - Completion Date: 2024-03-31 - Lead Sponsor: Hospital de Granollers ### Study Description In rectal cancer surgery, the organ/space surgical site infection (O/S-SSI) has an impact on patient's prognosis. Its influence in the oncologic outcomes remains controversial. The main objective is to assess the possible effect of O/S-SSI on long-term overall survival and cancer recurrence. ### Conditions - Rectal Cancer - Organ-Space Surgical Site Infection ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Rate of overall cancer recurrence - Overall survival Secondary Outcomes - Rate of Organ-space surgical site infection - Rate of surgical complications ### Location - Facility: Hospital General de Granollers, Granollers, Barcelona, 08402, Spain @@
## A CCTA Guided Management Strategy Versus a Standard of Care Strategy in Type 2 NSTEMI - NCT ID: NCT06382402 - Study ID: 23.0924 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2026-04-30 - Lead Sponsor: University of Louisville ### Study Description This study design is a prospective randomized control trial to compare outcomes between the utilization of coronary computed tomography angiography (CCTA) vs conservative treatment in type 2 NSTEMI. The targeted population is expectedly heterogeneous and inpatient setting who are admitted and diagnosed with type 2 NSTEMI. ### Conditions - Myocardial Injury ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - CCTA scan ### Outcomes Primary Outcomes - MACE - Cardiovascular (CV) mortality - Nonfatal MI, stroke - Hospitalization for unstable angina - Hospitalization for heart failure - Unplanned revascularization Secondary Outcomes - All-cause mortality - In-hospital and 90-day costs - Patient quality of life at 90 days - Diagnostic certainty scores - Individual components of the primary endpoint ### Location - Facility: University of Louisville School of Medicine, Division of Cardiovascular Diseases, Louisville, Kentucky, 40202, United States @@
## Efficacy of EMONO as an add-on Therapy to Conventional Antidepressants for the Treatment of Depressive Symptoms in Nursing-home Residents With Neurocognitive Disorders: a Randomized Controlled Trial- - NCT ID: NCT06382389 - Study ID: DR220204 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2026-08 - Lead Sponsor: University Hospital, Tours ### Study Description Depression in neurocognitive disorders (Alzheimers' disease and related disoders) is a highly prevalent condition, especially in nursing homes. While it is associated with significant distress, the current conventional antidepressants have shown only modest efficacy and exposed to potentially severe side effects.Recent evidence suggests that nitrous oxide (N2O) in its most commonly used packaging of EMONO (Equimolar Mixture of Oxygen and Nitrous Oxide) has rapid antidepressant properties and a good safety profile. However, no study has investigating the antidepressant effect of EMONO in a population of depressed older adults with moderate to severe neurocognitive disorders in nursing homes.The principal goal of the PROTO-EHPAD study is to compare the changes in depressive symptoms in such individuals in a randomized controlled trial with a follow up period of 8 weeks, with a dosage escalation procedure. ### Conditions - Depression - Neurocognitive Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - EMONO - Medical air ### Outcomes Primary Outcomes - Changes in the CORNELL depression severitý scale between S4 (one week after the last administration of MEOPA or medical air) and S1 (baseline). Secondary Outcomes - CORNELL scale and GDS scale at weeks 1, 2, 3, 4 and 8 - CGI-S and CGI-I scales at weeks 1, 2, 3, 4 and 8 - The measurement of well-being by the EVIBE visual analogue scale at weeks 1, 2, 3, 4, and 8 - Collection of adverse events at all study visits ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Analgesia Methods Applied in Gynecological Cancer Surgeries on Postoperative Analgesia - NCT ID: NCT06382376 - Study ID: 2024-60 - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2024-03-01 - Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital ### Study Description The aim of this study is to compare the effectiveness of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia in gynecological cancer surgeries.The key question(s) it aims to answer are:\[Is intrathecal morphine more effective in postoperative analgesia?\] Patients who underwent gynecological cancer surgery were examined retrospectively. The investigators evaluated the effect of intrathecal morphine and four-quadrant transversus abdominis plane block applied for postoperative analgesia on pain scores and postoperative opioid use. ### Conditions - Gynecological Cancer Surgery - Regional Anesthesia Morbidity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Intrathecal morphine administered group, Four quadrant transversus abdominis plane block applied group ### Outcomes Primary Outcomes - postoperative numerical rating scale Secondary Outcomes - postoperative opioid use ### Location - Facility: Başakşehir Çam and Sakura City Hospital, Istanbul, Basaksehir, N/A, Turkey @@
## Improving T2DM Detection Using Spot cHbA1c Test - a Cluster RCT - NCT ID: NCT06382363 - Study ID: UW21-363 - Status: RECRUITING - Start Date: 2022-06-11 - Completion Date: 2024-09-30 - Lead Sponsor: The University of Hong Kong ### Study Description Objectives: To evaluate the effectiveness of active opportunistic screening using point-of-care capillary Hemoglobin-A1c (POC-cHbA1c) testing, compared to venous HbA1c (vHbA1c) testing, in improving detection of type 2 diabetes mellitus (T2DM) among at-risk primary care patients.Design: Pragmatic cluster randomized controlled trial.Setting: 8 public primary care clinics in Hong Kong.Participants: A minimum of 776 patients (97 per clinic) who have ≥1 risk factor for T2DM, but no known diagnosis of DM or DM screening in the past 12 months.Intervention: Participants at intervention clinics (n=4) will be offered free POC-cHbA1c testing on-site, immediately informed of test results and DM risk, and scheduled for confirmatory oral glucose tolerance test (OGTT) if screened positive (i.e. HbA1c≥5.6%). Participants at control clinics will be offered free vHbA1c testing scheduled on a separate day, informed of test results and DM risk via phone, and scheduled for confirmatory OGTT if screened positive.Main outcome measures: Primary outcomes are uptake rate of POC-cHbA1c versus vHba1c testing, and difference in proportion of T2DM detected between intervention and control groups.Secondary outcomes include number-needed-to-screen to detect one more T2DM case.Data analysis: Participants' characteristics and test uptake rates will be summarized by descriptive statistics. Difference in the proportion of T2DM detected between groups will be compared using Chi-squared test. Number-needed-to screen to identify one additional patient with DM will be calculated.Expected results: A greater proportion of T2DM patients will be detected by POC-cHbA1c than vHbA1c due to a higher screening test uptake rate among the studied population. ### Conditions - Diabetes Mellitus - Pre-diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - POC-cHbA1c testing ### Outcomes Primary Outcomes - Proportional difference in detection of T2DM - Uptake rate Secondary Outcomes - Proportion of high-risk HbA1c concentration - Difference in uptake rate of OGTT - Number-needed-to-screen to detect one more T2DM case - Proportion of patients who refuse to join the study ### Location - Facility: Aberdeen Jockey Club General Out-Patient Clinic, Hong Kong, N/A, N/A, Hong Kong @@
## Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems - NCT ID: NCT06382350 - Study ID: KHL-002-2024 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-05 - Lead Sponsor: University Hospital, Motol ### Study Description The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy ### Conditions - Type 1 Diabetes Mellitus - Type 1 Diabetes Mellitus With Hypoglycemia - Drive ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MiniMed 780 G ### Outcomes Primary Outcomes - The frequency of hypoglycemia (<3.9 mmol/l) during the driving periods Secondary Outcomes - Period of time spent in a range between 3.9 and 4.5 mmol/l (a risky period) during driving. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Immediate Dental Implants in The Upper Anterior Region - NCT ID: NCT06382337 - Study ID: A03010240S - Status: NOT_YET_RECRUITING - Start Date: 2024-04-21 - Completion Date: 2025-04 - Lead Sponsor: Mansoura University ### Study Description The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically. ### Conditions - Teeth Loss - Alveolar Bone Resorption ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group A : ice cream cone technique - Group B : the vestibular socket therapy ### Outcomes Primary Outcomes - Bone changes Secondary Outcomes - soft tissue changes ### Location - Facility: Faculty of Dentistry Mansoura University, Mansoura, N/A, 7650001, Egypt @@
## The Psychological Impact of Mindfulness Intervention to Anterior Cruciate Ligament Reconstruction - NCT ID: NCT06382324 - Study ID: 202301280B0 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2025-12 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description Anterior cruciate ligament (ACL) reconstruction surgery is a common procedure performed by orthopedic surgeons. Postoperatively, patients often experience pain, muscle tension, and concerns about their ability to return to sports. These factors influence the recovery and return to sports capabilities of ACL patients. According to research, only 64% of patients are able to recover to their pre-injury level after surgery, and the success rate for returning to competitive sports is only 56%. Psychological factors during the recovery process may explain this disparity. ACL injury is associated with anxiety, pain reaction, and emotional disorders, with fear of re-injury being the most common obstacle to returning to sports, accounting for 19%. A study by Lentz et al. (2015) also found no significant differences in pain assessments between individuals who were afraid of re-injury and those who were able to return to sports at six months and one year after surgery. This suggests that fear of pain may limit activity and increase the risk of unsuccessful return to sports.Mindfulness intervention is a psychological approach that involves non-judgmental awareness and focus on moment to moment. Mindfulness practice is known to reduce stress in athletes, promote recovery, enhance athletic performance, and improve sleep quality. Good sleep quality contributes to emotional stability and physical recovery. Even short daytime naps can be beneficial for athletes. A review of 37 studies of moderate quality found that daytime napping can improve physical and cognitive performance, psychological state, and nighttime sleep.Therefore, investigators hypothesize that integrating mindfulness practice into daytime napping may lead to improved spirit upon waking, reduce sleep inertia, and over time, potentially increase the rate of return to sports after ACL reconstruction. ### Conditions - Anterior Cruciate Ligament (Acl) Reconstruction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - mindfulness practice of body scan - listening to light music ### Outcomes Primary Outcomes - Electroencephalogram (EEG) - Electrooculography (EOG) - Electromyography (EMG) - ECG (Electrocardiography) - Nasal/Oral airflow - Thermistor - Chest and abdominal belt - Oximetry - Snoring Secondary Outcomes - Karolinska Sleepiness Scale (KSS) - Five Facet Mindfulness Questionnaire (FFMQ) - State-Trait Anxiety Inventory (STAIS) - Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) (Short Version) ### Location - Facility: ChangGungMH, Keelung, N/A, 204004, Taiwan @@
## A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults - NCT ID: NCT06382311 - Study ID: 221824 - Status: RECRUITING - Start Date: 2024-04-18 - Completion Date: 2025-05-21 - Lead Sponsor: GlaxoSmithKline ### Study Description The aim of this study is to evaluate the safety, reactogenicity and immunogenicity of the Flu Pandemic messenger RNA (mRNA) vaccine (including dose-finding and dose-confirmation) administered healthy adults 18 to 85 years of age. ### Conditions - Influenza, Human ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: PREVENTION ### Interventions - Flu Pandemic mRNA_Dose level 1 - Flu Pandemic mRNA_Dose level 2 - Flu Pandemic mRNA_ Dose level 3. - Flu Pandemic mRNA_ Dose level 4 - Flu Pandemic mRNA_Dose level 5 - Flu Pandemic mRNA_Dose level 6 - Flu Pandemic mRNA_Dose level 7 - Placebo ### Outcomes Primary Outcomes - Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] - Percentage of participants with solicited administration site events [Phase 1 and Phase 2 Part A] - Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] - Percentage of participants with solicited systemic events [Phase 1 and Phase 2 Part A] - Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] - Percentage of participants with unsolicited adverse events (AEs) [Phase 1 and Phase 2 Part A] - Percentage of participants with medically attended adverse events (MAAEs) [Phase 1 and Phase 2 Part A] - Percentage of participants with serious adverse events (SAEs) [Phase 1 and Phase 2 Part A] - Percentage of participants with adverse events of special interest (AESIs) [Phase 1 and Phase 2 Part A] - Phase 1: Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 - Phase 1: Percentage of participants with increased in FDA toxicity grading in hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 29 - Phase 1: Percentage of participants with increased in haematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 - Phase 1: Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 29 - Percentage of participants with anti- hemagglutinin inhibition (HI) titers >= 1:40 at Day 43 [Phase 1 and Phase 2 Part A] - Percentage of participants with solicited administration site events [Phase 2 Part B] - Percentage of participants with solicited systemic events [Phase 2 Part B] - Percentage of participants with unsolicited AEs [Phase 2 Part B] - Percentage of participants with MAAEs [Phase 2 Part B] - Percentage of participants with SAEs [Phase 2 Part B] - Percentage of participants with AESIs [Phase 2 Part B] - Percentage of participants with increased in FDA toxicity grading for hematology and clinical chemistry laboratory parameters from baseline to any level of FDA toxicity grading at Day 8 [Phase 2 Part B] - Percentage of participants with increased in hematology and clinical chemistry laboratory parameters from normal values at baseline to abnormal values at Day 8 [Phase 2 Part B] - Percentage of participants with anti-HI titers >= 1:40 at Day 22 [Phase 2 Part B] Secondary Outcomes - Geometric mean titers (GMTs) of HA antibody titers [Phase 1 and Phase 2 Part A] - Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A] - Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] - Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] - Geometric mean increase (GMI) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] - Percentage of participants with HA antibody Seroconversion rate (SCR) [Phase 1 and Phase 2 Part A] - Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] - Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] - Seroconversion rate (SCR) of anti-HI antibody titers [Phase 1 and Phase 2 Part A] - Percentage of participants with anti-HI antibody titers >= 1:40 [Phase 1 and Phase 2 Part A] - Percentage of seropositive participants for the HA antibody titers [Phase 1 and Phase 2 Part A] - GMT of Anti-HI antibody titers [Phase 2 Part B] - GMI of anti-HI antibody titers [Phase 2 Part B] - GMI of anti-HI antibody titers [Phase 2 Part B] - GMI of anti-HI antibody titers [Phase 2 Part B] - Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] - Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] - Seroconversion rate (SCR) of anti-HI antibody titers [Phase 2 Part B] - Percentage of participants with anti-HI antibody >= 1:40 [Phase 2 Part B] - Percentage of participants with seropositivity of anti-HI antibody titers [Phase 2 Part B] ### Location - Facility: GSK Investigational Site, Anniston, Alabama, 36207, United States @@
## Cottonseed Oil Versus Matched PUFA Effects - NCT ID: NCT06382298 - Study ID: PROJECT00009332 - Status: NOT_YET_RECRUITING - Start Date: 2024-08 - Completion Date: 2028-05 - Lead Sponsor: University of Georgia ### Study Description Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk.The specific aims are:* Examine the impact of CSO vs. PUFA on fasting and postprandial lipids.* Examine the impact of CSO on other markers of chronic disease risk.Participants will be asked to:* Consume provided meal replacement shakes daily for 28-days.* Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of study materials,* Attend two longer (5.5h) testing visits which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast.Researchers will compare CSO vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets. ### Conditions - Dyslipidemia - Overweight and Obesity - Nutrition, Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - COTTONSEED OIL - MATCHED PUFA DIET - CONTROL ### Outcomes Primary Outcomes - Change in fasting serum lipoprotein and cholesterol concentrations - Change in fasting serum lipoprotein particle numbers - Change in fasting and postprandial plasma triglyceride concentrations - Change in fasting and postprandial plasma non-esterified fatty acid (NEFA) concentrations - Change in fasting and postprandial plasma glucose concentrations - Change in fasting and postprandial plasma insulin concentrations - Change in fasting and postprandial plasma appetite control hormones concentrations - Change in fasting and postprandial subjective feelings related to appetite - Change in fasting and postprandial plasma Malondialdehyde (MDA) - Change in fasting and postprandial plasma total antioxidant capacity - Change in fasting inflammatory cytokine concentrations - Change in fasting plasma markers of coagulation potential - Change in fasting and postprandial plasma angiopoietin-like (ANGPTL) proteins - Change in fasting insulin resistance metrics - Desaturation index Secondary Outcomes - Change in fasting serum hepatic enzymes - Change in fasting serum hepatic proteins - Change in fasting serum bilirubin - Change in additional fasting plasma inflammatory cytokine concentrations - Change in additional fasting plasma markers of coagulation potential - Change in acute dietary intake ### Location - Facility: University of Georgia, Athens, Georgia, 30602, United States @@
## The Effect of a Prolonged Peripheral Nerve Block on the Level of Pain After a Knee Replacement - NCT ID: NCT06382285 - Study ID: 0206-22-ASF - Status: NOT_YET_RECRUITING - Start Date: 2024-10-30 - Completion Date: 2026-01-31 - Lead Sponsor: Assaf-Harofeh Medical Center ### Study Description The aim of this study is to examine the effect of a prolonged peripheral nerve block (utilizing continuous adductor canal block) on the level of pain after a knee replacement surgery ### Conditions - Knee Replacement Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Continues peripheral block ### Outcomes Primary Outcomes - Pain level - Analgesic use Secondary Outcomes - Physiotherapy ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@