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## Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules - NCT ID: NCT06279533 - Study ID: LV232-02 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2024-07 - Lead Sponsor: Vigonvita Life Sciences ### Study Description This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement. ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - LV232/Placebo - LV232 ### Outcomes Primary Outcomes - Tmax - Cmax - T1/2 - AUC0-t - AUC0-24h - AUC0-∞ Secondary Outcomes - Number of participants with treatment emergent treatment-related adverse event(s) - Laboratory test - Vital signs - Number of participants with ECG findings of potential clinical importance ### Location - Facility: Shanghai Xuhui Central Hospital, Shanghai, N/A, N/A, China @@
## Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study. - NCT ID: NCT06279520 - Study ID: 2023-08-003 - Status: RECRUITING - Start Date: 2024-02-19 - Completion Date: 2024-12-31 - Lead Sponsor: Seoul National University Hospital ### Study Description The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result ### Conditions - Automobile Driving ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - VR Driving Simulator - Computerized Neurocognitive Function Test - Driver Test Station - On-road field driving Test ### Outcomes Primary Outcomes - Feasibility of VR driving simulator - Driving performance in simulator, measured by driving errors Secondary Outcomes ### Location - Facility: Seoul National University Hospital, Seoul, N/A, N/A, Korea, Republic of @@
## Efficacy of Hyaluronic Acid Injection in Knee Osteoarthritis - NCT ID: NCT06279507 - Study ID: PMK-00007 - Status: RECRUITING - Start Date: 2024-02-10 - Completion Date: 2025-06-30 - Lead Sponsor: Phramongkutklao College of Medicine and Hospital ### Study Description The aim of this clinical trial study is to compare the efficacy of Hyaluronic injection in patients with symptomatic knee osteoarthritis. The main questions it aims to answer are:* Is Hyaluronic acid injection improve pain symptom, joint stiffness, and joint function in patients with knee osteoarthritis* Is Hyaluronic acid injection improve knee performance status and health-related quality of life in patients with knee osteoarthritisParticipants will be allocated to receive one treatments; either Hyaluronic acid or normal saline injections after receiving glucocorticoid injection.Researchers will compare the Hyaluronic acid with normal saline injection to see if the former show superior effect in terms of pain, joint stiffness, function, as well as health-related quality of life comparing with placebo. ### Conditions - Knee Osteoarthritis - Pain, Joint - Stiffness of Knee, Not Elsewhere Classified - Quality of Life ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sodium Hyaluronate - Normal Saline - Triamcinolone Acetonide 10mg/mL ### Outcomes Primary Outcomes - Pain outcome measurement - Joint stiffness and function measurement - Overall symptom assessment Secondary Outcomes - Knee performance evaluation - Quality of life assessment ### Location - Facility: Phramongkutklao Hospital, Bangkok, N/A, 10400, Thailand @@
## Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors - NCT ID: NCT06279494 - Study ID: Sirolimus for GVHD prophylaxis - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-03 - Lead Sponsor: Peking University People's Hospital ### Study Description Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors. ### Conditions - Acute Leukemia - Myelodysplastic Syndromes - Severe Aplastic Anemia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Sirolimus - Abatacept - MMF - ATG ### Outcomes Primary Outcomes - Incidence of Grade 2-4 aGVHD within 100 days post transplantation Secondary Outcomes - Incidence of chronic GVHD (cGVHD) within 1 year post transplantation - Incidence of thrombotic microangiopathy within 1 year post transplantation ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy - NCT ID: NCT06279481 - Study ID: PUMCH-K2458 - Status: RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group. ### Conditions - Pain - Colonoscopy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nonpharmacological method ### Outcomes Primary Outcomes - Comparison of Visual Analogue Scale Mean Scores by Groups Secondary Outcomes - Comparison of State Trait Anxiety Inventory Mean Scores by Groups - Comparison of Vital Signs between Groups: Pulse Rate - Comparison of Vital Signs between Groups: Blood Pressure - Comparison of Vital Signs between Groups: Respiration Rate - Comparison of Vital Signs between Groups: Oxygen Saturation - Comparison of Patient Satisfaction of Colonoscopy between Groups - Comparison of Patient Willingness of Future Colonoscopy between Groups - Comparison of Adverse Effects in both groups ### Location - Facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, 100010, China @@
## Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis - NCT ID: NCT06279468 - Study ID: I-23PJ2232 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-06-01 - Lead Sponsor: Peking Union Medical College Hospital ### Study Description Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole. ### Conditions - Adolescent Idiopathic Scoliosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - intervertebral disc release - Ponte osteotomy ### Outcomes Primary Outcomes - The correction rate of axial rotation of the apex vertebrae Secondary Outcomes - Lumbar curve - UIV tilt - C7-CSVL - Lumbar lordosis - SVA - Radiographic parameters measured by CT scan: LIV and LIV+1 translation - LIV tilt - The lowest instrumented vertebra disc angle - Age - Gender - Risser grade of the patients at the time of surgery - number of fused spinal levels - length of operation - Scoliosis Research Society-22,SRS-22 score - the MOS item short from health survey, SF-36 score - EuroQol Five Dimensions Questionnaire, EQ-5D score - Perioperative total blood loss - Visible blood loss - Perioperative transfusion amounts - Perioperative transfusion rates - Rate of postoperative infection - The incidence of nerve damage - The incidence of loss of correction ### Location - Facility: Peking Union Medical College Hospital, Beijing, Beijing, 100035, China @@
## Pelvic Floor Muscle Exercise During Pregnancy - NCT ID: NCT06279455 - Study ID: E-74555795-050.01.04-392120 - Status: COMPLETED - Start Date: 2022-12-05 - Completion Date: 2023-10-30 - Lead Sponsor: Istanbul University - Cerrahpasa (IUC) ### Study Description This study was conducted to evaluate the effects of pelvic floor muscle exercises during pregnancy on sexual function, lower urinary tract symptoms and birth process. The research was conducted with pregnant women who applied to the Pregnancy Outpatient Clinic of Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine Hospital. Power analysis was performed to determine the number of samples to be included in the study. It was determined that 29 pregnant women should be included in each group (experimental and control). Considering the possibility of data loss, 50 pregnant women were included in each group. As a result of the exclusion of 8 women who withdrew from participating in the study, 5 women due to risky pregnancies (bleeding, preeclampsia and gestational diabetes) and 17 women due to cesarean delivery, the data of 35 pregnant women in the experimental group and 35 pregnant women in the control group were obtained. Pregnant women in the experimental group were gestational aged 18-20. Two sessions of training were given on female reproductive and urinary system anatomy, physiological changes during pregnancy and their effects on sexual life, and pelvic floor muscle exercises, using the "Pelvic Floor Health \& Sexual Life Training Booklet during Pregnancy" and the pelvic floor muscle exercise training video developed by the researcher between the weeks of pregnancy. Pregnant women were asked to perform pelvic floor muscle exercises, 3 sets a day, 3 days a week, for 12 weeks, starting from the 20th week of pregnancy, and record them in the Pelvic Floor Muscle Exercise Follow-up Form created by the researcher. Pregnant women in the control group were not given any training and were routinely monitored in the outpatient clinic. Pregnant women who apply to the outpatient clinic are examined by nurses, with their vital signs taken and anamnesis taken by the physician. Recommendations are made regarding the complaints of pregnant women. Non-stress tests are routinely applied to pregnant women who are at the 36th week of pregnancy and above. ### Conditions - Lower Urinary Tract Symptoms - Sexual Function ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Pelvic Floor Muscle Exercise ### Outcomes Primary Outcomes - Sexual Function - Lower Urinary Tract Symptoms - Birth Process Secondary Outcomes ### Location - Facility: Istanbul University-Cerrahpasa, Istanbul, N/A, N/A, Turkey @@
## Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort - NCT ID: NCT06279442 - Study ID: LACOG 0723 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-08 - Lead Sponsor: Latin American Cooperative Oncology Group ### Study Description This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites. ### Conditions - Carcinoma Adrenal - Carcinoma, Adrenocortical Recurrent ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Demographic and Clinical Characterization of Adrenocortical Carcinoma in Brazil Secondary Outcomes - Assessment of the Association Between Clinical, Pathological, Epidemiological Factors, and Therapeutic Modalities with Prognosis and Outcomes such as Overall Survival or Recurrence-Free Survival - Evaluating the Impact of Adjuvant Mitotane Use on Progression-Free Survival and Overall Survival ### Location - Facility: A.C. Camargo Cancer Center, São Paulo, N/A, 01.509-001, Brazil @@
## Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia - NCT ID: NCT06279429 - Study ID: KTGH11137 - Status: RECRUITING - Start Date: 2022-05-31 - Completion Date: 2024-12-31 - Lead Sponsor: Kuang Tien General Hospital ### Study Description Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia. ### Conditions - CKD - Sleep Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sideral® Sucrosomial Iron - Iron chewable tablet ### Outcomes Primary Outcomes - Insomnia Severity Index (ISI) - Pittsburgh Sleep Quality Index (PSQI) - Epworth sleepiness Scale (ESS) - Hemoglobin - Ferritin - Serum Iron - Transferrin Saturation - Erythrocyte sedimentation rate Secondary Outcomes ### Location - Facility: Kuang Tien General Hospital, Taichung, N/A, 433, Taiwan @@
## Expected Difficult Airway Management - NCT ID: NCT06279416 - Study ID: 2023-31 - Status: RECRUITING - Start Date: 2023-12-30 - Completion Date: 2024-12 - Lead Sponsor: Kocaeli City Hospital ### Study Description In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded. ### Conditions - Awake Intubation - Advanced Airway Techniques ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - fiberoptic intubation - laryngeal mask airway-mediated aintree catheter - videolaryngoscopy ### Outcomes Primary Outcomes - Comparison of advanced airway methods in the awake patient with difficult airway. Secondary Outcomes ### Location - Facility: Kocaeli City Hospital, Kocaeli, N/A, N/A, Turkey @@
## Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma - NCT ID: NCT06279403 - Study ID: IIT-2023-0277 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2029-03-01 - Lead Sponsor: RenJi Hospital ### Study Description Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy.Study Design:Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.Sample Size: 20 participants.Patient Grouping: Non-randomized.Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery. ### Conditions - Clear-cell Metastatic Renal Cell Carcinoma - Immune Checkpoint Inhibitors - Cytoreductive Nephrectomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Toripalimab - Cytoreductive Nephrectomy - Axitinib ### Outcomes Primary Outcomes - Pathological Major Response (MPR) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients - NCT ID: NCT06279390 - Study ID: 202305126RINC - Status: COMPLETED - Start Date: 2023-06-08 - Completion Date: 2023-10-30 - Lead Sponsor: National Taiwan University Hospital ### Study Description Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores \>30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society. ### Conditions - Intensive Care Unit Delirium ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - the incidence of delirium Secondary Outcomes - duration of ventilator use - rate of unplanned self-extubation - day of physical restraint - level of mobility - cumulative dose of sedatives ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## Examining the Effectiveness of Exercise Training After Cervical Laminoplasty Surgery - NCT ID: NCT06279377 - Study ID: Katip Celebi University - Status: RECRUITING - Start Date: 2023-05-05 - Completion Date: 2025-05-15 - Lead Sponsor: Izmir Katip Celebi University ### Study Description The goal of this clinical trial is to compare the effects of the stabilization exercise program applied after cervical laminoplasty surgery compared to standard exercise on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level). The main question\[s\] it aims to answer are:* Does the exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?* Does the stabilization exercise program applied after cervical laminoplasty surgery have an effect on pain, dysfunction, normal joint movement, proprioception, balance, muscle endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level)?Patients will start their first exercise session on the day they will be discharged from the hospital. Patients in both exercise groups will be provided with cervical normal joint movement (ROM), posture and patient education on the day of discharge. They will be asked to do posture exercises and neck exercises under the guidance of a physiotherapist. Patients in the stabilization exercise group (experiment) will undergo stabilization exercises under the supervision of a physiotherapist, in addition to the practices in the standard exercise group. Both groups will do a warm-up program before exercise and a cool-down program afterwards. Patients will be asked to do the exercises face to face with a physiotherapist 3 days a week. The first evaluations will be made on the day they come to the outpatient clinic for examination before surgery. Post-surgical evaluations will be made routinely after the exercise program is completed, when they are called by the physician for a check-up (6th week).Researchers will compare the standard exercise group with the stabilization exercise group to see if pain, dysfunction, normal joint movement, proprioception, balance, muscular endurance, postural alignment and related factors (kinesiophobia, awareness, quality of life, disability, physical activity level) are different. ### Conditions - Cervical Spine Disease - Surgery - Rehabilitation - Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stabilization Exercises - Standard Exercises ### Outcomes Primary Outcomes - Pain intensity - Dysfunction - Joint Range of Motion - Proprioception - Balance - Neck Extensor Muscle Endurance - Neck Flexor Muscles Endurance - Postural Alignment Secondary Outcomes - Kinesiophobia - Neck Awareness - Life Quality - Disability - Physical Activity Level ### Location - Facility: Izmir Katip Celebi University Ataturk Education and Research Hospital, İzmir, N/A, N/A, Turkey @@
## A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer - NCT ID: NCT06279364 - Study ID: SKB264-Ⅲ-11 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2026-07 - Lead Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ### Study Description The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting ### Conditions - Triple Negative Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SKB264 - Paclitaxel - Nab-paclitaxel - Capecitabine - Eribulin - Carboplatin ### Outcomes Primary Outcomes - Overall Survival (OS) - Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) Secondary Outcomes - Objective Response Rate (ORR) - Duration of Response (DoR) - Progression-Free Survival (PFS) assessed by Investigator - Disease control rate (DCR) - Time to Response (TTR) - Adverse events(AEs) and severe adverse events (SAEs) ### Location - Facility: Fudan University Shanghai Cancer Center, Shanghai, Shanghai, N/A, China @@
## Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer - NCT ID: NCT06279351 - Study ID: Thalicolorectal - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-12-31 - Lead Sponsor: Xinqiao Hospital of Chongqing ### Study Description 1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies. ### Conditions - Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Thalidomide+cetuximab+FOLFOX/FOLFIRI ### Outcomes Primary Outcomes - ETS Secondary Outcomes - ORR - DCR - PFS ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score - NCT ID: NCT06279338 - Study ID: [2023] No.0969 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-01-31 - Lead Sponsor: Wuhan Union Hospital, China ### Study Description Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score ### Conditions - Myelodysplastic Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Azacitidine Injection ### Outcomes Primary Outcomes - Progression-free survival (PFS) at 18 months post-transplant, month Secondary Outcomes - Overall survival (OS) at 18 months post-transplant, month ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve - NCT ID: NCT06279325 - Study ID: C.I. PI23/637 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-01-15 - Lead Sponsor: Universidad de Zaragoza ### Study Description Normal ageing presents subtle cognitive changes that can be detected before meeting the criteria for Mild cognitive impairment (MCI). Older people with low cognitive reserve and who receive limited cognitive stimulation are at greater risk of deterioration. In this regard, cognitive stimulation (CS) has been identified as an intervention that reduces this risk, provided that its design considers the differences in the level of cognitive reserve (CR) acquired throughout life and the baseline level of cognitive functioning. The general objective of this study is to evaluate, through a randomized clinical trial, the effectiveness of a computerized cognitive stimulation program, designed and adapted from Occupational Therapy based on the level of cognitive reserve in older adults in Primary Care. 100 participants will be randomized in a stratified manner according to the level of cognitive reserve (high/low), assigning 50 participants to the control group and 50 participants to the intervention group. The intervention group will carry out a computerized cognitive stimulation intervention designed and adapted from occupational therapy according to the level of cognitive reserve, through the "stimulus" platform. The main result expected to be achieved is the improvement of higher brain functions. As secondary results, the investigators expect that those cognitive aspects most vulnerable to ageing will decrease more slowly (in areas such as memory, executive function, attention and processing speed) and that the cognitive reserve of the participants will increase, in addition to being able to balance gender differences in these aspects. The investigators think that these results can positively impact the creation of adapted, meaningful and stimulating CS programs in older adults to prevent MCI and experience healthier ageing. ### Conditions - Mild Cognitive Impairment - Cognitive Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Computerized cognitive stimulation program - Face-to-face training-explanatory session ### Outcomes Primary Outcomes - MEC-35 (Spanish version of Folstein's Mini-Mental) - Cognitive Reserve Questionnaire (CRQ) Secondary Outcomes - Set-Test - The SDMT or Symbols and Digits Test - Color Word Stroop Test (CWST) - Verbal Learning Test (TAVEC) - Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Adaptogen Elixir on Sleep Improvement - NCT ID: NCT06279312 - Study ID: N202311065 - Status: RECRUITING - Start Date: 2024-02-26 - Completion Date: 2024-12-31 - Lead Sponsor: TCI Co., Ltd. ### Study Description This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. ### Conditions - Sleep Disorder - Anxiety Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Placebo drink - Adaptogen Elixir drink ### Outcomes Primary Outcomes - Sleep monitoring - Sleeping qualityy - Sleeping disorders Secondary Outcomes - Neuropeptide Y concentration - Cortisol concentration - Anxiety - Low Frequency/High Frequence (LF/HF) ratio ### Location - Facility: Taipei Medical University, Taipei, N/A, N/A, Taiwan @@
## Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision - NCT ID: NCT06279299 - Study ID: LLND - Status: RECRUITING - Start Date: 2022-08-01 - Completion Date: 2028-08-01 - Lead Sponsor: National Cancer Center, China ### Study Description The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection. ### Conditions - Rectal Neuroendocrine Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - lateral pelvic lymph node dissection ### Outcomes Primary Outcomes - The rate of lateral pelvic lymph node metastasis Secondary Outcomes - The rate of lymph node metastasis - Disease-free survival rate - Overall survival rate - Locoregional recurrence free survival rate - Radical resection (R0) ### Location - Facility: National Cancer Center, Beijing, Beijing, 100000, China @@
## Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder - NCT ID: NCT06279286 - Study ID: HS-10506-201 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-01 - Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. ### Study Description The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder. ### Conditions - Insomnia Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - HS-10506 - Placebo ### Outcomes Primary Outcomes - Incidence and severity of adverse events (AE) - Incidence and severity of serious adverse events (SAE) - Changes in laboratory test before and after drug administration - Changes in ECG before and after drug administration - Changes in Karolinska Sleepiness Scale (KSS) scores before and after drug administration - Change from baseline in the mean LPS measured by PSG on Night 13 and Night 14 Secondary Outcomes - The maximum plasma concentration (C[max]) - Time to reach the maximum plasma concentration (T[max]) - Area under the plasma concentration-time curve from time zero to last time of quantifiable concentration (AUC[0-t]) - Terminal elimination half-life (t1/2) - Change in latency to persistent sleep (LPS) relative to baseline on night 5 of PSG monitoring - Change in Wake After Sleep Onset (WASO) relative to baseline on night 5 of PSG monitoring - Change from baseline in mean LPS measured by PSG - Change from baseline in mean TST measured by PSG - Change from baseline in mean WASO measured by PSG - Change from baseline in the mean values of self-reported sleep-onset latency (sSOL) recorded in the sleep diary - Change from baseline in the mean values of self-reported total sleep time (sTST) recorded in the sleep diary - Incidence and severity of adverse events (AE) - Incidence and severity of serious adverse events (SAE) ### Location - Facility: Xuanwu Hospital Capital Medical University, Beijing, N/A, N/A, China @@
## A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment - NCT ID: NCT06279273 - Study ID: NZhong-005 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Shanghai Mental Health Center ### Study Description The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction. ### Conditions - Methamphetamine Use Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Transcranial direct current stimulation ### Outcomes Primary Outcomes - Frontal lobe activation level - cue-induced craving Secondary Outcomes - Cognitive function ### Location - Facility: Shanghai Mental Health Center, Shanghai, N/A, N/A, China @@
## National Robotics-Assisted Radical Prostatectomy Database - NCT ID: NCT06279260 - Study ID: 2023.295RMH21343Protocol_V2.0 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2030-12 - Lead Sponsor: Melbourne Health ### Study Description Surgical notes are detailed reports written by surgeons during and after surgeries. These notes cover everything from the techniques, instruments used, any issues with the surgical procedure and post-surgical care for the patient. This information is a treasure trove for researchers because they can study it to understand how surgeries go, what works best, and how certain treatments affect patients.By looking closely at these notes, researchers can find patterns and trends, helping them in understanding what makes surgeries successful and identify the best ways to perform them. This information is crucial for creating guidelines based on solid evidence. Also, these surgical notes are a goldmine for looking back at past surgeries to see how they have affected patients in the long run.The real power for research comes when we combine these surgical notes within the Electronic Medical Records (EMR) and research databases. This makes it easy to collect information systematically, making it simpler for researchers to study a large number of cases. Unfortunately, not many people have paid attention to this idea for a long time, leading to big gaps in the data collection.To address this issue, we aim to create a database that collects information from surgical notes effortlessly. This includes details about how surgeons are trained and how they progress. It's important to make sure that doctors work aligns with research - which is the best way to address data collection issues. This data can also help record different technical aspects of surgery and different surgeons' learning curve, making it easier to compare and improve training. Thus, we aim to standardise notes that are the same across different hospitals conducting robotic-assisted surgeries for prostatectomy. ### Conditions - Database - Prostate Cancer - Robotic-assisted Radical Prostatectomy - Surgical Outcomes - Oncological Outcomes - Patient Reported Outcome Measures - Learning Curve ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To provide a standardized framework, enabling robust evidence strengthening & analyses, trend identification, and the formulation of evidence-based guidelines for the individualized management of PCa. Secondary Outcomes - Patient reported quality of life outcome measures - Surgical - Oncological ### Location - Facility: Austin Healthcare, Melbourne, Victoria, 2084, Australia @@
## Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy - NCT ID: NCT06279247 - Study ID: KYLL-202212-011 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-09 - Lead Sponsor: Qilu Hospital of Shandong University ### Study Description Narcolepsy (NRL) is a rare chronic central nervous system dysfunction disease, which is more common in children and adolescents, and less common in adults. Its typical clinical features include excessive daytime sleep, paroxysmal cataplexy, sleep paralysis and sleep hallucination. In addition to the above typical manifestations, patients with narcolepsy can also manifest as hyperappetite, weight gain, multiple dreams, sleep fragmentation, anxiety and depression and other emotional disorders. In particular, in narcolepsy type 1 with cataplexy, cataplexy episodes can be confused with falls caused by seizures, transient ischemic attacks or neuromuscular disorders, or even mental conversion disorders. Due to its diverse clinical symptoms, it is easy to be missed and misdiagnosed.At present, the pathogenesis of narcolepsy is still unclear, and its pathogenesis may be related to immune, genetic, environmental, infection, central nervous system degeneration and other factors. This study aims to investigate the changes of body fluid proteomics and metabolomics in patients with narcolepsy, and to provide an important basis for the pathogenesis of narcolepsy. ### Conditions - Narcolepsy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - To screen potential molecular markers related to the biological characteristics and prognosis of narcolepsy. Secondary Outcomes ### Location - Facility: Qilu Hospital of Shandong University, Jinan, Shandong, 250012, China @@
## A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus - NCT ID: NCT06279234 - Study ID: C4001002 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2024-12-31 - Lead Sponsor: Pfizer ### Study Description The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple escalating oral doses of PF-06954522 in adult participants with inadequately controlled type 2 diabetes mellitus (T2DM) on metformin (Part A) and optionally in non-diabetic participants with obesity (Part B). ### Conditions - Type 2 Diabetes Mellitus (T2DM) - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Placebo - Rosuvastatin - Midazolam - Omeprazole - PF-06954522 ### Outcomes Primary Outcomes - Number of Participants Reporting Adverse Events - Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities - Number of Participants With Clinically Significan Change From Baseline in Vital Signs - Number of Participants With Clinically Significant Change From Baseline in 12-Lead ECGs - Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) - Number of Participants With Change From Baseline in Physical Examination Secondary Outcomes - Maximum Observed Plasma Concentration (Cmax) - Area Under the Curve from Time Zero to end of dosing interval (AUCtau) - Time to Reach Maximum Observed Plasma Concentration (Tmax) - Plasma Decay Half-Life (t1/2) - Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) - Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%) - Renal Clearance (CLr) ### Location - Facility: Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States @@
## Litfulo Capsules Special Investigation - NCT ID: NCT06279221 - Study ID: B7981055 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2030-06-25 - Lead Sponsor: Pfizer ### Study Description The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug. ### Conditions - Alopecia Areata ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - LITFULO ### Outcomes Primary Outcomes - Proportion of participants with adverse events (AEs) - Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less] Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Phosphoproteomic Profile of Children With Down Syndrome - NCT ID: NCT06279208 - Study ID: 2023-A00272-43 - Status: RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-09 - Lead Sponsor: Perha Pharmaceuticals ### Study Description One of the major causes of cognitive disorders limiting the learning abilities of children with Down's syndrome is excess activity of the DYRK1A protein kinase, whose gene is located on chromosome 21. Consequently, variations in the level of phosphorylation, and hence activity, of DYRK1A target proteins involved in synaptic transmission, could identify mechanisms underlying these cognitive disorders.Several studies have shown that plasma proteins can reflect a pathophysiological brain state. The investigators plan to carry out a phosphoproteomic study to determine the phosphorylation profile of plasma proteins in children with Down's syndrome, and identify potential DYRK1A-dependent pathophysiological mechanisms and biomarkers involved in the natural course of cognition in children with Down's syndrome. ### Conditions - Down Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Blood sample ### Outcomes Primary Outcomes - Phosphoproteomic profile Secondary Outcomes - Identification of brain proteins - Impact of environnement on phosphoproteomic profile - Impact of DYRK1A on Down Syndrome specific proteomic profile ### Location - Facility: CHU Grenoble, Grenoble, N/A, N/A, France @@
## Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment - NCT ID: NCT06279195 - Study ID: EH23-326 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-05 - Completion Date: 2025-08-02 - Lead Sponsor: NorthShore University HealthSystem ### Study Description The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing. ### Conditions - Pelvic Pain ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet ### Outcomes Primary Outcomes - Correlation between post-treatment pelvic pain and baseline uterine contraction frequency - Correlation between post-treatment pelvic pain and baseline sensory hypersensitivity Z-score. Secondary Outcomes ### Location - Facility: NorthShore University HealthSystem, Evanston, Illinois, 60201, United States @@
## Impact of Barre Stretching Among Dental Hygiene Students - NCT ID: NCT06279182 - Study ID: IRB-FY2024-106 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2024-04 - Lead Sponsor: Idaho State University ### Study Description The healthcare profession of dental hygiene can be a highly stressful academic path and occupation. Physical stressors can quickly lead to postural disturbances and musculoskeletal disorders (MSDs) due to instrument grasping while under muscle tension, working with vibrating instruments, and performing repetitive micromovements. Chronic, high stress levels have the potential to lead to burnout, fatigue, and other health problems, which can impact a student's ability to perform well in their clinical rotations and didactic studies and may translate into their workforce experiences after graduation.The purpose of this study is to determine whether a relationship exists between Barre stretching and reported stress and pain levels among entry-level dental hygiene students.This study will be a 6-week experimental randomized control trial (RCT) where participants will be assigned to a 15-minute Barre stretching and breathing video two times a week for the experimental group or control group. The continuous dependent variables in this study will be the reported stress levels and reported pain levels of the entry-level dental hygiene students. The independent variable will be the Barre stretching intervention. The participants will include students at two universities enrolled in an entry-level dental hygiene program as first-year students.Baseline data collection for each participant will be obtained, and the study will be analyzed using descriptive statistics, a paired t-test and independent t-test. The statistical significance level will be set at P=0.05. ### Conditions - Musculoskeletal Disorders - Stress Management - Perceived Stress - Reported Stress - Perceived Pain - Reported Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Barre Stretching Intervention ### Outcomes Primary Outcomes - Self-Reported Stress (Perceived Stress Scale) - Self-Reported Pain (Numerical Pain Rating Scale/Visual Analog Scale) Secondary Outcomes ### Location - Facility: Idaho State University, Pocatello, Idaho, 83209, United States @@
## The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection - NCT ID: NCT06279169 - Study ID: 2023-BRT-SBF-113355 - Status: RECRUITING - Start Date: 2024-04-24 - Completion Date: 2025-08-29 - Lead Sponsor: Bartın Unıversity ### Study Description It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design. ### Conditions - Pain, Acute - Newborn; Vitality ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Heart Sound - White Noise ### Outcomes Primary Outcomes - The Newborn Infant Pain Scale (NIPS) Secondary Outcomes - oxygen saturation - heart rate - Crying Time ### Location - Facility: Bartın University, Bartın, N/A, N/A, Turkey @@
## Optimal Frequency of Total Body Water Measurements by Bioelectrical Impedance Analysis to Prevent Intradialytic Hypotension - NCT ID: NCT06279156 - Study ID: MTU-EC-IM-0-014/65 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2023-02-28 - Lead Sponsor: Thammasat University Hospital ### Study Description The goal of this clinical trial was to compare the efficiencies of bioelectrical impedance analysis (BIA) measurement frequency in preventing intradialytic hypotension in end-stage renal disease (ESRD) patients undergoing regular hemodialysis. The main question aimed to answer about the optimum frequency of BIA measurements to prevent intradialytic hypotension.Participants underwent BIA measurements to determine their appropriate dry weight, and factors affecting intradialytic hypotension.Researchers compared the efficiencies of BIA measurements between the every-1-month group and the every-2-month group to prevent intradialytic hypotension. ### Conditions - Intradialytic Hypotension - End Stage Renal Disease on Dialysis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Bioelectrical Impedance Analysis (BIA) ### Outcomes Primary Outcomes - incidence rate ratio of intra-dialytic hypotension of every-1-month BIA to every-2-month BIA Secondary Outcomes - factors affecting intra-dialytic hypotension ### Location - Facility: Thammasat University Hospital, Pathum Thani, N/A, 12120, Thailand @@
## The Diagnostic Accuracy of Advanced Imaging in Identifying Suspected Skin Cancer (Basal Cell Carcinoma) Around the Eyes - NCT ID: NCT06279143 - Study ID: dOCT-pBCC - Status: RECRUITING - Start Date: 2024-04-04 - Completion Date: 2026-11-30 - Lead Sponsor: Vejle Hospital ### Study Description The purpose is to investigate the diagnostic value (sensitivity and specificity) of dermal-Optical Coherence Tomography (D-OCT, VivoSight Dx), in patients with clinically suspected BCC lesions inside the periocular region and compare these results to previous reports using D-OCT in diagnosing lesions outside the periocular area.The Hypotheses:* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is comparable to previous reports on BCC lesions outside the periocular region when the standard D-OCT probe is used.* The sensitivity and specificity of D-OCT in diagnosing BCC inside the periocular region is increased when the customised D-OCT probe is used.* The sensitivity and specificity of D-OCT in diagnosing periocular BCC is comparable to punch biopsy when both standard and the customised D-OCT probes are used.* D-OCT with the 10 and 20-millimeter standoff is capable of subtyping periocular BCC.* The inter-observer variation in diagnosing and sub-typing periocular BCC decreases with increasing experience in the scanning procedure.* The number of scans to correctly interpret D-OCT decreases with increasing experience in the scanning procedure.* Delineation of periocular BCC tumour extension is possible using both D-OCT probes ### Conditions - BCC - Basal Cell Carcinoma - BCC - Skin Diseases - Eyelid Tumor - Eyelid Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Diagnostic accuracy of D-OCT in diagnosing BCC inside the periocular region, compared to previous reports on lesions outside the periocular region Secondary Outcomes - Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for diagnosing BCC - Comparative diagnostic accuracy of D-OCT´s standard vs customized probe for subtyping BCC - Observer agreement in identifying presence/absence of BCC lesions, using D-OCT - Observer agreement in classifying BCC lesions into subtypes, using D-OCT - Observer agreement in mapping BCC lesions prior to surgery, using D-OCT - Quantification of learning curve in correctly diagnosing BCC over time with increasing experience with D-OCT - Quantification of learning curve in correctly identifying BCC subtypes over time with increasing experience with D-OCT - Quantification of skills in correctly demarcating BCC over time with increasing experience with D-OCT - Accuracy of D-OCT in delineation of periocular BCC extension prior to surgery ### Location - Facility: Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital, Vejle, Region Of Southern Danmark, 7100, Denmark @@
## Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations - NCT ID: NCT06279130 - Study ID: N23NEO - Status: RECRUITING - Start Date: 2024-01-29 - Completion Date: 2034-01-29 - Lead Sponsor: The Netherlands Cancer Institute ### Study Description In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed. ### Conditions - Resectable MMR-deficient Solid Tumors - Resectable MMR-proficient Solid Tumors ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - botensilimab - balstilimab ### Outcomes Primary Outcomes - Major pathological response rate Secondary Outcomes - Pathological response rates - Event free survival - Disease free survival - Overall survival - Radiological response ### Location - Facility: The Netherlands Cancer Institute, Amsterdam, Noord-Holland, 1066 CX, Netherlands @@
## The Effect of Therapeutic Touch on Exam Anxiety - NCT ID: NCT06279117 - Study ID: 2023/9/8 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-03-10 - Lead Sponsor: Dokuz Eylul University ### Study Description Aim: This study was planned to determine the effect of therapeutic touch applied to nursing students on test anxiety.Method: Students who met the inclusion criteria were divided into therapeutic touch and control groups using the randomization method. After the groups were determined, the students filled out the Introductory Information Form and the State Exam Anxiety Scale. 30 minutes before the exam, therapeutic touch was applied to each of the students, who were divided into groups, for 20 minutes. No application was made to the control group, and they were told to wait in the classroom where the group was waiting as they wished.Immediately after the application was completed, the scale was re-applied to both groups. ### Conditions - Test Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - therapeutic touch ### Outcomes Primary Outcomes - Text Anxiety - Text Anxiety Secondary Outcomes ### Location - Facility: Gizem Göktuna, İzmir, N/A, 35000, Turkey @@
## A Comparative Study of the Treatment of Real-world Patients With Clear Cell Carcinoma of the Ovary - NCT ID: NCT06279104 - Study ID: 2023-TJ-OCCC - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-05-01 - Lead Sponsor: Tongji Hospital ### Study Description The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are:* What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world?* Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients?* Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy?Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data. ### Conditions - Ovarian Clear Cell Carcinoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - physician's choice of chemotherapy - immune checkpoint inhibitor based therapy ### Outcomes Primary Outcomes - tumor response rate Secondary Outcomes - progression-free survival (PFS) - time to response (TTR) - duration of response (DOR) - disease control rate (DCR) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Correlation of Children and Parental Anxiety and Effectiveness of Breathing Exercises on Anxiety Reduction - NCT ID: NCT06279091 - Study ID: A0104023PP - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-05-23 - Completion Date: 2024-05-23 - Lead Sponsor: Mansoura University ### Study Description The purpose of this study to evaluate the correlation between children and parental dental anxiety as well as to evaluate the effectiveness of breathing exercises on anxiety reduction. ### Conditions - Dental Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Diaphragmatic Breathing - Bubble Blower Breathing - Tell Show Do ### Outcomes Primary Outcomes - scale of dental anxiety by Corah Dental Anxiety Scale (CDAS) - scale of dental anxiety by Facial Image Scale (FIS) - scale of dental anxiety by Venham Clinical Anxiety Scale (VCAS) - scale of dental anxiety by Pulse Oximeter Secondary Outcomes ### Location - Facility: Mansura University, Mansoura, Dakahlia, 35511, Egypt @@
## Long-term Effect of Steroid on Metabolic Diseases in Asthmatics - NCT ID: NCT06279078 - Study ID: AJOUIRB-DB-2023-446 - Status: RECRUITING - Start Date: 2023-12-30 - Completion Date: 2025-06-30 - Lead Sponsor: Ajou University School of Medicine ### Study Description The goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. The main hypothesis are:i. High cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma.ii. High cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age).iii. High cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma.iv. High cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications. ### Conditions - Asthma - Osteoporosis, Osteopenia - Osteoporosis Risk - Osteoporotic Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Corticosteroid ### Outcomes Primary Outcomes - Prevalence of osteoporosis/osteopenia Secondary Outcomes - Bone mineral density (BMD) score - Total alkaline phosphatase - Corrected calcium - Serum phosphate - Serum albumin - prevalence of steroid related comorbidities(Diabetes Mellitus, Hypertension, Hyperlipidemia, etc.) ### Location - Facility: Ajou University Medical Center, Suwon, Gyeonggi, 16499, Korea, Republic of @@
## Investigation of the Influence of the Human Microbiome on the Pathogenesis and Recurrence Probability in Giant Cell Arteritis - NCT ID: NCT06279065 - Study ID: 373/23-EP - Status: RECRUITING - Start Date: 2024-02-18 - Completion Date: 2028-02 - Lead Sponsor: University of Bonn ### Study Description The longitudinal observational study aims to assess the impact of the microbiome especially the gut-microbiome in the emergence and course of giant cell arteritis (GCA) patients. At diagnosis and 6 month follow up we will analyze the oral, blood and gut microbiome from GCA patients and healthy controls. Thereby identified potential candidate commensal will be further analyzed for possible interactions and influence on the immune system. ### Conditions - Giant Cell Arteritis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Analysis of blood and microbiome samples (stool, oral lavage) ### Outcomes Primary Outcomes - Significant differences in the composition of the microbiome Secondary Outcomes - Influence of the microbiome on therapy response e.g. increased probability of recurrence with accumulation of specific microbiome species - potential association of microbiom composition with application of immune modulating drugs ### Location - Facility: Clinic of Internal Medicine III, Department of Oncology, Haematology, Rheumatology and Clinical Immunology, University Hospital Bonn, Bonn, North Rhine-Westphalia, 53127, Germany @@
## Adolescent Projections During Transition in Prader-Willi Syndrome - NCT ID: NCT06279052 - Study ID: RC31/23/0535 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: University Hospital, Toulouse ### Study Description Single-center, cross-sectional qualitative study seeking to collect the experience of adolescence and the transition to adulthood of people affected by Prader-Willi syndrome in a population. To do this, the present will carry out a qualitative study with a reflexive thematic analysis of the data collected through semi-structured interviews using an interview guide. ### Conditions - Prader-Willi Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Phone interview ### Outcomes Primary Outcomes - Experience of the disease and aspirations regarding the future Secondary Outcomes ### Location - Facility: CHU de Toulouse, Toulouse, N/A, N/A, France @@
## Clinical Observation of Exosomes in Patients After Q-switched Laser Surgery - NCT ID: NCT06279039 - Study ID: KY20230116-06 - Status: RECRUITING - Start Date: 2022-09-01 - Completion Date: 2024-12-31 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description the goal of this half-face controlled study is to evaluate the effect of exosome-containing liquid dressings on the recovery of patients after Nd:YAG laser 532 treatment. ### Conditions - Exosome - Skin Regeneration - Laser ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Exosome liquid dressing ### Outcomes Primary Outcomes - Global Aesthetic Improvement Scale score - Dermatology Quality of life index Secondary Outcomes - post-inflammatory hyperpigmentation ### Location - Facility: Jie Dai, Nanjing, Jiangsu, 210006, China @@
## UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma - NCT ID: NCT06279026 - Study ID: PG-006-5 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-07-01 - Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. ### Study Description The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw. ### Conditions - Relapsed/Refractory Multiple Myeloma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - UTAA17 Injection ### Outcomes Primary Outcomes - DLT - RP2D Secondary Outcomes ### Location - Facility: The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215000, China @@
## Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment - NCT ID: NCT06279013 - Study ID: NRG-CC012CD - Status: NOT_YET_RECRUITING - Start Date: 2024-06-16 - Completion Date: 2028-05-01 - Lead Sponsor: NRG Oncology ### Study Description In this clinical trial, symptom monitoring (interactive voice response \[IVR\] is compared to automated telephone symptom management \[ATSM\] and telephone interpersonal counseling \[TIPC\]) for reducing symptom burden and psychological distress (depressive and anxiety symptoms) among people receiving oral anti-cancer treatment. Symptoms are the number one driver of treatment interruptions and unscheduled health services use. To reduce the risk of these events, symptom monitoring and management are necessary. However, these services are not implemented routinely, especially in the community oncology settings. Further, depressive and anxiety symptoms are a key barrier to enacting symptom self-management strategies. IVR is a form of symptom monitoring where patients, when called, enter their symptom ratings over the phone. Their symptom summary is sent to their provider, and patients may be advised to reach out to their oncology provider, based on their symptoms. The ATSM intervention combines IVR assessments with a Symptom Management and Survivorship educational handbook with self-management strategies. Patients receiving ATSM enter their symptom ratings over the phone and have their symptoms reported to their provider, but patients are also directed to the handbook for strategies to manage elevated symptoms. Patients receiving ATSM who report being anxious, discouraged, or sad will also receive TIPC, which targets psychological distress and its connection to social support and interpersonal communication. Information gathered from this study may help researchers learn more about the best ways to manage patient symptoms and improve patient outcomes. ### Conditions - Hematopoietic and Lymphoid System Neoplasm - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Counseling - Health Education - Interview - Medical Chart Review - Monitoring - Questionnaire Administration ### Outcomes Primary Outcomes - Symptom Severity/Toxicity Index Secondary Outcomes - Incidence of Unscheduled Health Services Usage ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery - NCT ID: NCT06279000 - Study ID: CTU 22/025 - Status: NOT_YET_RECRUITING - Start Date: 2024-10-01 - Completion Date: 2028-09-30 - Lead Sponsor: Cantonal Hospital of St. Gallen ### Study Description Perioperative myocardial injury/infarction (PMI) and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.However, research in recent years has yielded limited preventive and therapeutic measures for PMI/MACE. Recent studies in patients with chronic and acute coronary artery disease have shown that colchicine administration can reduce the risk of cardiovascular events.These encouraging results in non-surgical patients ask for a similar investigation in patients undergoing major non-cardiac surgery. The aim of the proposed study is to investigate the effects of perioperative colchicine administration on the incidence of PMI/MACE. ### Conditions - Cardiovascular Diseases - Cardiovascular Complication - Perioperative Complication - Myocardial Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Colchicine - Placebo ### Outcomes Primary Outcomes - Perioperative Myocardial Injury/Infarction - Major Adverse Cardiovascular Events Secondary Outcomes - New onset Atrial fibrillation - postoperative high sensitive cardiac Troponin T concentrations - long term cardiovascular outcome ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Cryoablation of Pericapsular Nerve Group (PENG) to Fascia Iliaca Catheter in Patients With a Hip Fracture - NCT ID: NCT06278987 - Study ID: ANES-2024-32661 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2026-12-01 - Lead Sponsor: University of Minnesota ### Study Description The purpose of this study is to determine if patients with hip fractures who undergo cryoablation of the PENG have improved pain control 30 days from surgery when compared to those who have a fascia iliaca catheter. ### Conditions - Hip Fractures ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - PENG block and cryoablation - fascia iliaca compartment block ### Outcomes Primary Outcomes - Maximum pain score on Post-operative day 30 - Opioid use - functional pain scores - number of patients using opioids - Length of Hospital Stay - Time to first ambulation - Number of patients returned home by Post Operative Day 30 Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K - NCT ID: NCT06278974 - Study ID: PDSFGOCLMC-2023-001 - Status: RECRUITING - Start Date: 2023-11-10 - Completion Date: 2025-05-01 - Lead Sponsor: He Eye Hospital ### Study Description The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 300 children aged 13-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year. ### Conditions - Myopia - Cost-effectiveness Analysis - Quality of Life ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Improvement in Quality of Life Scores - Cost-Effectiveness Analysis Secondary Outcomes - Clinical Effectiveness Analysis ### Location - Facility: HeEyeHospital, Shenyang, Liaoning, 110000, China @@
## Families Filming Infants Learning Movement - NCT ID: NCT06278961 - Study ID: IRB 2021-4329 - Status: RECRUITING - Start Date: 2021-01-28 - Completion Date: 2024-09-30 - Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago ### Study Description The study objective is to improve accuracy in the early detection of neurodevelopmental impairment, especially CP, by evaluating the timepoint (in weeks post term age) that the Prechtl GMA is most useful for prediction of neurodevelopmental impairment at two years of age in children with and without medical complexity. The study team plans to recruit 100 healthy, term-born infants and 250 infants at risk of developing CP for a total of 350 enrolled infants. ### Conditions - Infant Development - Cerebral Palsy - Motor Disorders - Neurological Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Observational ### Outcomes Primary Outcomes - Fidgety Movements in healthy, term born infants - Fidgety Movements in children with a range of medical complexities - Fidgety Movements and two-year Neurodevelopmental outcomes in health, term born infants - Fidgety Movements and two-year Neurodevelopmental outcomes in children with a range of medical complexities Secondary Outcomes ### Location - Facility: Feinberg School of Physical Therapy and Human Movement Sciences, Chicago, Illinois, 60611, United States @@
## Efficacy and Tolerability of Test Product Versus Cysteamine 5% in Treatment of Facial Epidermal Melasma - NCT ID: NCT06278948 - Study ID: LRP23023-depigmenting cream - Status: RECRUITING - Start Date: 2023-10-06 - Completion Date: 2024-06 - Lead Sponsor: Cosmetique Active International ### Study Description This interventional, randomized, investigator blinded, controlled study conducted in one centre consists in a 4-month evaluation period within the same season avoiding sunny season on 140 subjects with facial epidermal melasma. ### Conditions - Melasma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Group TP - Group CYS ### Outcomes Primary Outcomes - change in mMASI scoring - change in Investigator's Global Assessment (IGA) Secondary Outcomes - change in Subject Global Assessment of Improvement (SGAI) ### Location - Facility: MS Clinical Research Pvt. Ltd, Bangalore, N/A, N/A, India @@
## Lifestyle Tailored Offloading for Diabetic Foot Ulcers - NCT ID: NCT06278935 - Study ID: APP-24-00887 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-04 - Lead Sponsor: University of Southern California ### Study Description The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. ### Conditions - Diabetic Foot Ulcer - Diabetic Foot ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Lifestyle-based intervention by a occupational therapist ### Outcomes Primary Outcomes - Participant satisfaction Secondary Outcomes - Diabetes distress - Factors affecting offloading treatment - DFU-related outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma - NCT ID: NCT06278922 - Study ID: STUDY00001149 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-30 - Completion Date: 2028-09-30 - Lead Sponsor: University of Massachusetts, Worcester ### Study Description The U.S. Deaf community - a group of more than 500,000 Americans who communicate using American Sign Language (ASL) - experiences nearly triple the rate of lifetime problem drinking and twice the rate of trauma exposure compared to the general population. Although there are several treatments for alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) in hearing populations, none have been developed for or tested with Deaf clients. To address these barriers, the study team developed Signs of Safety, a Deaf-accessible therapy toolkit for treating AUD and PTSD. Their aims are to conduct a nationwide, virtual clinical trial to compare (1) Signs of Safety with (2) treatment as usual and (3) a no treatment control, to collect data on clinical outcomes, and to explore potential mediators and moderators of outcome. ### Conditions - PTSD - Alcohol; Use, Problem ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Seeking Safety + Signs of Safety toolkit - Treatment as usual ### Outcomes Primary Outcomes - Change from Baseline Percent Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback - Change from Baseline Percent Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback - Change from Baseline Percent Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback - Change from Baseline Percent Binge Drinking Days Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback - Change from Baseline Percent Binge Drinking Days Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback - Change from Baseline Percent Binge Drinking Days Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback - Change from Baseline Number of Drinks Per Month at Immediate Post-Treatment as Measured by the Alcohol Timeline Followback - Change from Baseline Number of Drinks Per Month at Three-month Follow-up as Measured by the Alcohol Timeline Followback - Change from Baseline Number of Drinks Per Month at Six-month Follow-up as Measured by the Alcohol Timeline Followback - Change from Baseline Past 30-day PTSD Severity to Immediate Post-Treatment as Measured by the PCL-5 - Change from Baseline Past 30-day PTSD Severity to Three-month Follow-up as Measured by the PCL-5 - Change from Baseline Past 30-day PTSD Severity to Six-month Follow-up as Measured by the PCL-5 Secondary Outcomes - Change from Baseline Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for Alcohol Use Disorder to Immediate Post-Treatment as measured by the DSM-5 AUD Assessment Tool - Change from Baseline Percent Days of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana - Change from Baseline Number of Instances of Drug Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana - Change from Baseline Percent Days of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana - Change from Baseline Number of Instances of Marijuana Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana - Change from Baseline Percent Days of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana - Change from Baseline Number of Instances of Tobacco Use Per Month at Immediate Post-Treatment as Measured by the Timeline Followback - Drugs, Cigarettes, and Marijuana - Change from Baseline Substance-related Problems at Immediate Post-Treatment as Measured by the Short Inventory of Problems Revised (SIPS-R) - Change from Baseline Alcohol Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) - Change from Baseline Drug Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) - Change from Baseline Marijuana Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) - Change from Baseline Tobacco Craving at Immediate Post-Treatment as Measured by the Brief Addiction Monitor - Revised (BAM-R) - Change from Baseline Psychosocial Functioning at Immediate Post-Treatment as Measured by the Outcome Questionnaire (OQ-30.2) for Adults ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Trigeminal Nerve Stimulation in Treatment-resistant Generalized Anxiety Disorder: a Feasibility Study - NCT ID: NCT06278909 - Study ID: 6036699 - Status: RECRUITING - Start Date: 2024-01-18 - Completion Date: 2025-06-30 - Lead Sponsor: Dr. Rafael Freire ### Study Description This is a feasibility study for trigeminal nerve stimulation (TNS) in patients with treatment-resistant generalized anxiety disorder (TR-GAD). Ten participants will receive TNS for 8 weeks as an augmentation strategy to pharmacological treatment for generalized anxiety disorder (GAD).* The primary objective is to ascertain if TNS is a safe and well-tolerated treatment for patients with TR-GAD.* The secondary objective will be to monitor changes in GAD symptom severity throughout the study.Results from this study will inform a randomized controlled trial to be conducted in the future. ### Conditions - Generalized Anxiety Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Trigeminal Nerve Stimulation ### Outcomes Primary Outcomes - Incidence of treatment-emergent adverse events - Incidence of treatment-emergent side effects measured with the NSEC - Response to treatment defined by CGI-I score below 3 Secondary Outcomes - Remission defined by CGI-S score below 3 - Change in anxiety severity measured by CGI-S - Change of anxiety symptoms measured with GAD-7 - Change of anxiety symptoms measured with PSWQ - Change of anxiety symptoms measured with BAI ### Location - Facility: Kingston Health Sciences Centre, Kingston, Ontario, N/A, Canada @@
## Early Neutropenic Fever De-escalation of Antibiotics Study - NCT ID: NCT06278896 - Study ID: 23-684-END - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2028-03-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description This is a randomized, open label clinical trial among individuals with hematologic conditions. The trial aims to evaluate the safety and clinical outcomes of de-escalating antibiotic therapy among stable individuals diagnosed with neutropenic fever, in which no bacterial infection has been identified. ### Conditions - Hematologic Malignancy - Febrile Neutropenia - Antibiotic Stewardship ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cessation of antibiotics ### Outcomes Primary Outcomes - Mortality, transfer to the ICU, septic shock, culture-confirmed bacteremia - Antibiotic utilization Secondary Outcomes - Mortality post F&N - Drug resistance - Clostridium difficile infection - Candidiasis - Adverse Events - Allergic Reactions - Bacteremia - Neutropenia - Length of stay - Readmissions - Fever ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Genomic Medicine Risk Assessment Care for Everyone - Implementation Phase - NCT ID: NCT06278883 - Study ID: Pro00115007 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-06-30 - Lead Sponsor: Duke University ### Study Description The "Genomic medicine Risk Assessment Care for Everyone" (GRACE)" intervention project will develop a scalable end-to-end solution for risk assessment and management that meets the needs of those populations living in low resource settings. The long-term goal is to increase access to and uptake of risk-informed evidence-based guidelines that will improve population health through better patient outcomes, higher quality of life, and decreased costs. The three primary aims are:Aim 1: Develop a scalable implementation framework that guides each unique clinical setting, including low resource settings, in deploying GRACE effectively for the needs of their patients and providers.Aim 2: Facilitate the potential for genomic medicine to promote population health by broadening access to and uptake of genomic risk assessment by the general population through a pragmatic implementation-effectiveness trial of GRACE.Aim 3: Reduce health disparities related to genomic medicine by allowing individual adaption of GRACE to suit their level of resources, education, and access within a pragmatic implementation-effectiveness trial.Three sets of participants will be engaged: patients (n=750), providers (n=25), and family members of "probands" (i.e., patients that have a genetic change that increases risk, n\~500).Patient participants will be asked to complete a baseline survey, enter their family health history information into MeTree (a family health history web-based platform) and complete a survey about their experience using the platform. Subsequent study procedures will depend on: 1) the results of their MeTree risk evaluation, 2) their acceptance/declination of genetic testing (for those categorized as needing testing by MeTree), and 3) the results of the test (for those accepting testing).Provider participants will be providers who are the primary care physicians treating one or more patients enrolled in the patient participant group. Providers will be notified on a patient by patient basis once the patient participant under their care has complete the risk assessment process and the risk report is available from MeTree. At study completion, provider participants will be asked to complete a survey about their demographics, practice, and experiences with the study.Blood relatives of the probands who are identified by the proband as open to engaging with the study will be contacted and offered genetic counseling and genetic testing. ### Conditions - Cardiovascular Diseases - Cancer - Liver Diseases - Hyperthermia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - Disease Risk Assessment ### Outcomes Primary Outcomes - Reach of genomic risk assessment - Utility of genomic risk assessment - Uptake of genetic counseling risk recommendations by the participant - Uptake of genetic testing recommendations by the provider Secondary Outcomes ### Location - Facility: UF Health Callahan, Callahan, Florida, 32011, United States @@
## Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial - NCT ID: NCT06278870 - Study ID: SYSKY-2023-431-02 - Status: RECRUITING - Start Date: 2023-09-06 - Completion Date: 2031-06-30 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description The goal of this multicentre, randomized, double-blind controlled, phase III clinical trial is to compare the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab (THP) for newly diagnosed recurrent/metastatic Human epidermal growth factor receptor 2 (HER2) positive advanced breast cancer, and to explore the impact of biomarkers on clinical efficacy and safety. The main questions it aims to answer are:* Analyse the efficacy and safety of disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of THP.* Explore the impact of biomarkers on clinical efficacy and safety of the combination of disitamab vedotin in combination with pyrotinib treatment.Participants in the experimental group will receive disitamab vedotin in combination with pyrotinib for 6-8 cycles (each cycle lasting 28 days), followed by maintenance treatment with trastuzumab in combination with pyrotinib. Participants in the control group will receive paclitaxel in combination with trastuzumab and pertuzumab for 6-8 cycles (each cycle lasting 21 days), followed by maintenance treatment with trastuzumab and pertuzumab.Researchers will compare disitamab vedotin in combination with pyrotinib versus the standard first-line treatment of paclitaxel in combination with trastuzumab and pertuzumab to see if disitamab vedotin in combination with pyrotinib could be a new option for first-line treatment of HER2-positive metastatic breast cancer. ### Conditions - HER2-positive Metastatic Breast Cancer - First-line Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - disitamab vedotin - Pyrotinib - trastuzumab - Pertuzumab - taxane drug ### Outcomes Primary Outcomes - Progression Free Survival (PFS) Secondary Outcomes - Overall Survival (OS) - Disease control rate (DCR) - Objective Response Rate (ORR) - Clinical Benefit rate (CBR) - Adverse Events (Based on CTCAE 5.0 standards) - Quality of Life (QoL) by Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) - Exploration of biomarkers ### Location - Facility: Sun Yat-sen Memorial Hospital,Sun Yat-sen University, Guangzhou, Guangdong, 510000, China @@
## SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr) - NCT ID: NCT06278857 - Study ID: QCGC-001/2023 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2028-06-30 - Lead Sponsor: Queensland Centre for Gynaecological Cancer ### Study Description The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions.Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks.This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer. ### Conditions - Endometrial Cancer Stage I - Mmr Deficiency - Endometrioid Endometrial Adenocarcinoma - Immune-related Adverse Event ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] ### Outcomes Primary Outcomes - Determine the absence endometrial cancer following protocol treatment regimen of dostarlimab. Secondary Outcomes - Determine the safety and tolerability of dostarlimab in participants with early-stage MMR deficient endometrioid endometrial adenocarcinoma. - TEAEs/irAEIs Leading to Study Drug Discontinuation - TEAEs/irAEIs Leading to Study Withdrawal - Clinically Significant Changes in Haematology - Clinically Significant Changes in Clinical Chemistry - Clinically Significant Changes in Thyroid Function - Abnormal Vital Signs - Abnormal Electrocardiogram (ECG) Parameters - Clinically Significant Abnormal Physical Examination - Concomitant Medications ### Location - Facility: Westmead Hospital, Sydney, New South Wales, 2145, Australia @@
## Exercise Capacity Improvement by Conduction System Pacing in heArt Failure patieNts Without Compelling CRT inDication - NCT ID: NCT06278844 - Study ID: 3020 - Status: RECRUITING - Start Date: 2023-12-12 - Completion Date: 2027-12 - Lead Sponsor: University Hospital, Antwerp ### Study Description This randomized controlled trial aims to investigate the impact of conduction system pacing in comparison to right ventricular apical pacing on exercise capacity, as measured by peak oxygen uptake (VO2peak), in heart failure patients with indication for pacing but no compelling indication for cardiac resynchronization therapy (CRT). The mechanisms of exercise intolerance in heart failure patients influenced by conduction system pacing will be assessed. ### Conditions - Heart Failure With Reduced Ejection Fraction - Heart Failure With Preserved Ejection Fraction - Heart Conduction Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Conduction system pacing - Right ventricular apical pacing ### Outcomes Primary Outcomes - Exercise capacity Secondary Outcomes - Exercise capacity - Echocardiographic parameters (Ejection Fraction) - QRS width - Biomarker, N-terminal pro B-type natriuretic peptide levels - Health-related quality of life scores ### Location - Facility: Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, 2650, Belgium @@
## Efficacy of Structured SOcial COnsultation and Support in Reducing the FINancial Burden of Radiotherapy - NCT ID: NCT06278831 - Study ID: 2023-02645 - Status: RECRUITING - Start Date: 2023-07-08 - Completion Date: 2024-10-15 - Lead Sponsor: University Medical Center Goettingen ### Study Description Objectives:* Assess the extent of financial burden of patients undergoing radiotherapy* Identify clinical and socio-economical factors correlated with the occurrence and extent of financial toxicity* Design a structured social consultation to reduce financial burden induced by radiotherapyInclusion criteria:1. age ≥ 18 years of age2. indication for radiation treatment of a malignant disease3. Karnofsky Performance score (KPS) ≥ 70%4. Life expectancy ≥ 3 monthsExclusion criteria:1. Inability to provide informed consent2. Inability to attend study visits and fulfill data collection requirements3. Simultaneous participation in other studies which could interfere with this study Primary outcome: Financial burden as expressed by the COST score, measured at baseline and 3 months after completion of radiotherapySecondary outcomes:* Socio-Economic factors at baseline* Health-related quality of life (EORTC QLQ-C30) at baseline and 3 months* Depression (PHQ-9) at baseline and 3 months* Coping mechanisms to address financial burdenPrimary Endpoint: Influence of secondary outcomes on changes of the primary outcome (COST-Score) between baseline and 3 months.Secondary Endpoints:* Changes in the COST-Score over time* Changes in PHQ-9 over time* Changes in EORTC QLQ-C30 over timeThis is an exploratory pilot study. To assess the compliance and effectiveness of the used methods all patients willing to participate in the given time period will be enrolled.To be assessed for eligibility: n = 300 To be allocated/randomised (if applicable) to trial: n = 150 To be analysed: n = 120 ### Conditions - Financial Toxicity ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire ### Outcomes Primary Outcomes - Financial Toxicity Secondary Outcomes - Factors that may influence the occurrence or extent of financial burden - Factors that may influence the occurrence or extent of financial burden - Factors that may influence the occurrence or extent of financial burden - Factors that may influence the occurrence or extent of financial burden ### Location - Facility: University Medical Center Göttingen, Göttingen, Niedersachsen, 37075, Germany @@
## Effects of Telerehabilitation on Brain Network Connectivity - NCT ID: NCT06278818 - Study ID: MNESYS-PE0000006 - Status: RECRUITING - Start Date: 2023-12-07 - Completion Date: 2026-03-01 - Lead Sponsor: University of Pavia ### Study Description The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers.This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions.The study aims to:* Identify correlations between improvement in cognitive performance and functional brain data.* Use acquired knowledge to develop neurologically guided TR approaches for broader use.The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up.The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Telerehabilitation - Control Condition ### Outcomes Primary Outcomes - Changes in resting-state brain networks functional connectivity after NBTC treatment - Changes in resting-state EEG coherence after NBTC treatment - Changes in resting-state EEG coherence after HomeCore treatment - Changes in resting-state brain networks functional connectivity after SMRT treatment Secondary Outcomes - Changes in neuropsychological and caregiver burden measures after TR ### Location - Facility: IRCCS Mondino Foundation, Pavia, N/A, 27100, Italy @@
## Adaptation and Validation of the LUNS for Use in Turkey. - NCT ID: NCT06278805 - Study ID: ayk22 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-02-01 - Lead Sponsor: Uşak University ### Study Description According to the most up-to-date knowledge, there is no Turkish comprehensive and validated instrument to assess stroke survivors' unmet needs in the longer term. So, this study aims to translate and adapt the LUNS into Turkish and examine its psychometric properties in survivors living at home after a stroke.Our hypothesis in this study is:- The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) is a valid tool for assessing the unmet needs of stroke patients in the Turkish population. ### Conditions - Stroke - Disability Physical - Quality of Life ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - The reliability and validity study of the T-LUNS ### Outcomes Primary Outcomes - The Turkish Longer-term Unmet Needs after Stroke Questionnaire (T-LUNS) - The Stroke Impact Scale 3.0 (SIS) Secondary Outcomes ### Location - Facility: University of Usak, Uşak, N/A, 64200, Turkey @@
## Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure - NCT ID: NCT06278792 - Study ID: Z-2021104 - Status: COMPLETED - Start Date: 2022-03-07 - Completion Date: 2024-01-05 - Lead Sponsor: Ziekenhuis Oost-Limburg ### Study Description The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:* difference in natriuresis and diuresis* feasibility of the protocol.Participants will be asked to gather two 24 h urine collections.Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours. ### Conditions - Acute Decompensated Heart Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Diuretic protocol - Standard of Care ### Outcomes Primary Outcomes - Urinary sodium excretion after 48 hours Secondary Outcomes - Urinary output after 48 hours - Urinary sodium excretion on daily base - Urinary output on daily base - Achievement of decongestion ### Location - Facility: Ziekenhuis Oost-Limburg AV, Genk, Limburg, 3600, Belgium @@
## Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression - NCT ID: NCT06278779 - Study ID: X23-0311 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2027-04 - Lead Sponsor: The George Institute ### Study Description The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:* How the two formulations compare in terms of their effectiveness in treating TRD.* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes. ### Conditions - Treatment Resistant Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Esketamine group - Racemic ketamine ### Outcomes Primary Outcomes - Montgomery-Asberg Depression Rating Scale (MADRS) Secondary Outcomes - Montgomery-Asberg Depression Rating Scale (MADRS) score - Response - Montgomery-Asberg Depression Rating Scale (MADRS) - Remission - Montgomery-Asberg Depression Rating Scale (MADRS) - DASS-21 - Clinical Global Impression-Improvement (CGI-I) - Clinical Global Impression-Severity (CGI-S) - Columbia Suicide Severity Rating Scale (C-SSRS) - Speed of response - Clinical Global Impression-Improvement (CGI-I) - Psychotomimetic symptoms - Suicide attempts or gestures - Number of Participants with urinary symptoms, as assessed using the Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) - Cognitive Failure Questionnaire scores (CFQ) - Ketamine liking/craving score - Number of Participants with urinary symptoms, as assessed using the Ketamine Side Effect Tool (KSET) - Acceptability Questionnaire - All-cause dropouts - Recovering Quality of Life Questionnaire (REQOL-10) - WHO Disability Assessment Scale (WHODAS-12) - Patient Health Questionnaire-9 (PHQ-9) - Assessment of Quality of Life Questionnaire (AQoL-8D) - Resource Use Questionnaire (RUQ) ### Location - Facility: Royal Prince Alfred Hospital, Camperdown, New South Wales, 2050, Australia @@
## A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration - NCT ID: NCT06278766 - Study ID: M24-416 - Status: COMPLETED - Start Date: 2024-02-21 - Completion Date: 2024-04-19 - Lead Sponsor: AbbVie ### Study Description The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose. ### Conditions - Healthy Volunteer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - ABBV-552 ### Outcomes Primary Outcomes - Number of Participants with Adverse Events (AEs) - Maximum observed concentration (Cmax) of ABBV-552 - Time to Cmax (peak time, Tmax) of ABBV-552 - Terminal phase elimination rate constant (λz) of ABBV-552 - Terminal phase elimination half-life (t1/2) of ABBV-552 - Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552 - Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552 - Amount of ABBV-552 excreted in the urine over the sampling period (Aeu) - Percent of ABBV-552 excreted in the urine - Renal clearance ABBV-552 (CLr) - Amount of ABBV-552 excreted in the feces over the sampling period (Aef) - Percent radioactivity excreted in the feces Secondary Outcomes ### Location - Facility: Fortrea Clinical Research Unit Inc /ID# 262684, Madison, Wisconsin, 53704, United States @@
## Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy - NCT ID: NCT06278753 - Study ID: 2025/05/02 - Status: RECRUITING - Start Date: 2021-07-01 - Completion Date: 2024-04-01 - Lead Sponsor: Tepecik Training and Research Hospital ### Study Description For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared. ### Conditions - Bladder Injury - Ureter Injury - Surgical Injury - Complication of Surgical Procedure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - carbon dioxide cystoscopy ### Outcomes Primary Outcomes - It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy. Secondary Outcomes - It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses. ### Location - Facility: Tepecik Training and Research Hospital, İzmir, Eurasia, 35090, Turkey @@
## Upper Extremity Pathologies in Spinal Cord Injuries - NCT ID: NCT06278740 - Study ID: SCIUSG24 - Status: NOT_YET_RECRUITING - Start Date: 2024-02-26 - Completion Date: 2025-03-26 - Lead Sponsor: Afyonkarahisar Health Sciences University ### Study Description This study aims to determine the relationship between upper extremity pathologies and demographic data, duration of manual wheelchair use, duration of injury, physical examination and musculoskeletal ultrasound measurements in patients with spinal cord injuries. ### Conditions - Spinal Cord Injuries - Upper Extremity Problem - Musculoskeletal Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Musculoskeletal Ultrasound ### Outcomes Primary Outcomes - Comparison of US findings among participants Secondary Outcomes - Visual Analog Scale (VAS) - The Physical Examination of the Shoulder Scale (PESS) - The Quick Disability of the Arm, Shoulder, and Hand (Quick DASH) - American Spinal Injury Association (ASIA) Impairment Scale - The Spinal Cord Independence Measure (SCIM-III) ### Location - Facility: Afyonkarahisar Health Sciences University, Afyonkarahisar, N/A, 03100, Turkey @@
## Development and Validation of the Prediction Model for Functional Mitral Regurgitation Regression in Heart Failure Patients Taking Guideline-directed Medical Therapy - NCT ID: NCT06278727 - Study ID: SYSKY-2023-1173-01 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description This observational study is to develop and validate the prediction model for functional mitral regurgitation regression in heart failure patients taking GDMT. The patients diagnosed ≥2+ functional mitral regurgitation by ultrasonic cardiogram are enrolled in this study and would be clinically followed by at least one year (clinical visit at 3 months, 6 months, and 12 months), and then by when the endpoints are reached. ### Conditions - Mitral Regurgitation - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - angiotensin-converting enzyme inhibitors/angiotensin II receptor blocker/angiotensin receptor-neprilysin inhibitor - The development of the prediction model ### Outcomes Primary Outcomes - FMR regression rate Secondary Outcomes - FMR regression rate - composite endpoint ### Location - Facility: Sun-Yatsen Memorial Hospital, Canton, Guangdong, N/A, China @@
## Influence of an Inspiratory Muscle Fatigue Protocol on Healthy Youngs on Respiratory Muscle Strength and Heart Rate Variability - NCT ID: NCT06278714 - Study ID: 0012 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-04 - Completion Date: 2024-03-20 - Lead Sponsor: Sierra Varona SL ### Study Description Respiratory muscle training represents an effective method increasingly utilized in both sports and healthcare domains, employing various devices, among which threshold devices are prominent. The aim of this study is to determine the relationship between inspiratory muscle fatigue and maximal inspiratory pressure, diaphragmatic strength (guided by ultrasound image) and heart rate variability.According to our hypothesis, the execution of a protocol inducing inspiratory muscle fatigue in healthy youngs could influence cardiorespiratory function.In this study, subjects will be divided into three groups: the experimental group , the activation group and the control group.Measurements of variables, such as maximal inspiratory pressure, heart rate variability and diaphragmatic strength (ultrasound image), will be conducted. ### Conditions - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Inspiratory muscle training ### Outcomes Primary Outcomes - Respiratory muscle strength - Diaphragmatic thickness and thickening fraction - Diaphragm movement curve - Heart rate variability Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Late-evening Snacks on Patients With Primary Hepatocellular Carcinoma After Hepatectomy - NCT ID: NCT06278701 - Study ID: 2024-003-01 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-07-30 - Lead Sponsor: DU Yao ### Study Description Late-evening snacks, in which a portion of food is moved to bedtime while the total amount of food eaten per day remains unchanged, can effectively improve the metabolic state of accelerated catabolism.The goal of this clinical trial is to learn about the effects of late-evening snacks on health conditions of hepatocellular carcinoma patients who underwent hepatectomy, and to further explore the effects of late-evening snacks on patients' metabolic patterns. The main question it aims to answer are: • the effect of late-evening snacks on the nutritional status of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on the recovery of liver function in liver cancer hepatectomy patients;* the effect of late-evening snacks on the complication rate of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on long-term quality of life of hepatic resection patients with hepatocellular carcinoma;* the effect of late-evening snacks on the metabolic pattern of hepatic resection patients with hepatocellular carcinoma.After learning about the 2 dietary modalities of the late-evening snacks and regular diet, patients will be placed in the different groups according to your preference. Patients who enter the test group will have additional meal 1h before bedtime every day, while patients in the control group will have normal diet. Patients will be asked to :* eat 1h before bedtime;* follow the doctor's instructions during their stay in the hospital;* have follow-up examinations at 1 month, 3 months and 6 months after the operation, after which blood samples will be collected for metabolite testing. ### Conditions - Liver Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - late-evening snacks ### Outcomes Primary Outcomes - Albumin rising Secondary Outcomes - Prealbumin rising - Decrease in Alanine Aminotransferase - Decrease in Aspartate Aminotransferase - Decrease in Cholinesterase - Decrease in Total bilirubin - Lower total hospitalization costs - Relapse-Free Survival - Improved quality of life ### Location - Facility: Drum Tower Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, 210008, China @@
## Precision Probiotic Supplementation in Individuals With Mild Cognitive Impairment - NCT ID: NCT06278688 - Study ID: 112R10438Y - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2027-07-31 - Lead Sponsor: National Yang Ming University ### Study Description The overarching goal of this randomized-controlled trial is to investigate the role and mechanism of the microbiota-gut-brain axis in MCI. The main questions it aims to answer are:Aim 1: To investigate the association between gut microbiota, MCI and AD biomarkers. Investigators plan to compare gut microbiota profiles in a well-characterized cohort between individuals with MCI and cognitively normal adults using metagenomics sequencing data. Also, the relationship between gut microbiota and AD biomarkers, such as amyloid PET and plasma tau, will be explored in MCI and cognitively normal adults.Aim 2: To determine the efficacy of precision probiotic supplementation on cognitive decline (primary outcome) and functional brain changes (secondary outcome) in individuals with MCI due to AD using a randomized, double-blind, placebo-controlled trial. Investigators plan to recruit 120 individuals with MCI due to AD, i.e., MCI with positive amyloid biomarkers. Participants will be randomized to a 12-month supplement of precision probiotics based on the individual gut probiotic profile or placebo. The primary outcome measure will be the changes in cognitive functions over 6 months (primary endpoint) and 12 months. The secondary outcome measure will be resting-state functional brain changes.Aim 3: To investigate potential mediators underlying the effect of probiotic supplementation. The most apparent mediator will be a shift or changes in gut microbiota. Other potential mediators will be related to decreased lipopolysaccharide, proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin (IL)-6 and IL-10, and increased brain- derived neurotrophic factor, short-chain fatty acid, etc. ### Conditions - Mild Cognitive Impairment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Precision probiotics ### Outcomes Primary Outcomes - The changes in attention - The changes in memory - The changes in executive function Secondary Outcomes - The changes in global cognition at the 12th month from baseline. - The changes in brain imaging at the 12th month from baseline. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Multiple Study of Electroaccpuncture in ARDS - NCT ID: NCT06278675 - Study ID: SEOVA - Status: NOT_YET_RECRUITING - Start Date: 2024-05-10 - Completion Date: 2026-12-31 - Lead Sponsor: Nanjing University of Traditional Chinese Medicine ### Study Description In order to clarify the clinical efficacy of electroacupuncture on inhibiting systemic inflammatory response, improving respiratory mechanics parameters and prognosis in patients with sepsis-related ARDS. ### Conditions - Acute Respiratory Distress Syndrome - Sepsis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Acupuncture needles ### Outcomes Primary Outcomes - Respiratory mechanics indicators 1 - Respiratory mechanics indicators 2 - Respiratory mechanics indicators 3 - Respiratory mechanics indicators 4 - Respiratory mechanics indicators 5 - Respiratory mechanics indicators 6 - Respiratory mechanics indicators 7 Secondary Outcomes - Sedation and analgesia - Sedative drug use - Analgesic drug use - Inflammatory factors - CD4、CD8、CD4/CD8 - Vasoactive drugs applications - CRRT applications - ECMO applications - All-cause mortality to day 28 - All-cause mortality to day 60 - ICU-free days - Hospital-free days ### Location - Facility: Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, Jiangsu, 210029, China @@
## Cohort Multiple Randomized Controlled Trial in Pediatric Asthma - NCT ID: NCT06278662 - Study ID: CIRCUS cmRCT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2034-04-01 - Lead Sponsor: Mattienne van der Kamp ### Study Description The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).Primary Objectives within cmRCT cohort:* Provide a framework for multiple randomized (eHealth) interventions for asthmatic children* Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.Secondary Objectives within cmRCT cohort:* Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.* Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.* Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations). ### Conditions - Pediatric Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - video directly observed therapy (vDOT) ### Outcomes Primary Outcomes - Asthma control - Pediatric Asthma Quality of Life - Quality of care - Self-management capacity - Healthcare use - Wheather data - Air quality - Pollen - Medication delivery Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Relaxation and Guided Imagery as an Intervention for Asthma - NCT ID: NCT06278649 - Study ID: 2023-161-Multi-site - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-01-01 - Lead Sponsor: Pace University ### Study Description The purpose of the current study is to investigate the usefulness of a Relaxation and Guided Imagery intervention for the reduction of asthmatic symptoms in adults and children whose asthma symptoms are aggravated, or triggered by anxiety. This study will replicate the previous literature to further investigate the impact that a Relaxation and Guided Imagery intervention can have on anxiety and related asthmatic symptoms using a multiple baseline (small sample size) research design. Participants will fill out questionnaires, listen to RGI audio tapes, and provide lung functioning samples by blowing into a spirometer. ### Conditions - Asthma - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Relaxation and Guided Imagery ### Outcomes Primary Outcomes - Asthma - Asthma - Anxiety Secondary Outcomes - Quality of Life ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Laparoscopic Ultrasound Examination: Analysis of Feasibility - NCT ID: NCT06278636 - Study ID: 5745 - Status: RECRUITING - Start Date: 2023-07-18 - Completion Date: 2025-01-30 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery.The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon. ### Conditions - Gynecologic Cancer - Surgical Procedure, Unspecified ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Laparoscopi ultrasound examination ### Outcomes Primary Outcomes - feasibility of the laparoscopic Secondary Outcomes - the learning curve of fellow surgeons - the performance of fellow surgeons ### Location - Facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, N/A, 00168, Italy @@
## Focal Muscle Vibration in Parkinson's Disease - NCT ID: NCT06278623 - Study ID: 4935 - Status: RECRUITING - Start Date: 2023-05-11 - Completion Date: 2025-12-01 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations. ### Conditions - Parkinson Disease - Postural; Defect - Rehabilitation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Focal Muscle Vibratory Energy (EVM) Treatment ### Outcomes Primary Outcomes - Tinetti scale Secondary Outcomes - NRS numeric rating scale of pain - Stabilometric Test - Mc Gill Pain questionnaire ### Location - Facility: Gianpaolo Ronconi, Roma, N/A, 00168, Italy @@
## Pelvic Exenteration and Laterally Extended Pelvic Resection - NCT ID: NCT06278610 - Study ID: 3612 - Status: RECRUITING - Start Date: 2020-11-19 - Completion Date: 2025-01-31 - Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS ### Study Description Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool. ### Conditions - Gynecologic Cancer - Surgical Procedure, Unspecified ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PELVIC EXENTERATION ### Outcomes Primary Outcomes - pelvic exenteration resection. Secondary Outcomes - accuracy of US with the accuracy of MRI ### Location - Facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, N/A, 00168, Italy @@
## Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device - NCT ID: NCT06278597 - Study ID: GLC02-22 - Status: RECRUITING - Start Date: 2023-09-05 - Completion Date: 2025-01-24 - Lead Sponsor: Fondazione G.B. Bietti, IRCCS ### Study Description The aim of the study is to evaluate an objective, non-invasive optical device able to quantify, without eye contact, the width of the irido-corneal angle and to better identify cases of narrow angle or angle closure that may be prevented with relatively simple treatments. ### Conditions - Glaucoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SCREENING ### Interventions - NACA Estimator ### Outcomes Primary Outcomes - Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by Van Herick (VH) test at slit lamp - Agreement between the automatic Narrow Anterior Chamber Angle Estimator grading of peripheral anterior chamber width with clinical grading as performed by gonioscopy. Secondary Outcomes - Reproducibility (intra-session) and repeatability (inter-session) of the peripheral anterior chamber width (PACW) evaluation by the Narrow Anterior Chamber Angle Estimator - Sensitivity and specificity of NACA Estimator grading of PACW in detecting primary angle closure suspects as classified by clinical gonioscopy. ### Location - Facility: IRCCS Fondazione GB Bietti, Roma, N/A, 00184, Italy @@
## iLux Treatment for Meibomian Gland Dysfunction - NCT ID: NCT06278584 - Study ID: 2020001-00 - Status: COMPLETED - Start Date: 2020-10-15 - Completion Date: 2022-02-28 - Lead Sponsor: Clínica de Oftalmología de Cali S.A ### Study Description Summary:Purpose: To compare the safety and efficacy of eyelid treatment with the ILux®-MGD Treatment System in one session versus five sessions of mechanical meibomian gland expression (MMGE) in patients with moderate to severe meibomian gland dysfunction (MGD).Methods: Prospective, randomized, open-label, controlled clinical trial comparing one session of the ILux® MGD Treatment System versus five sessions of MMGE in both eyes of 130 patients aged ≥18 years with OSDI scores ≥13, total MGS of 15 in the lower lid of each eye and NI-TBUT \<10 s, who were randomized 1:1 to ILux® or MMGE. ### Conditions - Meibomian Gland Dysfunction - Eyes Dry Chronic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - iLUX Treatment System ### Outcomes Primary Outcomes - Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Non Invasive Tear break-up time (NI-TBUT) in seconds. - Effectiveness defined as changes from baseline to 1, 3, 6, 9 and 12 months in Meibomian gland scores (MGS). Secondary Outcomes ### Location - Facility: Clínica de Oftalmología de Cali S.A, Cali, Valle Del Cauca, 760036, Colombia @@
## Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes - NCT ID: NCT06278571 - Study ID: R-2018-785-100 - Status: RECRUITING - Start Date: 2023-01-30 - Completion Date: 2025-12-03 - Lead Sponsor: Coordinación de Investigación en Salud, Mexico ### Study Description The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico.The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs.nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10.Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients). ### Conditions - Female ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Educational intervention with App and web site education - Educational interventión with web site education - Control group with nutritional therapy ### Outcomes Primary Outcomes - Number of participants with glycosylated hemoglobin at control goals - Number of participants with iipid profile in control targets - Number of participants with body mass index profile in control target Secondary Outcomes - Number of patients with changes to a healthy lifestyle - The proportion of patients with adequate knowledge of diabetes ### Location - Facility: Instituto Mexicano Del Seguro Social, Ciudad de mexico, N/A, 03100, Mexico @@
## Psychological Factors Influencing Cancer Post-traumatic Growth - NCT ID: NCT06278558 - Study ID: 2023-02-01 - Status: RECRUITING - Start Date: 2023-11-10 - Completion Date: 2027-11-10 - Lead Sponsor: Centre Hospitalier de Valenciennes ### Study Description The study focuses on post-traumatic growth (positive changes linked to appreciation of life, personal strengths, social relationships...) in the context of different types of cancer and with a longitudinal approach to the care pathway. The aim of the study is to better understand whether psychological variables (emotional competence, psychological flexibility, psychological distress) and patients' care satisfaction, assessed at the start of the cancer treatment pathway, can influence their post-traumatic growth at the end of the chemotherapy protocol and 6 months later. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Interviews with a psychologist/psychiatrist ### Outcomes Primary Outcomes - Post-traumatic growth - Post-traumatic growth - Post-traumatic growth Secondary Outcomes - Satisfaction of supportive care needs - Satisfaction of supportive care needs - Satisfaction of supportive care needs - Emotional competence - Emotional competence - Emotional competence - Anxiety and depression symptoms - Anxiety and depression symptoms - Anxiety and depression symptoms - Psychological flexibility - Psychological flexibility - Psychological flexibility ### Location - Facility: Centre Hospitalier de Valenciennes, Valenciennes, N/A, 59300, France @@
## Trial Evaluating Modified FOLFIRINOX and Modified FOLFOX in the Treatment of Locally Advanced or Metastatic Small Bowel Adenocarcinoma - NCT ID: NCT06278545 - Study ID: MANFREDI PHRCK 2022 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2029-02 - Lead Sponsor: Centre Hospitalier Universitaire Dijon ### Study Description Randomized, non-comparative, open-label, multi-centre Phase II study to evaluate modified FOLFIRINOX and modified FOLFOX in the locally advenced or metastatic small bowel adenocarcinoma.The primary objective is to assess the percentage of patients alive without prograssion at 8 months. ### Conditions - Locally Advanced or Metastatic Small Bowel Adenocarcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - modified FOLFORINOX - Modified FOLFOX ### Outcomes Primary Outcomes - Assess the percentage of patients alive without progression Secondary Outcomes ### Location - Facility: Chu Dijon Bourgogne, Dijon, N/A, 21000, France @@
## Validation of the Lithuanian Version of the BNSS, CDSS, and the SCoRS - NCT ID: NCT06278532 - Study ID: NEGKOG - Status: RECRUITING - Start Date: 2023-12-11 - Completion Date: 2026-12-11 - Lead Sponsor: Lithuanian University of Health Sciences ### Study Description This study aims to validate the Lithuanian version of the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale in a Lithuanian sample. This will be done by comparing results obtained from the Brief Negative Symptoms Scale, Calgary Depression Scale for Schizophrenia, and Schizophrenia Cognition Rating Scale with results obtained from the Positive and Negative Symptoms Scale, the Montgomery Asberg Depression Rating Scale, and the Montreal Cognitive Assessment test. ### Conditions - Schizophrenia - Negative Symptoms in Schizophrenia - Depressive Symptoms Due to Primary Psychotic Disorder (Diagnosis) - Cognitive Deficit ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Brief Negative Symptoms Scale - The Calgary Depression Scale for Schizophrenia - The Schizophrenia Cognition Rating Scale ### Outcomes Primary Outcomes - Validated Lithuanian version of the Brief Negative Symptoms Scale. - Validated Lithuanian version of the Calgary Depression Scale for Schizophrenia. - Validated Lithuanian version of the Schizophrenia Cognition Rating Scale. Secondary Outcomes - Correlation between negative symptoms and cognitive deficits of schizophrenia - Correlation between depressive symptoms and cognitive deficits of schizophrenia - Correlation between negative symptoms, cognitive deficits, depressive symptoms of schizophrenia and health-related quality of life ### Location - Facility: Lithuanian University of Health Sciences Hospital Kaunas Clinics, Kaunas, N/A, LT-50161, Lithuania @@
## CARdiAc Mri and BiOLogical samplEs at the Acute Phase of a Myocardial Infarction (CARAMBOLE) - NCT ID: NCT06278519 - Study ID: CARAMBOLE - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-09-01 - Lead Sponsor: Poitiers University Hospital ### Study Description ST-Segment Elevation Myocardial infarction (STEMI) corresponding to acute occlusion of cornary artery is the most severe ischemic myocardial disease and a leading cause of mortality of heart failure worldwide. Although acute mortality from STEMI has decreased over the last decades, the prognosis remains pejorative and difficult to anticipate. The best management of STEMI patients depends of predictive factors of clinical prognosis and justifies an active research of these factors, in particular the mechanisms leading to deleterious left ventricular remodeling, myocardial inflammation, reperfusion injury including the no-reflow phenomenon which is a major determinant of heart failure. Cohorts of consecutive STEMI patients, with a comprehensive assessment of clinical, biological and imaging parameters are needed to offer the basis for new hypothese for research or interventions and to precisely evaluate the quality of care provided.The main objective of this study is to identify new markers: clinical, biological and imaging, treatment response and prognosis after STEMI.Secondary objectives of the CARAMBOLE cohort are to establish a comprehensive clinical databse, completed with biological samples and imaging data, that can be used in the following areas:* Descriptive epidemiology of STEMI and myocardial reperfusion* Evaluation of the clinical implications of the realization of a cardiac MRI at the acute phase of STEMI (regarding no-reflow, LVEF, intra cardiac thrombi)* Treatments observatory: safety, efficacy, indication of treatments provided in real life compared to the treatments recommended, adherence to treatments, costs* Quality of life, personal, familial, social and professional consequences of myocardial infarction* Research of new diagnostic and prognosis biomarkers* Research projects (e.g risk of developping cgnitive disorders in patients with STEMI as compared to the general population)Participants will undergo:* a cardiac MRI at the acute phase of their STEMI (5 +/- 3 days) then at 1 year follow-up* biological samples including blood, urinary and feces samples, at the acute phase of their STEMI (from admission and up to 8 days) then at 1 year follow-up* questionnaire assessment regarding their quality of life, cognitive status,and socio-economic conditions at the acute phase and 1 year follow-up of their STEMI. ### Conditions - Myocardial Infarction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Blood, urinary and feces collection - Cardiac MRI - Quality of life and cognitive status questionnaire ### Outcomes Primary Outcomes - Major Adverse cardiac Events (MACE) Secondary Outcomes - Infarct size - Infarct size - No-reflow size - No-reflow size - Cardiac enzymes rate - Cardiac enzymes rate - Cardiac enzymes rate - Cardiac enzymes rate - Inflammatory markers rate - Inflammatory markers rate - Inflammatory markers rate - Inflammatory markers rate - Gut microbiota profiling - Gut microbiota profiling - Genitourinary microbiota profiling - Genitourinary microbiota profiling - EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version) - EQ-5D-3L score (European Quality of Life 5 Dimensions 3 Level version) - Codex test - Codex test ### Location - Facility: C.H.U. of Poitiers, Poitiers, N/A, 86000, France @@
## Resection or Ablation of Small Kidney Tumors - NCT ID: NCT06278506 - Study ID: 4612 - Status: RECRUITING - Start Date: 2024-01-31 - Completion Date: 2037-12 - Lead Sponsor: Karolinska University Hospital ### Study Description Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer. ### Conditions - Kidney Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Ablation - Surgery ### Outcomes Primary Outcomes - Number of participants with surgical complications according to Clavien-Dindo grade 2-5 - Radiological signs of a residual tumor at the 6-month follow-up - Number of postoperative hospitalization days (LOS) Secondary Outcomes - Cancer-specific survival (CSS) - Overall survival (OS) - Change in eGFR one year after treatment ### Location - Facility: Karolinska University Hospital, Stockholm, N/A, 14186, Sweden @@
## A Clinical Study of AL2846 Capsule Combined With Gemzar Injection in the Treatment of Advanced Pancreatic Cancer - NCT ID: NCT06278493 - Study ID: AL2846-I-0002 - Status: COMPLETED - Start Date: 2018-08-23 - Completion Date: 2023-05-01 - Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. ### Study Description This is a clinical study to observe the tolerance and primary efficacy of AL2846 capsules combined with Gemzar injection in patients with pancreatic cancer, and to determine the recommended dosage and administration method for subsequent clinical studies. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - AL2846 capsules - Gemzar ### Outcomes Primary Outcomes - Dose limiting toxicity (DLT) - Maximum tolerated dose (MTD) Secondary Outcomes ### Location - Facility: Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, 300181, China @@
## Clinical Trial to Evaluate the Regeneration of Articular Cartilage Through Arthroscopy After MegaCarti® Application - NCT ID: NCT06278480 - Study ID: LNC-MECA-003 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-06-23 - Completion Date: 2024-02-29 - Lead Sponsor: L&C Bio ### Study Description The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. During the 48-week confirmatory clinical trial of MegaCarti®, patients who simultaneously underwent high tibial osteotomy(HTO) were treated with a group in which MegaCarti® was implanted after microfracture and a group in which microfracture alone was performed. Cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery. ### Conditions - Osteoarthritis, Knee ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MegaCarti® - microfracture ### Outcomes Primary Outcomes - Comparison of the ICRS-Cartilage Repair Assessment grade-Overall repair assessment - Comparison of macroscopic status of regenerated cartilage Secondary Outcomes - Comparison of IKDC score - Comparison of VAS score - Comparison of KOOS score - Comparison of WOMAC score - Comparison of Kellgren-Lawrence grade - Comparison of HKA angle, Posterior Tibial slope ### Location - Facility: Yonsei University Health System, Gangnam Severance Hospital, Seoul, N/A, 06273, Korea, Republic of @@
## Frequency of Cognitive Dysfunction in Patients With Chronic Low Back Pain - NCT ID: NCT06278467 - Study ID: KonyaBeyhekimTRH2023 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2024-02-12 - Lead Sponsor: Konya Beyhekim Training and Research Hospital ### Study Description This study evaluates cognitive dysfunction status and related factors in patients with chronic low back pain over the age of 60. ### Conditions - Cognitive Dysfunction - Low Back Pain ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - visual pain scale (VASpain/fatigue), Beck depression index (BDI), - Pain catastrophizing scale, sleep quality with a single Likert type question in the Pittsburgh questionnaire - Roland Morris Disability Questionnaire, quality of life with Short Form-36 ( SF-36), - Montreal Cognitive Assessment Scale (MOCA); Standard Mini mental test (SMMT) ### Outcomes Primary Outcomes - Montreal Cognitive Assessment Scale (MOCA) - Standard Mini mental test (SMMT) - Short Form-36 ( SF-36) - Beck depression scale (BDI) - Roland Morris Disability Questionnaire - A single Likert type question in the Pittsburgh questionnaire (Sleep quality) - VAS pain and VAS fatigue - Pain catastrophizing scale Secondary Outcomes ### Location - Facility: Konya Beyhekim Training and Research Hospital, Konya, Selçuklu, 42060, Turkey @@
## Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) - NCT ID: NCT06278454 - Study ID: NrtPac-1 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: Chengdu New Radiomedicine Technology Co. LTD. ### Study Description This is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study. And the independent review committee (IRC) will be formed to monitor efficacy data through the study. ### Conditions - Unresectable Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - NRT6008 Injection + Systematic chemotherapy ### Outcomes Primary Outcomes - Maximum tolerated dose (MTD) or the recommended phase Ⅱ dose (RP2D) - Dose-limiting toxicity (DLT) - Adverse events (AE) and severe adverse events (SAE) Secondary Outcomes - Objective response rate (ORR) - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Resection rate (R0 and R1) ### Location - Facility: Henan Cancer Hospital, Zhengzhou, Henan, N/A, China @@
## The Effect of White Noise and Kangaroo Care Practices on Stress Parameters in Newborns With Heel Lancing - NCT ID: NCT06278441 - Study ID: Zila Özlem KIRBAŞ - Status: COMPLETED - Start Date: 2023-01-01 - Completion Date: 2024-02-10 - Lead Sponsor: Karadeniz Technical University ### Study Description Aim: It is an examination of the effects of white noise and kangaroo care on some physiological parameters (pulse, saturation, crying duration) and stress markers (cortisol and glucose-regulated protein 78 (GRP78)) in heel lancing in newborns.Methods: In this parallel-group, randomized controlled study, healthy newborns with a gestational age of ≥37 weeks, birth weight of \>2500 g, and an Apgar score of ≥8 at the 1st minute and 5th minute were included. White noise and kangaroo care were applied to newborns in the intervention groups for heel lancing.Results: Ninety newborns were randomized into three groups (30 in each group). A statistically significant difference was determined between the median values of total crying time according to groups (p\<0.001). A statistically significant difference was determined between the median values of pulse measurements according to the interaction of group and time (p\<0.001). A statistically significant difference was determined between the median values of saturation measurements according to groups (p=0.001). A statistically significant difference was determined between the mean values of cortisol and GRP78 measurements according to the group and time interaction (p\<0.001).Conclusion: It was concluded that white noise and kangaroo care help reduce newborns' stress in the case of heel lancing. ### Conditions - Healthy Newborns ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Kangaroo care and White noise ### Outcomes Primary Outcomes - Ninety newborns were randomized into three groups (30 in each group). Secondary Outcomes ### Location - Facility: Bayburt University, Bayburt, N/A, 69100, Turkey @@
## Genotype, Phenotype, and Disease Progression of Developmental Epileptic Encephalopathy With Onset Before 2 Years of Age - NCT ID: NCT06278428 - Study ID: DEE UMC - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2028-11-01 - Lead Sponsor: Number 2 Children's Hospital, Ho Chi Minh City ### Study Description According to estimates by the World Health Organization in 2019, more than 50 million people around the world have epilepsy. Nearly 80% of patients with epilepsy live in developing countries. Among them, children under 2 years old are the group with the highest incidence of epilepsy, and at the same time, the most dangerous epilepsy groups are also likely to start at these ages. World medical literature on epileptic encephalopathy and early-onset development before 2 years of age records that 71% of children have severe intellectual disability and 60% of children show signs of autism spectrum disorder, of which Children with epileptic and developmental encephalopathy due to genetic causes are at higher risk of developing neurodevelopmental disorders than children with epileptic and developmental encephalopathy due to other causes. However, in Vietnam, there is no research on this topic.The question is what are the phenotypes, genotypes, and progression after 2 years of follow-up of Vietnamese children with epileptic and developmental encephalopathy with onset before 2 years of age? ### Conditions - Epilepsy; Seizure - Child Development - Gene Abnormality - Early Onset Disorder ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Genotye of early-onset developmental epileptic encephalopathy Secondary Outcomes ### Location - Facility: Children hospital number 2, Ho Chi Minh, N/A, 700000, Vietnam @@
## Physiologically Based Cord Clamping To Improve Neonatal Outcomes After Elective Cesarean Delivery - NCT ID: NCT06278415 - Study ID: P2021/Neonat/PhyCord 1 - Status: RECRUITING - Start Date: 2024-01-21 - Completion Date: 2024-09 - Lead Sponsor: Queen Fabiola Children's University Hospital ### Study Description Before birth, the baby's lungs are filled with fluid and babies do not use the lungs to breathe, as the oxygen comes from the placenta. As delivery approaches, the lungs begin to absorb the fluid. After vaginal delivery, the umbilical cord is clamped and cut after a delay that allows some of the blood in the umbilical cord and placenta to flow back into the baby. Meanwhile, as the baby breathes for the first time, the lungs fill with air and more fluid is pushed out. However, it does not always work out that way. Some babies need to be delivered via cesarean section, a surgical delivery requiring incisions through the abdominal and uterine walls. After cesarean section, the mother is often unable to hold the baby close right away as a result of her own post-surgical care. Moreover, a baby born by planned cesarean section may have breathing problems because of extra fluid staying in the lungs. Thus, the baby must breathe quicker and harder to get enough oxygen enter into the lungs. Although the baby is usually getting better within one or two days, the treatment requires close monitoring, breathing help, and nutritional help as the baby is too tired to suck and swallow milk. Sometimes, the baby cannot recover well and show greater trouble breathing needing intensive care. This further separates the mother and her baby. A possible mean to help the baby to adapt better after cesarean section while staying close to the mother is to delay cord clamping when efficient breathing is established, either spontaneously or after receiving breathing help at birth. In this study, we intend to test this procedure in term infants born by planned cesarean section and see whether the technique helps the baby to better adapt after birth and to better initiate a deep bond with the mother. ### Conditions - Transient Tachypnea of the Newborn ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Physiological based cord clamping - Differed cord clamping ### Outcomes Primary Outcomes - Rate of neonatal mortality - Rate of neonatal resuscitation - Rate of neonatal respiratory morbidity - Number of admission to the NICU or special care baby unit Secondary Outcomes - Success of PBCC - Time to first breath/cry - Changes in physiological variables during neonatal transition - Changes in physiological variables during neonatal transition - Changes in physiological variables during neonatal transition - Changes in physiological variables during neonatal transition - Changes in physiological variables during neonatal transition - Changes in physiological variables during neonatal transition - Early neonatal parameters - Early neonatal parameters - Hemoglobin level - Bilirubin level - Number of neonatal adverse events - Maternal perioperative parameters - Maternal perioperative parameters - Maternal perioperative parameters - Maternal perioperative parameters - Number of maternal adverse events - Rate of maternal-infant bonding - Rate of maternal-infant bonding - Rate of maternal-infant bonding - Child developmental assessment - Parental satisfaction survey ### Location - Facility: CHU Brugmann, Brussels, N/A, 1020, Belgium @@
## Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi. - NCT ID: NCT06278402 - Study ID: JinnahH - Status: COMPLETED - Start Date: 2023-07-01 - Completion Date: 2024-01-16 - Lead Sponsor: Jinnah Hospital ### Study Description To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥ 2. ### Conditions - Alopecia Areata - Alopecia Totalis - Alopecia Universalis ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Tofacitinib ### Outcomes Primary Outcomes - Alopecia Secondary Outcomes ### Location - Facility: Misbah Zari Qadir, Karachi, Sindh, N/A, Pakistan @@
## Single Ascending Dose, Food Effects and Drug-Drug Interactions of ACC017 Tablets in Healthy Adult Participants - NCT ID: NCT06278389 - Study ID: ADYY-ACC017-101 - Status: RECRUITING - Start Date: 2024-01-24 - Completion Date: 2024-04-23 - Lead Sponsor: Jiangsu Aidea Pharmaceutical Co., Ltd ### Study Description The objective of this clinical trial is to investigate the safety and tolerability of single ascending dose ACC017 tablets in Chinese healthy adult participants. This study aims to address the following major questions:* Recommended dosage for ACC017 tablets used in phase Ib/IIa trial;* The pharmacokinetic (PK) characteristics of single dose ACC017 tablets;* The effect of food (FE) on the PK of ACC017 tablets;* Drug-drug interactions (DDIs) when ACC017 tablets are co-administered with emtricitabine and tenofovir alafenamide fumarate (FTC/TAF) tablets (II). ### Conditions - Healthy Adult Participants ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - ACC017 tablets - Emtricitabine and Tenofovir Alafenamide Fumarate Tablets ### Outcomes Primary Outcomes - Frequency, causality, severity, and expectedness of adverse events (AEs) - ACC017 PK parameter: Cmax (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: C24h (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: AUC0-t (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: AUC0-∞ (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: Tmax (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: t1/2 (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: Vz/F (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: CL/F (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: λz (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: AUC_%Extrap (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: MRT0-t (after a single mono-drug administration under the fasting condition) - ACC017 PK parameter: MRT0-∞ (after a single mono-drug administration under the fasting condition) Secondary Outcomes - Vital signs: temperature - Vital sign: pulse - Vital signs: blood pressure - Vital signs: respiration - Electrocardiogram (ECG): heart rate - Electrocardiogram (ECG): PR interval - Electrocardiogram (ECG): QRS duration - Electrocardiogram (ECG): QTc interval - ACC017 PK parameter: Cmax - ACC017 PK parameter: C24h - ACC017 PK parameter: AUC0-t - ACC017 PK parameter: AUC0-∞ - ACC017 PK parameter: Tmax - ACC017 PK parameter: t1/2 - ACC017 PK parameter: Vz/F - ACC017 PK parameter: CL/F - ACC017 PK parameter: λz - ACC017 PK parameter: AUC_%Extrap - ACC017 PK parameter: MRT0-t - ACC017 PK parameter: MRT0-∞ ### Location - Facility: Beijing Ditan Hospital Capital Medical University, Beijing, N/A, 100015, China @@
## Evaluation of Diagnoses and Clinical Outcomes in Children Undergoing MRI Scans - NCT ID: NCT06278376 - Study ID: f/2023/045 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-04-25 - Completion Date: 2024-12-31 - Lead Sponsor: Jessa Hospital ### Study Description The aim of this study is to evaluate the indications and therapeutical consequences of MRI scans of (young) children undergoing risky remote anaesthesia. The investigators want to aim for a clear indication in children undergoing MRI in the future before undergoing possible unnecessary procedures and MRI scans. ### Conditions - Magnetic Resonance Imaging ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence Secondary Outcomes - Therapeutical implications: diagnosis - Therapeutical implications: treatment - Clinical indications - Evaluation of body part - Evaluation of symptoms - Clinical outcome: adverse event - Clinical outcome: surgery - Clinical outcome: admission to hospital - Clinical outcome: mortality - Evaluation of age - Influence of COVID-19 pandemic ### Location - Facility: Jessa hospital, Hasselt, N/A, 3500, Belgium @@
## Sexual Nursing Care in Stroke Patients - NCT ID: NCT06278363 - Study ID: StrokeSex_23 - Status: RECRUITING - Start Date: 2023-11-01 - Completion Date: 2025-04-30 - Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo" ### Study Description The study aims to assess the impact of "sexual nursing care" on sexual dysfunctions in Italian stroke patients.The method involves a randomized clinical trial with two groups: one receiving specific sexual care and the other standard care, both involving the partner. Various assessment scales are used, and four outpatient interventions are administered over six months.Results indicate improvement in body awareness, management of sexual dysfunctions, relational dynamics, and quality of life for both patients and partners.In conclusion, the importance of sexual health in stroke patients is highlighted as an indicator of quality of life. Targeted nursing interventions can facilitate timely diagnosis and a personalized approach to patients and partners. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Sexual Nursing care - Standard Nursing Care ### Outcomes Primary Outcomes - Effectiveness of "sexual nursing care" intervention in enhancing sexual awareness Secondary Outcomes - psychosocial well-being and relational dynamics of stroke patients and their partners ### Location - Facility: IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy/Messina, 98124, Italy @@
## Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis - NCT ID: NCT06278350 - Study ID: D2570-201 - Status: RECRUITING - Start Date: 2024-02-04 - Completion Date: 2025-03-31 - Lead Sponsor: InventisBio Co., Ltd ### Study Description This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis . ### Conditions - Plaque Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - D-2570 - Placebo ### Outcomes Primary Outcomes - Percentage of subjects with at least 75% improvement in PASI Secondary Outcomes - Percentage of subjects with at least 75% improvement in PASI - Percentage of subjects with at least 90% improvement in PASI - Percentage of subjects with 100% improvement in PASI - Percentage improvement in PASI - Percentage of subjects with a PGA - The main PK parameters ：Time to maximum measured plasma concentration（Tmax） - The main PK parameters ：Peak Plasma Concentration（Cmax) - The main PK parameters：Area under the plasma concentration versus time curve（AUC） - The main PK parameters：Vz/F (apparent volume of distribution) - The main PK parameters： Half-life（t1/2） - The main PK parameters： Mean Residence Time (MRT) - The main PK parameters：CL/F (apparent clearance) - Weight and height will be combined to report BMI in kg/m^2 - Incidence and severity of AEs based on NCI CTCAE V5.0 - Incidence and severity of TEAEs based on NCI CTCAE V5.0 ### Location - Facility: Peking University People's Hospital, Beijing, N/A, N/A, China @@
## X-linked Moesin Associated Immunodeficiency - NCT ID: NCT06278337 - Study ID: C19-35 - Status: RECRUITING - Start Date: 2021-08-12 - Completion Date: 2027-01-12 - Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France ### Study Description Moesin deficiency was initially described in 7 male participants aged 4 to 69 years and is characterized by lymphopenia of the 3 lineages and moderate neutropenia. Genetically, 6 out of 7 participants had the same missense mutation in the moesin gene located on the X chromosome. The 7th patient has a mutation leading to the premature introduction of a STOP codon into the protein.Clinically the 7 participants with X-linked moesin-associated immunodeficiency all presented with recurrent bacterial infections of the respiratory, gastrointestinal or urinary tracts, and some had severe varicella.Therapeutically, in the absence of a molecular diagnosis and due to his SCID-like phenotype, one patient was treated with geno-identical hematopoietic stem cell transplantation . The remaining are untreated or treated with immunoglobulin substitution and/or prophylactic antibiotics.Since this study, the moesin gene has been integrated into DNA chips used for the molecular diagnosis of immune deficiencies in several countries. Physicians in Canada, the United States, Japan, South Africa and Europe have contacted us with a total of 16 known participants to date. Because of their very low severe, uncontrolled CMV infection and the absence of treatment recommendations, two 2 American participants were treated with allogeneic transplantation with severe post-transplant complications (1), and one of the participants died as a result of the transplant. Management of XMAID participants therefore varies widely from country to country, depending on age at diagnosis and clinical picture. It ranges from no treatment treatment (associated with recurrent infections and skin manifestations), IgIv substitution and/or antibiotic prophylaxis antibiotic prophylaxis, with low toxicity and apparent efficacy, and allogeneic transplantation, with all the risks risks involved (graft-related toxicity, graft versus host, disease, rejection, risk of infection). The Investigators therefore feel it is important to review the diagnosis, clinical presentation and management of X-MAID participants. The study the investigator propose will enable to understand the presentation of X-MAID participants, establish guidelines and provide the best treatment for each patient according to his or her clinical picture ### Conditions - Immune Deficiency - Autoimmune Diseases - Infections - Diagnosis ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - genetic restrospective study ### Outcomes Primary Outcomes - The main objective Secondary Outcomes - Secondary objectives1 ### Location - Facility: National Institutes of Health, Bethesda, Maryland, 20892, United States @@
## Effectiveness of a Nasal Spray on Viral Respiratory Infections - NCT ID: NCT06278324 - Study ID: C1736 - Status: RECRUITING - Start Date: 2024-01-26 - Completion Date: 2024-07 - Lead Sponsor: CEN Biotech ### Study Description There is no cure for cold or flu, most people recover in about within two weeks. Paracetamol may be used to reduce aches or treat fever, headache, or body aches. Antiviral solutions ranging from simple universal saline solutions to novel compounds have been proposed to provide a temporary barrier to prevent viral infection and propagation.The nasal spray "Humer Stop Virus" is indicated in patients presented with early symptoms of viral respiratory infection. This spray forms a protective barrier in the nasal mucosa which is the main entry of the upper air respiratory system viruses. The spray traps the viruses and helps the organism to eliminate them before they multiply themselves.This clinical investigation is conducted to assess the performance, clinical benefit and safety of this nasal spray in patients with early symptoms of acute respiratory disease whether or not infection is related to common cold, flu or COVID virus. Indeed, presence of early symptoms of acute respiratory infection does not always imply viral infectionAntigen self-tests are available to confirm viral infection with flu viruses or severe acute respiratory syndrome (SARS-CoV-2). However, influenza and other winter viruses are not systematically searched for in general population, because this is of neither collective nor individual interest. To be as pragmatic as possible, we chose to assess performance and safety of the nasal spray on intended users in real conditions. Patients with early symptoms of cold, flu or COVID, are enrolled regardless their PCR test positivity confirming viral infection at the time of enrollment. For study needs, the primary endpoint, which aims to assess the performance of the nasal spray in terms of stopping the viral infection, is assessed in a subgroup of patients with a positive PCR test with flu, COVID or common cold virus in the nasal sample collected at enrollment. ### Conditions - Acute Respiratory Tract Infection - Flu, Human - COVID-19 - Common Cold ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Nasal Spray HSV Treatment ### Outcomes Primary Outcomes - Performance of nasal spray in eliminating viruses Secondary Outcomes - Changes from baseline in viral load - Rate of patients cleared from viral infection - Rate of patients with improved viral infection - Rate of patients with worsening viral infection - Rate of patients with new viral infection - Changes in symptom severity - Duration of illness - Time to clinical improvement of the symptoms - Adverse event occurence ### Location - Facility: Cen Experimental, Dijon, Burgundy, 21000, France @@
## Correlation of Toxins With Gastrointestinal (GI) and Overall Health - NCT ID: NCT06278311 - Study ID: 20235761 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-02 - Lead Sponsor: Vibrant America Clinical Lab ### Study Description The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health. ### Conditions - Gastrointestinal Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Determination of the Total Toxicity score - Determination of the Symptom score - Determination of the Diagnosis score Secondary Outcomes - Determination of individual scores ### Location - Facility: Los Angeles Integrative Gastroenterology and Nutrition, Inc, Los Angeles, California, 90067, United States @@
## Different Level of ECSWT in Post Mastectomy Lymphedema - NCT ID: NCT06278298 - Study ID: REC/012/003318 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-01-01 - Lead Sponsor: Cairo University ### Study Description to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol) ### Conditions - Lymphedema of Upper Limb ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Shockwave - CDT ### Outcomes Primary Outcomes - lymphedema volume - skin thickness of the arm Secondary Outcomes ### Location - Facility: Cairo University, Giza, Dokki, 12612, Egypt @@
## Effect of Agonist GLP1 on Adipose Tissue in Patients Undergoing Bariatric Surgery - NCT ID: NCT06278285 - Study ID: 21-AOIP-01 - Status: RECRUITING - Start Date: 2024-03-06 - Completion Date: 2026-03-01 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description Normalizing weight gain and preventing the redistribution of body fat is a major health issue, and could help prevent the onset of various symptoms of metabolic syndrome. Above all, it is important to understand the mechanisms by which these different treatments affect adipose tissue. To this end, the investigators will first study the impact of GLP-1 analogues on adipose tissue. The main objective is to show that subjects treated with a GLP-1 agonist have a significant change in their oxytocin levels compared with subjects not treated with a GLP-1 agonist. ### Conditions - Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Blood GLP1 - Blood No treated GLP1 ### Outcomes Primary Outcomes - Rate of oxytocin Secondary Outcomes - Fibrosis rate ### Location - Facility: CHU de Nice - Hôpital de l'Archet, Nice, Alpes-maritimes, 06200, France @@
## AI Evaluation of Pancreatic Exocrine Insufficiency in CP Patients - NCT ID: NCT06278272 - Study ID: AIPEI - Status: COMPLETED - Start Date: 2023-03-01 - Completion Date: 2024-01-01 - Lead Sponsor: Changhai Hospital ### Study Description Early assessment of pancreatic exocrine insufficiency (PEI) is crucial for determining appropriate chronic pancreatitis (CP) treatment plans, thereby avoiding unnecessary suffering and further complications in patients. A total of 504 patients with CP who underwent fecal elastase-1 test and contrast-enhanced CT at Changhai Hospital between January 2018 and April 2023 were enrolled in this study. The investigators aim to establish a fully automated workflow to establish a PEI classification model based on radiomic features, semantic features and deep learning features on enhanced CT images for evaluating the severity of PEI. ### Conditions - Chronic Pancreatitis - Exocrine Pancreatic Insufficiency - Machine Learning - Deep Learning ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Classification of pancreatic exocrine insufficiency Secondary Outcomes ### Location - Facility: Changhai Hospital, Shanghai, N/A, 200433, China @@
## Telerehabilitation Program Bases Aerobic and Baduanjin Exercises in Post Stroke Elderly Patients - NCT ID: NCT06278259 - Study ID: P.T.REC/012/005023 - Status: RECRUITING - Start Date: 2024-02-20 - Completion Date: 2025-09-30 - Lead Sponsor: Cairo University ### Study Description It is an interventional study in which 60 stroke patients estimated to enroll according to random allocation and will divided into two groups. The study group participants will involve in Telerehabilitation sessions will be based on low-impact rhythmic movements, guided by video with the Baduanjin exercise program ,the control group will receive the same aerobic exercises only ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Telerehabilitation program bases aerobic and Baduanjin exercises - Telerehabilitation program bases aerobic exercises ### Outcomes Primary Outcomes - physical function Secondary Outcomes - Cognitive function - sleep quality - participants' satisfaction with the program ### Location - Facility: Faculty of Physical Therapy, Cairo, Dokki, 11432, Egypt @@
## Investigating the Muscarinic System in Schizophrenia Using Positron Emission Tomography - NCT ID: NCT06278246 - Study ID: 050/2021 - Status: NOT_YET_RECRUITING - Start Date: 2024-02 - Completion Date: 2029-02 - Lead Sponsor: Centre for Addiction and Mental Health ### Study Description Within the schizophrenia population, there are individuals that respond to first-line antipsychotic treatments while others do not. The availability of muscarinic M4 subtype receptors (M4R) may play a role as to whether a person with schizophrenia is responsive to first-line antipsychotics or not. The goal of this observational study is to compare the availability of M4R in antipsychotic-free patients with schizophrenia and matched healthy controls. In addition, M4R availability in schizophrenia patients will be examined in relation to response to first line antipsychotics and clinical and cognitive measures. This study may help better understand antipsychotic resistance in schizophrenia and lead to the development of new treatment options, particularly for cognitive deficits and negative symptoms. ### Conditions - Schizophrenia - Schizophreniform Disorders ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PET Scan ### Outcomes Primary Outcomes - M4 receptor expression - Clinical Data Statistical Analysis Secondary Outcomes - Statistical Analysis of Cognitive Data - Statistical Analysis of Psychopathological Personality Traits in Health Control Group ### Location - Facility: Centre for Addiction and Mental Health, Toronto, Ontario, M5T1R8, Canada @@