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## Oral Enteral Nutrition Tube Feeding on Stroke Survivors - NCT ID: NCT06301646 - Study ID: IOE-psy - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Ahmadu Bello University Teaching Hospital ### Study Description The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom. ### Conditions - Cerebrovascular Accident ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding - comprehensive rehabilitation therapy ### Outcomes Primary Outcomes - Social Functioning Scale Secondary Outcomes - Social Support Questionnaire - Anxiety - Depression ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia - NCT ID: NCT06301633 - Study ID: IOE-STROKE - Status: COMPLETED - Start Date: 2022-01-31 - Completion Date: 2023-12-30 - Lead Sponsor: Muhammad ### Study Description This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube Feeding - comprehensive rehabilitation therapy ### Outcomes Primary Outcomes - Penetration-Aspiration Scale Secondary Outcomes - Body weight - total protein - albumin - Yale pharyngeal residue severity rating scale - Patient health questionnaire-9 - Swallowing Quality of Life questionnaire ### Location - Facility: The 1st afi. Hos., Zhenzhou, N/A, N/A, China @@
## Intra-articular Injection: A Innovational Approach for Joint Disorder - NCT ID: NCT06301620 - Study ID: GUANJIEQIANG - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint DysfunctionThe main question it aims to answer is:• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction ### Conditions - Temporomandibular Joint Dysfunction ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Routine rehabilitation treatment - Intra-articular Injection ### Outcomes Primary Outcomes - Friction Index Secondary Outcomes - The Visual Analog Scale - The maximum mouth opening limit - Mann Assessment of Swallowing Ability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients - NCT ID: NCT06301607 - Study ID: Feedingamount - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-06 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intermittent Oro-esophageal Tube Feeding - Nasogastric Tube - comprehensive rehabilitation therapy ### Outcomes Primary Outcomes - Feeding Amount Secondary Outcomes - total protein level - hemoglobin level - albumin level - prealbumin level - Body weight - Functional Oral Intake Scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Impact of Neck and Facial Exercises on Swallowing Function in Elderly Individuals - NCT ID: NCT06301594 - Study ID: Dys-prevent - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-03 - Lead Sponsor: Muhammad ### Study Description The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each. ### Conditions - Dysphagia ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Systematic simple swallowing training ### Outcomes Primary Outcomes - Swallowing-Related Quality of Life Questionnaire Secondary Outcomes - Eating Assessment Tool-10 - Time consumed in eating - Standardized Swallowing Assessment - Water Swallow Test ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant - NCT ID: NCT06301581 - Study ID: ABIntl-23-42 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2025-12 - Lead Sponsor: Advanced Bionics AG ### Study Description This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices. ### Conditions - Cochlear Hearing Loss ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Freiburger monosyllabic word recognition score in quiet in the implanted ear Secondary Outcomes ### Location - Facility: Medizinische Hochschule Hannover, Hannover, N/A, D-30625, Germany @@
## Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation - NCT ID: NCT06301568 - Study ID: ABIntl-23-12 - Status: RECRUITING - Start Date: 2024-01-22 - Completion Date: 2024-05 - Lead Sponsor: Advanced Bionics AG ### Study Description This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks. ### Conditions - Cochlear Hearing Loss ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Freiburger monosyllabic word recognition score in quiet Secondary Outcomes - HSM sentence score or OlSa recognition score in quiet ### Location - Facility: Medizinische Hochschule Hannover, Hannover, N/A, D-30625, Germany @@
## Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms - NCT ID: NCT06301555 - Study ID: db2023 - Status: COMPLETED - Start Date: 2023-11-01 - Completion Date: 2024-02-01 - Lead Sponsor: Adai Technology (Beijing) Co., Ltd. ### Study Description Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined. ### Conditions - Depression - Anxiety ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Reinforcement learning algorithm powered cognitive and behavioral intervention - cognitive and behavioral intervention ### Outcomes Primary Outcomes - PHQ9 Response - GAD7 Response Secondary Outcomes ### Location - Facility: the First Hospital of China Medical University, Shenyang, Liaoning, N/A, China @@
## Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation - NCT ID: NCT06301542 - Study ID: 2020P003474 - Status: RECRUITING - Start Date: 2024-02-07 - Completion Date: 2024-05-01 - Lead Sponsor: Brigham and Women's Hospital ### Study Description The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home. ### Conditions - Post-stroke ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Functional electrical stimulation ### Outcomes Primary Outcomes - Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients Secondary Outcomes - Accurate motion assistance while using the functional electrical stimulation in the laboratory. - Accurate motion assistance while using the functional electrical stimulation in the home. ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## The Efficacy and Tolerability of Canagliflozin in Healthy Individual - NCT ID: NCT06301529 - Study ID: ALRx008 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-12 - Completion Date: 2024-04-29 - Lead Sponsor: AgelessRx ### Study Description The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol. ### Conditions - Healthy Aging ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Invokana Pill ### Outcomes Primary Outcomes - Change in blood glucose values after taking Canagliflozin Secondary Outcomes - Number of participants with treatment-related side effects through collected survey responses ### Location - Facility: AgelessRx, Ann Arbor, Michigan, 48104, United States @@
## Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD - NCT ID: NCT06301516 - Study ID: HM20027823 - Status: RECRUITING - Start Date: 2024-02-16 - Completion Date: 2024-12 - Lead Sponsor: Virginia Commonwealth University ### Study Description Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD. ### Conditions - Conduct Disorder - Conduct Disorders in Children - Conduct Disorders in Adolescence - Callous-Unemotional Traits ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Virtual Reality - Comparative Control ### Outcomes Primary Outcomes - Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits - Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder - Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems - Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation - Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition Secondary Outcomes ### Location - Facility: Virginia Commonwealth University, Richmond, Virginia, 23298, United States @@
## Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB) - NCT ID: NCT06301503 - Study ID: 0103/UN14.2.2.VII.14/LT/2024 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2024-04-25 - Lead Sponsor: Udayana University ### Study Description The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia.The main questions it aims to answer are:* Will there be a significant difference in QoR-40 scores between both groups?* Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours?* Will the combined LPB-SNB significantly increases postoperative duration of analgesia?Participants will:* Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants.* Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire.Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries. ### Conditions - Lower Extremity Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - USG Guided Combined LPB-SNB with Isobaric Bupivacaine - Control ### Outcomes Primary Outcomes - Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire Secondary Outcomes - Postoperative Intravenous Opioid Consumption - Postoperative Analgesia Duration ### Location - Facility: Prof. Dr. I.G.N.G. Ngoerah General Hospital, Denpasar, Bali, 80114, Indonesia @@
## The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome - NCT ID: NCT06301490 - Study ID: Taif university - Status: COMPLETED - Start Date: 2024-01-11 - Completion Date: 2024-03-02 - Lead Sponsor: Taif University ### Study Description BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale. ### Conditions - Subacromial Impingement Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Myofascial Release ### Outcomes Primary Outcomes - pain intensity - disability Secondary Outcomes - rang of motion - psychological distress, and health-related quality of life (HRQoL) ### Location - Facility: Taif University, Taif, Makkah, 11099, Saudi Arabia @@
## PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial - NCT ID: NCT06301477 - Study ID: 23/109X - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-03-01 - Lead Sponsor: Children's Hospital of Eastern Ontario ### Study Description To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes. ### Conditions - Inflammatory Bowel Diseases - Crohn Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Resistant Starch - Placebo ### Outcomes Primary Outcomes - Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis - Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis - Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis Secondary Outcomes - Change in intensification as measured by anti-TNFa dose escalation - Change in intensification as measured by anti-TNFa interval shortening - Change in disease activity - Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples - Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples - Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire - Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire - Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P ### Location - Facility: Children's Hospital of Eastern Ontario, Ottawa, Ontario, K1H 8L1, Canada @@
## Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer - NCT ID: NCT06301464 - Study ID: B-2003-603-103 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2003-03-01 - Completion Date: 2025-12-31 - Lead Sponsor: Seoul National University Bundang Hospital ### Study Description The aim of this study to validate the role of pepsinogens in gastric cancer screening. ### Conditions - Gastric Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - The level of serum pepsinogens Secondary Outcomes ### Location - Facility: Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of @@
## Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia - NCT ID: NCT06301451 - Study ID: XD2021-1 - Status: RECRUITING - Start Date: 2022-04-01 - Completion Date: 2024-12-01 - Lead Sponsor: Sun Jia ### Study Description In the past 30 years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia patients has increased significantly. Hyperlipidemia is a disease caused by abnormal blood lipid levels, also known as abnormal lipid metabolism. Common clinical indicators include total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL) and high-density lipoprotein ( HDL).The number of patients with abnormal blood lipid levels in China accounts for as high as 40% of the total. It is estimated that between 2010 and 2030,cardiovascular disease events will increase by 9.2 million, which seriously endangers human health and becomes a high risk factor for various cardiovascular diseases, such as atherosclerosis. One of the pathological foundations of atherosclerosis is that abnormal lipid levels in the body cause a large amount of lipid to be deposited in the arterial endothelial matrix, which is phagocytosed by smooth muscle and macrophages to form foam cells.Hydrogen, the lightest and smallest molecular gas in the atmosphere, is considered a novel antioxidant that reduces oxidative stress. Accumulating evidence from various biomedical fields in clinical studies and experimental models of many diseases suggests that hydrogen inhalation or drinking hydrogen-containing solutions can be used as a therapeutic strategy. Due to the special physical properties of hydrogen gas that is easy to diffuse, hydrogen molecules can penetrate cell membranes to reach organelles and cell nuclei. Hydrogen's moderate reducing properties make it effective in reducing cytotoxicity, protecting nuclear DNA and mitochondria, and reducing the risk of lifestyle-related diseases and cancer.In addition, hydrogen intake can reduce oxidative stress, improve cellular function, and reduce chronic inflammation, which are associated with the pathology and etiology of hyperlipidemia and other related diseases. Molecular hydrogen can regulate important metabolic functions such as signal transduction, protein phosphorylation, miRNA expression, and autophagy. Studies have shown that intake of hydrogen water in APOE knockout mice can reduce serum total cholesterol and low-density lipoprotein levels and prevent the progression of atherosclerosis. A study by Song et al. in 2013 included 20 subjects who drank 0.9 to 1 L of hydrogen-rich water per day for 10 weeks, and the subjects' LDL-C levels decreased significantly before and after treatment. Another study showed that subjects with underlying lipid metabolism abnormalities were treated with high-concentration hydrogen water (5.5mmol/d) for up to 24 weeks, and serum total cholesterol and low-density lipoprotein levels were significantly reduced. Protein function and redox status (eg, increased serum superoxide dismutase and decreased malondialdehyde) were improved, markers of inflammation (eg, serum tumor necrosis factor-alpha) decreased and fasting blood glucose decreased. At present, the research on the treatment of hyperlipidemia with hydrogen water is very limited. The portable hydrogen water hydrogen machine used in this study has passed the registration test of the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. In order to evaluate the use of the portable hydrogen water hydrogen machine for hyperlipidemia The efficacy and safety of adjuvant therapy in patients, this clinical trial is specially carried out. ### Conditions - Hyperlipidemias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine ### Outcomes Primary Outcomes - Percent change from baseline in LDL-C at 3 months of intervention. Secondary Outcomes - Absolute change from baseline in LDL-C at 3 months of intervention. - Percent change from baseline in LDL-C at 1 month of intervention. - Absolute change from baseline in LDL-C at 1 month of intervention. - Percent change from baseline in LDL-C at 6 months of intervention. - Absolute change from baseline in LDL-C at 6 months of intervention. - Percent change from baseline in triglycerides at 1 month of intervention. - Absolute change from baseline in triglycerides at 1 month of intervention. - Percent change from baseline in triglycerides at 3 months of intervention. - Absolute change from baseline in triglycerides at 3 months of intervention. - Percent change from baseline in triglycerides at 6 months of intervention. - Absolute change from baseline in triglycerides at 6 months of intervention. - Percent change from baseline in total cholesterol at 1 month of intervention. - Absolute change from baseline in total cholesterol at 1 month of intervention. - Percent change from baseline in total cholesterol at 3 months of intervention. - Absolute change from baseline in total cholesterol at 3 months of intervention. - Percent change from baseline in total cholesterol at 6 months of intervention. - Absolute change from baseline in total cholesterol at 6 months of intervention. - Percent change from baseline in HDL cholesterol at 1 month of intervention. - Absolute change from baseline in HDL cholesterol at 1 month of intervention. - Percent change from baseline in HDL cholesterol at 3 months of intervention. - Absolute change from baseline in HDL cholesterol at 3 months of intervention. - Percent change from baseline in HDL cholesterol at 6 months of intervention. - Absolute change from baseline in HDL cholesterol at 6 months of intervention. - Percent change from baseline in non-HDL cholesterol at 1 month of intervention. - Absolute change from baseline in non-HDL cholesterol at 1 month of intervention. - Percent change from baseline in non-HDL cholesterol at 3 months of intervention. - Absolute change from baseline in non-HDL cholesterol at 3 months of intervention. - Percent change from baseline in non-HDL cholesterol at 6 months of intervention. - Absolute change from baseline in non-HDL cholesterol at 6 months of intervention. - Percent change from baseline in small and dense LDL at 1 month of intervention. - Absolute change from baseline in small and dense LDL at 1 month of intervention. - Percent change from baseline in small and dense LDL at 3 months of intervention. - Absolute change from baseline in small and dense LDL at 3 months of intervention. - Percent change from baseline in small and dense LDL at 6 months of intervention. - Absolute change from baseline in small and dense LDL at 6 months of intervention. - Percent change from baseline in apolipoprotein B at 1 month of intervention. - Absolute change from baseline in apolipoprotein B at 1 month of intervention. - Percent change from baseline in apolipoprotein B at 3 months of intervention. - Absolute change from baseline in apolipoprotein B at 3 months of intervention. - Percent change from baseline in apolipoprotein B at 6 months of intervention. - Absolute change from baseline in apolipoprotein B at 6 months of intervention. - Percent change from baseline in TNF-alpha at 1 month of intervention. - Absolute change from baseline in TNF-alpha at 1 month of intervention. - Percent change from baseline in TNF-alpha at 3 months of intervention. - Absolute change from baseline in TNF-alpha at 3 months of intervention. - Percent change from baseline in TNF-alpha at 6 months of intervention. - Absolute change from baseline in TNF-alpha at 6 months of intervention. - Adverse Event (AE) Frequency - Severe Adverse Event (SAE) Frequency - Device deficiency rate ### Location - Facility: Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, N/A, China @@
## Dalpiciclib in HR+/HER2- ABC - NCT ID: NCT06301438 - Study ID: LY2024-022-A - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2028-12 - Lead Sponsor: RenJi Hospital ### Study Description To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer. ### Conditions - Advanced Breast Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - dalpiciclib ### Outcomes Primary Outcomes - Progression-Free Survival Secondary Outcomes - Adverse events ### Location - Facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, N/A, 200127, China @@
## MRD Response-adapted Allo-HSCT for Adverse-risk AML - NCT ID: NCT06301425 - Study ID: TROPHY-AML01 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2028-05-01 - Lead Sponsor: Peking University People's Hospital ### Study Description This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Intervention group - Control group ### Outcomes Primary Outcomes - Event-free survival (EFS) Secondary Outcomes - Relapse - Leukemia-free survival (LFS) - Non-relapse mortality (NRM) - Overall survival (OS) - Acute graft-versus-host disease (aGvHD) - Chronic graft-versus-host disease (cGvHD) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Combination of Hypothermia and Thrombectomy in Acute Stroke - NCT ID: NCT06301412 - Study ID: COTTIS-2_Version4.0-13Nov23 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2026-06-18 - Lead Sponsor: University of Freiburg ### Study Description The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed.Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications. ### Conditions - Ischemic Stroke - Large Vessel Occlusion - Endovascular Treatment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - hypothermia ### Outcomes Primary Outcomes - functional outcome Secondary Outcomes - infarction volume - increase in infarction - recanalization result - neurological improvement - outcome at discharge - shift in functional outcome - very good clinical outcome - mortality - Length of ventilation - Length of stay - body temperature - time to groin puncture - time to recanalization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study - NCT ID: NCT06301399 - Study ID: Rituximab01 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-20 - Completion Date: 2026-12-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma ### Conditions - Advanced Hepatocellular Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy ### Outcomes Primary Outcomes - ORR Secondary Outcomes - PFS - OS - DoR - DCR ### Location - Facility: Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, 300060, China @@
## Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients - NCT ID: NCT06301386 - Study ID: EVOLUTION - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-01 - Lead Sponsor: Fudan University ### Study Description The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups. ### Conditions - Colon Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Everolimus - PD-1 ### Outcomes Primary Outcomes - objective response rate (ORR) Secondary Outcomes - progression-free survival (PFS） - overall survival (OS) - disease control rate (DCRs) - advert events ### Location - Facility: Anyang Tumor Hospital, Anyang, Henan, N/A, China @@
## Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis - NCT ID: NCT06301373 - Study ID: SYSKY-2023-1185-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2030-04-01 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy.This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48.This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines. ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Methotrexate Combined With Tofacitinib - Methotrexate ### Outcomes Primary Outcomes - The proportion of subjects who achieved ACR20 Secondary Outcomes - Changes in disease activity scores (DAS28-CRP) relative to baseline - Changes in disease activity scores (DAS28-ESR) relative to baseline - Changes in disease activity scores (SDAI) relative to baseline - Changes in disease activity scores (CDAI) relative to baseline - Proportion of subjects with low disease activity and remission (SDAI standard) at weeks 4, 8, 12, 24, 36, and 48 after treatment - The proportion of subjects who met ACR50 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment - The proportion of subjects who met ACR70 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment - Changes in the Disability Index (HAQ-DI) of the Health Assessment Questionnaire relative to baseline - Changes in EQ-5D-5L relative to baseline - The proportion of subjects with joint destruction progression at 48 weeks after treatment ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support - NCT ID: NCT06301360 - Study ID: KOSMOS2 2023-04956-01 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2025-12-31 - Lead Sponsor: Daniel Maroti ### Study Description Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.The research question for this specific study is:Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD? ### Conditions - Functional Somatic Disorder - Somatic Symptom Disorder - Functional Somatic Syndromes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Internet based Emotional Awareness and Expression Therapy (I-EAET) ### Outcomes Primary Outcomes - Patient Health Questionnaire -15 (PHQ-15) - Numeric Rating Scales according to EURONET-SOMA Secondary Outcomes - Generalized Anxiety Disorder-7 (GAD-7) - Patient Health Questionnaire-9 (PHQ-9) - Post traumatic stress disorder checklist-5 (PCL-5) - Difficulties in Emotion Regulation Scale-16 (DERS-16) - Sheehan Disability Scale (SDS) - The revised illness perception questionnaire (IPQ-R) ### Location - Facility: Stockholm University, Stockholm, N/A, 10691, Sweden @@
## Learning Through Play Plus for Psychosis - NCT ID: NCT06301347 - Study ID: LTP+P - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-30 - Lead Sponsor: Pakistan Institute of Living and Learning ### Study Description Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia. ### Conditions - Psychosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Learning through Play Plus ### Outcomes Primary Outcomes - Recruitment Rate - Attrition Rate - Intervention attendance log Secondary Outcomes - Positive and Negative Syndrome Scale - Psychotic Rating Scale - Parenting Stress Index - Maternal Attachment Inventory - Knowledge attitude and practices of Child Development - Calgary Depression Scale - Social and Occupational Functioning Scale - Euro-Qol 5 Dimensions - Client Service Receipt Inventory - Ages and Stages Questionnaire - Manchester Assessment of Caregiver-Infant Interaction - Bayley Scale of infant development - Child Height - Child Weight - Child head circumference ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy - NCT ID: NCT06301334 - Study ID: Soh-Med-24-01-11MS - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-08-01 - Lead Sponsor: Sohag University ### Study Description A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complicationsThough epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy ### Conditions - Pain Mangement of Thoracotomy ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Bupivacaine 0.25% Injectable Solution ### Outcomes Primary Outcomes - study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy. Secondary Outcomes - The secondary outcome is the total postoperative morphine consumption, time of first analgesic, ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients - NCT ID: NCT06301321 - Study ID: 461_2566 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2024-07-30 - Lead Sponsor: Siriraj Hospital ### Study Description Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves. ### Conditions - Chronic Myelogenous Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Sensitivity - Specificity Secondary Outcomes ### Location - Facility: Siriraj hospital, Bangkok, N/A, 10700, Thailand @@
## A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial - NCT ID: NCT06301308 - Study ID: 2022021 - Status: WITHDRAWN - Start Date: 2023-10-01 - Completion Date: 2024-02-29 - Lead Sponsor: Second Xiangya Hospital of Central South University ### Study Description The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C. ### Conditions - Bladder Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Intraurethral lidocaine gel alone - Intraurethral lidocaine gel + lidocaine 2% injection - intraurethral lidocaine gel + liquid paraffinl ### Outcomes Primary Outcomes - Access the pain score using the Visual Analogue Scale (VAS) Secondary Outcomes - Postoperative complications ### Location - Facility: The second xiangya hospital, Changsha, Hunan, 410000, China @@
## Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients Suspicious of Early-stage Lung Cancer - NCT ID: NCT06301295 - Study ID: 2402-017-136 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-01 - Completion Date: 2026-12-31 - Lead Sponsor: Pusan National University Hospital ### Study Description This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing. ### Conditions - Lung Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Ultarthin bronchoscopy with intratumoral washing ### Outcomes Primary Outcomes - Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid Secondary Outcomes - Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue - Turn-around time - Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease - NCT ID: NCT06301282 - Study ID: 2021-02341 - Status: RECRUITING - Start Date: 2023-03-03 - Completion Date: 2025-12 - Lead Sponsor: University Hospital, Geneva ### Study Description Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states ### Outcomes Primary Outcomes - Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge Secondary Outcomes - Correlation of electroencephalographic resting-state oscillatory activity with motor scores during the levodopa challenge ### Location - Facility: University Hospital, Geneva, Geneva, N/A, 1204, Switzerland @@
## A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia - NCT ID: NCT06301269 - Study ID: 202312124RINA - Status: RECRUITING - Start Date: 2024-03-10 - Completion Date: 2024-07-30 - Lead Sponsor: National Taiwan University Hospital ### Study Description The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.The main questions it aims to answer are:1. What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?2. Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?3. What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?Participants will fill out the questionnaire to complete the study. ### Conditions - Dementia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - N/A ### Outcomes Primary Outcomes - Self-Compassion Scale - PHQ-9 Scale - Quality-of-Life Scale Secondary Outcomes ### Location - Facility: National Taiwan University Hospital, Taipei, N/A, 100, Taiwan @@
## Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa - NCT ID: NCT06301256 - Study ID: I8F-NS-I002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-11 - Completion Date: 2025-03-11 - Lead Sponsor: Florida Academic Centers Research and Education, LLC ### Study Description The purpose of this study is to determine the clinical efficacy and safety of tirzepatide in subjects with moderate to severe hidradenitis suppurativa. The study will be conducted over 24 weeks on active therapy followed by a eight-week observational follow-up visit. The total length of the study will be 32 weeks . ### Conditions - Hidradenitis Suppurativa ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TIRZEPATIDE ### Outcomes Primary Outcomes - Hidradenitis Suppurativa Clinical Response (HiSCR) 50% Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Molecular Signature of Inactivity Induced Exercise Responsiveness - NCT ID: NCT06301243 - Study ID: FY24-62 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2025-12-31 - Lead Sponsor: Concordia University Wisconsin ### Study Description Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases. ### Conditions - Metabolic Diseases - Aerobic Exercise ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Inactivity ### Outcomes Primary Outcomes - Circulating lipid and carbohydrate metabolism - Basal and post-exercise gene expression with inactivity Secondary Outcomes ### Location - Facility: Kevin J Gries, Mequon, Wisconsin, 53092, United States @@
## Home- vs. Hospital-based Surgical Training - NCT ID: NCT06301230 - Study ID: PLET-2022 - Status: COMPLETED - Start Date: 2020-09-01 - Completion Date: 2021-12-31 - Lead Sponsor: Clarunis - Universitäres Bauchzentrum Basel ### Study Description The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data. ### Conditions - Surgical Training ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Portable Laparoscopic Trainer (PLET) ### Outcomes Primary Outcomes - Exercise time - Assessment rating Secondary Outcomes - Qualitative feedback ### Location - Facility: Clarunis Universitäres Bauchzentrum Basel, Basel, N/A, 4002, Switzerland @@
## Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain - NCT ID: NCT06301217 - Study ID: NO: PT. BU. EC. 7 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-12-17 - Completion Date: 2024-03-20 - Lead Sponsor: Delta University for Science and Technology ### Study Description Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain , there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue. ### Conditions - Neck Pain - Electromyohgraph ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - There is no intervention ### Outcomes Primary Outcomes - Neck disability - Curvature angle of the cervical spine - root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula Secondary Outcomes ### Location - Facility: Delta university for science and technology, Gamasa, Dakahleya, 7731168, Egypt @@
## Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients - NCT ID: NCT06301204 - Study ID: 21.06.2022-E.67046 - Status: COMPLETED - Start Date: 2022-03-01 - Completion Date: 2023-11-01 - Lead Sponsor: Bezmialem Vakif University ### Study Description The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data. ### Conditions - Tranexamic Acid - Orthognathic Surgery - Edema - Bleeding ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tranexamic acid injection - Saline ### Outcomes Primary Outcomes - intraoperative bleeding during the surgery (ml) Secondary Outcomes - postoperative edema calculation for the first 1-3 and 7 day (cm) - intraoperative surgical site evaluation (Fromme Scale) - Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day ### Location - Facility: Bezmialem Vakıf Universty, Istanbul, Fatih, 34093, Turkey @@
## The Effect of Semaglutide on Cardiovascular Markers and Liver Function - NCT ID: NCT06301191 - Study ID: 133/21-02-2022 - Status: RECRUITING - Start Date: 2022-03-01 - Completion Date: 2024-05-01 - Lead Sponsor: Attikon Hospital ### Study Description Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study.25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors.At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function. ### Conditions - Diabetes Type 2 ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Semaglutide, 1.0 mg/mL - Dipeptidyl Peptidase 4 inhibitor ### Outcomes Primary Outcomes - Comparison of arterial stiffness markers difference among treatment groups - Comparison of endothelial glycocalyx thickness difference among treatment groups - Comparison of liver stiffness difference among treatment groups Secondary Outcomes ### Location - Facility: Attikon University General Hospital, Athens, N/A, 12462, Greece @@
## Effect of Vitamin D Injection on Hypertrophic Scars and Keloids - NCT ID: NCT06301178 - Study ID: 12548 - Status: RECRUITING - Start Date: 2024-02-27 - Completion Date: 2026-02-20 - Lead Sponsor: Mostafa Bahaa ### Study Description Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes ### Conditions - Dermatologic Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cholecalciferol ### Outcomes Primary Outcomes - Clinical scoring by Vancouver Scale Score Secondary Outcomes ### Location - Facility: faculty of medicine-Fayoum university, Fayoum, N/A, 63519, Egypt @@
## TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma - NCT ID: NCT06301165 - Study ID: 2023-FXY-129 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2028-12-31 - Lead Sponsor: Sun Yat-sen University ### Study Description The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc. ### Conditions - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TPC induction chemotherapy - GP induction chemotherapy ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Overall survival - Distant progression - Locoregional progression - Short-term response rate - Incidence of acute and late toxicity ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China @@
## Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy - NCT ID: NCT06301152 - Study ID: E2-22-1905 - Status: COMPLETED - Start Date: 2022-09-01 - Completion Date: 2023-05-30 - Lead Sponsor: Ankara City Hospital Bilkent ### Study Description Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment. ### Conditions - Lateral Epicondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - high intensive laser - extracorporeal shock wave therapy ### Outcomes Primary Outcomes - Visual analog scale Secondary Outcomes - Quick Disability Arm, Shoulder and Hand questionary, - hand grip strength - musculoskeletal ultrasonography ### Location - Facility: Emine Esra Bilir, Ankara, Çankaya, 06800, Turkey @@
## Goat Milk Infant Formula Comfort Study - NCT ID: NCT06301139 - Study ID: P17-004 - Status: COMPLETED - Start Date: 2019-05-01 - Completion Date: 2024-02-01 - Lead Sponsor: Ausnutria Hyproca B.V. ### Study Description In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops. ### Conditions - Gastrointestinal Diseases - Cow's Milk Intolerance ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Goat milk-based infant formula - Cow's milk-based infant formula with probiotic drops ### Outcomes Primary Outcomes - Cow's Milk-related Symptoms Secondary Outcomes - Cow's Milk-related Symptoms - Parental stress - Parental quality of life - Weight - Length - Weight-for-age - Length-for-age - Weight-for-length ### Location - Facility: HM hospitales, Madrid, N/A, 28015, Spain @@
## Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries - NCT ID: NCT06301126 - Study ID: P.T.REC/012/004985 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-03-01 - Lead Sponsor: Cairo University ### Study Description After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain. ### Conditions - Abdomen Hernia - Respiratory Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Virtual reality - conventional physical therapy exercise program ### Outcomes Primary Outcomes - Forced vital capacity (FVC) Secondary Outcomes - Forced expiratory volume in 1 second (FEV1) - Peak expiratory flow (PEF) - Respiratory muscle strength - diaphragmatic mobility - Functional capacity ### Location - Facility: Faculty of Physical Therapy, Giza, N/A, 12111, Egypt @@
## This Research Study Examines the Effects of Cannabidiol-infused Candy on Reducing the Bacteria Causing Tooth Decay, When Comparing it to a Sugar Free Candy on Adults. - NCT ID: NCT06301113 - Study ID: IRB#: 01202023_torabiDH_CBDloz - Status: COMPLETED - Start Date: 2023-01-27 - Completion Date: 2023-02-11 - Lead Sponsor: West Coast University ### Study Description The goal of this clinical trial is to compare the effect of CBD candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults The main question is to see whether CBD have any effect on reducing the number of Streptococcus mutans, in the oral cavity the main bacteria causing tooth decay.Participants will be randomly placed in a group, and assigned to take either CBD-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days.A sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth. ### Conditions - Tooth Decay ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - CBD infused candy - Sugar free Candy ### Outcomes Primary Outcomes - To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis. Secondary Outcomes ### Location - Facility: West Coast University, Anaheim, California, 92802, United States @@
## Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT - NCT ID: NCT06301100 - Study ID: E20230371 - Status: RECRUITING - Start Date: 2023-04-28 - Completion Date: 2024-12-31 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT. ### Conditions - Image Quality and Contouring Accuracy of the Tumor in Radiotherapy ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Dual energy CT after routine simulation ### Outcomes Primary Outcomes - DICE value Secondary Outcomes ### Location - Facility: Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huan-Hu-Xi, Tianjin, Tianjin, 300381, China @@
## Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App - NCT ID: NCT06301087 - Study ID: WP-2024-01 - Status: COMPLETED - Start Date: 2022-05-01 - Completion Date: 2024-02-08 - Lead Sponsor: Weprom ### Study Description The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :* the median age of possible neurodevelopmental disorders notification of infants* the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data ### Conditions - Development, Child - Postnatal Depression ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Web Application ### Outcomes Primary Outcomes - Time to neurodevelopment desorder diagnostic Secondary Outcomes - User's satisfaction - Relevance of the neurodevelopmental desorder notification - Rate of mothers'postnal depression - Time of mothers'postnatal depression ### Location - Facility: ILC, Le Mans, N/A, N/A, France @@
## The Phase I Study of HS-10509 in Chinese Adult Subjects - NCT ID: NCT06301074 - Study ID: HS-10509-101 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. ### Study Description The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia.Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part. ### Conditions - Schizophrenia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - HS-10509 - Placebo ### Outcomes Primary Outcomes - Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment. - Changes from baseline in lab tests - Changes from baseline in vital signs - Change from baseline in body weight - Change from baseline in Electrocardiogram (ECG) - Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) - Change from baseline in Abnormal Involuntary Movement Scale (AIMS) - Change from baseline in Barnes Akathisia Rating Scale (BARS) - Change from baseline in Simpson-Angus Scale (SAS) Secondary Outcomes - Cmax - Tmax - AUC0-t - AUC0-∞ - λz - t½ - CL/F - Vd/F - MRT - Css, max - Css, min - Css, av - Tss, max - AUCss - Change from Baseline in Positive and Negative Syndrome Scale (PANSS) ### Location - Facility: The First Hospital of Jilin University, Changchun, Jilin, N/A, China @@
## Focal Microvibration and Chronic Lumbosacral Radicular Pain - NCT ID: NCT06301061 - Study ID: PB001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Federico II University ### Study Description The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question\[s\] it aims to answer are:* Can focal microvibration improve pain in this patient population?* Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy. ### Conditions - Pain, Chronic - Lumbosacral Radiculopathy - Radicular; Neuropathic ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Equistasi® - Sham - Gabapentin; Pregabalin; Duloxetine; Amitriptyline ### Outcomes Primary Outcomes - Pain intensity Secondary Outcomes - Pain interference in daily life - Disability ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma - NCT ID: NCT06301048 - Study ID: BFHHZS20230203 - Status: COMPLETED - Start Date: 2023-11-07 - Completion Date: 2023-12-07 - Lead Sponsor: Beijing Friendship Hospital ### Study Description This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates. ### Conditions - Duodenal Adenoma - Complication of Treatment ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Stent Placement in Pancreatic and Bile Ducts ### Outcomes Primary Outcomes - Rate of complications - Rate of complete resection Secondary Outcomes - Rate of recurrence ### Location - Facility: Beijing Friendship Hospital, Beijing, Beijing, 100050, China @@
## Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group - NCT ID: NCT06301035 - Study ID: 2024-01-012 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-18 - Completion Date: 2024-12-31 - Lead Sponsor: Samsung Medical Center ### Study Description Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure. ### Conditions - Acute Respiratory Failure ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Asymmetric High flow nasal cannula - Standard(symmetric) High flow nasal cannula ### Outcomes Primary Outcomes - Respiratory Rate Oxygenation (ROX) Index Secondary Outcomes - The Lowest value of SpO2 within 24 hours after extubation - PaO2/FiO2 - SpO2/FiO2 - changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT) - Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index) - Respiratory rate - work of breath (Modified Borg Scale, MBS) - systolic blood pressure - mean arterial pressure - heart rate - Rate of reintubation within 7 days - Length of ICU stay - Length of hospital stay - ICU Mortality - Hospital Mortality - 28 Day Mortality - 90 Day Mortality ### Location - Facility: Samsung Medical Center, Seoul, N/A, N/A, Korea, Republic of @@
## Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus - NCT ID: NCT06301022 - Study ID: WXZ-Finerenone - Status: RECRUITING - Start Date: 2022-12-15 - Completion Date: 2024-12-31 - Lead Sponsor: First Affiliated Hospital of Harbin Medical University ### Study Description Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.Methods:Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer. ### Conditions - Chronic Kidney Diseases ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - 24 hours urinary total protein - estimate Gromerular filtration rate - serum potassium Secondary Outcomes ### Location - Facility: First Aaffiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China @@
## The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray - NCT ID: NCT06301009 - Study ID: AI-CAC-PVS - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-01 - Lead Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino ### Study Description The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing. ### Conditions - Cardiovascular Diseases - Atherosclerosis - Coronary Artery Calcification ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - AI-CAC score ### Outcomes Primary Outcomes - Diagnostic accuracy of the AI-CAC score to identify the presence of subclinical atherosclerosis on chest x-ray Secondary Outcomes - Percentage of individuals with a therapeutic management change by the attending physician based on the CAC score, with concordant AI-CAC. - Comparison of ASCVD events occurring in patients without (AI-CAC=0) vs. with subclinical atherosclerosis (AI-CAC >0) based on the AI-CAC score, as assessed by Kaplan Meier estimates of ASCVD events occurring until study completion. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb - NCT ID: NCT06300996 - Study ID: STUDY23110042 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2029-05 - Lead Sponsor: Marco Capogrosso ### Study Description Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted. ### Conditions - Spinal Muscular Atrophy - Spinal Muscular Atrophy Type 3 - Spinal Muscular Atrophy Type II - Spinal Muscular Atrophy 4 - SMA ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads) ### Outcomes Primary Outcomes - Muscle Weakness Torque - Number and Severity of Adverse Events Secondary Outcomes - Muscle Weakness Muscle Activation - Motor Function ROM - Motor Function RULM - Motor Function Fatigue - Discomfort/Pain - Sensorimotor Network Structure Density - Impression - Sensorimotor Network Structure Integrity - Sensorimotor Network Function - Cortico-spinal Tract Integrity - Spinal Circuit Excitability - Motoneuron Firing Rates - Motor Firing Number ### Location - Facility: University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States @@
## Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being - NCT ID: NCT06300983 - Study ID: PR(AG)398/2022 - Status: COMPLETED - Start Date: 2022-09-15 - Completion Date: 2022-10-31 - Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute ### Study Description Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups. ### Conditions - Quality of Life - Myositis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Psychoeducative - Placebo ### Outcomes Primary Outcomes - Health related quality of life Secondary Outcomes ### Location - Facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona, Barcelona, N/A, 08035, Spain @@
## Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia - NCT ID: NCT06300970 - Study ID: 0900f3eb81e634a9 - Status: COMPLETED - Start Date: 2022-08-09 - Completion Date: 2023-08-16 - Lead Sponsor: Centers for Disease Control and Prevention ### Study Description To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia. ### Conditions - Plasmodium Falciparum - Malaria - Uncomplicated Malaria ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Amodiaquine-artesunate (ASAQ) - Artemether+Lumefantrine (AL) ### Outcomes Primary Outcomes - Number of Participants with Early Treatment Failure (ETF) - Number of Participants with Late Treatment Failure (LTF) - Number of Participants with Adequate Clinical and Parasitological Response (APCR) Secondary Outcomes - Number of Patients with Adverse Events ### Location - Facility: Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County, Sinje, Grand Cape Mount County, N/A, Liberia @@
## Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children - NCT ID: NCT06300957 - Study ID: IRB00023124 - Status: RECRUITING - Start Date: 2023-10-24 - Completion Date: 2026-10-31 - Lead Sponsor: Johns Hopkins Bloomberg School of Public Health ### Study Description This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential. ### Conditions - Program Evaluation - Child Sexual Abuse - Perpetration of Child Sexual Abuse - Prevention Intervention ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Help Wanted Prevention Intervention - Waitlist Control ### Outcomes Primary Outcomes - Sexual Behavior Involving Minors Scale (SBIMS). - Sexual Child Molestation Risk Assessment (SChiMRA) score Secondary Outcomes - Depression, Anxiety and Stress Scale-21 (DASS-21) - Suicidal Ideation Attributes Scale (SIDAS) - General Self-Efficacy Scale - Short Form (GSE-6). - Revised University of California, Los Angeles (UCLA) Loneliness Scale - Self-Efficacy Scale Related to Minors (SESM) - Hypersexual Behavior Inventory-19 score - Sexual Attraction to Children - Cognitions of internet sexual offending score - Cognitions that condone and support sexual offending against children scale - short form - Emotional Congruence with Children score - Brief Aggression Questionnaire score - Short Self-Regulation Questionnaire score - Alcohol Use Disorders Identification Test (AUDIT) score - Recent Alcohol & Cannabis Use score ### Location - Facility: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, 21231, United States @@
## The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery - NCT ID: NCT06300944 - Study ID: Ran Gao-2023-12 - Status: RECRUITING - Start Date: 2023-12-01 - Completion Date: 2024-10-01 - Lead Sponsor: General Hospital of Ningxia Medical University ### Study Description The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia. ### Conditions - Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - saline - Esketamine ### Outcomes Primary Outcomes - Moderate to severe pain - Incidence of adverse reactions including nausea, vomiting and dizziness - Sleep quality Secondary Outcomes - Remifentanil dosage - Additional post-operative analgesics - Postoperative exhaust time of patients ### Location - Facility: General Hospital of Ningxia Medical University, Yinchuan, Ningxia, N/A, China @@
## KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention - NCT ID: NCT06300931 - Study ID: KAPSDFE0948 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-10 - Lead Sponsor: Cairo University ### Study Description This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention. ### Conditions - SDF ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - educational lecture ### Outcomes Primary Outcomes - Assessment of knowledge levels and attitude regarding SDF use before educational intervention Secondary Outcomes - Assessment of knowledge levels and attitude regarding SDF use after educational intervention Correlation between demographic data and use of SDF. ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA - NCT ID: NCT06300918 - Study ID: 2024-KY76 - Status: RECRUITING - Start Date: 2024-03-08 - Completion Date: 2025-08-01 - Lead Sponsor: Jie Li ### Study Description The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points. ### Conditions - The Condition of Fundus Neovascularization ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Time ### Outcomes Primary Outcomes - The number of fundus neovascularization seen in FFA. - The area of fundus neovascularization seen in FFA (using PD size as measurement). - The intensity of neovascularization fluorescein leakage Secondary Outcomes ### Location - Facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial, Chendu, Sichuan, 610014, China @@
## Clinical Study on Malodor - NCT ID: NCT06300905 - Study ID: CRO-2023-05-OMO-SNA-YPZ - Status: COMPLETED - Start Date: 2023-06-01 - Completion Date: 2023-07-02 - Lead Sponsor: Colgate Palmolive ### Study Description This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use. ### Conditions - Oral Malodor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - test product - Control product ### Outcomes Primary Outcomes - Organoleptic Oral Malodor Evaluations Secondary Outcomes ### Location - Facility: West China Dental Institute of Chengdu, Chengdu, Sichuan, 610041, China @@
## Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections - NCT ID: NCT06300892 - Study ID: SURG-2023-31841 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-01 - Lead Sponsor: University of Minnesota ### Study Description This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.* Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.* Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation. ### Conditions - Open GI Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No intervention ### Outcomes Primary Outcomes - alpha diversity composition - microbial community composition - pathogenic strain of bacteria Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique - NCT ID: NCT06300879 - Study ID: 2023-1058 - Status: RECRUITING - Start Date: 2024-01-01 - Completion Date: 2026-06-30 - Lead Sponsor: Huashan Hospital ### Study Description This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22. ### Conditions - Gastric Cancer - Adenocarcinoma of Esophagogastric Junction ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique ### Outcomes Primary Outcomes - Assess intraoperative Perioperative Safety by Duration of surgery. - Assess intraoperative Perioperative Safety by Duration of anastomosis. - Assess intraoperative Perioperative Safety by blood loss . - Postoperative recovery course - Postoperative TNM staging by Pathological findings . Secondary Outcomes - The incidence of postoperative reflux esophagitis - The incidence of postoperative anastomotic stenosis - Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30 - Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale ### Location - Facility: Huashan Hospital, Fudan University, Shanghai, Shanghai, 200040, China @@
## Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste - NCT ID: NCT06300866 - Study ID: CRO-2020-04-PGN-LLU-YPZ - Status: COMPLETED - Start Date: 2020-08-18 - Completion Date: 2021-03-08 - Lead Sponsor: Colgate Palmolive ### Study Description The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use. ### Conditions - Gingivitis - Plaque, Dental ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Test - Control ### Outcomes Primary Outcomes - Whole-Mouth Gingivitis Measurement - Whole-Mouth Dental Plaque Measurement Secondary Outcomes ### Location - Facility: Loma Linda University School of Dentistry, Loma Linda, California, 92350, United States @@
## Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups. - NCT ID: NCT06300853 - Study ID: 2023-07 - Status: RECRUITING - Start Date: 2023-11-14 - Completion Date: 2025-11 - Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar ### Study Description This is an experimental study without drug and device, non-profit, single-center.The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank. ### Conditions - COVID-19 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses ### Outcomes Primary Outcomes - Cellular response evaluation: flow cytometry profiles (proportions of cells) - Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD) - Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD) - Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml) - Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml) - Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml). - Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml) - Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml) - Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml). Secondary Outcomes - Neutralization assays against different human Coronavirus (hCoV). - Whole genome sequencing analysis results ### Location - Facility: IRCCS Sacro Cuore Don Calabria hospital, Negrar, Verona, 37024, Italy @@
## Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH) - NCT ID: NCT06300840 - Study ID: 2023_49 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-04 - Lead Sponsor: Hanna van Eijsden ### Study Description The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction.The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing.Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on).It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt. ### Conditions - Vestibular Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - BalanceBelt ### Outcomes Primary Outcomes - Mobility and Balance Score (MBS) Secondary Outcomes - General functioning - physical activity_NRS - physical activity_steps - Fear of falling - fatigue - falls - structured interview on compliance on wearing the Balancebelt(R) - Questionnaire: vestibular activity avoiding instrument (VAAI) - Questionnaire: Dizziness handicap inventory (DHI) - modified Clinical Test of Sensory Interaction on Balance (mCTSIB) - Dynamic Gait Index (DGI) - Timed up and Go test (TUG) ### Location - Facility: Gelre Hospitals, Apeldoorn, Gelderland, 7334 DZ, Netherlands @@
## The Effect of Structured Digital-Based Education Given to Nursing Students - NCT ID: NCT06300827 - Study ID: 2023 - 1302 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: Gazi University ### Study Description Turkey is a risky country in terms of disasters. Preparedness and awareness for all disasters affecting the whole world gain value. Disaster literacy is an important approach to evaluating disaster preparedness and awareness processes. Disaster literacy is defined as the ability of an individual to access, read, understand, and use the information necessary to make informed decisions and follow instructions in the context of mitigation, preparation, response, and recovery during a disaster Disaster literacy needs to be increased to raise awareness among individuals and minimize disaster risk. Along with the awareness studies, it is also important to identify the disaster preparedness belief in order to encourage individuals to change potentially harmful behavior. Belief in disaster preparedness; It may vary according to the perception of experiencing a disaster, the perceived severity of the disaster, the benefits of being prepared for a disaster, the perceived barriers to being prepared for a disaster, being prepared, and the individual's belief in his or her ability to cope with a disaster. It may be useful to determine both disaster preparedness beliefs and disaster literacy levels of individuals at the social level. It is predicted that when multiple interventions are brought together in the learning process, there will be a faster and more lasting effect. In this study, which aims to use education and information technology together, a structured digital-based educational intervention is planned. The intervention program was structured by taking advantage of both the advantages of the digital world and active learning methods in order to keep the student active. The program is eight weeks and consists of seven dimensions and the purpose of the program is based on accessing information, understanding, information, making decisions, and applying information. The planned study aimed to determine the effect of structured digital-based education given to university students studying in the nursing department on their disaster literacy and disaster preparedness belief levels. ### Conditions - 18 Years and Over ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Structured digital-based training ### Outcomes Primary Outcomes - Disaster Literacy Scale - General Disaster Preparedness Belief Scale Using the Health Belief Secondary Outcomes ### Location - Facility: Gazi University, Ankara, N/A, N/A, Turkey @@
## The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy - NCT ID: NCT06300814 - Study ID: ERU-HEM-EU-01 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-01 - Lead Sponsor: TC Erciyes University ### Study Description This study was planned as a randomized controlled experimental study with a pretest-posttest design to determine the effect of parental supervision and video-guided progressive relaxation exercise (PRE) and music recital on sleep, quality of life and emotional states in children with epilepsy aged 9-16 years. The main questions it aims to answer are as follows:According to the evaluation of children with epilepsy, does the progressive relaxation exercise applied to children have an effect on sleep, quality of life and emotional states? According to the evaluation of children with epilepsy, does music recital applied to children have an effect on sleep quality of life and emotional states? The study consisted of 45 children (15 children in the progressive relaxation exercise group, 15 children in the music recital group and 15 children in the control group). Ethics committee approval, permission from the institutions and informed consent of the children were obtained for the conduct of the study. A value of p\<0.05 was considered statistically significant in data analysis. ### Conditions - Epilepsy in Children ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Progressive relaxation exercise group - Music recital group ### Outcomes Primary Outcomes - The Children's Sleep Habits Questionnaire (CSHQ) Secondary Outcomes - The Pediatric Quality of Life Inventory (PedsQL) - The Me and My School Questionnaire (M&MS) ### Location - Facility: Erciyes University, Kayseri, N/A, N/A, Turkey @@
## Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy - NCT ID: NCT06300801 - Study ID: 2023-48 - Status: NO_LONGER_AVAILABLE - Start Date: N/A - Completion Date: N/A - Lead Sponsor: Erol Olcok Corum Training and Research Hospital ### Study Description Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio (CAR). The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula. The participants invitation is based on the detection of a pancreatic fistula. This study is conducted for research purposes and participation is voluntary. No interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form. ### Conditions - Pancreatic Fistula After Pancreaticoduodenectomy - C-Reactive Protein - Albumin ### Study Design - Type: EXPANDED_ACCESS - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease - NCT ID: NCT06300788 - Study ID: 23-AOI-02 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-10-01 - Lead Sponsor: Centre Hospitalier Universitaire de Nice ### Study Description The investigator aim to identify the role of inorganic pyrophosphate and other anti-calcifying molecules in vascular disease in children with chronic kidney disease, with a view to developing therapeutic approaches aimed at limiting the onset of vasculopathy. ### Conditions - Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - PPI and T50 dosing ### Outcomes Primary Outcomes - Plasma pyrophosphate concentration [PPi]pl in children with CKD Secondary Outcomes - Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation - Markers of phosphocalcic metabolism - Urinary PPi concentration - Markers of vascular damage in CKD ### Location - Facility: CHU Nice - Hôpital de l'Archet 2, Nice, Alpes-Mritimes, 06300, France @@
## Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite - NCT ID: NCT06300775 - Study ID: 123789 - Status: RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-06-01 - Lead Sponsor: Cairo University ### Study Description This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition ### Conditions - Posterior Cross Bite ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - modified hyrax - quad helix ### Outcomes Primary Outcomes - Chewing difficulty Secondary Outcomes ### Location - Facility: Cairo univeristry, Cairo, N/A, N/A, Egypt @@
## RCT Exudate Management Cutimed Sorbion Product Range - NCT ID: NCT06300762 - Study ID: C3079 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-06-30 - Lead Sponsor: BSN Medical GmbH ### Study Description The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated. ### Conditions - Venous Leg Ulcer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Superabsorbent dressing application ### Outcomes Primary Outcomes - Exudate management performance Secondary Outcomes - Dressing change frequency - Moisture-associated skin damages - Occurrence clinical relevant peri-wound skin changes - Changes in wound tissue and general wound pain - Need for debridement after product removal - Patient satisfaction with treatment and product - HCP satisfaction with treatment and product - Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments) ### Location - Facility: Niels Stensen Klinik, Christliches-Klinikum-Melle, Melle, Niedersachsten, 49624, Germany @@
## Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis - NCT ID: NCT06300749 - Study ID: LE-CCM - Status: COMPLETED - Start Date: 2018-10-30 - Completion Date: 2019-01-03 - Lead Sponsor: Mesut Arslan ### Study Description İt is aimed to examine the effect of chiropractic cervical manipulation on pain, functionality and grip strength in patients with lateral epicondylitis and whether it is preferable to placebo. ### Conditions - Lateral Epicondylitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Chiropractic Cervical Manipulation - Sham Technique Practice ### Outcomes Primary Outcomes - Numerical Pain Scale (NPS) - Grip Strength - Patient Rated Tennis Elbow Evaluation (PRTEE) Secondary Outcomes ### Location - Facility: Bitlis Eren University, Bitlis, N/A, 13000, Turkey @@
## Design of a Predictive Score for Contamination of Pediatric Blood Cultures - NCT ID: NCT06300736 - Study ID: 2023PI247 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2022-01-01 - Completion Date: 2024-10-01 - Lead Sponsor: Central Hospital, Nancy, France ### Study Description The contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. It is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time.On a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination.Contamination has major consequences for patient management. Studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. In children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. It also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test.The aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive". ### Conditions - Bacteremia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Blood culture diagnosis Secondary Outcomes - Score performance ### Location - Facility: CHRU Nancy, Nancy, N/A, 54000, France @@
## Clinical Study of BRL-101 in Severe SCD - NCT ID: NCT06300723 - Study ID: 2024-BRL-101-SCD-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-25 - Completion Date: 2026-06-15 - Lead Sponsor: Bioray Laboratories ### Study Description This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101). ### Conditions - Sickle Cell Disease ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - BRL-101 ### Outcomes Primary Outcomes - Proportion of stem cell engrafted subjects - Time to neutrophil engraftment - Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion Secondary Outcomes ### Location - Facility: First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530021, China @@
## Outcomes and Risk Factors of CPR in PICU - NCT ID: NCT06300710 - Study ID: CPR in PICU - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Assiut University ### Study Description 1. To detect the frequency and the underlying causes of cardiopulmonary arrest .2. To detect outcome of CPR3. To identify the associated risk factors for the different outcomes after CPR among those patients ### Conditions - Cardio Respiratory Arrest ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - incidence of cardiac arrest and survival to discharge from the PICU (dead versus alive) Secondary Outcomes - Rate of risk factors associated with outcome of CPR ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project - NCT ID: NCT06300697 - Study ID: HUM00235532 - Status: RECRUITING - Start Date: 2024-02-15 - Completion Date: 2027-03 - Lead Sponsor: University of Michigan ### Study Description This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.This is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types. ### Conditions - Atopic Dermatitis - Food Allergy - Healthy ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Data and biospecimen collection - Skin biopsies - Oral Food Challenge (OFC) procedures ### Outcomes Primary Outcomes - Anaphylaxis occurrence rates in each group Secondary Outcomes - Anaphylaxis severity in each group - Reaction rates in each group - Anaphylaxis likelihood in each group based on the Brighton score ### Location - Facility: University of Michigan, Ann Arbor, Michigan, 48109, United States @@
## Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition - NCT ID: NCT06300684 - Study ID: SBS-2022-0085 - Status: RECRUITING - Start Date: 2022-11-11 - Completion Date: 2025-01 - Lead Sponsor: American University of Beirut Medical Center ### Study Description This study aims to investigate the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleep patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are intricately linked, with dysregulated sleep associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can affect hormonal balance and circadian rhythm. Insomnia and obesity are interrelated public health concerns, with CBTi showing efficacy in improving sleep. This study will recruit participants with insomnia and randomly assign them to receive either CBTi or basic sleep hygiene education. Baseline assessments will include validated questionnaires about insomnia, dietary habits, and physical activity and a 7-day 24-hour diet recall sheets, as well as actigraphy for sleep parameters, and physical activity assessments. The intervention will last for four weeks, with post-intervention assessments conducted similarly to baseline. ### Conditions - Insomnia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cognitive Behavioral Therapy for Insomnia (CBT-i) ### Outcomes Primary Outcomes - Change in Bed Time - Change in Get Up Time - Change in Time in Bed - Change in Sleep Onset Latency (in minutes). - Change in Sleep Efficiency - Change in Wake After Sleep Onset - Change in Late-Night Eating Occasions number - Change in Eating Window Duration and Fasting Window Duration - Change in Number of Meals Secondary Outcomes ### Location - Facility: Lebanese American University, Jbaïl, Keserwan-Jbeil Governorate, 1102-2801, Lebanon @@
## The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance - NCT ID: NCT06300671 - Study ID: PNSÖ-Subtalar pronation - Status: RECRUITING - Start Date: 2023-12-15 - Completion Date: 2024-05-30 - Lead Sponsor: Bahçeşehir University ### Study Description The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. The hip joint can affect the frontal plane alignment from proximal to distal, while the foot and ankle complex can also affect it from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal; is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature. Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. In another study, it is mentioned that there is limited evidence about the effect of foot posture on postural stability. Although there are studies in the literature examining the effects of subtalar joint pronation on lower extremity alignment and postural stability, studies need to examine the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect. ### Conditions - Balance Disorders - Foot Injury - Lower Extremity Problem ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - Foot Posture Index-6 ### Outcomes Primary Outcomes - Postural Stability Secondary Outcomes - Frontal Plane Projection Angle - Foot and Ankle Ability Measurement - Navicular Drop Test - Weight bearing lunge test - Countermovement jump test without arm swing ### Location - Facility: Bahcesehir University, Besiktas, Istanbul, 34353, Turkey @@
## Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery - NCT ID: NCT06300658 - Study ID: 900/2/24 - Status: RECRUITING - Start Date: 2024-03-09 - Completion Date: 2024-09-01 - Lead Sponsor: Aswan University ### Study Description The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery. ### Conditions - Stellate Ganglion Block - Arteriovenous Fistula - Hemodialysis - Major Lower Limb Orthopedic Surgery ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Stellate ganglion block ### Outcomes Primary Outcomes - Fistula flow rate Secondary Outcomes - Peak systolic velocity (PSV) - End diastolic velocity (EDV) - Incidence of failure - Adverse effects ### Location - Facility: Aswan University, Aswan, N/A, 81528, Egypt @@
## SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform - NCT ID: NCT06300645 - Study ID: SPLATTvsTATT in recurrent CTEV - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-17 - Completion Date: 2026-03-01 - Lead Sponsor: Assiut University ### Study Description Congenital talipes equinovarus, is a common congenital foot deformity involving hindfoot equinus and varus, along with mid-/forefoot adduction and cavus. Currently, the Ponseti method is the preferred initial treatment for idiopathic clubfoot1. Despite the initial phase's remarkable efficacy in correcting clubfeet, there remains a notable recurrence rate after Ponseti treatment2* Numerous studies demonstrate a very high success rate during early follow-ups, ranging from 92% to 100%3* Nonetheless, recurrence remains a challenge for orthopedic surgeons. A common trigger for recurrence is the dynamic supination of the foot, which results from excessive activation of the tibialis anterior muscle during ankle dorsiflexion4Multiple studies indicate that tibialis anterior tendon transfer (TATT) is an effective tool for management of clubfoot recurrence, particularly dynamic supination5* The widely used technique involves transferring the entire tendon through a drill hole in the lateral cuneiform and anchoring it on the plantar aspect of the foot using a sewing button and felt pad6* While effective, this procedure raises the risk of pressure sores due to button placement on the sole7Split anterior tibialis tendon transfer (SPLATT) to peroneus brevis is a well-described treatment strategy of varus foot deformities in patients with neuromuscular disorders8* The technique has been reported to achieve successful deformity correction while avoiding skin problems associated with external button placement on the sole of the foot in tendon-to-bone transfers8The present study aims to assess the outcome of utilizing SPLATT to peroneus brevis procedure in the treatment of recurrent CTEV in comparison to the original total TATT to the lateral cuneiform ### Conditions - Recurrent Congenital Talipes Equinovarus ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - SPLATT ### Outcomes Primary Outcomes - Correction of recurrent congenital talipes Secondary Outcomes ### Location - Facility: Assiut university hospital, Assiut, N/A, 71515, Egypt @@
## Geriatric Locomotive Syndrome and Related Factors in Older Adults - NCT ID: NCT06300632 - Study ID: Geriatric Locomotive Syndrome - Status: RECRUITING - Start Date: 2024-04-15 - Completion Date: 2024-07-01 - Lead Sponsor: Kırıkkale University ### Study Description It has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed. However, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age. Early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life. Based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals. ### Conditions - Locomotive Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - geriatric locomotive syndrome ### Outcomes Primary Outcomes - Geriatric Locomotive Function Scale - Two Step Test - Stand Up Test - Tampa Kinesiophobia Scale - Physical Activity Scale for the Elderly (PASE) - Short Physical Performance Battery - Fatigue Severity Scale - Montreal Cognitive Assessment Scale (MoCA) Secondary Outcomes ### Location - Facility: Ayşe Abit Kocaman, Kırıkkale, N/A, N/A, Turkey @@
## Pilates+4MS: Pilates Intervention for Multiple Sclerosis - NCT ID: NCT06300619 - Study ID: 2022-066 - Status: COMPLETED - Start Date: 2022-04-05 - Completion Date: 2022-08-25 - Lead Sponsor: University of Colorado, Colorado Springs ### Study Description The goal of this clinical trial is to test the physical health benefits of seated Pilates in the multiple sclerosis (MS) population. The main questions it aims to answer are: 1) is it feasible to deliver a seated Pilates class for 12 weeks, twice weekly over Zoom in a group format among participants with mild, moderate, and severe multiple sclerosis? 2) what are the mobility, balance, and symptom benefits of a 12-week seated Pilates class? 3) Does incorporating hip and shoulder stabilization augment the benefits compared to a standard seated Pilates protocol? 4) Are there benefits to physical activity participation? Participants will be screened over the phone for eligibility criteria and then scheduled for in-person data collection. In person data collection will involve: 1) completing the Timed 25-Foot Walk a total of 4 times, 2) the Timed Up and Go a total of 4 times, 3) the Berg Balance Scale a total of 2 times, and 4) a set of 8 questionnaires about multiple sclerosis symptoms and impact, and physical activity behavior. Participants will receive a FitBit and then will be randomized into the Pilates only group or the Pilates+4-Quadrant stability group for the intervention. The intervention is 12 weeks long, both groups meet twice weekly on Zoom for 60 minutes with 1 of 2 instructors and other class participants (12 per group). They wear the FitBit for all 12 weeks and then return for testing to repeat testing items 1-4 above. Researchers will compare the functional outcomes between the Pilates only group and the Pilates+4-Quadrant Stability group to see if there are differences in mobility, balance and physical activity outcomes. ### Conditions - Multiple Sclerosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Pilates+4 - Pilates ### Outcomes Primary Outcomes - Timed 25 Foot Walk - Timed Up and Go - Berg Balance Scale Secondary Outcomes - Triaxial Accelerometer (FitBit) Physical Activity Data (minutes of wear time in sedentary time and light, moderate and vigorous physical activity) - The Godin-Shepherd Leisure Time Exercise Questionnaire - Late-Life Function and Disability Instrument Short Form - Leeds Multiple Sclerosis Quality of Life Scale - Modified Fatigue Impact Scale - Multiple Sclerosis Impact Scale ### Location - Facility: Hybl Sports Medicine and Performance Center, Colorado Springs, Colorado, 80918, United States @@
## Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia - NCT ID: NCT06300606 - Study ID: NOL1 and RA - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2024-04-15 - Lead Sponsor: American Hospital of Paris ### Study Description This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement. ### Conditions - Regional Anesthesia - Pain - Intraoperative Monitoring ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - NOL monitoring ### Outcomes Primary Outcomes - pain score - pain score Secondary Outcomes - sedative requirement - anxiolytic requirement - failure of regional anesthesia ### Location - Facility: Gilles BOCCARA, Neuilly-sur-Seine, N/A, 92200, France @@
## Activity of Chronic Inflammation in PCOS - NCT ID: NCT06300593 - Study ID: 1072.6120.292.2022-1 - Status: RECRUITING - Start Date: 2024-01-15 - Completion Date: 2024-06-30 - Lead Sponsor: Jagiellonian University ### Study Description Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes. ### Conditions - Polycystic Ovary Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D - Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters ### Outcomes Primary Outcomes - Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes - Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes - Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes - Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes - Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes - Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes Secondary Outcomes - Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes - Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes - Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes - Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes - Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes - Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes - Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes ### Location - Facility: Jagiellonian University Medical College, Krakow, N/A, 31-501, Poland @@
## Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers - NCT ID: NCT06300580 - Study ID: M23-991 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-03 - Completion Date: 2024-10-30 - Lead Sponsor: AbbVie ### Study Description The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer \[11C\]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects.ABBV-932 is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom.Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days.Participants will be confined for approximately 15 days. Participants will receive 3 \[11C\]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - ABBV-932 ### Outcomes Primary Outcomes - Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET) - Number of Participants with Adverse Events (AEs) Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis. - NCT ID: NCT06300567 - Study ID: CFTR-RD misdiagnosis - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2026-11-02 - Lead Sponsor: Hôpital Necker-Enfants Malades ### Study Description Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis ### Conditions - CFTR-RD ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - data collection ### Outcomes Primary Outcomes - lung Imaging Secondary Outcomes - lung infection - pancreatic function ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## 10th Mountain Healthy Minds Program App Study - NCT ID: NCT06300554 - Study ID: 2023-1653 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2024-06 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members. ### Conditions - Well-Being, Psychological ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Healthy Minds Program App ### Outcomes Primary Outcomes - System Usability Scale Score - Acceptability of Intervention Measure (AIM) - Intervention Appropriateness Measure (IAM) - Feasibility of Intervention Measure (FIM) - HMP App Usage: Did you use the Healthy Minds Program App (Yes or No) - HMP App Usage: Did you download the Healthy Minds Program App (Yes or No) Secondary Outcomes - Change in Perceived Stress Score - Change in WHO-5 Well-Being Score - Change in PROMIS Depression Score - Change in PROMIS Anxiety Score - Change in Meaning of Life Questionnaire - Presence Subscale Score - Change in NIH Toolbox Loneliness Score - Change in Suicide Cognitions Scale Score - HMP App Usage: How many times did you use the HMP App ### Location - Facility: University of Wisconsin, Madison, Wisconsin, 53705, United States @@
## Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease - NCT ID: NCT06300541 - Study ID: 940730 - Status: RECRUITING - Start Date: 2021-04-01 - Completion Date: 2027-12-01 - Lead Sponsor: Sahlgrenska University Hospital, Sweden ### Study Description Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality.The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course.The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function. ### Conditions - Inflammatory Bowel Diseases - Sarcopenia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Colectomy ### Outcomes Primary Outcomes - Number of participants with increase in muscle mass as assessed by DEXA scan. Secondary Outcomes ### Location - Facility: Sahlgrenska University Hospital, Gothenburg, N/A, 41345, Sweden @@
## Pemigatinib for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma or Marginal Zone Lymphoma - NCT ID: NCT06300528 - Study ID: OSU-23423 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-30 - Completion Date: 2025-12-31 - Lead Sponsor: Narendranath Epperla ### Study Description This phase II trial tests how well pemigatinib works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Pemigatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ### Conditions - Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue - Recurrent Mantle Cell Lymphoma - Recurrent Marginal Zone Lymphoma - Recurrent Nodal Marginal Zone Lymphoma - Recurrent Splenic Marginal Zone Lymphoma - Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue - Refractory Mantle Cell Lymphoma - Refractory Marginal Zone Lymphoma - Refractory Nodal Marginal Zone Lymphoma - Refractory Splenic Marginal Zone Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Bone Marrow Aspiration - Bone Marrow Biopsy - Computed Tomography - Pemigatinib - Positron Emission Tomography ### Outcomes Primary Outcomes - Overall response rate (ORR) Secondary Outcomes - Complete response (CR) rate - Duration of response (DOR) - Progression-free survival (PFS) - Overall survival (OS) - Incidence of adverse events (AEs) ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation - NCT ID: NCT06300515 - Study ID: PI23/00396 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-12-31 - Lead Sponsor: Alejandro Lucia ### Study Description Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units. ### Conditions - Hematopoietic System--Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Control Group (Active Comparator) - Intervention Group ### Outcomes Primary Outcomes - Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up - Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up Secondary Outcomes - Change in isometric leg muscle strength from baseline to follow-up - Change in dynamic lower-limb muscle strength from baseline to follow-up - Change in upper-limb muscle strength from baseline to follow-up - Change in respiratory muscle strength from baseline to follow-up - Change in the 'ventilatory threshold' (VT) from baseline to follow-up - Change in left ventricle (LV) ejection fraction from baseline to follow-up - Change in left ventricle (LV) fractional shortening from baseline to follow-up - Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up - Change in total cardiac mass from baseline to follow-up - Change in functional mobility (stairs test) from baseline to follow-uo - Change in functional mobility (chair rising) from baseline to follow-up - Change in functional mobility (Quick Function test) from baseline to follow-up - Change in body mass index (BMI) from baseline to follow-up - Change in adiposity index from baseline to follow-up - Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up - Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up - Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up - Change in physical activity (PA) from baseline to end of treatment - Change in ankle-dorsiflexion from baseline to end of treatment - Change in psychological status (health-related quality of life) from baseline to follow-up - Change in psychological status (fatigue) from baseline to follow-up - Change in lymphocyte subpopulations from baseline to follow-up - Change in immune phenotype from baseline to follow-up - Change in survival from baseline to follow-up - Change in treatment tolerability from baseline to follow-up - Change in treatment toxicities from baseline to follow-up - Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge - Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge - Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge - Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge ### Location - Facility: Hospital 12 de Octubre, Madrid, N/A, 28041, Spain @@
## Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs) - NCT ID: NCT06300502 - Study ID: 2023P003620 - Status: NOT_YET_RECRUITING - Start Date: 2024-06 - Completion Date: 2025-12 - Lead Sponsor: Massachusetts General Hospital ### Study Description This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site.This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place. ### Conditions - Neurofibromas, Cutaneous - Neurofibromatosis 1 ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: OTHER ### Interventions - Kybella - Asclera - 755nm Alexandrite Laser - 1064nm Nd:YAG Laser ### Outcomes Primary Outcomes - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Secondary Outcomes - Numeric Rating Scale (NRS-11)/Patient Satisfaction - Skindex 16 - Patient Reported Outcomes - Clinician Reported Outcomes ### Location - Facility: Wellman Center for Photomedicine, Boston, Massachusetts, 02114, United States @@
## Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer - NCT ID: NCT06300489 - Study ID: CARTOnG-2401 - Status: RECRUITING - Start Date: 2024-03-03 - Completion Date: 2025-10-31 - Lead Sponsor: Zhejiang Cancer Hospital ### Study Description This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 \* 28 and \* 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study，and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy. ### Conditions - Rectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - irinotecan liposomes+capecitabine ### Outcomes Primary Outcomes - DLT（dose-limiting toxicity） - MTD（maximum tolerable dose） Secondary Outcomes ### Location - Facility: Zhejiang Cancer Hospital, Hangzhou, Zhejiang, N/A, China @@
## Safety and Efficacy of a Single Subretinal Injection of JWK006 Gene Therapy in Subjects With Stargardt Disease(STGD1) - NCT ID: NCT06300476 - Study ID: 2023-1511 - Status: ACTIVE_NOT_RECRUITING - Start Date: 2023-11-20 - Completion Date: 2029-12-30 - Lead Sponsor: West China Hospital ### Study Description The purpose of the study is to assess the safety and efficacy of JWK006 in Stargardt Disease(STGD1).JWK006 is packed by adeno-associated virus vector that expressing ABCA4 gene. ### Conditions - Stargardt Disease 1 ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - JWK006 ### Outcomes Primary Outcomes - Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events) Secondary Outcomes - Visual acuity - Ophthalmoscope Measurement - Qualitative and quantitative assessments of autofluorescence pattern (FAF) - multifocal electroretinogram (mfERG) ### Location - Facility: West China Hospital, Chengdu, Sichuan, 610044, China @@
## Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases - NCT ID: NCT06300463 - Study ID: 23-06026214 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2027-03 - Lead Sponsor: Weill Medical College of Cornell University ### Study Description The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:* whether these combinations of immunotherapy change the tumor microenvironment in the liver* whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastasesParticipants will be randomly assigned to one of the following:* Botensilimab and balstilimab* Botensilimab, balstilimab, and AGEN1423* Botensilimab, balstilimab, and radiationParticipants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years. ### Conditions - Colorectal Cancer Metastatic - Liver Metastases - Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Botensilimab - Balstilimab - AGEN1423 - Radiation ### Outcomes Primary Outcomes - Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm Secondary Outcomes - Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm - Pathological Response Rate Per Arm - Radiographic Response Rate Per Arm - Number of Participants Per Arm with ctDNA Clearance ### Location - Facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, 10065, United States @@
## Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy - NCT ID: NCT06300450 - Study ID: 2022P002171 - Status: RECRUITING - Start Date: 2023-03-01 - Completion Date: 2025-07-30 - Lead Sponsor: Brigham and Women's Hospital ### Study Description This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy. ### Conditions - Peripheral Artery Disease - Peripheral Vascular Diseases - Dyslipidemias ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Computer Alert ### Outcomes Primary Outcomes - Frequency of prescription of oral LDL-C-lowering therapy Secondary Outcomes - Change in LDL-C level ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program - NCT ID: NCT06300437 - Study ID: MS-372-2023 - Status: RECRUITING - Start Date: 2024-03-03 - Completion Date: 2024-08-01 - Lead Sponsor: Kasr El Aini Hospital ### Study Description In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program. ### Conditions - Intubation ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - jaw thrust - control (sub laxed jaw) ### Outcomes Primary Outcomes - time to successful endotracheal tube insertion Secondary Outcomes - Number of attempts to successful intubation - Complication ### Location - Facility: Cairo university hospitals, Cairo, N/A, N/A, Egypt @@
## Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC - NCT ID: NCT06300424 - Study ID: KY2024-162 - Status: RECRUITING - Start Date: 2024-04 - Completion Date: 2027-09 - Lead Sponsor: Guangdong Provincial People's Hospital ### Study Description Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions. ### Conditions - Non Small Cell Lung Cancer - EGFR Gene Mutation ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - almonertinib - Carboplatin - Nab paclitaxel ### Outcomes Primary Outcomes - Major Pathological Response (MPR) Secondary Outcomes - Pathological Complete Response (pCR) - Objective Response Rate (ORR) ### Location - Facility: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, 510080, China @@
## SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery - NCT ID: NCT06300411 - Study ID: SRG-514-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-09 - Lead Sponsor: SURGE Therapeutics ### Study Description This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts. ### Conditions - Breast Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - SRG-514 ### Outcomes Primary Outcomes - Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability] - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Secondary Outcomes - Pharmacokinetics of SRG-514 - Pharmacokinetics of SRG-514 - Pharmacodynamics of SRG-514 - Wound healing ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## IAMA-6 Oral Dose Study in Healthy Adults - NCT ID: NCT06300398 - Study ID: ECS_IAMA23_0101 - Status: RECRUITING - Start Date: 2024-01-08 - Completion Date: 2024-09 - Lead Sponsor: Iama Therapeutics S.r.l. ### Study Description The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults. ### Conditions - Neurodevelopmental Disorders ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: OTHER ### Interventions - IAMA-6 - Placebo ### Outcomes Primary Outcomes - Number of participants with adverse events (AEs) - Number of participants with serious adverse events (SAEs) - Number of participants with physical examination abnormalities - Number of participants with vital sign abnormalities - Number of participants with electrocardiogram (ECG) abnormalities - Number of participants with clinical laboratory abnormalities - Number of participants with hearing abnormalities Secondary Outcomes - Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses - Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses - T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses - AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses - Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses - CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses - λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses - Urine volume - Na+ excretion - K+ excretion - Sleep assessment ### Location - Facility: Centro Ricerche Cliniche Di Verona S.r.l., Verona, N/A, N/A, Italy @@
## Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes - NCT ID: NCT06300385 - Study ID: IstanbulBUFC5 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-07-01 - Lead Sponsor: Istanbul Bilgi University ### Study Description Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes. ### Conditions - Sports Injury ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Electromyostimulation - Strengthening exercises ### Outcomes Primary Outcomes - Visual analog scale - Strength measurement - Fatigue assessment - Grip strength assessment Secondary Outcomes ### Location - Facility: Istanbul Bilgi University, Istanbul, N/A, 34440, Turkey @@
## Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors - NCT ID: NCT06300372 - Study ID: Medipol Hospital 2 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2024-08-01 - Lead Sponsor: Istanbul Medipol University Hospital ### Study Description Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery. ### Conditions - Liver Failure - Acute Postoperative Pain ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - M-TAPA plane block - Postoperative pain management ### Outcomes Primary Outcomes - Opioid consumption (Fentanyl PCA) Secondary Outcomes - Pain scores (Numerical rating scale-NRS - Need for rescue analgesia (meperidine) - Adverse events ### Location - Facility: Istanbul Medipol University Mega Hospital Complex, Istanbul, Bagcilar, N/A, Turkey @@
## Prognostic Indicators of Gullian-Barre Syndrome - NCT ID: NCT06300359 - Study ID: Prognostic indicators of GBS - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-06 - Lead Sponsor: Assiut University ### Study Description Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments. ### Conditions - Guillain-Barre Syndrome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prognostic indicators of Gullian-Barre syndrome Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@

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