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## Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration - NCT ID: NCT06323746 - Study ID: HR-EEG-CSAR - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-12 - Lead Sponsor: University of Sharjah ### Study Description The goal of this Randomized clinical trial is to learn about how fixing neck curvature and head posture right away affects heart rate, brainwaves, and muscle coordination in college athletes. The main question it aims to answer:- Whether forward head posture (FHP) may play a crucial role in affecting heart rate variability, brainwaves, and muscle coordination. ### Conditions - Cervical Lordosis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Denneroll cervical traction orthodontic ### Outcomes Primary Outcomes - Cervical Sagittal Alignment Radiographs - Cervical Sagittal Alignment Radiographs Secondary Outcomes - Heart rate Variability (HRV) physiological parameter - Corticomuscular Coherence ### Location - Facility: University of Sharjah, Sharjah, N/A, 0000, United Arab Emirates @@
## Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up. - NCT ID: NCT06323733 - Study ID: 2CAPA - Status: ENROLLING_BY_INVITATION - Start Date: 2024-01-01 - Completion Date: 2026-01 - Lead Sponsor: Peyrachon Romane ### Study Description The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms.Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention. ### Conditions - Cachexia-Anorexia Syndrome ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise Intervention ### Outcomes Primary Outcomes - Health-Related Quality of Life Secondary Outcomes - Body weight - Body mass index - Lean mass - Fat mass - Aerobic fitness - Muscular strength of the lower limbs - Handgrip strength - Static balance ability - Appetite - Cancer-related Fatigue - Physical Activity and Sedentary Levels - Stages of change for exercise - Exercise beliefs ### Location - Facility: SPORMED, Rennes, Bretagne, 35000, France @@
## Signs of Central Sensitization in Tension-type Headache - NCT ID: NCT06323720 - Study ID: ONZ-2023-0442 - Status: RECRUITING - Start Date: 2024-02-23 - Completion Date: 2025-12 - Lead Sponsor: University Ghent ### Study Description The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:- Are signs of central sensitization present in tension-type headache?Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group. ### Conditions - Tension-Type Headache ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Quantitative Sensory Testing ### Outcomes Primary Outcomes - Pain sensitivity for heat stimuli - Pain sensitivity for cold stimuli - Pain sensitivity for electrical stimuli - Pain sensitivity for pressure - Function of the pain facilitating pathways - Function of the pain inhibiting pathways Secondary Outcomes ### Location - Facility: Ghent University, Ghent, East-Flanders, 9000, Belgium @@
## The IMPACT Implementation-Effectiveness Trial - NCT ID: NCT06323707 - Study ID: IMPACT - Status: NOT_YET_RECRUITING - Start Date: 2024-03-15 - Completion Date: 2027-03-15 - Lead Sponsor: McMaster University ### Study Description More Canadians are surviving cancer, however, individuals with cancer live with side effects for years after treatments have ended. The physical and psychosocial benefits of regular physical activity (PA) during and after cancer treatment are well established. However, less than 30% of individuals with cancer meet current PA recommendations and PA levels decline significantly during treatment. PA services within the cancer institution to support well-being during treatment are not available for survivors across Ontario. Strategies are needed within cancer centres to close the gap between the evidence and clinical practice.What is the purpose? To evaluate the effectiveness of a novel exercise and education strategy for individuals with cancer during treatment.What are we proposing to do? This project includes two parts. In Part 1 participants will be put into one of three groups. Group 1 (Exercise \& self-management) will include eight sessions of supervised, institution-based exercise and self-management education. Group 2 (self-management only) will include eight virtual self-management education sessions with an exercise professional. Group 3 will receive usual care (i.e., no intervention).In Part 2 participants who attended less than 75% of their sessions will be asked to complete an interview on the barriers to continuing with the study during cancer treatment.Why is this work important? Findings from this trial will inform the way PA services are provided within cancer institutions across Ontario. This novel strategy incorporates both institution-based and home-based exercise strategies during treatment and highlights the importance of individuals with cancer taking an active role in managing their condition during treatment. This can prevent future complications and decrease burden on the individual and the healthcare system. Results will inform future decisions on PA implementation strategies for cancer survivors with diverse needs across Ontario. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Exercise - Self-management e-module ### Outcomes Primary Outcomes - Physical activity level Secondary Outcomes - Physical activity level - Physical activity level - Quality of life - Quality of life - Quality of life - Level of exercise knowledge - Level of exercise knowledge - Level of exercise knowledge - Health status - Health status - Health status - Aerobic capacity - Aerobic capacity - Aerobic capacity - Cardiovascular outcomes - Blood pressure - Cardiovascular outcomes - Blood pressure - Cardiovascular outcomes - Blood pressure - Cardiovascular outcomes - Heart rate - Cardiovascular outcomes - Heart rate - Cardiovascular outcomes - Heart rate - Health care utilization - Health care utilization - Health care utilization ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery - NCT ID: NCT06323694 - Study ID: Attesa chirurgia-1 - Status: COMPLETED - Start Date: 2022-05-15 - Completion Date: 2024-02-16 - Lead Sponsor: Istituto Ortopedico Rizzoli ### Study Description The objective of this qualitative prospective observational study is to analyze the cognitive aspect, the emotional-behavioral state and the quality of life of patients during their stay on the waiting list for two categories of lumbar spinal surgery: arthrodesis and percutaneous vertebroplasty.Hypothesis:Considering the existing evidence that associates some peculiar psychological components (expectations, beliefs, fears, coping strategies) of the patient and the outcome of spinal surgery, as well as the importance that the waiting time for the intervention assumes for recovery post-operative, this study aims to investigate the subjective perception of one's condition and the waiting period prior to the expected spinal surgery.This is a qualitative prospective observational study, monocentric with variable sample up to the level of saturation. The blind members are the staff who will listen to the recordings of the interviews and prepare the summary table of the same and the statistical researcher who will perform the analyzes.The selection of the participants will be carried out in such a way as to ensure a heterogeneous sample in terms of age, sex and experience and as representative as possible of the population studied.The number of participants in qualitative studies is usually determined by intentional sampling, based on the need to understand the full range of possible responses, to obtain the so-called data saturation.All patients on the waiting lists of the Department of Spinal Surgery, for vertebral arthrodesis or percutaneous vertebroplasty are considered eligible.The two types of surgery differ both in the surgical procedure and in the duration of the wait before surgery, which is 1-2 months for vertebroplasty and more than one year for spinal arthrodeses which are not of urgency or priority. ### Conditions - Spinal Surgery ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - quality of life ### Outcomes Primary Outcomes - Descriptive survey for vertebroplasty patients - Descriptive survey for spinal arthrodeses patients Secondary Outcomes ### Location - Facility: Istituto Ortopedico Rizzoli, Bologna, N/A, 40136, Italy @@
## Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study） - NCT ID: NCT06323681 - Study ID: Leading Study - Status: RECRUITING - Start Date: 2024-02-04 - Completion Date: 2027-08 - Lead Sponsor: Qing XIe ### Study Description Previous clinical practice and exploratory studies suggest that some patients who have not achieved functional cure in the first round of interferon therapy can achieve HBsAg clearance by interferon retreatment (intermittent therapy), which can reduce the occurrence of complications such as liver fibrosis, liver cirrhosis and liver cancer, and its clinical benefit is expected to be higher than that of NAs monotherapy.This study is aimed to conduct a large-scale, multicenter, prospective study to confirm the benefit of peginterferon-based therapies in these populations. It expected to enroll about 2000 patients with chronic hepatitis B who have received prior interferon therapy and achieved a good response but without function cure, patients receive either interferon-based therapy or NAs monotherapy, according to their wishes and doctors' professional recommendations, with a ratio of 2:1 between the two groups, and all patients treated for 48 weeks. The HBsAg clearance rate before and after treatment, safety, etc. will be analyzed. ### Conditions - Chronic Hepatitis b ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Peginterferon α-2b based treatment group - NAs monotherapy group ### Outcomes Primary Outcomes - Proportion of patients with HBsAg below the lower limit of detection. Secondary Outcomes - Decrease of HBV DNA levels at week 48 compared to baseline. - Proportion of patients with HBV DNA below the lower limit of detection. - Decrease of HBsAg levels at week 48 compared to baseline. - Proportion of patients with HBsAg seroconversion. - Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive. - Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive. - Serious adverse events. ### Location - Facility: Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, N/A, China @@
## Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment - NCT ID: NCT06323668 - Study ID: H-23067693 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2038-01-31 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection.The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection).The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection. ### Conditions - Cardiac Implantable Electronic Device Infection ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cardiac implantable electronic device extraction - Empirical antibiotic therapy ### Outcomes Primary Outcomes - Rate of death or relapse bacteremia Secondary Outcomes - Days alive and out-of-hospital - Rate of death - Rate of readmission for any cause - Rate of cardiac implantable electronic device extraction - Rate of relapse bacteremia (the same microorganism) - Rate of bacteremia (all species) - Rate of definite CIED infection ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects - NCT ID: NCT06323655 - Study ID: VP-VEC-162-1201 - Status: COMPLETED - Start Date: 2018-07-19 - Completion Date: 2018-08-28 - Lead Sponsor: Vanda Pharmaceuticals ### Study Description The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects. ### Conditions - Healthy Volunteers ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: BASIC_SCIENCE ### Interventions - Tasimelteon - Active Control Placebo - Tasimelteon Placebo - Active Control ### Outcomes Primary Outcomes - Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP) Secondary Outcomes ### Location - Facility: Vanda Investigational Site, Laval, Quebec, N/A, Canada @@
## Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia - NCT ID: NCT06323642 - Study ID: F.1-1/20ERB/SZABMU/941 - Status: RECRUITING - Start Date: 2023-09-01 - Completion Date: 2024-03-31 - Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University ### Study Description Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia. ### Conditions - Pneumonia - Probiotics ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - probiotic containing Lactobacillus rhamnosus GG. - placebo ### Outcomes Primary Outcomes - Number of days in hospital Secondary Outcomes - Number of days with cough, fever ### Location - Facility: Pakistan Institute of Medical Sciences, Islamabad, Punjab, 12000, Pakistan @@
## Effects of Recursive Self-feedback on Speech Production in Aphasia - NCT ID: NCT06323629 - Study ID: STUDY006201 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2025-03 - Lead Sponsor: University of South Florida ### Study Description The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:• To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?Participants will be engaged in the following activities:* They will perform language and cognitive tasks.* Afterwards, they will receive treatments using tablets and headphones at no cost to them.* The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.* The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.* Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production. ### Conditions - Aphasia - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Adaptive recursive self-feedback procedure - Non-adaptive recursive self-feedback procedure ### Outcomes Primary Outcomes - Speaking rate - Speech initiation latency in milliseconds Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics - NCT ID: NCT06323616 - Study ID: 2023/2343 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2024-09-01 - Lead Sponsor: Istanbul University ### Study Description Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \>12 points for the diagnosis of ED is 100% and the specificity is 94.5%.Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed. ### Conditions - Anesthesia - Emergence Delirium - Anesthesia Awareness - Behavior Child Problems - Postoperative Delirium - Postoperative Complications ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SCREENING ### Interventions - MAC adjustment to PSI between 25 and 50 ### Outcomes Primary Outcomes - ED/EA incidence Secondary Outcomes - mYPAS - PSI <25 episode duration - PSI >50 episode duration - PSI <25 number of episodes - PSI >50 number of episodes - Suppresyon ratio - SEF95R - SEF95L - Mean blood pressure - Heart rate - SpO2 - Total amount of sevoflurane used - Total amount of remifentanil used - MAC - Waking up time - Pupil size - Anesthesia duration - Surgery duration - PHBQ - Ped-PADS - Time of discharge from hospital ### Location - Facility: Istanbul University, Istanbul, N/A, N/A, Turkey @@
## Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic - NCT ID: NCT06323603 - Study ID: 3-1 - Status: RECRUITING - Start Date: 2023-06-30 - Completion Date: 2024-09 - Lead Sponsor: Ricard Marcos ### Study Description The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics. ### Conditions - Occupational Exposure - Genotoxicity - Damage Dna ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Micro and nanoplastic ### Outcomes Primary Outcomes - Characterization of macro and nanoplastics - Genotoxic evaluation by the Micronucleus assay - Genotoxic evaluation by the Comet assay - Cytokine release - Microbiota analysis from feces by MinIOn Secondary Outcomes - Analyses of surrogate biomarkers ### Location - Facility: Textile industry, Helsinki, N/A, N/A, Finland @@
## Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study - NCT ID: NCT06323590 - Study ID: UAB 2372 - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2028-05 - Lead Sponsor: University of Alabama at Birmingham ### Study Description The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy. ### Conditions - Acute Myeloid Leukemia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - rates of complete remission Secondary Outcomes ### Location - Facility: University of Alabama at Birmingham, Birmingham, Alabama, 35294, United States @@
## Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA - NCT ID: NCT06323577 - Study ID: TUH rKA vs MA TKA - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2026-05-31 - Lead Sponsor: Thammasat University Hospital ### Study Description The goal of this RCT is to investigate efficacy between restricted kinematic alignment and mechanical alignment TKA in simultaneous bilateral TKA patients.The main question\[s\] it aims to answer are:* Does rKA have better functional outcomes than MA in simultaneous bilateral TKA patients?* Does rKA have lower pain score than MA in simultaneous bilateral TKA patients? Participants will undergo simultaneous bilateral TKA and randomized one side will use rKA and the other side will use MA. ### Conditions - Osteoarthritis, Knee - TKA ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Restricted kinematic alignment - Mechanical alignment ### Outcomes Primary Outcomes - Forgotten joint score Secondary Outcomes - Modified WOMAC score - Range of motion - Pain score - Hip knee ankle angle - Complications - Incidence of soft tissue releasing ### Location - Facility: Thammasat University, Khlong Luang, Pathum Thani, 12120, Thailand @@
## Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease. - NCT ID: NCT06323564 - Study ID: 21C223 - Status: RECRUITING - Start Date: 2023-01-13 - Completion Date: 2025-01-13 - Lead Sponsor: Istituto Auxologico Italiano ### Study Description The main aim of this study is to demonstrate how disorders characterized by different types of "inflexibility", cognitive-affective type for Anorexia nervosa and motor one for Parkinson's disease, have an impact on how emotional stimuli are processed and on the transition within emotional states. ### Conditions - Anorexia Nervosa - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Neuropsychological tests in PD - Self-report questionnaires in PD - International Affective Picture System (IAPS) - Neuropsychological tests in AN - Self-report questionnaires in AN - Analysis of bio-humoral parameters ### Outcomes Primary Outcomes - Change in International Affective Picture System (IAPS) Secondary Outcomes - Change in self-report questionnaires - STAI - Change in self-report questionnaires - BDI - Change in Heart rate variability - Change in analysis of bio-humoral parameters ### Location - Facility: Istituto Auxologico Italiano, Oggebbio, N/A, 28824, Italy @@
## The Effect of Mother's Smell and Breast Milk Smell on Pain - NCT ID: NCT06323551 - Study ID: 2023/50 - Status: RECRUITING - Start Date: 2024-03-14 - Completion Date: 2024-12-24 - Lead Sponsor: Tarsus University ### Study Description The research was planned as a randomized controlled study to investigate the effect of breast milk smell and mother's smell applied while heel blood was taken to term babies in the Mersin City EAH Neonatal Intensive Care Unit between October and December 2023, on acute pain and crying duration. During the heel prick procedure, which is routinely performed in the neonatal intensive care unit, no pharmacological/non-pharmacological method will be applied to the control group to reduce the baby's pain before, during and after the heel prick. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure.In the study group that will be made to smell the mother's scent; The mother of each baby whose heel blood will be taken will be given a specially made cover made of 100% cotton yarn, sterilized the day before, and the mother will be asked to put the cover on her bare skin (on her bare skin) after the shower and to keep the cover on the mother's chest for one night (8 hours). It will be placed 15 cm away from the baby and smelled 5 minutes before and 5 minutes after the heel prick attempt. The baby's pain score will be evaluated by the observing nurse according to the NIPS pain scale 5 minutes before, during and 5 minutes after the procedure. ### Conditions - Newborn; Vitality - Pain - Crying ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - Mother's Smell - Mother's Breast Milk Smell ### Outcomes Primary Outcomes - Neonatal Infant Pain Scale Secondary Outcomes - criying time ### Location - Facility: Tarsus State Hospital, Mersin, N/A, N/A, Turkey @@
## Cohort Study on Plant-based Diets (COPLANT Study) - NCT ID: NCT06323538 - Study ID: 01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2047-03-31 - Lead Sponsor: German Federal Institute for Risk Assessment ### Study Description The Cohort on Plant-based Diets (COPLANT) study is a multi-centre cohort study that starts baseline recruitment from 2024 to 2027 with approximately 6,000 participants in Germany and Austria. The COPLANT study focuses on vegan (no animal products), vegetarian (no meat and fish, but dairy products and eggs), pescetarian (no meat, but fish) and omnivorous (mixed diet including all possible animal products) diets. The aim of the COPLANT study is to gain new insights on health benefits and risks as well as social, ecological and economic effects of different plant-based diets in comparison to a mixed diet. In addition to a detailed dietary survey using an app adapted to the needs of this study, the baseline examination includes measurements of body composition, bone health, cardiovascular risk factors, diabetes risk, contaminants and lifestyle. For the basic laboratory program, fasting blood, 24-hour urine collection and a stool sample are taken from all study participants. Furthermore, specific aspects of dietary behavior, physical activity and other lifestyle factors are collected via questionnaires. Follow-up studies are planned at intervals of 5, 10 and 20 years after the baseline visit. ### Conditions - Dietary Exposure - Diabetes Mellitus, Type 2 - Cardiovascular Diseases - Bone Loss - Sustainability - Exposure - Obesity - Vitamin Deficiency - Mineral Deficiency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Incidence of diabetes type 2 Secondary Outcomes - Incidence of cardiovascular diseases - Incidence of cancer - Vitamin B12 - Holo-transcobalamine - Homocysteine - Methylmalonic acid - Vitamin B1 status - Vitamin B2 status - Vitamin B6 status - Vitamin C status - Vitamin D status - Vitamin E status - Iron - Ferritin - Transferrin - Zinc status - Selenium status - Iodine status - Blood pressure - Blood lipids - Fasting insulin - Fasting glucose - Glycated hemoglobin (HbA1c) - C-peptide - Osteocalcin - Ostase - Parathormone - N-terminal propeptide of type I procollagen (PINP) - C-terminal telopeptide of type I collagen (CTX) - Creatinine - Uric acid - Cytstatin C - Thyroid stimulating hormone (TSH) - Free triiodothyronine (fT3) - Free thyroxine (fT4) - Body fat - Skeletal muscle mass - Total Body Water - Energy intake - Nutrient intake - Intake of dietary supplements - Intake of medication ### Location - Facility: University Vienna, Vienna, N/A, 1090, Austria @@
## TCR Reserved and Power3 Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma - NCT ID: NCT06323525 - Study ID: CHN-PLAGH-BT-083 - Status: RECRUITING - Start Date: 2024-04-17 - Completion Date: 2027-04-25 - Lead Sponsor: Chinese PLA General Hospital ### Study Description The safety and efficacy of the chimeric antigen receptor (CAR)-T, a CD19-targeting, TRAC and Power3 double genes deleted allogeneic CAR-T cell product, are undergoing rigorous evaluation in non-Hodgkin's lymphoma (NHL) subjects from our ATHENA trial (NCT06014073). Unexpectedly, expansion of the initial residual CD3-positive CAR T from products were measured in patients' peripheral blood (PB) without exception. Accompanying with host immune reconstitution and appearance of the detectable B cells, the CD3-positive allogenic CAR T cells exhibited a compelling amplification advantage over CD3-negative CAR T cells. The amplification of CD3-positive CAR T cell population dynamically suppressed host B cell recovery, and presumably surveilled the recurrence or progression of tumors, but did not induce typical Graft-versus-host-disease (GvHD). Additionally, a series of in vitro experiments illustrated that the HLA-mismatched fratricide between host T cells and TCR-reserved Power3-deleted allogenic CAR T cells was markedly slashed, which in combination with our observed clinical safety date supported the notion that only genomic deletion of Power3 gene in allo-CAR T cells is sufficient to overcome GvHD and host T cell-mediated rejection response.In the ATHENA-2 study, our design is to preserve the expression of the TCR on T cells from healthy donors while selectively disabling the Power3 gene to prepare ATHENA-2 CAR T cells. This approach harnesses the tonic signaling of CAR T cells, resulting in enhanced persistence and improved response to treatment. The purpose of this study is to evaluate the safety and efficacy of ATHENA-2 in B-cell NHL. ### Conditions - Non-hodgkin Lymphoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - TCR reserved and Power3 gene knock-out allogeneic CD19-targeting CAR-T cell (ATHENA-2 CAR-T) - Fludarabine - Cyclophosphamide ### Outcomes Primary Outcomes - Phase 1: Incidence of adverse events (AEs) defined as DLT - Phase 1: Recommended phase 2 dose (RP2D) - Phase 2: 3-month objective response rate (ORR) - Phase 2: Complete response (CR) rate - Phase 2: Duration of Response (DOR) - Phase 2: Overall Survival (OS) - Phase 2: Progression Free Survival (PFS) Secondary Outcomes - Phase 1 and phase 2: Pharmacokinetics: Level of ATHENA-2 CAR-positive T cells circulating in blood over time - Phase 1 and phase 2: Pharmacodynamics: Level of CD19+ cells in peripheral blood - Phase 1 and phase 2: Level of serum cytokines in peripheral blood - Phase 1: 3-month ORR - Phase 1: OS - Phase 1: PFS - Phase 2: Incidence of AEs ### Location - Facility: Biotherapeutic Department of Chinese PLA General Hospital, Beijing, Beijing, 100853, China @@
## Pulmonary Arteyr Denervation for Heart Failure - NCT ID: NCT06323512 - Study ID: Nanjing - Status: NOT_YET_RECRUITING - Start Date: 2024-06-01 - Completion Date: 2025-12-30 - Lead Sponsor: Nanjing First Hospital, Nanjing Medical University ### Study Description Prolonged pulmonary venous congestion culminates in pulmonary hypertension, defined as a mean pulmonary arterial pressure \> 20 mmHg and pulmonary artery wedge pressure \>15 mmHg at rest, as determined by right heart catheterization. Pulmonary hypertension secondary to heart failure (PH-HF) is further stratified into isolated post-capillary pulmonary hypertension (Ipc-PH, pulmonary vascular resistance (PVR) is ≤2 Woods Unit) and combined pre- and post-capillary pulmonary hypertension (Cpc-PH, PVR \> 2 Woods Unit), the later reflecting additional pulmonary vascular constriction or remodeling in addition to passive PH. While medications tailored for World Health Organization defined Group I pulmonary arterial hypertension are not endorsed for PH-HF according to current guidelines, the coexistence of pulmonary hypertension exacerbates the severity of heart failure. Given the presence of pulmonary arterial vasoconstrictor and heightened sympathetic nervous activity in patients with heart failure, the PADN-5 study has demonstrated the safety and efficacy of pulmonary artery denervation (PADN) for patients with CpcPH, characterized by the improvements in left ventricular ejection fraction, cardiac output, clinical outcome, and reductions in left atrial pressure, pulmonary arterial pressure, and PVR. Our objective is to assess the feasibility, safety, and efficacy of PADN for patients with heart failure independent of left ventricular ejection fraction (HFrEF or HFpEF) without pulmonary hypertension (N=30, 15 with HFrEF and another 15 with HFpEF). ### Conditions - Heart Failure ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Pulmonary artery denervation (PADN) ### Outcomes Primary Outcomes - Left ventricular ejection fraction - Tricuspid annuls peak systolic excursion (TAPSE) - 6 minute walk distance changes Secondary Outcomes - All-cause death - Rehospitalization - NT-proBNP - Superoxide dismutase (SOD) 3 - Plasma noradrenaline ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Outcome of Induced Atypical Atrial Flutter - NCT ID: NCT06323499 - Study ID: UK Essen - Status: COMPLETED - Start Date: 2018-04-01 - Completion Date: 2021-10-31 - Lead Sponsor: University Hospital, Essen ### Study Description Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. There are no data whether induction of AAF is a feasible approach in these cases.Methods: The investigators retrospectively analyzed patients who underwent catheter ablation of AAF and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced AAF.For this retrospective study, the investigators analyzed patients undergoing ablation of AAF between April 2018 and January 2021 that were identified from the ablation database at the West German Heart and Vascular Center, Essen. All patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. In case the documentation was not performed at the institution, relevant documents and ECGs were requested and reviewed.This single-center cohort study was conducted at the University Hospital Essen, Germany, in accordance with the Declaration of Helsinki and its amendments and was approved by the institutional review board of the University of Essen (number 21-10341-BO). Written informed consent was obtained from all study participants.The primary study endpoint was to evaluate the outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. The investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure. ### Conditions - Tachyarrhythmia - Atypical Atrial Flutter - Induction of Arryhthmia - Clinical Outcome ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Induction of atypical atrial flutter ### Outcomes Primary Outcomes - Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Secondary Outcomes - Type of recurrence during follow-up - Occurrence and results of repeat ablations at our institution ### Location - Facility: University Hospital Essen, Essen, Nordrhein-Westfalen, 45147, Germany @@
## Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression - NCT ID: NCT06323486 - Study ID: 23-015-B - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03-30 - Lead Sponsor: Ontario Shores Centre for Mental Health Sciences ### Study Description The CogniTReaD study is a pilot clinical trial that will compare the effects of active accelerated bilateral sequential theta burst stimulation (absTBS) and sham or inactive treatment. The goal is to see if absTBS can help older adults with treatment-resistant depression (TRD) by looking at dual-task cost and mood, as well as other cognitive functions, anxiety levels, quality of life, and physical performance, while also checking for any treatment side effects. The study will recruit participants who will receive different study treatments in a specific order. The study will be double-blinded, meaning neither the participants nor the researchers will know who is receiving which treatment. The study will include people who are 50 years old or older and diagnosed with treatment-resistant depression with at least a moderate severity of depression. This study seeks to discover if absTBS can modify a dementia risk marker (i.e., dual-task cost and depression) in older patients with TRD, and to determine the effect size for larger investigations in the future. ### Conditions - Depressive Disorder, Treatment-Resistant ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - active accelerated bilateral sequential theta burst stimulation and sham treatment ### Outcomes Primary Outcomes - Change in Dual-task Cost - Change in Hamilton Depression Rating Scale 17 (HAMD-17) score - Adverse events (AE) Secondary Outcomes - Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score - Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score - Change in Trail Making A (TMT-A) score - Change in Trail Making B (TMT-B) score - Change in Digit Symbol Substitution Test (DSST) score - Change in Digit Span Forward (DSF) score - Change in Digit Span Backward (DSB) score - Change in Category Verbal Fluency (CVF) score - Change in Montreal Cognitive Assessment (MoCA) score - Change in Colour Word Interference Test (CWIT) score - Change in Patient Health Questionnaire-9 (PHQ-9) score - Change in Geriatric Depression Scale 30 (GDS-30) score - Change in Generalized Anxiety Disorder 7 (GAD-7) score - Change in Short Form 36 (SF-36) score - Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score - Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score - Change in Clinical Global Impression (CGI) score - Change in Short Physical Performance Battery (SPPB) score - Change in Timed Up & Go (TUG) score ### Location - Facility: Ontario Shores Centre for Mental Health Sciences, Toronto, Ontario, L1N 5S9, Canada @@
## Maitake for Integrative Cancer Care - NCT ID: NCT06323473 - Study ID: Maitake001 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2025-09-01 - Lead Sponsor: The Canadian College of Naturopathic Medicine ### Study Description Maitake is an edible mushroom that is used for both its nutritional and medicinal properties. Human and animal studies have shown Maitake may help improve immune function; however, its effectiveness in people with cancer is not clear. The investigators aim to measure if Maitake has any immunomodulatory effects when given alongside conventional systemic cancer therapy. ### Conditions - Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Black Maitake Prothera ### Outcomes Primary Outcomes - Changes in absolute neutrophil count Secondary Outcomes - Incidence of febrile neutropenia - Change in neutrophil to lymphocyte ratio (NLR) - Change in platelet to lymphocyte ratio (PLR) - Change in high-sensitivity C-reactive protein (CRP) - Changes in Quality of Life - Changes in hemoglobin A1c (HbA1c) - Incidence of adverse events - Incidence of dose reductions or delays in systemic therapy - Addition of new medications to combat neutropenia ### Location - Facility: The Centre for Health Innovation, Ottawa, Ontario, K2P 0M7, Canada @@
## Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer - NCT ID: NCT06323460 - Study ID: OSU-23083 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-12-31 - Lead Sponsor: Ohio State University Comprehensive Cancer Center ### Study Description This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood. ### Conditions - Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 - Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 - Oropharyngeal Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Biospecimen Collection - Carboplatin - Cisplatin - Computed Tomography - External Beam Radiation Therapy - Paclitaxel - Positron Emission Tomography - Questionnaire Administration ### Outcomes Primary Outcomes - Positron emission tomography complete response Secondary Outcomes - Progression free survival - Incidence of adverse events - Quality of life (QOL) ### Location - Facility: Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States @@
## Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia - NCT ID: NCT06323447 - Study ID: PC002 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-30 - Completion Date: 2025-05-28 - Lead Sponsor: Leuko Labs, Inc. ### Study Description Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy. ### Conditions - Diffuse Large B Cell Lymphoma - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - PointCheck ### Outcomes Primary Outcomes - PointCheck Accuracy Secondary Outcomes - PointCheck Precision - PointCheck Usability - PointCheck Errors - PointCheck Safety ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Spinal CSF Leaks in Chronic Subdural Hematoma - NCT ID: NCT06323434 - Study ID: spice1 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-10 - Lead Sponsor: University of Freiburg ### Study Description Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population.The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks.Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH.Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures. ### Conditions - Chronic Subdural Hematoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - evidence of a spinal CSF leak (yes/no) Secondary Outcomes - Number of identified CSF leak types: - Number of diagnostic procedures performed: - Number, and site of interventions needed for cSDH: - Color of hematoma evacuated: - Age - body height - body weight - Body mass index (BMI) - sex - Karnofsky Index - Anti-platelet therapy intake - Anticoagulation intake - Blood pressure medication intake - Lipid regulation medication intake - Hormonal regulation medication intake - Immunotherapeutic medication intake - other medication intake - history of trauma - national institutes of health stroke scale (NIHSS) - gait disorder - Modified Rankin Scale (mRS) - Headache-Impact-Test (HIT)-6 - current working capacity, - complaints - headache severity - Days within the last month - maximum duration being continuously upright - severeness of dizziness - Severeness of shoulder- and neck pain - severeness of nausea - severeness of hearing disturbances and tinnitus - severeness of cognitive deficits - severeness of visual disturbances - exhaustion - ability to focus and concentrate - Patient's Global Impression of Change (PGIC) - Self-Administered Comorbidity Questionnaire (SCQ) - 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index - 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale - Hematocrit - Size of the chronic subdural hematoma - Volumetry of the cranial compartments - Bern-Score according to Dobrocky et al - Spinal longitudinal extradural fluid collection (SLEC) - DiverTICula (TIC) ### Location - Facility: University of Freiburg, Freiburg, Baden-Württemberg, 79106, Germany @@
## Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer - NCT ID: NCT06323421 - Study ID: STUDY2023-1359 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-22 - Completion Date: 2025-08-31 - Lead Sponsor: University of Illinois at Chicago ### Study Description Many neighborhoods in Chicago experience daily exposure to stressors including economic inopportunity and violent crime in public spaces. There is mounting evidence that chronic psychosocial stress can facilitate carcinogenesis by modulating the gut microbiome and immune system. The proposed research aims to study the practice of mindfulness to mitigate CPS and reduce colorectal cancer risk factors among Black American women at elevated risk. ### Conditions - Mindfulness - Colon Cancer - Females ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: PREVENTION ### Interventions - Mindfulness ### Outcomes Primary Outcomes - Feasibility measures - Acceptability Secondary Outcomes ### Location - Facility: University of Illinois at Chicago, Chicago, Illinois, 60612, United States @@
## Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas - NCT ID: NCT06323408 - Study ID: BZKF-AYA_1.0 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2026-03 - Lead Sponsor: University Hospital Regensburg ### Study Description The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape. ### Conditions - Glioma, Malignant - Embryonal Tumor - Medulloblastoma - Ependymoma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Tissue, blood, cerebrospinal-spinal fluid ### Outcomes Primary Outcomes - AI processing of MRI fand PET or diagnosis - AI processing of MRI and PET for evaluation of response and relapse - Quality control analysis in radiotherapy - Analysis of response in liquid biopsies - Target molecules in tissue and liquid biopsies - Evaluation of progression free survival Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye - NCT ID: NCT06323395 - Study ID: JGL-DED-VIZ-SLB 21 - Status: COMPLETED - Start Date: 2022-06-01 - Completion Date: 2022-12-01 - Lead Sponsor: Jadran Galenski laboratorij d.d. ### Study Description The clinical investigation was intended to investigate the efficacy, ocular tolerability and safety of Vizol S Lipid Balance, a new eye drops, emulsion developed by JADRAN - GALENSKI LABORATORIJ d.d., in patients with moderate to severe evaporative DED after a treatment for 30 days. ### Conditions - Dry Eye Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Vizol S LIPID BALANCE eye drops - ophthalmic saline eye drops ### Outcomes Primary Outcomes - Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30) Secondary Outcomes - Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) - percent (%) change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15) and from Visit 1 (baseline) to Visit 3 (day 30) - Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30) - Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30) - Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30) ### Location - Facility: Special eye hospital - Beogradski oftalmološki centar, Belgrad, N/A, 11000, Serbia @@
## Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma - NCT ID: NCT06323382 - Study ID: Liver Project 6 - Status: RECRUITING - Start Date: 2021-01-01 - Completion Date: 2024-12-30 - Lead Sponsor: Sun Yat-sen University ### Study Description Atezolizumab + Bevacizumab was superior to sorafenib in overall survival in advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD1) and PDL1 inhibitor, was effective and tolerable in patients with advanced hepatocellular carcinoma. We aimed to describe the efficacy and safety of locoregional therapy combined with Bevacizumab and PD1/L1 inhibitor in patients with advanced hepatocellular carcinoma who can not receive radical therapy. ### Conditions - Advanced Hepatocellular Carcinoma - Anti-PD1/PDL1 Antibody - Bevacizumab ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Locoregional therapy - Bevacizumab - Atezolizumab - Tislelizumab - Toripalimab - Sintilimab - Camrelizumab ### Outcomes Primary Outcomes - Progression-Free-Survival (PFS) Secondary Outcomes - Overall survival (OS) - Objective response rate (ORR) - Adverse events ### Location - Facility: Chinese PLA hospital, Beijing, Beijing, 100853, China @@
## Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma - NCT ID: NCT06323369 - Study ID: SYSKY-2023-1283-02 - Status: RECRUITING - Start Date: 2024-03-25 - Completion Date: 2029-09-25 - Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ### Study Description A prospective, randomized, open-label, multicenter Phase 2 trial designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy followed by surgery versus up-front surgery in resectable clinically node-negative head and neck squamous cell carcinoma. ### Conditions - Head and Neck Squamous Cell Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Tislelizumab（neoadjuvant） - Cisplatin （neoadjuvant） - Nab-paclitaxel （neoadjuvant） - Surgical resection - Cisplatin（adjuvant） - Tislelizumab（adjuvant） - Radiation - Carboplatin（neoadjuvant） - Carboplatin（adjuvant） ### Outcomes Primary Outcomes - Disease-Free Survival(DFS ) - Lymph node positivity rate Secondary Outcomes - Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events - Pathological complete response (pCR) rate - Major Pathological Response (MPR) rate - lymph node division - Event-free Survival (EFS) - Overall survival (OS) - Disease-Free Survival(DFS ) ### Location - Facility: Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Guangzhou, Yuexiu, 510120, China @@
## A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis - NCT ID: NCT06323356 - Study ID: TAK-279-PsO-3005 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2026-03-27 - Lead Sponsor: Takeda ### Study Description The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times. ### Conditions - Generalized Pustular Psoriasis - Erythrodermic Psoriasis ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - TAK-279 ### Outcomes Primary Outcomes - Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 - Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16 Secondary Outcomes - Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52 - Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits - Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52 - Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 - Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits - Percentage of Participants Achieving PASI-75 at Week 52 - Percentage of Participants Achieving PASI-90 at Week 16 and Week 52 - Percentage of Participants Achieving PASI-100 at Week 16 and Week 52 - Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits - Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits - Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52 - Change from baseline in ssPGA at Weeks 16 and 52 - Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52 - Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52 - Change from Baseline in DLQI at Week 16 and Week 52 - Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline - Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52 - Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52 - Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52 - Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52 - Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52 - Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis ### Location - Facility: Nagoya City University Hospital, Nagoya, Aichi, N/A, Japan @@
## Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits - NCT ID: NCT06323343 - Study ID: 00040976 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-28 - Completion Date: 2025-01-31 - Lead Sponsor: Medical College of Wisconsin ### Study Description The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments?Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment.The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication. ### Conditions - Patient Empowerment ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Video Intervention - Webpage links ### Outcomes Primary Outcomes - Parents' communication behaviors measure Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation - NCT ID: NCT06323330 - Study ID: I-1623 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-11-30 - Lead Sponsor: All India Institute of Medical Sciences, New Delhi ### Study Description The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question\[s\] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms. ### Conditions - Stroke Rehabilitation - Aphasia, Broca ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Speech rehabilitation ### Outcomes Primary Outcomes - Western Aphasia Battery Score Secondary Outcomes - Western Aphasia Battery Score - functional Near Red Spectroscopy measures - modified Rankin Score - Fugl Meyer Assessment Scores ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures - NCT ID: NCT06323317 - Study ID: UW 21-405 - Status: RECRUITING - Start Date: 2023-12-18 - Completion Date: 2025-03-31 - Lead Sponsor: The University of Hong Kong ### Study Description The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates.Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes.Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points.The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability. ### Conditions - Coronary Artery Bypass Grafting - Heart Valve Replacement - Transcatheter Aortic Valve Implantation - Frailty ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Multi-component exercise programme - Attention Placebo - Structured preoperative education - Nutritional optimization - Stress management ### Outcomes Primary Outcomes - The Short Physical Performance Battery (SPPB) - Weakness/ Grip Strength (Fried Phenotype Frailty Assessment) - Slowness (Fried Phenotype Frailty Assessment) - Low Physical Activity (Fried Phenotype Frailty Assessment) - Self-reported Exhaustion (Fried Phenotype Frailty Assessment) - Unintentional Weight Loss (Fried Phenotype Frailty Assessment) - The Seattle Angina Questionnaire (SAQ) - The MacNew Heart Disease Health-Related Quality of Life Questionnaire Secondary Outcomes - The Hospital Anxiety and Depression Scale (HADS) - Biomarkers-Serum albumin - Biomarkers- C-reactive protein - Major adverse cardiac and cerebrovascular events (MACCE) - Hospital Length of stay - Hospital Readmissions ### Location - Facility: Polly Wai Chi, Hong Kong, Please Select, 00000, Hong Kong @@
## Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis - NCT ID: NCT06323304 - Study ID: 701/HDDD-DHYD - Status: RECRUITING - Start Date: 2024-03-13 - Completion Date: 2024-06 - Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City ### Study Description Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression.Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy.This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR. ### Conditions - Itching - Runny Nose - Sneezing - Nasal Congestion ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Auricular acupressure - Sham acupressure - Standard treatment ### Outcomes Primary Outcomes - The change of nasal and non nasal symptom scores Secondary Outcomes - The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score - The change of relief medication usage - Proportion of intervention-related adverse events ### Location - Facility: University of Medical Center HCMC - Branch no.3, Ho Chi Minh, N/A, 700000, Vietnam @@
## Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study - NCT ID: NCT06323291 - Study ID: MCC-23077 - Status: RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-03 - Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute ### Study Description This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers. ### Conditions - Pancreatic Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: HEALTH_SERVICES_RESEARCH ### Interventions - Coaching Sessions ### Outcomes Primary Outcomes - Recruitment Rate - Participant Acceptance of the Digital Health Coaching Program - Participant Ease of Usability of the Digital Health Coaching Program - Feasibility of Utilizing the Digital Health Coaching Program Secondary Outcomes ### Location - Facility: Moffitt Cancer Center, Tampa, Florida, 33612, United States @@
## Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease - NCT ID: NCT06323278 - Study ID: PD&REHAB - Status: RECRUITING - Start Date: 2021-12-21 - Completion Date: 2027-12 - Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico ### Study Description The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment. ### Conditions - Parkinson Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cognitive training ### Outcomes Primary Outcomes - Efficacy of the cognitive training on cognitive function in PD patients with GBA mutation compared to a control group of PD patients without genetic mutations. Secondary Outcomes - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. - The effect of cognitive training on behavioural aspects in PD patients. ### Location - Facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, N/A, N/A, Italy @@
## A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer - NCT ID: NCT06323265 - Study ID: ARL-SCLC-001 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2026-04-01 - Lead Sponsor: Hebei Medical University Fourth Hospital ### Study Description The purpose of this study is to assess efficacy and safety of patients who receive Adebrelimab combined with chemotherapy±chest radiotherapy as first-line treatment of extensive stage small cell lung cancer in the real world. ### Conditions - Extensive Stage Small Cell Lung Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Adebrelimab + chemotherapy - ±chest radiotherapy ### Outcomes Primary Outcomes - Progression free survival (PFS) Secondary Outcomes - Objective response rate (ORR) - Disease control rate (DCR) - Duration of Overall Response（DoR） - Overall survival (OS) - Adverse events ### Location - Facility: Jun Wang, Shijiazhuang, Hebei, N/A, China @@
## A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia - NCT ID: NCT06323252 - Study ID: MastihaOil-HT - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-10-30 - Lead Sponsor: Harokopio University ### Study Description Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.The effects of the intervention will be evaluated via clinical and laboratory markers. ### Conditions - Hypertriglyceridemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - MastihaOil - nutritional counsel ### Outcomes Primary Outcomes - Change in blood triglycerides Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma - NCT ID: NCT06323239 - Study ID: SBRT/LDRT+PD-1+GP for r/mNPC - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2028-04-01 - Lead Sponsor: Sun Yat-sen University ### Study Description This is a prospective, single-arm, phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of SBRT and LDRT combined with programmed death 1 (PD-1) antibody and chemotherapy in recurrent/metastatic nasopharyngeal carcinoma patients. ### Conditions - Nasopharyngeal Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - SBRT - Low-dose Radiotherapy (LDRT) - Toripalimab - Gemcitabine - Cisplatin - IMRT ### Outcomes Primary Outcomes - Progression-free survival Secondary Outcomes - Overall Survival - Objective Response Rate - Disease Control Rate - Adverse Events - QoL ### Location - Facility: Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, N/A, China @@
## The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis - NCT ID: NCT06323226 - Study ID: 2024-312-1 - Status: RECRUITING - Start Date: 2019-01-01 - Completion Date: 2025-06-01 - Lead Sponsor: West China Hospital ### Study Description This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life. ### Conditions - Sepsis - Children, Only ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Mortality Secondary Outcomes ### Location - Facility: West China Hospital of Sichuan University, Chendu, Sichuan, N/A, China @@
## Efficacy and Safety Study of 610 in Patients With Severe Asthma - NCT ID: NCT06323213 - Study ID: SSGJ-610-BA-III-01 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-09 - Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. ### Study Description The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma. ### Conditions - Asthma ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - 610 - Placebo ### Outcomes Primary Outcomes - Annualized rate of severe exacerbation events Secondary Outcomes - Time to first severe exacerbation event - Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit - Change from baseline in ACQ score - Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ) - Change in pre-bronchodilator forced expiratory volume (FEV1) - Assessment of adverse events (AEs) ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA - NCT ID: NCT06323200 - Study ID: 202400221B0 - Status: COMPLETED - Start Date: 2015-09 - Completion Date: 2023-03 - Lead Sponsor: Chang Gung Memorial Hospital ### Study Description This study aimed to address the impact of lymphedema duration on the quality of lymphatic vessels as well as the outcome after LVA using propensity score matching. ### Conditions - Lymphedema ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - lymphaticovenous anastomosis ### Outcomes Primary Outcomes - Volume change after LVA. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Optimization of Cervical Collections in Pregnancy - NCT ID: NCT06323187 - Study ID: 4656 - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2031-02-28 - Lead Sponsor: Dr. Sascha Drewlo ### Study Description Fetal cells are not easily obtained from pregnant patients; this curtails testing to assess the health of the fetus and the mother. Currently, the only way of diagnosing fetal genetic or chromosomal abnormalities is by invasive techniques, such as chorionic villous sampling (CVS) and amniocentesis performed at 10 to 13 weeks and after 15 weeks of gestation, respectively. Although small, there is a risk for fetal loss with these procedures. Transcervical cell sampling (TCS), similar to a Pap smear, is a platform that meets the requirements for prenatal genetic testing (genetic testing with fetal cells obtained before birth), as well as diagnosis of maternal pregnancy complication, at a very early stage of pregnancy (as early as 5 weeks) and carries low risk for the mother and the developing fetus.This study will examine cervical fluid collected using various noninvasive methods for TCS in pregnant women. The number of placental cells will be assessed against similarly obtained samples from nonpregnant women of reproductive age who lack cells derived from a placenta. Participating volunteers will provide written informed consent. Only standard medical procedures and approved devices will be used for collection of cervical fluid, minimizing risk to the participants and their fetuses. No test results or other benefits will be available to the participants. ### Conditions - Cervix; Pregnancy - Inherited Genetic Conditions (Diagnosis) - Preeclampsia - Fetal Growth Retardation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Cervical Sampling ### Outcomes Primary Outcomes - Cellular content - Cell-free content Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise - NCT ID: NCT06323174 - Study ID: NN9388-4895 - Status: RECRUITING - Start Date: 2024-03-19 - Completion Date: 2025-11-04 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cagrilintide - Semaglutide - Placebo ### Outcomes Primary Outcomes - Change in glycated haemoglobin (HbA1c) Secondary Outcomes - Relative change in body weight - Number of participants who achieve greater than or equal to (>=) 10% body weight reduction - Number of participants who achieve >=15% body weight reduction - Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) - Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol) - Change in Fasting Plasma Glucose (FPG) - Number of participants who achieve >=5% body weight reduction - Number of participants who achieve >=20% body weight reduction - Change in waist circumference - Change in systolic blood pressure (SBP) - Change in diastolic blood pressure (DBP) - Ratio to baseline in high sensitivity C-reactive protein (hsCRP) - Ratio to baseline in lipids: Total cholesterol - Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol - Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol - Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol - Ratio to baseline in lipids: Triglycerides - Ratio to baseline in lipids: Free fatty acids - Ratio to baseline in lipids: Non-HDL cholesterol - Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication) - Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo) - Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score - Change in SF-36v2 score: Physical Component Summary score - Change in SF-36v2 score: Mental Component Summary score - Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score - Change in leptin - Change in soluble leptin receptor - Number of Treatment Emergent Adverse Events (TEAEs) - Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter - Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold ### Location - Facility: National Research Institute_Huntington Park, Huntington Park, California, 90255, United States @@
## A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin - NCT ID: NCT06323161 - Study ID: NN9388-7637 - Status: RECRUITING - Start Date: 2024-03-26 - Completion Date: 2025-11-04 - Lead Sponsor: Novo Nordisk A/S ### Study Description This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year. ### Conditions - Type 2 Diabetes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Cagrilintide - Semaglutide - Placebo ### Outcomes Primary Outcomes - Change in Glycated Haemoglobin (HbA1c) Secondary Outcomes - Relative Change in Body Weight - Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction - Number of Participants Who Achieve ≥15% Body Weight Reduction - Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]) - Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol) - Change in Fasting Plasma Glucose (FPG) - Change in Insulin Dose - Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units - Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals) - Number of Participants Who Achieve ≥5% Body Weight Reduction - Number of Participants Who Achieve ≥20% Body Weight Reduction - Change in Waist Circumference - Change in Systolic Blood Pressure (SBP) - Change in Diastolic Blood Pressure (DBP) - Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol - Ratio to Baseline in Lipids: Triglycerides - Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol - Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol - Ratio to Baseline in Lipids: HDL Cholesterol - Ratio to Baseline in Lipids: Total Cholesterol - Ratio to Baseline in Lipids: Free Fatty Acids - Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score - Change in SF-36v2: Physical Component Summary Score - Change in SF-36v2: Mental Component Summary Core - Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score - Change in Leptin - Change in Soluble Leptin Receptor - Number of Treatment Emergent Adverse Events (TEAEs) - Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter) - Number of Clinically Significant Hypoglycaemic Episodes (level 3) ### Location - Facility: Valley Clinical Trials, Inc., Northridge, California, 91325, United States @@
## Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022) - NCT ID: NCT06323148 - Study ID: ECTOP-1022 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2029-03-31 - Lead Sponsor: Fudan University ### Study Description This study plans to conduct ctDNA testing on EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients after radical surgery (R0 resection). Patients with positive ctDNA testing will receive standard treatment according to clinical guidelines, while patients with negative ctDNA testing will be assessed based on comprehensive clinical and pathological characteristics. After receiving or not receiving standard adjuvant chemotherapy, patients will be randomly assigned in a 1:1 ratio to either the observation follow-up group (experimental group) or the osimertinib adjuvant treatment group (control group). The aim is to explore whether observation follow-up for patients with negative ctDNA after surgery has a prognosis non-inferior to osimertinib treatment, and to investigate the disease-free survival rate of EGFR mutation-positive stage II-IIIA (N1-N2) NSCLC patients with positive ctDNA after surgery receiving osimertinib adjuvant treatment, providing more precise treatment guidance for adjuvant therapy in this specific type of NSCLC patients with EGFR mutation-positive tumors. ### Conditions - Lung Cancer - EGFR Gene Mutation - Minimal Residual Disease ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Osimertinib - No adjuvant therapy ### Outcomes Primary Outcomes - The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group. Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Nutrition Assessment in Advanced Cancer Patients - NCT ID: NCT06323135 - Study ID: 2019-725 - Status: COMPLETED - Start Date: 2019-09-17 - Completion Date: 2023-09-11 - Lead Sponsor: West China Hospital ### Study Description The goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. We aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population. ### Conditions - Advanced Cancer - Nutrition Aspect of Cancer - Prognostic Cancer Model ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - All-cause mortality Secondary Outcomes - length of stay in hospital ### Location - Facility: West China Hospital, Sichuan Universit, Chengdu, Sichuan, 610041, China @@
## A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures. - NCT ID: NCT06323122 - Study ID: Plating Techniques 2023 - Status: COMPLETED - Start Date: 2021-01-01 - Completion Date: 2023-12-01 - Lead Sponsor: October 6 University ### Study Description The main goal in management of mandibular fractures is to restore the pre-injury form and function, with the least disability and shortest recovery period. ### Conditions - Mandibular Fractures ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - 2.0 miniplates - 2.3 high profile miniplates - 3D miniplates ### Outcomes Primary Outcomes - Surgery Time Secondary Outcomes - complication - fracture stability ### Location - Facility: October 6U, Cairo, N/A, 12566, Egypt @@
## US Imaging for the Assessment of LUTS - NCT ID: NCT06323109 - Study ID: 2023-1331 - Status: RECRUITING - Start Date: 2023-11-28 - Completion Date: 2027-01-01 - Lead Sponsor: University of Wisconsin, Madison ### Study Description The purpose of this research is to develop an ultrasound (US) based urodynamics (UDS) evaluation of voiding based on successful magnetic resonance imaging (MRI)-UDS evaluation. Both US and MRI are non-invasive imaging techniques, but US is a more cost-effective and widely available technology. 80 participants will be enrolled and will be on study for up to 2.5 hours (1.5 hour MRI and 1 hour US). ### Conditions - Lower Urinary Tract Symptoms - BPH ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - MRI-UDS; US-UDS; MCUD ### Outcomes Primary Outcomes - MRI Urodynamics - Change in Bladder Volume - MRI Urodynamics - Change in Urine Velocity - MRI Urodynamics - Change in Pressure - Bladder outlet obstruction index (BOOI) - Bladder contractility index (BOI) - International Prostate Symptom Score (IPSS) Secondary Outcomes ### Location - Facility: University of Wisconsin, Madison, Wisconsin, 53705, United States @@
## Development of Clinical Decision Support System for Severe Patients With Polytrauma - NCT ID: NCT06323096 - Study ID: AR13067824 - Status: RECRUITING - Start Date: 2020-12-01 - Completion Date: 2024-12-31 - Lead Sponsor: Semey State Medical University ### Study Description The goal of this observational study is to develop a Clinical Decision Support System for severe patients with polytrauma. The main questions it aims to answer are:* Is it possible to predict the development of systemic inflammatory response syndrome for the next 24 h after admission?* Is it possible to predict the development of blood loss \>25% of blood volume for the next 24 h after admission?* Is it possible to predict the development of acute traumatic coagulopathy for the next 24 h after admission?* Is it possible to predict the development of pneumonia in polytrauma patients?* Is it possible to predict the outcome in polytrauma patients?No intervention is planned for this study. ### Conditions - Polytrauma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Prediction of SIRS - Rate of ATC prediction in the 24 h after admission using the developed CDSS. - Rate of hemorrage prediction in the 24 h after admission using the developed CDSS. - Rate of pneumonia prediction using the developed CDSS. Secondary Outcomes ### Location - Facility: Emergency Hospital, Semey, Abai, 071400, Kazakhstan @@
## The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy in Nursing Students - NCT ID: NCT06323083 - Study ID: 006 - Status: COMPLETED - Start Date: 2022-11-07 - Completion Date: 2023-06-30 - Lead Sponsor: Selcuk University ### Study Description The study was conducted to determine the effect of Emotional Freedom Technique (EFT) on perceived stress and general self-efficacy in obstetrics and gynecology nursing lesson in undergraduate nursing students with fear of birth.The samples were applied to undergraduate nursing students satisfying the research criteria in a state university nursing faculty in Konya at November 2022. ### Conditions - Emotion Regulation - Stress - Self Efficacy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Emotional Freedom Technique ### Outcomes Primary Outcomes - General Self-Efficacy Scale - Perceived Stress Scale - The Subjective Units of Distress Scale Secondary Outcomes ### Location - Facility: Selcuk University, Konya, N/A, N/A, Turkey @@
## Effects of Watermelon or Low-fat Cookie Consumption on Wellness - NCT ID: NCT06323070 - Study ID: HS-2023-0281 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2025-12 - Lead Sponsor: San Diego State University ### Study Description The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults. ### Conditions - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Low-fat cookies - Watermelon ### Outcomes Primary Outcomes - Change of sexual health questionnaire scores - Change of skin hydration scores - Change of microbiome diversity Secondary Outcomes - Change of depression questionnaire scores ### Location - Facility: School of Exercise and Nutritional Sciences, San Diego, California, 92182, United States @@
## Modulating Reward Learning Using Transcranial Magnetic Stimulation - NCT ID: NCT06323057 - Study ID: Pro2022000444_CLFMT - Status: RECRUITING - Start Date: 2024-02-14 - Completion Date: 2025-04-30 - Lead Sponsor: Rutgers, The State University of New Jersey ### Study Description Our specific aim is to examine the effects of TMS on reward processing during goal-directed behavior. In these experiments the investigators will utilize a scalp-recorded brain oscillation called frontal midline theta that is believed to index the sensitivity of the cingulate cortex to reward feedback. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in decision making tasks, and if so, whether it would affect the encoding of rewards and subsequent choices during task performance. ### Conditions - Behavior ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Single pulse TMS to the frontal cortex ### Outcomes Primary Outcomes - Event-related Brain Oscillation: Frontal Midline Theta - Reward learning Secondary Outcomes ### Location - Facility: Rutgers University - Newark, Newark, New Jersey, 07102, United States @@
## MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence - NCT ID: NCT06323044 - Study ID: I-3920723 - Status: NOT_YET_RECRUITING - Start Date: 2024-06-15 - Completion Date: 2029-06-15 - Lead Sponsor: Roswell Park Cancer Institute ### Study Description This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication. ### Conditions - Acute Lymphoblastic Leukemia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Best Practice - Biospecimen Collection - Electronic Health Record Review - Interview - Medical Device Usage and Evaluation - Medical Device Usage and Evaluation - Survey Administration ### Outcomes Primary Outcomes - Medication adherence Secondary Outcomes ### Location - Facility: Roswell Park Cancer Institute, Buffalo, New York, 14263, United States @@
## Spontaneous Eye Blinking in Disorders of Consciousness - NCT ID: NCT06323031 - Study ID: Blink-DoC - Status: NOT_YET_RECRUITING - Start Date: 2024-05 - Completion Date: 2025-11 - Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus ### Study Description Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months. ### Conditions - Disorders of Consciousness ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Clinical Diagnosis Secondary Outcomes ### Location - Facility: Coma Science Group, GIGA-Consciousness, University of Liege, Liege, N/A, 4000, Belgium @@
## Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty. - NCT ID: NCT06323018 - Study ID: 384T-26 - Status: RECRUITING - Start Date: 2024-03-20 - Completion Date: 2027-03 - Lead Sponsor: University of Tartu ### Study Description Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. Cemented hip arthroplasty is mainly indicated for elderly patients with poor bone quality and multiple comorbidities. Bone cement implantation syndrome is associated with cemented hip arthroplasty and it has been shown to increase cardiovascular and renal complication and brain damage postoperatively. The aim of this project is to elucidate whether remote-ischemic preconditioning (RIPC) has multi-organ protective effect in cemented hip arthroplasty patients. ### Conditions - Osteoarthritis, Hip - Cardiovascular Diseases - Bone Cement Implantation Syndrome - Kidney Diseases ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Remote Ischemic Preconditioning - SHAM ### Outcomes Primary Outcomes - Myocardial injury Secondary Outcomes - Cardiovascular injury - Clinical serious complications - Carotid-femoral pulse velocity - Augmentation index - Brain injury - Kidney Injury - Total antioxidative capacity (TAC) - Oxidative stress level (total peroxide levels) - Inflammation level - Low molecular weight metabolites (uM) ### Location - Facility: University of Tartu, Tartu, Tartumaa, 50406, Estonia @@
## [Trial of device that is not approved or cleared by the U.S. FDA] - NCT ID: NCT06323005 - Study ID: 2024-0024 - Status: WITHHELD - Start Date: N/A - Completion Date: N/A - Lead Sponsor: [Redacted] ### Study Description No description available. ### Conditions - No conditions listed. ### Study Design - Type: N/A - 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 @@
## App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3 - NCT ID: NCT06322992 - Study ID: R41CA271962 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-05 - Lead Sponsor: Daynamica, Inc. ### Study Description The goal of this observational study is to develop a mobile app for cancer patients undergoing treatments. In Aim 3, patients will rate the quality of the app using the Mobile App Rating Scale (MARS) and their satisfaction with the three key app features. The outcome of this project will be a final prototype app with 70% of patients indicating an overall MARS score of 4.0 or more and satisfaction with the three features. ### Conditions - Cancer ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - APP satisfaction - APP rating Secondary Outcomes ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth - NCT ID: NCT06322979 - Study ID: # R-PED-11-23-3074 - Status: RECRUITING - Start Date: 2023-11-22 - Completion Date: 2024-12 - Lead Sponsor: Tanta University ### Study Description Following the randomization procedure, children will be divided into 2 groups (25 immature anterior permanent incisors in each group): Group I will be treated with MTA as apical plug while group II will be treated with Premixed Bioceramic Putty as apical plug. After working length determination, instrumentation, and irrigation of the root canals, apical plug will be done. in MTA Group, MTA will be placed into the apical 4 mm of root canals, then a moist cotton pellet will be placed and the access cavity will be restored with glass-ionomer-based restoration. Next day, glass-ionomer-based restoration and the cotton pellet will be removed, then the coronal restoration will be completed with GIC, composite. In the Premixed Bioceramic Putty group, Well-Root™ PT will be placed into the apical 4 mm of the canals. After 12 min, the coronal and middle third of the root canal will be filled with gutta-percha. The coronal restoration will be completed with GIC, composite.children will be recalled for clinical and radiographical follow-up after 6 and12 months after treatment. ### Conditions - Periapical Periodontitis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Mineral trioxide aggregate - Premixed Bioceramic Putty ### Outcomes Primary Outcomes - the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) - the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA) Secondary Outcomes - Change in the periapical index (PAI) ### Location - Facility: Tanta University, Tanta, Gharbia, 6624033, Egypt @@
## Learning and Living With Wildfire Smoke - NCT ID: NCT06322966 - Study ID: STUDY00017745 - Status: RECRUITING - Start Date: 2023-09-04 - Completion Date: 2028-05-26 - Lead Sponsor: University of Washington ### Study Description The proposed intervention in this Youth Participatory Action Research (YPAR) proposal will improve knowledge and awareness of the health impacts of air pollution exposure, will elevate the youth voice, improve youth self-efficacy and lead to behavior changes that would reduce exposure to air pollution in a high school setting. These outcomes will be accomplished through the introduction of a new air quality curriculum, called AirActions, into freshman science classes, and the establishment of an after-school air quality monitoring program.All students enrolled in freshman Honors Biology (Pueblo East and Montrose High Schools), Intro to Agriculture (The STEAD School) and Environmental Science (Grand Junction High School) will participate in the new air quality curriculum, as it will be built into the existing lesson plans. For the after-school monitoring program, the PI and participating teachers (Letters A and B) will recruit 10 to 15 students at each school to be involved in the Student Research Cohort (SRC). Information on this program and how to apply will be shared with students through their health and science classes, included in the school newsletter, and posted on billboards around the school. Students will be identified within the following inclusion criteria: 1) freshman or sophomores in high school and 2) participation in the AirActions curriculum. New students will be recruited each year to keep a consistent group as students leave and/or graduate. New students will be brought up to speed by carry-over students, and each new year will represent a separate SRC dedicated to a specific goal. ### Conditions - Behavior and Behavior Mechanisms - Health Knowledge, Attitudes, Practice ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: OTHER ### Interventions - Air Action Curriculum ### Outcomes Primary Outcomes - Number of students, staff, teacher and administrators with higher scores on a Likert-style questionnaire for content knowledge learning objectives. - Scores on Likert-style questionnaire to evaluate behavior change around air quality. - Change in student exposure to air pollution calculated through measurements of indoor particulate matter and indoor carbon dioxide. Secondary Outcomes ### Location - Facility: University of Washington, Seattle, Washington, 98195, United States @@
## Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage - NCT ID: NCT06322953 - Study ID: RG442-21 - Status: NOT_YET_RECRUITING - Start Date: 2024-07-01 - Completion Date: 2028-07-31 - Lead Sponsor: Walton Centre NHS Foundation Trust ### Study Description Older people falling from a standing height is the most common cause of hospital admission for head injury. Up to 1 in 3 patients admitted are taking a tablet medication which thins the blood, known as an oral anticoagulant. This type of medication can increase the likelihood of bleeding in the brain. Many patients are taking oral anticoagulation due to having an irregular heartbeat (called atrial fibrillation) or because of having a previous stroke or blood clots. When a scan shows blood in the brain, oral anticoagulation is nearly always stopped. However, this leaves the question of when it is safe to restart them. The risk of making the bleeding in the brain worse must be balanced against the risk of having a stroke or blood clots. There is no clear evidence on the safest time to restart oral anticoagulation, but most neurosurgeons advise restarting them 1-4 weeks after head injury. The number of people who have a bleed on their brain after a head injury is increasing and further brain bleeding or a stroke can have a serious effect on patients' lives and their on-going healthcare needs. Public and patient groups have highlighted that many patients want to stop taking oral anticoagulation after a bleed but they may be unaware of the vital importance of restarting this medication to prevent strokes and blood clots. The most popular oral anticoagulation prescribed has changed in recent years from warfarin to newer medications called Direct Oral Anti-Coagulants (DOACs).This trial will recruit 1084 people who are admitted to hospital with a bleed on the brain caused by a head injury who were taking oral anticoagulation before their head injury and have been prescribed a Direct Oral Anti-Coagulant (DOAC) for previously diagnosed medical condition. Patients on other Oral Anti-Coagulants, such as Warfarin may also be able to take part. The main purpose of the trial is to determine when is most beneficial time for people to start or restart a DOAC after their head injury. People will be asked to start the medication either 1 week or 4 weeks after their head injury. They will be then followed closely for 12 weeks and any major bleeding events or a blood clots (thrombotic events) such as a stroke or heart attack will be recorded. The study will also look at the person's overall quality of life, how they recover physically, the number of people who die, the costs of the treatment, and the attitudes of people and their caregivers to starting or restarting a DOAC. ### Conditions - Traumatic Intracranial Haemorrhage ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Direct-Acting Oral Anticoagulants (used as per local standard practice) ### Outcomes Primary Outcomes - Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH. Secondary Outcomes - Time to first haemorrhagic or thrombotic event. - Time to first haemorrhagic event - Time to first thrombotic event - Time to death - Functional outcome measured using modified Rankin Scale (mRS) - Functional outcome measured using Barthel Index - Functional outcome measured using extended Glasgow Outcome Scale (GOS-E) - Overall Quality of Life measured by EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire - Patient/caregiver attitudes to (re)starting OAC - Healthcare resource use ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes - NCT ID: NCT06322940 - Study ID: 2024-10463 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-12-31 - Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre ### Study Description The objective of the study is to determine the effect of dairy product matrices on insulin sensitivity in overweight and obese adults with prediabetes. Females and males (30-65 y) will be recruited from the greater Montreal area. Upon screening, those with prediabetes will complete a 2-wk run-in period in which participants will consume 1 serving/d of regular-fat dairy products (milk, yogurt, or cheese). Adherent participants will be randomized by sex into 1 of 3 groups: ≤1 serving/d of dairy (limited dairy) or 2-3 servings/d of reduced-fat or regular-fat dairy for 12 weeks. Participants will be instructed on how to incorporate foods into their diet to prevent changes in their body weight. The hyperinsulinemic-euglycemic clamp will be used before and after the intervention to document potential changes in insulin sensitivity as the primary outcome. In addition, glycemic variables, body composition, and cardiometabolic risk factors will be assessed as secondary outcomes. Adherence to intervention will be assessed at each visit by food diaries and a record of consumed dairy products. ### Conditions - PreDiabetes - Overweight and Obesity ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - 250 mL serving size, 3.25% fat content - 175 g serving size, ≥2% fat content - 50 g serving size, ≥28% fat content ### Outcomes Primary Outcomes - Change in whole-body insulin sensitivity Secondary Outcomes - Change in glucose tolerance - Change in Matsuda index - Change in Insulinogenic index - Change in oral disposition index - Change in Homeostatic Model Assessment for Insulin Resistance - Change in glycated hemoglobin - Change in total lean body mass - Change in total fat mass - Change in visceral fat mass - Change in systolic blood pressure - Change in diastolic blood pressure - Change in lipid profile ### Location - Facility: RI-MUHC, Montréal, Quebec, H4A 3J1, Canada @@
## PatIent exPeRiences and prEFerence of trEatment foR Multiple Myeloma - NCT ID: NCT06322927 - Study ID: CFTsp231 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-31 - Completion Date: 2024-09-30 - Lead Sponsor: The Christie NHS Foundation Trust ### Study Description This is a qualitative (interview) study to explore the experiences of people receiving treatment for MM and to understand what matters most to them when making treatment decisions. ### Conditions - Multiple Myeloma ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Patient Interview ### Outcomes Primary Outcomes - Patient Experience and Preference Secondary Outcomes - Treatment and Preference Differences ### Location - Facility: The Christie NHS Foundation Trust, Manchester, Greater Manchester, M20 4BX, United Kingdom @@
## A Novel Scoring System for Predicting the Success of PCI in Patients With CTO - NCT ID: NCT06322914 - Study ID: 029 - Status: COMPLETED - Start Date: 2012-01 - Completion Date: 2023-11 - Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University ### Study Description The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success. ### Conditions - Chronic Total Occlusion (CTO) ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - PCI technical success Secondary Outcomes ### Location - Facility: First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China @@
## The Effect Of Vertical Releasing Incision On Implant Procedures - NCT ID: NCT06322901 - Study ID: TDH-2018-7883 - Status: COMPLETED - Start Date: 2018-08-05 - Completion Date: 2020-10-02 - Lead Sponsor: TC Erciyes University ### Study Description This study evaluated the clinical and biochemical aspects of flap design in dental implant applications regarding implantation success and patient comfort. In this split-mouth randomized controlled clinical trial, a vertical releasing incision was made at the distal end of the crestal incision on the test side, and the control side received a crestal incision alone. Sixty-eight implants were placed in 17 patients. Peri-implant groove fluid was collected on postsurgical days 3, 7, 30, and 90; OPG and RANKL levels were assessed to determine bone formation and resorption around the implants. Cortisol levels were assessed in peri-implant groove fluid at postsurgical days 3, 7, and 14. Visual analog scale (VAS), and swelling measurements were taken postoperatively. Panoramic and periapical X-rays were obtained immediately post-surgery and at 3 months. No significant marginal bone loss difference was observed between the test and control sides at 3 months. The RANKL/OPG ratio, cortisol levels, VAS scores, and swelling scores were higher in the test vs. control sides. Overall, while the use of a vertical incision has advantages, such as increasing the visual field of the surgeon and improving the ease of the operation, this approach should be used only when necessary, given the disadvantages of increased bone resorption mediators in the peri-implant tissue and reduced postoperative patient comfort. ### Conditions - Bone Loss - Flap Design ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: PREVENTION ### Interventions - Flap ### Outcomes Primary Outcomes - Bone loss Secondary Outcomes ### Location - Facility: Erciyes University Faculty of Dentistry, Melikgazi, Kayseri, 38039, Turkey @@
## Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D) - NCT ID: NCT06322888 - Study ID: 23-676 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2025-12-31 - Lead Sponsor: Dana-Farber Cancer Institute ### Study Description The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.The names of the study groups in this study are:* Exercise Training Group* Waitlist Control Group ### Conditions - Breast Cancer - Breast Cancer Female ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: PREVENTION ### Interventions - Exercise Training Program ### Outcomes Primary Outcomes - Change in Irisin in Exercise Group - Change in Irisin in Control Group Secondary Outcomes - Change in Tissue Markers in Exercise Group - Change in Tissue Markers in Control Group - Change in Biomarkers in Exercise Group - Meso scale - Change in Biomarkers in Exercise Group - Mass cytometry - Change in Biomarkers in Control Group - Meso Scale - Change in Biomarkers in Control Group - Mass cytometry - Change in Participant Weight in Exercise Group - Change in Participant Weight in Control Group - Change in Cardiorespiratory Fitness in Exercise Group - Change in Cardiorespiratory Fitness in Control Group - 10-Repetition Max Test in Exercise Group - 10-Repetition Max Test in Control Group - Change in Minutes of Total Exercise for Exercise Group - Change in Minutes of Total Exercise for Control Group ### Location - Facility: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States @@
## A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection - NCT ID: NCT06322875 - Study ID: SKCCOL002 - Status: NOT_YET_RECRUITING - Start Date: 2024-03 - Completion Date: 2024-12 - Lead Sponsor: DeYi Aesthetic Medical Clinic ### Study Description To evaluate the efficacy and safety of recombinant humanized collagen (type III) solution for injection combined with SkinCeuticals recombinant humanized collagen (RHC) serum Participants will be assessed by subjective questionnaire (FACE-Q Satisfaction with skin,Global Aesthetic Improvement Scale, et al) and some medical instruments (VISIA,Ultrascan UC22 et al) ### Conditions - Facial Wrinkles ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Recombinant type III humanized collagen solution for injection - SkinCeuticals recombinant humanized collagen (RHC) serum - Regular face cream smear ### Outcomes Primary Outcomes - FACE-Q Satisfaction with skin Secondary Outcomes - Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates - Subject Global Aesthetic Improvement Scale (S-GAIS) Rates - Improvement rate assessed by Atlas - Change in Cutometer® dual Analysis Score - Change in VISIA® Skin Analysis Score - FACE-Q Satisfaction with Outcome - FACE-Q Satisfaction with skin - Change of the thickness and density of subjects' facial dermis ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery - NCT ID: NCT06322862 - Study ID: H-23042430 - Status: RECRUITING - Start Date: 2024-03-05 - Completion Date: 2027-02-01 - Lead Sponsor: Rigshospitalet, Denmark ### Study Description This is a prospective, multicentre, non-randomized cohort study using real-time intraoperative visualization of bowel perfusion by indocyanine green (ICG) in all-cause bowel ischemia.At intraoperative finding of bowel ischemia, the initial intraoperative plan is noted and resection margins marked with a steril pen. A fluorescence angiography will be performed and the surgeon will note whether the suspected ischemic bowel is perfused, whether there is a change in the resection margins in centimeters, and if the intraoperative plan has changed. If resection is indicated and the strategy of choice is an anastomosis, a renewed fluorescence angiography will be performed to assess anastomotic perfusion. ### Conditions - Bowel; Ischemic, Acute ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: DIAGNOSTIC ### Interventions - Indocyanine green ### Outcomes Primary Outcomes - Change of strategy Secondary Outcomes - Anastomosis - Quantification using q-ICG - Stomas - Second-look - Anastomotic leaks - Postoperative medical complications - Postoperative surgical complications - Mortality ### Location - Facility: Department of Organ Surgery and Transplantation, Copenhagen, Hovedstaden, 2100, Denmark @@
## Active Elements of Digital Single-session Interventions - NCT ID: NCT06322849 - Study ID: STU00220591 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2024-06 - Lead Sponsor: Northwestern University ### Study Description Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.The secondary aims of this study are to:1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change. ### Conditions - Depression ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: FACTORIAL - Primary Purpose: TREATMENT ### Interventions - Psychoeducation - Testimonials and Saying is believing exercises - Action planning - Breathing exercise ### Outcomes Primary Outcomes - Patient Health Questionnaire-8 Secondary Outcomes - Patient Health Questionnaire-8 - Beck Hopelessness Scale-4 - Balanced measure of Psychological Needs scale ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home - NCT ID: NCT06322836 - Study ID: Protocol ID ABR number 83536 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-02-07 - Completion Date: 2024-06-01 - Lead Sponsor: RAV Brabant MWN ### Study Description The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.The main question\[s\] it aims to answer are:Primary objective:In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.Secondary objectives:Safety endpoint:Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care. ### Conditions - Emergency Medical Services - Electric Countershock ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - Duble current electro cardioversion ### Outcomes Primary Outcomes - completion of cardioversion to sinus rhythm Secondary Outcomes - Incidence of treatment-emergent adverse events (Safety endpoint a) - Incidence of treatment-emergent adverse events (Safety endpoint b) ### Location - Facility: RAV Brabant MWN, 's-Hertogenbosch, Noord Brabant, 5212VM, Netherlands @@
## Direct Thawing of Vitrified Human Blastocyst - NCT ID: NCT06322823 - Study ID: 2010.432 - Status: COMPLETED - Start Date: 2020-01-01 - Completion Date: 2023-12-31 - Lead Sponsor: Chinese University of Hong Kong ### Study Description There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide. ### Conditions - IVF ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - direct thawing - Vitrification ### Outcomes Primary Outcomes - blastocysts survival rate Secondary Outcomes - ferilization rate - pregnancy rate - live birth rate ### Location - Facility: David Yiu Leung Chan, Hong Kong, N/A, 000000, Hong Kong @@
## ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial - NCT ID: NCT06322810 - Study ID: ESP vs. PIFB - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2026-04-01 - Lead Sponsor: Taichung Veterans General Hospital ### Study Description This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\].The main questions it aims to answer are:* Does ESPB provide superior analgesia than PIFB* Do patients who receive ESPB have better recovery outcomes ### Conditions - Analgesia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Erector spinae plane block (ESPB) - Pecto-intercostal fascial plane blok (PIFB) ### Outcomes Primary Outcomes - 48hr opioid consumption Secondary Outcomes - Postoperative static pain scores-Day 1 - Postoperative static pain scores-Day 2 - Postoperative dynamic pain scores-Day 1 - Postoperative dynamic pain scores-Day 2 - postoperative incentive spirometry volume (ml)-Day 1 - postoperative incentive spirometry volume (ml)-Day 2 - postoperative incentive spirometry volume (ml)-Day 3 - QoL15 (pre-op) - QoL15 (POD3) ### Location - Facility: Taichung Veterans General Hospital, Taichung, N/A, 407, Taiwan @@
## The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement - NCT ID: NCT06322797 - Study ID: rTMSinStroke - Status: RECRUITING - Start Date: 2022-07-19 - Completion Date: 2024-12-31 - Lead Sponsor: MinYoung Kim, MD, PhD ### Study Description A randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke. ### Conditions - Stroke ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - rTMS - rTMS - Sham ### Outcomes Primary Outcomes - Change of Fugl-Meyer Assessment Secondary Outcomes - Change of Range of motion - Change of Berg Balance Scale - Change of Motor Assessment Scale - Change of Trunk Imbalance Scale - Change of Functional Ambulation Category - Change of Time up and go - Change of Manual muscle Test - Change of Action reach arm test - Change of Jebsen taylor hand function test - Change of Functional Independence Measure - Change of Modified Barthel index - Change of National Institutes of Health Stroke Scale - Change of Korean Mini Mental State Exam - Change of Clinical Dementia Rating - Change of Global Deterioration Scale - Change of Geriatric Depression Scale - Change of Brain imaging - Change of Electroencephalography - Change of Evoked Potential - Changes in test results of WBC(/uL), RBC(/uL), , Hct(%), PLT(/uL), Hgb(g/dL) - Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL) - Changes in test results of AST(IU/L), ALT(IU/L) - Change of Motricity index ### Location - Facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center, Seongnam, N/A, 13496, Korea, Republic of @@
## DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA - NCT ID: NCT06322784 - Study ID: LiJingjing - Status: COMPLETED - Start Date: 2022-11-01 - Completion Date: 2024-02-10 - Lead Sponsor: Shenzhen People's Hospital ### Study Description The goal of this clinical trial is to test in Rheumatoid arthritis. The main question it aims to answer are:* To verify the effect of dietary fiber supplementation on reducing the level of inflammation;* To verify the effect of dietary fiber supplementation on improving disease activity and quality of life in patients with rheumatoid arthritis .To verify the effect of dietary fiber supplementation on regulating the production of anti-inflammatory short-chain fatty acid in the gut of patients with rheumatoid arthritis.The experimental group was supplemented with dietary fiber for 12 weeks, and the control group was fed with the Mediterranean diet. Before and after the intervention, 1 tube of 3ml blood and 1 soybean-sized stool were taken and a questionnaire was made ### Conditions - Rheumatoid Arthritis ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Oat bran (dietary fiber) ### Outcomes Primary Outcomes - Disease activity score - Quality of life score Secondary Outcomes - Compliance of oat bran - Inflammatory indicators :TNF- α - Inflammatory indicators:IL-6 - Inflammatory indicators :IL-10 - Inflammatory indicators: ESR - Inflammatory indicators :CRP - gut flora - Adjustment of anti rheumatic drugs ### Location - Facility: Jingjing Li, Shenzhen, Guangdong, 518000, China @@
## Women's Refusal to Participate in a Randomized Trial Involving First-trimester Screening for Pre-eclampsia: Factors Associated With Refusal and Reasons for Acceptance and Refusal - NCT ID: NCT06322771 - Study ID: APHP240376 - Status: RECRUITING - Start Date: 2024-04-11 - Completion Date: 2025-03 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. The secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate. ### Conditions - Pregnancy Related ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Questionnaire - Questionnaire ### Outcomes Primary Outcomes - Factors associated with women's refusal Secondary Outcomes - Number of acceptations - Number of refusals - Demographic characteristics - Questionnaire "acceptance" - Questionnaire "refusal" ### Location - Facility: Port-Royal Maternity, Paris, IDF, 75014, France @@
## Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome - NCT ID: NCT06322758 - Study ID: APHP230851 - Status: NOT_YET_RECRUITING - Start Date: 2024-09-01 - Completion Date: 2026-12-01 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description Acute respiratory distress syndrome (ARDS) is associated with high mortality, some of which can be attributed to ventilator-induced lung injury (VILI) when artificial ventilation is not customized to the severity of lung injury. As ARDS is characterized by a decrease in aerated lung volume, reducing tidal volume (VT) from 12 to 6 mL/kg of predicted body weight (PBW) was shown to improve survival more than 20 years ago. Since then, the VT has been normalized to the PBW, meaning to the theoretical lung size (before the disease), rather than tailored to the severity of lung injury, i.e., to the size of aerated lung volume. During ARDS, the aerated lung volume is correlated to the respiratory system compliance (Crs). The driving pressure (ΔP), defined as the difference between the plateau pressure and the positive end expiratory pressure, represents the ratio between the VT and the Crs. Therefore, the ΔP normalizes the VT to a surrogate of the aerated lung available for ventilation of the diseased lung, rather than to the theoretical lung size of the healthy lung, and thus represents more accurately the actual strain applied to the lungs. In a post hoc analysis of 9 randomized controlled trials, Amato et al. found that higher ΔP was a better predictor of mortality than higher VT, with an increased risk of death when the ΔP \> 14 cm H2O. These findings have been confirmed in subsequent meta-analysis and large-scale observational data. In a prospective study including 50 patients, the investigators showed that a ΔPguided ventilation strategy targeting a ΔP between 12 and 14 cm H2O significantly reduced the mechanical power, a surrogate for the risk of VILI, compared to a conventional PBW-guided ventilation. In the present study, the investigators hypothesize that the physiological individualization of ventilation (ΔP-guided VT) may improve the outcome of patients with ARDS compared to traditional anthropometrical adjustment (PBW-guided VT) ### Conditions - Acute Respiratory Distress Syndrome ARDS ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Tidal volume customization in the acute respiratory distress syndrome ### Outcomes Primary Outcomes - Mortality - Number of days free from mechanical ventilation Secondary Outcomes - Ventilator parameters - Arterial blood gases - Mortality - Number of days alive without ventilation - Sequential Organ Failure Assessment score (SOFA) - Number of days alive without catecholamine - Number of days alive without continuous sedation - Number of days alive without neuromuscular blockers - Number of prone position sessions - Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R - Occurrence of ventilator-associated pneumothorax - Time to pressure support ventilation; - Duration of weaning unreadiness - Duration of weaning - The rate of tracheostomy - Total duration of mechanical ventilation - Length of stay ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy - NCT ID: NCT06322745 - Study ID: 1986 - Status: RECRUITING - Start Date: 2023-06-01 - Completion Date: 2025-03-01 - Lead Sponsor: Al-Azhar University ### Study Description To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy. ### Conditions - Renal Tumor - Renal Malignant Tumor ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy - Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy ### Outcomes Primary Outcomes - Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping). - Suture time and operative time in minutes - Intraoperative number of sutures for renorraphy - Intraoperative Blood loss - Blood transfusion rate - Renal function: serum creatinine - Renal function: estimated GFR (eGFR) - Transforming growth factor beta (TGF-β) urine level - Monocyte chemoattractant protein (MCP-1) urine level Secondary Outcomes - Hospital stay - Post operative pain ### Location - Facility: Urology Department, Al-Azhar University Hospitals, Cairo, N/A, 11511, Egypt @@
## Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care - NCT ID: NCT06322732 - Study ID: APHP191125 - Status: NOT_YET_RECRUITING - Start Date: 2024-09 - Completion Date: 2025-09 - Lead Sponsor: Assistance Publique - Hôpitaux de Paris ### Study Description The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term.Perinatal asphyxia is a serious and often unexpected pathology, requiring urgent multidisciplinary care (obstetric - pediatric - intensive care, etc.) with a high level of technical expertise and care coordination. Because of its rarity and complexity, it may be subject to suboptimal care.The aim of this study is to provide feedback within the center itself, coupled in 1/3 of cases with a confidential investigation into the search for and understanding of suboptimal care.Primary endpoint:Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy (AIE) or neonatal death related to severe perinatal asphyxia. ### Conditions - Perinatal Asphyxia ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - sub-optimal perinatal care Secondary Outcomes - Frequency of suboptimal care - Relationship - Outcome - Characteristics of suboptimal care - Determinantes of suboptimal care - Ad-hoc survey ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU - NCT ID: NCT06322719 - Study ID: INVIBLADE - Status: NOT_YET_RECRUITING - Start Date: 2024-05-01 - Completion Date: 2024-05-30 - Lead Sponsor: Hospital Clinico Universitario de Santiago ### Study Description Tracheal intubation in the intensive care unit (ICU) is associated with high incidence of difficult intubation and complications. Videolaryngoscopes (VLs) devices have been proposed to improve airway management, and the use of VLs are recommended as first-line or after a first-attempt failure using direct laryngoscopy in ICU airway management algorithms. Although until relatively few years ago there were doubts about whether videolaryngoscopes had advantages over direct laryngoscopy for endotracheal intubation (ETI) in critically ill patients, two recent studies (DEVICE (1), INTUBATE (2)), and a Cochrane review (3) have confirmed that videolaryn should be used?, and what is the best blade? . There are two types of blades commonly used with videolaryngoscopes: the "Macintosh" blade with a slight curvature, and hyperangulated blades. The "Macintosh" blades have a lower angle of vision, but they have the advantage of being similar to the blades commonly used in direct laryngoscopy, making them easy to use for the person performing the ETI. Hyperangulated blades have a greater angle of vision, improving glottic visualization, especially in patients with an anterior glottis. However, the need to overcome this angulation could potentially hinder the passage of the endotracheal tube to the vocal cords. It is unknown if either blade has any advantage for intubating critically ill patients. ### Conditions - Acute Respiratory Failure - Intubation - Intubation; Difficult or Failed - Videolaryngoscopy - Intubation Complication ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Hyperangulated blade videolaryngoscope - Macintosh blade videolaryngoscope ### Outcomes Primary Outcomes - Difference in the first attempt intubation success rate (percentage) Secondary Outcomes - Difference in the overall success rate - Number of intubation attempts - Modified Cormack-Lehane grade of glottic view - Diference in the incidence of "easy intubation" - Duration of tracheal intubation - Reason for unsuccessful intubation on the first attempt - Number of videolaryngoscopy attempts - Number of attempts to cannulate the trachea with a bougie or an endotracheal tube - Operator-assessed difficulty of intubation - Need for additional airway equipment - Need to change the device for intubation - Complications of tracheal intubation ### Location - Facility: University Clinical Hospital of Santiago de Compostela, Santiago de Compostela, A Coruña, 15866, Spain @@
## A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021 - NCT ID: NCT06322706 - Study ID: ABSK021-105 - Status: NOT_YET_RECRUITING - Start Date: 2024-03-28 - Completion Date: 2025-12-31 - Lead Sponsor: Abbisko Therapeutics Co, Ltd ### Study Description Part A: a single-center, randomized, open-label, three-cycle study to evaluate the pharmacokinetic (PK) profile of different doses of ABSK021 Capsules and the effect of a high-fat meal on the pharmacokinetic profile of ABSK021 Capsules in healthy subjects Part B: a single-center, open-label, fixed-sequence study to evaluate the effect of multiple oral doses of Omeprazole Enteric-coated Tablets on the PK profile of ABSK021 Capsules in healthy subjects ### Conditions - Healthy Subjects ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: CROSSOVER - Primary Purpose: TREATMENT ### Interventions - ABSK021 - Omeprazole ### Outcomes Primary Outcomes - Cmax - tmax - AUC0-∞ - AUClast Secondary Outcomes - AE - SAE - blood pressure - respiratory rate - ECG QT Interval - t1/2 - CL/F - Vz/F ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) - NCT ID: NCT06322693 - Study ID: 213348 - Status: RECRUITING - Start Date: 2016-07-08 - Completion Date: 2027-02-19 - Lead Sponsor: GlaxoSmithKline ### Study Description This is a first-in-human study evaluating the anti-T cell immunoglobulin and mucin containing protein-3 (TIM-3) antibody TSR-022. The study will be conducted in 2 parts with Part 1 consisting of dose escalation and Part 2 dose expansion. Part 1 will determine the recommended Phase 2 dose (RP2D) of TSR-022 and Part 2 will evaluate the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy. ### Conditions - Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - TSR-022 - Nivolumab - TSR-042 - TSR-033 - Docetaxel - Pemetrexed - Cisplatin - Carboplatin ### Outcomes Primary Outcomes - Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs) - Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs) - Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs) - Part 1: Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, treatment emergent adverse events (TEAEs), TEAEs leading to death and immune-related adverse events (irAEs) - Part 1: Number of participants with clinically significant changes in laboratory parameters, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications - Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 Secondary Outcomes - Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1 - Part 2 (A, B, C, D) : ORR by Immune related RECIST (irRECIST) - Part 2: Duration of response (DOR) by RECIST v 1.1 - Part 2 (A, B, C, D) : DOR by irRECIST - Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1 - Part 2 (A, B, C, D) : DCR by irRECIST - Part 2: Progression-free survival (PFS) by RECIST v 1.1 - Part 2 (A, B, C, D) : PFS by irRECIST - Parts 1 and 2 (A, B, C, D, E, F) : Serum concentration of TSR-022 - Part 1d: Serum concentration of TSR-033 - Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042 - Part 2 (A, B, C, D, F): Serum concentration of TSR-042 - Part 2: Overall survival (OS) - Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy - Part 1b: Cmin of TSR-022 in combination with nivolumab - Part 1c: Cmin of TSR-022 in combination with TSR-042 - Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033 - Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy - Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab - Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042 - Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033 - Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy - Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab - Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042 - Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033 - Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy - Part 1b: t1/2 of TSR-022 and in combination with nivolumab - Part 1c: t1/2 of TSR-022 in combination with TSR-042 - Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033 - Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy - Part 1b: AUCtau of TSR-022 and in combination with nivolumab - Part 1c: AUCtau of TSR-022 in combination with TSR-042 - Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033 - Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022 - Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022 - Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042 - Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042 - Part 1d: Number of participants with ADA to TSR-033 - Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death - Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP) ### Location - Facility: GSK Investigational Site, Goodyear, Arizona, 85338, United States @@
## Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy - NCT ID: NCT06322680 - Study ID: ZSPAC-03 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2027-02-01 - Lead Sponsor: Shanghai Zhongshan Hospital ### Study Description Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF. ### Conditions - Pancreaticoduodenectomy ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Main pancreatic duct and biliary duct external drainage - Main pancreatic duct and biliary duct internal drainage ### Outcomes Primary Outcomes - The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery Secondary Outcomes - Surgical Complications: Incidence and grading of complications within 90 days after surgery - Surgical Complications: Clavien-Dindo classification - Surgical Complications: Mortality rate - Surgical Complications: reoperation rate - Surgical Complications: readmission rate - Surgical Complications: rate of digital subtraction angiography for postoperative pancreatic hemorrhage - Surgical Complications: Total cost of perioperative treatment - Surgical Complications: Length of hospital stay - Adjuvant treatment: Proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery - Adjuvant treatment: Interval between the start of adjuvant treatment and surgery - Long-term survival related to malignant tumors: Overall survival (OS) - Long-term survival related to malignant tumors: Disease-free survival (DFS) ### Location - Facility: Zhongshan Hospital, Shanghai, Shanghai, 200000, China @@
## A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab - NCT ID: NCT06322667 - Study ID: BAN2401-J081-401 - Status: RECRUITING - Start Date: 2023-12-22 - Completion Date: 2027-12-31 - Lead Sponsor: Eisai Co., Ltd. ### Study Description The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab. ### Conditions - Alzheimer's Disease ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No Intervention ### Outcomes Primary Outcomes - Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H) - Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA Secondary Outcomes - Number of Participants With Infusion Related Reaction ### Location - Facility: Eisai trial site 2, Hiroshima, N/A, N/A, Japan @@
## A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients - NCT ID: NCT06322654 - Study ID: 2023/ABM/01/00004/P/02 - Status: RECRUITING - Start Date: 2023-12-21 - Completion Date: 2027-07 - Lead Sponsor: Wiktor Dega University Orthopedic and Rehabilitation Hospital ### Study Description A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion.The objective of research:The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models.1. Research period: 4 years2. Patients age: 0-21 y.o.3. Group size: 200 patients (100 patients in each group)4. Assignment of patients to study groups in a randomised manner ### Conditions - SMA ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Robotically Assisted Locomotion - Robotically Assisted Verticalization ### Outcomes Primary Outcomes - Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale - Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation. - Functional assessment of patients using GMFM (Gross Motor Function Measure) scale - X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density - Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0 Secondary Outcomes - Hospitalization during or between rehabilitations that take place each 6 months - Occurence of discomfort during therapy requiring abrupt interruption or significant modification - Number of fractures ### Location - Facility: Wiktor Dega University Orthopedic and Rehabilitation Hospital, Poznań, N/A, 61-545, Poland @@
## A Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Nephrologists - NCT ID: NCT06322641 - Study ID: DAS-8092 - Status: ENROLLING_BY_INVITATION - Start Date: 2024-03-26 - Completion Date: 2024-04-26 - Lead Sponsor: Novo Nordisk A/S ### Study Description The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with Atherosclerotic Cardiovascular Disease (ASCVD) and Chronic Kidney Disease (CKD) ### Conditions - Atherosclerotic Cardiovascular Disease (ASCVD) - Chronic Kidney Disease (CKD) - Systemic Inflammation ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - No treatment given ### Outcomes Primary Outcomes - Nephrologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD Secondary Outcomes ### Location - Facility: KJT Group, Inc., Rochester, New York, 14623, United States @@
## A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients - NCT ID: NCT06322628 - Study ID: VSA006-2001 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2026-07 - Lead Sponsor: Visirna Therapeutics HK Limited ### Study Description Human genetic studies have shown that loss of function (LOF) mutations in HSD17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as NASH, without significant adverse phenotypes.VSA006 is a siRNA drug targeting HSD17β13 mRNA in the liver and reduce the protein level of HSD17β13. Based on phase 1 study results in healthy volunteers and NASH/suspected NASH patients, this phase 2 study is designed to evaluate the efficacy, safety, PK profiles and immunogenicity of VSA006 in Chinese NASH patients. ### Conditions - Nash ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - VSA006 - Placebo ### Outcomes Primary Outcomes - Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH - Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis Secondary Outcomes - Compared with placebo, the percentage change in serum alanine aminotransferase (ALT) - Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline - Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline - Compared with placebo, the change and percentage change in noninvasive markers of fibrosis from baseline: FIB-4, NAFLD fibrosis score, and AST/PLT ratio index (APRI) - Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis - Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006 - Maximum observed concentration (Cmax) of VSA006 - Time of maximum concentration of VSA006 (Tmax) - Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006 - anti-drug antibodies (ADAs) of VSA006 ### Location - Facility: N/A, N/A, N/A, N/A, N/A @@
## Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy - NCT ID: NCT06322615 - Study ID: MC221001 - Status: RECRUITING - Start Date: 2023-08-08 - Completion Date: 2025-12-31 - Lead Sponsor: Mayo Clinic ### Study Description This clinical trial evaluates whether acupressure is helpful to reduce anxiety related to chemotherapy. Anxiety is experienced by many patients with cancer. Anxiety can be related to chemotherapy and may contribute to other symptoms, such as nausea and poor quality of life. Some patients diagnosed with cancer express interest in non-medicinal ways to manage symptoms. Acupressure is a noninvasive intervention that can be used for many different symptoms. Acupressure is well tolerated with minimal reports of adverse reactions, making it a good choice for patients with cancer. This study may help researchers learn whether acupressure is useful for managing anxiety in patients undergoing chemotherapy. ### Conditions - Hematopoietic and Lymphatic System Neoplasm - Malignant Solid Neoplasm ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Acupressure Therapy - Educational Intervention - Electronic Health Record Review - Questionnaire Administration ### Outcomes Primary Outcomes - Number of patients approached about undergoing acupressure intervention (Feasibility) - Number of patients interested in the initial acupressure intervention in the chemotherapy unit (Feasibility) - Number of patients interested in the home acupressure intervention (Feasibility) - Time taken for each nurse-led acupressure intervention in the chemotherapy unit (Feasibility) - Patient-reported changes in acute anxiety Secondary Outcomes ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors - NCT ID: NCT06322602 - Study ID: 23-009112 - Status: RECRUITING - Start Date: 2024-02-28 - Completion Date: 2029-03 - Lead Sponsor: Mayo Clinic ### Study Description This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor. ### Conditions - Brain Neoplasms ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: BASIC_SCIENCE ### Interventions - Intracranial Catheter Placement - Lumbar Puncture - Biopsy - Biospecimen Collection - Computed Tomography ### Outcomes Primary Outcomes - Feasibility of Ommaya reservoir placement Secondary Outcomes - Utility of Ommaya reservoir ### Location - Facility: Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States @@
## Evaluation of Human Efficacy of SOD Like Super Drink - NCT ID: NCT06322589 - Study ID: CMUH112-REC3-175 - Status: RECRUITING - Start Date: 2024-03-01 - Completion Date: 2024-12-31 - Lead Sponsor: TCI Co., Ltd. ### Study Description To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human ### Conditions - Dermatology ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: OTHER ### Interventions - SOD like Super Drink - placebo drink ### Outcomes Primary Outcomes - the volume of skin wrinkles - the roughness of skin texture - the change of skin elasticity - the change of Total Anti-oxidative Capacity (TAC) of blood - the change of Superoxide Dismutase (SOD) of blood - the change of Glutathione S-transferase (GST) of blood - the change of Glutathione (GSH) of blood - the change of Malondialdehyde (MDA) of blood - the change of immune-related cytokines of blood Secondary Outcomes - the change of skin surface hydration - the change of skin Transepidermal Water Loss (TEWL) - the change of Skin Melanin Index - the change of Skin Erythema Index ### Location - Facility: China Medical University of department of cosmeceutics, Taichung City, N/A, 406040, Taiwan @@
## 177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma - NCT ID: NCT06322576 - Study ID: IRB00347750 - Status: NOT_YET_RECRUITING - Start Date: 2024-04 - Completion Date: 2035-12 - Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ### Study Description This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2.If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling. ### Conditions - Adenoid Cystic Carcinoma ### Study Design - Type: INTERVENTIONAL - Allocation: NA - Intervention Model: SINGLE_GROUP - Primary Purpose: TREATMENT ### Interventions - 177Lu-PNT2002 ### Outcomes Primary Outcomes - Absorbed dose in tumor and normal organs - Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC. Secondary Outcomes - Stability of Disease: Proportion of patients with Stable Disease - Progression Free Survival - Overall Survival - Duration of Response - Xerostomia questionnaire (XQ) score - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43) ### Location - Facility: Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States @@
## Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRC - NCT ID: NCT06322563 - Study ID: LTC004-202 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-01 - Completion Date: 2025-03-01 - Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital ### Study Description This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in combination with regorafenib in patients with mCRC. A safety introductory trial was conducted to receive LTC004 in combination with regorafenib before starting the formal trial. After completing a 28-day safety assessment, safety will be confirmed before entering the formal trial phase. Further evaluation of the safety and efficacy of LTC004 in combination with regorafenib in the treatment of mCRC ### Conditions - Advanced/Metastatic Colorectal Cancer ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: SEQUENTIAL - Primary Purpose: TREATMENT ### Interventions - LTC004+regorafenib ### Outcomes Primary Outcomes - Treatment-Emergent Adverse Events-Safety and Tolerability - SAE-Safety and Tolerability Secondary Outcomes - ORR - DCR - PFS - OS ### Location - Facility: Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, 300060, China @@
## Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial - NCT ID: NCT06322550 - Study ID: beingapatient - Status: COMPLETED - Start Date: 2019-10-29 - Completion Date: 2023-02-01 - Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf ### Study Description This study was preregistered 2019 under https://osf.io/nczhj. Since JAMA requires a registration with ClinicalTrials.gov, we post-register the study here with the identical informations from OSF (see there)Migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. Clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. Therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. In order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls. ### Conditions - Role-expectancy on Patient Reported Outcomes ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - cover story ### Outcomes Primary Outcomes - self-reported vestibular symptoms Secondary Outcomes - differences in motion sickness susceptibility using a standardized motion sickness questionnaire - differences in disability level using a standardized motion sickness questionnaire - differences in headache days per month - differences in headache burden and migraine disability questionnaires ### Location - Facility: UKE, Hamburg, N/A, 20246, Germany @@
## Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective - NCT ID: NCT06322537 - Study ID: 23-5339 - Status: NOT_YET_RECRUITING - Start Date: 2024-04-02 - Completion Date: 2025-11-01 - Lead Sponsor: University Health Network, Toronto ### Study Description All heart surgery patients universally require hydration, which is given through a vein in the arm, but practices for treating patients are not universal. There are disagreements about whether crystalloids should be used alone or in combination with albumin. This question has important implications because albumin is an expensive blood product in relatively limited supply, and 20% of its use is by heart surgery patients. The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery, as well as, key patient outcomes. ### Conditions - Cardiovascular Surgical Procedures - Albumin ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions ### Outcomes Primary Outcomes - Albumin - Crystalloid, volume dose and type administered Secondary Outcomes ### Location - Facility: Royal Columbian Hospital, New Westminster, British Columbia, V3L 3W7, Canada @@
## Study on Gamma Sensory Flicker for Insomnia - NCT ID: NCT06322524 - Study ID: FirstShanxiMU_jsk - Status: COMPLETED - Start Date: 2021-05-01 - Completion Date: 2022-12-30 - Lead Sponsor: The First Affiliated Hospital of Shanxi Medical University ### Study Description This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring. ### Conditions - Sleep Quality - Sleep Duration - Sleep Onset Latency ### Study Design - Type: OBSERVATIONAL - Allocation: N/A - Intervention Model: N/A - Primary Purpose: N/A ### Interventions - Gamma sensory flicker ### Outcomes Primary Outcomes - Treatment adherence rate - Patient treatment adherence rate - Incidence rate of adverse reaction - Differences in sleep duration between the first and eighth weeks - Differences in sleep onset latencies between the first and eighth weeks - Differences in awakening times between the first and eighth weeks Secondary Outcomes - pre-sleep efficiency. - post-sleep efficiency. ### Location - Facility: Yong Xu, Taiyuan, Shanxi, 030000, China @@
## Dialogical Family Guidance PostDoc Study - NCT ID: NCT06322511 - Study ID: HUS/7626/2023 - Status: RECRUITING - Start Date: 2024-01-02 - Completion Date: 2027-12-31 - Lead Sponsor: Tampere University ### Study Description This new family intervention, called Dialogical Family Guidance (DFG) is developed to target family needs especially in families with a child with neurodevelopmental disorders. PhD study showed, that this intervention is functioning with this target group. Participants (families) experienced that they got information, guidance to ordinary life and that the DFG-therapists were listening to them and above all, helping with individual problems and questions. DFG include six meetings and professionals need to attend on a 3-day long education before using this intervention. ### Conditions - Family Dynamics - Family Relations - Family Support ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: SUPPORTIVE_CARE ### Interventions - Dialogical Family Guidance (DFG) ### Outcomes Primary Outcomes - FAFHES Secondary Outcomes - DFG-questionnaire - SDQ-p questionnaire (Strengths and difficulties regarding the child) ### Location - Facility: Helsinki university hospital, Helsinki, N/A, 00029, Finland @@
## Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity - NCT ID: NCT06322498 - Study ID: INFLAM.UTERUS-HMO-CTIL - Status: RECRUITING - Start Date: 2023-01-18 - Completion Date: 2024-12 - Lead Sponsor: Hadassah Medical Organization ### Study Description A prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. Eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. After fixation of the transcervical catheter, we will flush 2 ml sterile NaCl 0.9% into the uterine cavity and aspirate the fluid. After collecting all samples, the samples will be snap frozen and stored at -80o C, until they undergo an immunological analysis. ### Conditions - Infertility Due to Nonimplantation - Infertility Secondary - Cesarean Section Complications ### Study Design - Type: INTERVENTIONAL - Allocation: NON_RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - Uterine lavage ### Outcomes Primary Outcomes - Inflammatory cell population Secondary Outcomes ### Location - Facility: Hadassah Medical Organization, Jerusalem, N/A, N/A, Israel @@
## Online Self-management in Fibromyalgia - NCT ID: NCT06322485 - Study ID: P16.230 - Status: COMPLETED - Start Date: 2017-01-25 - Completion Date: 2021-01-26 - Lead Sponsor: Leiden University ### Study Description This study has been previously registered with the National Trial Registry (NTR6267) that has been cancelled. The registered trial has been automatically transferred to a new "Landelijk Trial Register", which does not contain all correct information on the current study and where no corrections can be made. Hence, the current study has been registered again with ClinicalTrials.gov.The goal of this clinical trial is to study the effectiveness of an internet-based self-management intervention in adult patients with fibromyalgia. A randomized controlled trial (RCT) will be performed, in which 70 participants will be randomized to either the self-management intervention or a waitlist control condition (patients in the waitlist condition will receive the intervention after the intervention ends in the intervention group, i.e., after 6 months). The primary effect constitutes of the difference in change in pain coping between patients in the intervention and control condition from baseline to post-intervention. As secondary outcomes, a number of other psychological and physical outcome measures will be assessed (e.g., health-related quality of life, well-being, pain impact on daily life, pain cognitions). Also, cost-effectiveness of the intervention and the quality of the therapeutic relationship will be measured. ### Conditions - Fibromyalgia ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: TREATMENT ### Interventions - Internet-based self-management intervention ### Outcomes Primary Outcomes - Change in pain coping Secondary Outcomes - Change in well-being - Change in illness cognitions - Change in pain coping strategies - Change in Illness Perceptions - Change in pain - Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress - Change in health-related quality of life - Change in fibromyalgia impact - Change in health-related quality of life ### Location - Facility: Fibrocentrum, Leiden, Zuid-Holland, 2321 GL, Netherlands @@
## The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users - NCT ID: NCT06322472 - Study ID: 138956 - Status: COMPLETED - Start Date: 2021-01-10 - Completion Date: 2022-02-12 - Lead Sponsor: Uskudar University ### Study Description The aim was to examine the relationship between home literacy of parents whose has children who use cohlear implant and family demographic characteristics and phonological awareness skills of children with cochlear implant. ### Conditions - Cochlear Implants - Child Language - Literacy - Phonological (Speech) Disorder ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: DIAGNOSTIC ### Interventions - The Turkish Early Language Development Test (TEDIL) - The Family Literacy Scale - The Early Childhood Phonological Sensitivity Scale (PASECP) - The Early Literacy Home Environment Scale (ELHES) - Demographic Questionaries ### Outcomes Primary Outcomes - The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants - The data Family Literacy Scale from parents - The data Early Literacy Home Environment Scale (ELVES) from parents Secondary Outcomes ### Location - Facility: Uskudar University, Istanbul, N/A, N/A, Turkey @@
## Effect of Sport Education on Physical Fitness and Learning Attitude Among Junior High School Students - NCT ID: NCT06322459 - Study ID: Junlong Zhang - Status: RECRUITING - Start Date: 2024-02-25 - Completion Date: 2024-07-05 - Lead Sponsor: Universiti Putra Malaysia ### Study Description Since the outbreak of COVID-19, students; sports environment and time have been severely compressed, which has had an unprecedented impact on their physical fitness and sports learning attitude. Therefore, it is urgent to adopt an effective teaching mode that aligns with curriculum reform to improve students; physical quality and learning attitude. The Sports Education Model is one of the most popular teaching models in Western developed countries, but the application in China and the related evidence of improving students; physical quality and learning attitude towards sports are relatively scarce. This study compares and analyzes the influence of the Sports Education Model and Traditional Teaching on junior middle school students; physical fitness and learning attitude, aiming to provide theoretical support for improving students; physical fitness and learning attitude and promoting the Sports Education Model in China. Promote the healthy development of junior middle school students. ### Conditions - Physical Fitness ### Study Design - Type: INTERVENTIONAL - Allocation: RANDOMIZED - Intervention Model: PARALLEL - Primary Purpose: BASIC_SCIENCE ### Interventions - Sport Education Curriculum - Normal teaching ### Outcomes Primary Outcomes - Cardiovascular fitness test - Flexibility test - Speed test Secondary Outcomes ### Location - Facility: The 19th Middle School, Qinhuangdao, Hebei, 066000, China @@

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