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protocolSection identificationModule nctId: NCT06323746, orgStudyIdInfo id: HR-EEG-CSAR, briefTitle: Exploring Heart Rate Variability, EEG Pattern, and Corticomuscular Coherence After Cervical Sagittal Alignment Restoration, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Sharjah, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cervical Lordosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Permuted block randomization to ensure an equal number of allocations in each of the two groups (intervention and wait list group). Each random block will be stored in opaque sealed envelopes consecutively numbered with a third researcher. Once each participant officially joins the study the researcher will open the subsequent envelop., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Denneroll cervical traction orthodontic, outcomesModule primaryOutcomes measure: Cervical Sagittal Alignment Radiographs, primaryOutcomes measure: Cervical Sagittal Alignment Radiographs, secondaryOutcomes measure: Heart rate Variability (HRV) physiological parameter, secondaryOutcomes measure: Corticomuscular Coherence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Sharjah, city: Sharjah, zip: 0000, country: United Arab Emirates, contacts name: Ibrahim Mostafa Abuamr, professor, role: CONTACT, email: iabuamr@sharjah.ac.ae, contacts name: Shima Zadeh, Research Assistant, role: SUB_INVESTIGATOR, contacts name: Ibrahim Mostafa Abuamr, Professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.33737, lon: 55.41206, hasResults: False
protocolSection identificationModule nctId: NCT06323733, orgStudyIdInfo id: 2CAPA, briefTitle: Exercise Intervention for Patients With Cancer Cachexia: Effects of a 12-week Program and One-year Follow-up., acronym: 2CAPA, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Peyrachon Romane, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cachexia-Anorexia Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Intervention, outcomesModule primaryOutcomes measure: Health-Related Quality of Life, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Lean mass, secondaryOutcomes measure: Fat mass, secondaryOutcomes measure: Aerobic fitness, secondaryOutcomes measure: Muscular strength of the lower limbs, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Static balance ability, secondaryOutcomes measure: Appetite, secondaryOutcomes measure: Cancer-related Fatigue, secondaryOutcomes measure: Physical Activity and Sedentary Levels, secondaryOutcomes measure: Stages of change for exercise, secondaryOutcomes measure: Exercise beliefs, otherOutcomes measure: Compliance to exercise intervention, otherOutcomes measure: Reasons for absence, otherOutcomes measure: Timing of absences, otherOutcomes measure: Fidelity to session duration, otherOutcomes measure: Fidelity to session intensity, otherOutcomes measure: Reasons to modify exercise sessions, otherOutcomes measure: Incidence of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SPORMED, city: Rennes, state: Bretagne, zip: 35000, country: France, geoPoint lat: 48.11198, lon: -1.67429, hasResults: False
protocolSection identificationModule nctId: NCT06323720, orgStudyIdInfo id: ONZ-2023-0442, briefTitle: Signs of Central Sensitization in Tension-type Headache, acronym: CSTTH, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Tension-Type Headache, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Quantitative Sensory Testing, outcomesModule primaryOutcomes measure: Pain sensitivity for heat stimuli, primaryOutcomes measure: Pain sensitivity for cold stimuli, primaryOutcomes measure: Pain sensitivity for electrical stimuli, primaryOutcomes measure: Pain sensitivity for pressure, primaryOutcomes measure: Function of the pain facilitating pathways, primaryOutcomes measure: Function of the pain inhibiting pathways, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ghent University, status: RECRUITING, city: Ghent, state: East-Flanders, zip: 9000, country: Belgium, contacts name: Jessica Van Oosterwijck, Prof., role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, hasResults: False
protocolSection identificationModule nctId: NCT06323707, orgStudyIdInfo id: IMPACT, briefTitle: The IMPACT Implementation-Effectiveness Trial, acronym: IMPACT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2027-03-15, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: McMaster University, class: OTHER, collaborators name: Canadian Cancer Society (CCS), collaborators name: Hamilton Health Sciences Corporation, collaborators name: Niagara Health System, descriptionModule briefSummary: 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., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 129, type: ESTIMATED, armsInterventionsModule interventions name: Exercise, interventions name: Self-management e-module, outcomesModule primaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Physical activity level, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: Level of exercise knowledge, secondaryOutcomes measure: Level of exercise knowledge, secondaryOutcomes measure: Level of exercise knowledge, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Aerobic capacity, secondaryOutcomes measure: Cardiovascular outcomes - Blood pressure, secondaryOutcomes measure: Cardiovascular outcomes - Blood pressure, secondaryOutcomes measure: Cardiovascular outcomes - Blood pressure, secondaryOutcomes measure: Cardiovascular outcomes - Heart rate, secondaryOutcomes measure: Cardiovascular outcomes - Heart rate, secondaryOutcomes measure: Cardiovascular outcomes - Heart rate, secondaryOutcomes measure: Health care utilization, secondaryOutcomes measure: Health care utilization, secondaryOutcomes measure: Health care utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323694, orgStudyIdInfo id: Attesa chirurgia-1, briefTitle: Quality of Life, Expectations, Thoughts and Fears of Patients on the Waiting List for Spinal Surgery, acronym: chirurgia-1, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-15, primaryCompletionDateStruct date: 2024-01-25, completionDateStruct date: 2024-02-16, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, collaborators name: University of Bologna, descriptionModule briefSummary: 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., conditionsModule conditions: Spinal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: quality of life, outcomesModule primaryOutcomes measure: Descriptive survey for vertebroplasty patients, primaryOutcomes measure: Descriptive survey for spinal arthrodeses patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Ortopedico Rizzoli, city: Bologna, zip: 40136, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
protocolSection identificationModule nctId: NCT06323681, orgStudyIdInfo id: Leading Study, briefTitle: Pegylated Interferon α in Previously Interferon-treated CHB（Leading Study）, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-04, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Qing XIe, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Hepatitis b, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2016, type: ESTIMATED, armsInterventionsModule interventions name: Peginterferon α-2b based treatment group, interventions name: NAs monotherapy group, outcomesModule primaryOutcomes measure: Proportion of patients with HBsAg below the lower limit of detection., secondaryOutcomes measure: Decrease of HBV DNA levels at week 48 compared to baseline., secondaryOutcomes measure: Proportion of patients with HBV DNA below the lower limit of detection., secondaryOutcomes measure: Decrease of HBsAg levels at week 48 compared to baseline., secondaryOutcomes measure: Proportion of patients with HBsAg seroconversion., secondaryOutcomes measure: Proportion of patients with HBeAg below the lower limit of detection for patients with baseline HBeAg positive., secondaryOutcomes measure: Proportion of patients with HBeAg seroconversion for patients with baseline HBeAg positive., secondaryOutcomes measure: Serious adverse events., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Infectious Diseases, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, status: RECRUITING, city: Shanghai, state: Shanghai, country: China, contacts name: Qing Xie, MD, PhD., role: CONTACT, phone: 0086-021-64370045, phoneExt: 680403, email: xieqingrjh@163.com, contacts name: Honglian Gui, MD,PhD, role: CONTACT, phone: 0086-021-64370045, phoneExt: 680419, email: lillian_ghl@163.com, contacts name: Qing Xie, MD, PhD., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06323668, orgStudyIdInfo id: H-23067693, briefTitle: Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment, acronym: CIEDOUT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2038-01-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cardiac Implantable Electronic Device Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized open label trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: None (Open Label), enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac implantable electronic device extraction, interventions name: Empirical antibiotic therapy, outcomesModule primaryOutcomes measure: Rate of death or relapse bacteremia, secondaryOutcomes measure: Days alive and out-of-hospital, secondaryOutcomes measure: Rate of death, secondaryOutcomes measure: Rate of readmission for any cause, secondaryOutcomes measure: Rate of cardiac implantable electronic device extraction, secondaryOutcomes measure: Rate of relapse bacteremia (the same microorganism), secondaryOutcomes measure: Rate of bacteremia (all species), secondaryOutcomes measure: Rate of definite CIED infection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323655, orgStudyIdInfo id: VP-VEC-162-1201, briefTitle: Evaluation of Next-Day Residual Effects of Tasimelteon Compared With Placebo and Active Control in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-07-19, primaryCompletionDateStruct date: 2018-08-28, completionDateStruct date: 2018-08-28, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Vanda Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to investigate next-day residual effects of tasimelteon compared with placebo and active control in healthy subjects., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Tasimelteon, interventions name: Active Control Placebo, interventions name: Tasimelteon Placebo, interventions name: Active Control, outcomesModule primaryOutcomes measure: Next-day effects on simulated driving performance as measured by changes in Standard Deviation of Lateral Position (SDLP), eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Vanda Investigational Site, city: Laval, state: Quebec, country: Canada, geoPoint lat: 45.56995, lon: -73.692, hasResults: False
protocolSection identificationModule nctId: NCT06323642, orgStudyIdInfo id: F.1-1/20ERB/SZABMU/941, briefTitle: Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shaheed Zulfiqar Ali Bhutto Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pneumonia, conditions: Probiotics, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized control trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: probiotic containing Lactobacillus rhamnosus GG., interventions name: placebo, outcomesModule primaryOutcomes measure: Number of days in hospital, secondaryOutcomes measure: Number of days with cough, fever, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 2 Years, stdAges: CHILD, contactsLocationsModule locations facility: Pakistan Institute of Medical Sciences, status: RECRUITING, city: Islamabad, state: Punjab, zip: 12000, country: Pakistan, contacts name: Nighat Haider, FCPS, role: CONTACT, phone: 03212125768, email: nighathaider@hotmail.com, contacts name: rashiqa saadat, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.72148, lon: 73.04329, hasResults: False
protocolSection identificationModule nctId: NCT06323629, orgStudyIdInfo id: STUDY006201, briefTitle: Effects of Recursive Self-feedback on Speech Production in Aphasia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, collaborators name: Center for Smart Use of Technologies to Assess Real-world Outcomes, descriptionModule briefSummary: 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., conditionsModule conditions: Aphasia, conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Adaptive recursive self-feedback procedure, interventions name: Non-adaptive recursive self-feedback procedure, outcomesModule primaryOutcomes measure: Speaking rate, primaryOutcomes measure: Speech initiation latency in milliseconds, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323616, orgStudyIdInfo id: 2023/2343, briefTitle: The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Anesthesia, conditions: Emergence Delirium, conditions: Anesthesia Awareness, conditions: Behavior Child Problems, conditions: Postoperative Delirium, conditions: Postoperative Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Single-Blind, Prospective, Interventional, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: MAC adjustment to PSI between 25 and 50, outcomesModule primaryOutcomes measure: ED/EA incidence, secondaryOutcomes measure: mYPAS, secondaryOutcomes measure: PSI <25 episode duration, secondaryOutcomes measure: PSI >50 episode duration, secondaryOutcomes measure: PSI <25 number of episodes, secondaryOutcomes measure: PSI >50 number of episodes, secondaryOutcomes measure: Suppresyon ratio, secondaryOutcomes measure: SEF95R, secondaryOutcomes measure: SEF95L, secondaryOutcomes measure: Mean blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: SpO2, secondaryOutcomes measure: Total amount of sevoflurane used, secondaryOutcomes measure: Total amount of remifentanil used, secondaryOutcomes measure: MAC, secondaryOutcomes measure: Waking up time, secondaryOutcomes measure: Pupil size, secondaryOutcomes measure: Anesthesia duration, secondaryOutcomes measure: Surgery duration, secondaryOutcomes measure: PHBQ, secondaryOutcomes measure: Ped-PADS, secondaryOutcomes measure: Time of discharge from hospital, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istanbul University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Meltem Savran Karadeniz, Assoc. Prof., role: CONTACT, phone: 009005334845563, email: mskaradeniz@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Istanbul University, status: RECRUITING, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06323603, orgStudyIdInfo id: 3-1, briefTitle: Biomonitoring of Occupationally Populations Exposed to Micro and Nanoplastic, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-30, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Ricard Marcos, class: OTHER, collaborators name: Finnish Institute of Occupational Health, descriptionModule briefSummary: The biomonitoring study aims to evaluate genotoxic damage and other parameters of exposure in different occupational exposed populations that work directly with different plastics., conditionsModule conditions: Occupational Exposure, conditions: Genotoxicity, conditions: Damage Dna, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Micro and nanoplastic, outcomesModule primaryOutcomes measure: Characterization of macro and nanoplastics, primaryOutcomes measure: Genotoxic evaluation by the Micronucleus assay, primaryOutcomes measure: Genotoxic evaluation by the Comet assay, primaryOutcomes measure: Cytokine release, primaryOutcomes measure: Microbiota analysis from feces by MinIOn, secondaryOutcomes measure: Analyses of surrogate biomarkers, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Textile industry, status: COMPLETED, city: Helsinki, country: Finland, geoPoint lat: 60.16952, lon: 24.93545, locations facility: Recycling company, status: COMPLETED, city: Alicante, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Textile Industry, status: COMPLETED, city: Alicante, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Control recruitment, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Susana Pastor, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
protocolSection identificationModule nctId: NCT06323590, orgStudyIdInfo id: UAB 2372, secondaryIdInfos id: UAB, type: OTHER, domain: UAB, briefTitle: Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: rates of complete remission, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Omer Jamy, role: CONTACT, phone: 205-934-2721, email: omerjamy@uabmc.edu, contacts name: Omer Jamy, role: CONTACT, phone: 2059342721, email: omerjamy@uabmc.edu, contacts name: Omer Jamy, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
protocolSection identificationModule nctId: NCT06323577, orgStudyIdInfo id: TUH rKA vs MA TKA, briefTitle: Comparing Efficacy Between Restricted Kinematic Alignment vs Mechanical Alignment in Bilateral TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-05-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Osteoarthritis, Knee, conditions: TKA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Restricted kinematic alignment, interventions name: Mechanical alignment, outcomesModule primaryOutcomes measure: Forgotten joint score, secondaryOutcomes measure: Modified WOMAC score, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Pain score, secondaryOutcomes measure: Hip knee ankle angle, secondaryOutcomes measure: Complications, secondaryOutcomes measure: Incidence of soft tissue releasing, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thammasat University, status: RECRUITING, city: Khlong Luang, state: Pathum Thani, zip: 12120, country: Thailand, contacts name: Yot Tanariyakul, M.D., role: CONTACT, phone: 663930257, email: y.tanariyakul@gmail.com, contacts name: Nattapol Tammachote, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False
protocolSection identificationModule nctId: NCT06323564, orgStudyIdInfo id: 21C223, briefTitle: Exploring Emotional Intelligence and Cognitive Flexibility in Anorexia Nervosa and Parkinson's Disease., acronym: INTELLEGO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-13, primaryCompletionDateStruct date: 2024-08-13, completionDateStruct date: 2025-01-13, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Anorexia Nervosa, conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Neuropsychological tests in PD, interventions name: Self-report questionnaires in PD, interventions name: International Affective Picture System (IAPS), interventions name: Neuropsychological tests in AN, interventions name: Self-report questionnaires in AN, interventions name: Analysis of bio-humoral parameters, outcomesModule primaryOutcomes measure: Change in International Affective Picture System (IAPS), secondaryOutcomes measure: Change in self-report questionnaires - STAI, secondaryOutcomes measure: Change in self-report questionnaires - BDI, secondaryOutcomes measure: Change in Heart rate variability, secondaryOutcomes measure: Change in analysis of bio-humoral parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Oggebbio, zip: 28824, country: Italy, contacts name: Riccardo Cremascoli, MD, PhD, role: CONTACT, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
protocolSection identificationModule nctId: NCT06323551, orgStudyIdInfo id: 2023/50, briefTitle: The Effect of Mother's Smell and Breast Milk Smell on Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-07-14, completionDateStruct date: 2024-12-24, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Tarsus University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Newborn; Vitality, conditions: Pain, conditions: Crying, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Mother's Smell, interventions name: Mother's Breast Milk Smell, outcomesModule primaryOutcomes measure: Neonatal Infant Pain Scale, secondaryOutcomes measure: criying time, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 15 Days, stdAges: CHILD, contactsLocationsModule locations facility: Tarsus State Hospital, status: RECRUITING, city: Mersin, country: Turkey, contacts name: Atiye Karakul, Ass. Prof., role: CONTACT, phone: 90(324) 600 00 33, phoneExt: 2231, email: atiyekarakul@gmail.com, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False
protocolSection identificationModule nctId: NCT06323538, orgStudyIdInfo id: 01, briefTitle: Cohort Study on Plant-based Diets (COPLANT Study), acronym: COPLANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2047-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: German Federal Institute for Risk Assessment, class: OTHER, collaborators name: Max Rubner-Institut, collaborators name: University of Bonn, collaborators name: Research Institute for Plant-Based Nutrition, collaborators name: University of Jena, collaborators name: University of Regensburg, collaborators name: Heidelberg University, collaborators name: University of Vienna, descriptionModule briefSummary: 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., conditionsModule conditions: Dietary Exposure, conditions: Diabetes Mellitus, Type 2, conditions: Cardiovascular Diseases, conditions: Bone Loss, conditions: Sustainability, conditions: Exposure, conditions: Obesity, conditions: Vitamin Deficiency, conditions: Mineral Deficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 6000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Incidence of diabetes type 2, secondaryOutcomes measure: Incidence of cardiovascular diseases, secondaryOutcomes measure: Incidence of cancer, secondaryOutcomes measure: Vitamin B12, secondaryOutcomes measure: Holo-transcobalamine, secondaryOutcomes measure: Homocysteine, secondaryOutcomes measure: Methylmalonic acid, secondaryOutcomes measure: Vitamin B1 status, secondaryOutcomes measure: Vitamin B2 status, secondaryOutcomes measure: Vitamin B6 status, secondaryOutcomes measure: Vitamin C status, secondaryOutcomes measure: Vitamin D status, secondaryOutcomes measure: Vitamin E status, secondaryOutcomes measure: Iron, secondaryOutcomes measure: Ferritin, secondaryOutcomes measure: Transferrin, secondaryOutcomes measure: Zinc status, secondaryOutcomes measure: Selenium status, secondaryOutcomes measure: Iodine status, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Blood lipids, secondaryOutcomes measure: Fasting insulin, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: C-peptide, secondaryOutcomes measure: Osteocalcin, secondaryOutcomes measure: Ostase, secondaryOutcomes measure: Parathormone, secondaryOutcomes measure: N-terminal propeptide of type I procollagen (PINP), secondaryOutcomes measure: C-terminal telopeptide of type I collagen (CTX), secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Uric acid, secondaryOutcomes measure: Cytstatin C, secondaryOutcomes measure: Thyroid stimulating hormone (TSH), secondaryOutcomes measure: Free triiodothyronine (fT3), secondaryOutcomes measure: Free thyroxine (fT4), secondaryOutcomes measure: Body fat, secondaryOutcomes measure: Skeletal muscle mass, secondaryOutcomes measure: Total Body Water, secondaryOutcomes measure: Energy intake, secondaryOutcomes measure: Nutrient intake, secondaryOutcomes measure: Intake of dietary supplements, secondaryOutcomes measure: Intake of medication, otherOutcomes measure: Heavy metals, otherOutcomes measure: Halogenated, polycyclic aromatic hydrocarbons (dioxins), otherOutcomes measure: Mycotoxins, otherOutcomes measure: Per- and polyfluoroalkyl substances (PFAS), otherOutcomes measure: Microbiome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Vienna, city: Vienna, zip: 1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Max Rubner-Institut, city: Karlsruhe, state: Baden-Württemberg, zip: 76131, country: Germany, contacts name: Benedikt Merz, PhD, role: CONTACT, email: benedikt.merz@mri.bund.de, geoPoint lat: 49.00937, lon: 8.40444, locations facility: Friedrich-Schiller University, city: Jena, state: Thuringia, zip: 07743, country: Germany, contacts name: Christine Dawczynski, PhD, role: CONTACT, phone: +49 3641 949656, email: christine.dawczynski@uni-jena.de, geoPoint lat: 50.92878, lon: 11.5899, locations facility: The German Federal Institut for Risk Assessment, city: Berlin, zip: 10589, country: Germany, contacts name: Cornelia Weikert, Prof, role: CONTACT, phone: +49 30 1841255000, email: Cornelia.Weikert@bfr.bund.de, geoPoint lat: 52.52437, lon: 13.41053, locations facility: University Bonn, city: Bonn, country: Germany, contacts name: Ute Nöthlings, Prof, role: CONTACT, email: noethlings@uni-bonn.de, geoPoint lat: 50.73438, lon: 7.09549, locations facility: Research Institute for Plant-Based Nutrition, Gießen, city: Gießen, zip: 35444, country: Germany, contacts name: Markus Keller, PhD, role: CONTACT, email: keller@ifpe-giessen.de, geoPoint lat: 50.58727, lon: 8.67554, locations facility: University Heidelberg, city: Heidelberg, zip: 69120, country: Germany, contacts name: Ina Danquah, role: CONTACT, email: ina.danquah@uni-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, locations facility: University Regensburg, city: Regensburg, zip: 93053, country: Germany, contacts name: Michael Leitzmann, Prof, role: CONTACT, email: Michael.Leitzmann@klinik.uni-regensburg.de, contacts name: Beate Fischer, role: CONTACT, email: Beate.Fischer@klinik.uni-regensburg.de, geoPoint lat: 49.01513, lon: 12.10161, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-11-20, uploadDate: 2024-02-23T09:43, filename: Prot_000.pdf, size: 1528917, hasResults: False
protocolSection identificationModule nctId: NCT06323525, orgStudyIdInfo id: CHN-PLAGH-BT-083, briefTitle: TCR Reserved and Power3 Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2026-04-25, completionDateStruct date: 2027-04-25, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Non-hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: TCR reserved and Power3 gene knock-out allogeneic CD19-targeting CAR-T cell (ATHENA-2 CAR-T), interventions name: Fludarabine, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: Phase 1: Incidence of adverse events (AEs) defined as DLT, primaryOutcomes measure: Phase 1: Recommended phase 2 dose (RP2D), primaryOutcomes measure: Phase 2: 3-month objective response rate (ORR), primaryOutcomes measure: Phase 2: Complete response (CR) rate, primaryOutcomes measure: Phase 2: Duration of Response (DOR), primaryOutcomes measure: Phase 2: Overall Survival (OS), primaryOutcomes measure: Phase 2: Progression Free Survival (PFS), secondaryOutcomes measure: Phase 1 and phase 2: Pharmacokinetics: Level of ATHENA-2 CAR-positive T cells circulating in blood over time, secondaryOutcomes measure: Phase 1 and phase 2: Pharmacodynamics: Level of CD19+ cells in peripheral blood, secondaryOutcomes measure: Phase 1 and phase 2: Level of serum cytokines in peripheral blood, secondaryOutcomes measure: Phase 1: 3-month ORR, secondaryOutcomes measure: Phase 1: OS, secondaryOutcomes measure: Phase 1: PFS, secondaryOutcomes measure: Phase 2: Incidence of AEs, otherOutcomes measure: Phase 1: Level of donor-specific antibody (DSA) in blood., otherOutcomes measure: Phase 1: Level of human anti-mouse antibodies (HAMA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biotherapeutic Department of Chinese PLA General Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Weidong Han, M.D, role: CONTACT, phone: +86-010-66937463, email: hanwdrsw@sina.com, contacts name: Qingming Yang, M.D, role: SUB_INVESTIGATOR, contacts name: Yang Liu, M.D, role: SUB_INVESTIGATOR, contacts name: Jinhong Shi, M.S, role: SUB_INVESTIGATOR, contacts name: Chunmeng Wang, M.S, role: SUB_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Biotherapeutic Department of Chinese PLA General Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Weidong Han, Ph.D, role: CONTACT, phone: +86-010-55499341, email: hanwdrsw@sina.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: EdiGene Inc, status: RECRUITING, city: Beijing, country: China, contacts name: Zixuan Pang, Ph.D, role: CONTACT, phone: 010-80733899, email: zxpang@edigene.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: School of Life Sciences, Peking University, status: RECRUITING, city: Beijing, country: China, contacts name: Wensheng Wei, Ph.D, role: CONTACT, phone: 010-62757794, email: wswei@pku.edu.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06323512, orgStudyIdInfo id: Nanjing, briefTitle: Pulmonary Arteyr Denervation for Heart Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: 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)., conditionsModule conditions: Heart Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Pulmonary artery denervation (PADN), outcomesModule primaryOutcomes measure: Left ventricular ejection fraction, primaryOutcomes measure: Tricuspid annuls peak systolic excursion (TAPSE), primaryOutcomes measure: 6 minute walk distance changes, secondaryOutcomes measure: All-cause death, secondaryOutcomes measure: Rehospitalization, secondaryOutcomes measure: NT-proBNP, secondaryOutcomes measure: Superoxide dismutase (SOD) 3, secondaryOutcomes measure: Plasma noradrenaline, otherOutcomes measure: All outcomes will be stratified by HFrEF and HFpEF, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323499, orgStudyIdInfo id: UK Essen, briefTitle: Outcome of Induced Atypical Atrial Flutter, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-04-01, primaryCompletionDateStruct date: 2021-10-31, completionDateStruct date: 2021-10-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Tachyarrhythmia, conditions: Atypical Atrial Flutter, conditions: Induction of Arryhthmia, conditions: Clinical Outcome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 76, type: ACTUAL, armsInterventionsModule interventions name: Induction of atypical atrial flutter, outcomesModule primaryOutcomes measure: Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure., secondaryOutcomes measure: Type of recurrence during follow-up, secondaryOutcomes measure: Occurrence and results of repeat ablations at our institution, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Essen, city: Essen, state: Nordrhein-Westfalen, zip: 45147, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False
protocolSection identificationModule nctId: NCT06323486, orgStudyIdInfo id: 23-015-B, briefTitle: Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression, acronym: CogniTReaD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ontario Shores Centre for Mental Health Sciences, class: OTHER, collaborators name: Sunnybrook Health Sciences Centre, descriptionModule briefSummary: 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., conditionsModule conditions: Depressive Disorder, Treatment-Resistant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: We will enroll patients who are willing to be randomized to either the accelerated bilateral sequential theta burst stimulation (absTBS)-sham or sham-absTBS treatment sequence arms. In the absTBS-sham sequence, participants shall receive the active absTBS treatment at Week 1, followed by sham treatment at Week 3, while in the sham-absTBS sequence, participants shall receive sham treatment at Week 1, followed by the active absTBS treatment at Week 3. The primary rationale for employing this sequential treatment strategy for both arms in this trial is to ensure that those assigned to the sham-absTBS group do not have to wait for longer periods to begin receiving the active absTBS therapy and to maintain blinding continuity., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: We shall perform a double-blinding system where the participants, study investigators, transcranial magnetic stimulation (TMS) technicians (those who operate and administer TMS procedures), and research assistants (outcome assessors) are masked to the assignment of the enrolled participants., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: active accelerated bilateral sequential theta burst stimulation and sham treatment, outcomesModule primaryOutcomes measure: Change in Dual-task Cost, primaryOutcomes measure: Change in Hamilton Depression Rating Scale 17 (HAMD-17) score, primaryOutcomes measure: Adverse events (AE), secondaryOutcomes measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) score, secondaryOutcomes measure: Change in Alzheimer's Disease Assessment Scale-Cognitive-13 (ADAS-Cog-13) plus modalities score, secondaryOutcomes measure: Change in Trail Making A (TMT-A) score, secondaryOutcomes measure: Change in Trail Making B (TMT-B) score, secondaryOutcomes measure: Change in Digit Symbol Substitution Test (DSST) score, secondaryOutcomes measure: Change in Digit Span Forward (DSF) score, secondaryOutcomes measure: Change in Digit Span Backward (DSB) score, secondaryOutcomes measure: Change in Category Verbal Fluency (CVF) score, secondaryOutcomes measure: Change in Montreal Cognitive Assessment (MoCA) score, secondaryOutcomes measure: Change in Colour Word Interference Test (CWIT) score, secondaryOutcomes measure: Change in Patient Health Questionnaire-9 (PHQ-9) score, secondaryOutcomes measure: Change in Geriatric Depression Scale 30 (GDS-30) score, secondaryOutcomes measure: Change in Generalized Anxiety Disorder 7 (GAD-7) score, secondaryOutcomes measure: Change in Short Form 36 (SF-36) score, secondaryOutcomes measure: Change in Alzheimer Disease Cooperative Study - Activities of Daily Living inventory (ADCS-ADL) score, secondaryOutcomes measure: Change in Lawton-Brody Instrumental Activities of Daily Living (LB-IADL) score, secondaryOutcomes measure: Change in Clinical Global Impression (CGI) score, secondaryOutcomes measure: Change in Short Physical Performance Battery (SPPB) score, secondaryOutcomes measure: Change in Timed Up & Go (TUG) score, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ontario Shores Centre for Mental Health Sciences, status: RECRUITING, city: Toronto, state: Ontario, zip: L1N 5S9, country: Canada, contacts name: Amer M. Burhan, MBChB, MSc, role: CONTACT, phone: 905.430.4055, phoneExt: 4019, email: burhana@ontarioshores.ca, contacts name: Adrian I. Espiritu, MD, role: CONTACT, phone: 905.430.4055, phoneExt: 6271, email: espiritua@ontarioshores.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06323473, orgStudyIdInfo id: Maitake001, briefTitle: Maitake for Integrative Cancer Care, acronym: Maitake, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The Canadian College of Naturopathic Medicine, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Uncontrolled single arm clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Black Maitake Prothera, outcomesModule primaryOutcomes measure: Changes in absolute neutrophil count, secondaryOutcomes measure: Incidence of febrile neutropenia, secondaryOutcomes measure: Change in neutrophil to lymphocyte ratio (NLR), secondaryOutcomes measure: Change in platelet to lymphocyte ratio (PLR), secondaryOutcomes measure: Change in high-sensitivity C-reactive protein (CRP), secondaryOutcomes measure: Changes in Quality of Life, secondaryOutcomes measure: Changes in hemoglobin A1c (HbA1c), secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Incidence of dose reductions or delays in systemic therapy, secondaryOutcomes measure: Addition of new medications to combat neutropenia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Centre for Health Innovation, city: Ottawa, state: Ontario, zip: K2P 0M7, country: Canada, contacts name: Mark Legacy, role: CONTACT, phone: 613-792-1222, phoneExt: 1, email: mlegacy@thechi.ca, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Canadian College of Naturopathic Medicine - Integrative Cancer Centre, city: Toronto, state: Ontario, zip: M2K 1E2, country: Canada, contacts name: Daniel Lander, role: CONTACT, phone: 416-498-1255, phoneExt: 280, email: dlander@ccnm.edu, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06323460, orgStudyIdInfo id: OSU-23083, secondaryIdInfos id: NCI-2024-00904, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, conditions: Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, conditions: Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Carboplatin, interventions name: Cisplatin, interventions name: Computed Tomography, interventions name: External Beam Radiation Therapy, interventions name: Paclitaxel, interventions name: Positron Emission Tomography, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Positron emission tomography complete response, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Quality of life (QOL), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Sujith Baliga, role: CONTACT, phone: 614-293-5066, email: Sujith.baliga@osumc.edu, contacts name: Sujith Baliga, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06323447, orgStudyIdInfo id: PC002, briefTitle: Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia, acronym: PC002, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-28, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Leuko Labs, Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Diffuse Large B Cell Lymphoma, conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 210, type: ESTIMATED, armsInterventionsModule interventions name: PointCheck, outcomesModule primaryOutcomes measure: PointCheck Accuracy, secondaryOutcomes measure: PointCheck Precision, secondaryOutcomes measure: PointCheck Usability, secondaryOutcomes measure: PointCheck Errors, secondaryOutcomes measure: PointCheck Safety, eligibilityModule sex: ALL, minimumAge: 10 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323434, orgStudyIdInfo id: spice1, briefTitle: Spinal CSF Leaks in Chronic Subdural Hematoma, acronym: SPICE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Freiburg, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Subdural Hematoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: evidence of a spinal CSF leak (yes/no), secondaryOutcomes measure: Number of identified CSF leak types:, secondaryOutcomes measure: Number of diagnostic procedures performed:, secondaryOutcomes measure: Number, and site of interventions needed for cSDH:, secondaryOutcomes measure: Color of hematoma evacuated:, secondaryOutcomes measure: Age, secondaryOutcomes measure: body height, secondaryOutcomes measure: body weight, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: sex, secondaryOutcomes measure: Karnofsky Index, secondaryOutcomes measure: Anti-platelet therapy intake, secondaryOutcomes measure: Anticoagulation intake, secondaryOutcomes measure: Blood pressure medication intake, secondaryOutcomes measure: Lipid regulation medication intake, secondaryOutcomes measure: Hormonal regulation medication intake, secondaryOutcomes measure: Immunotherapeutic medication intake, secondaryOutcomes measure: other medication intake, secondaryOutcomes measure: history of trauma, secondaryOutcomes measure: national institutes of health stroke scale (NIHSS), secondaryOutcomes measure: gait disorder, secondaryOutcomes measure: Modified Rankin Scale (mRS), secondaryOutcomes measure: Headache-Impact-Test (HIT)-6, secondaryOutcomes measure: current working capacity,, secondaryOutcomes measure: complaints, secondaryOutcomes measure: headache severity, secondaryOutcomes measure: Days within the last month, secondaryOutcomes measure: maximum duration being continuously upright, secondaryOutcomes measure: severeness of dizziness, secondaryOutcomes measure: Severeness of shoulder- and neck pain, secondaryOutcomes measure: severeness of nausea, secondaryOutcomes measure: severeness of hearing disturbances and tinnitus, secondaryOutcomes measure: severeness of cognitive deficits, secondaryOutcomes measure: severeness of visual disturbances, secondaryOutcomes measure: exhaustion, secondaryOutcomes measure: ability to focus and concentrate, secondaryOutcomes measure: Patient's Global Impression of Change (PGIC), secondaryOutcomes measure: Self-Administered Comorbidity Questionnaire (SCQ), secondaryOutcomes measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index, secondaryOutcomes measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale, secondaryOutcomes measure: Hematocrit, secondaryOutcomes measure: Size of the chronic subdural hematoma, secondaryOutcomes measure: Volumetry of the cranial compartments, secondaryOutcomes measure: Bern-Score according to Dobrocky et al, secondaryOutcomes measure: Spinal longitudinal extradural fluid collection (SLEC), secondaryOutcomes measure: DiverTICula (TIC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Freiburg, city: Freiburg, state: Baden-Württemberg, zip: 79106, country: Germany, contacts name: Katharina Wolf, Dr., role: CONTACT, phone: +4076127093556, email: katharina.wolf@uniklinik-freiburg.de, contacts name: Jürgen Beck, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Amir El Rahal, Dr., role: SUB_INVESTIGATOR, contacts name: Niklas Lützen, Dr., role: SUB_INVESTIGATOR, contacts name: Horst Urbach, Prof., role: SUB_INVESTIGATOR, contacts name: Mukesch J Shah, Dr., role: SUB_INVESTIGATOR, contacts name: Christian Taschner, Prof., role: SUB_INVESTIGATOR, contacts name: Marco Reisert, Dr., role: SUB_INVESTIGATOR, contacts name: Manou Overstijns, role: SUB_INVESTIGATOR, contacts name: Katharina Wolf, Dr., role: SUB_INVESTIGATOR, contacts name: Florian Volz, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 47.9959, lon: 7.85222, hasResults: False
protocolSection identificationModule nctId: NCT06323421, orgStudyIdInfo id: STUDY2023-1359, briefTitle: Targeting Chronic Stress for Reducing Risk Factors for Colorectal Cancer, acronym: MindCRC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Illinois at Chicago, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Mindfulness, conditions: Colon Cancer, conditions: Females, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness, outcomesModule primaryOutcomes measure: Feasibility measures, primaryOutcomes measure: Acceptability, otherOutcomes measure: Body mass index, otherOutcomes measure: Stress measure, otherOutcomes measure: Fasting glucose, otherOutcomes measure: Gut microbiota composition, otherOutcomes measure: Gut inflammation, otherOutcomes measure: Adiposity, otherOutcomes measure: Epinephrine, otherOutcomes measure: Norepinephrine, otherOutcomes measure: Cortisol, otherOutcomes measure: Resting heart rate, otherOutcomes measure: Blood lipids, otherOutcomes measure: Fasting insulin, otherOutcomes measure: Hemoglobin A1c, otherOutcomes measure: Systemic inflammation, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Illinois at Chicago, city: Chicago, state: Illinois, zip: 60612, country: United States, contacts name: Lisa Tussing-Humphreys, PhD, role: CONTACT, phone: 312-355-5521, email: tussing@uic.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06323408, orgStudyIdInfo id: BZKF-AYA_1.0, briefTitle: Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas, acronym: BZKF-AYA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University Hospital Regensburg, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Glioma, Malignant, conditions: Embryonal Tumor, conditions: Medulloblastoma, conditions: Ependymoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Tissue, blood, cerebrospinal-spinal fluid, outcomesModule primaryOutcomes measure: AI processing of MRI fand PET or diagnosis, primaryOutcomes measure: AI processing of MRI and PET for evaluation of response and relapse, primaryOutcomes measure: Quality control analysis in radiotherapy, primaryOutcomes measure: Analysis of response in liquid biopsies, primaryOutcomes measure: Target molecules in tissue and liquid biopsies, primaryOutcomes measure: Evaluation of progression free survival, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 39 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323395, orgStudyIdInfo id: JGL-DED-VIZ-SLB 21, briefTitle: Vizol S Lipid Balance Efficacy and Safety Study in Patients With Dry Eye, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Jadran Galenski laboratorij d.d., class: INDUSTRY, collaborators name: Poseidon CRO, descriptionModule briefSummary: 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., conditionsModule conditions: Dry Eye Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-centre, randomised, parallel-group, controlled (placebo), double-blind study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: As the clinical trial will be conducted in a double-blind way, both investigators and patients will be blind with respect to the treatment administered. For the purpose of individual unblinding of a patient's treatment the investigator will receive a sealed emergency envelope for each patient containing the treatment code (Only in case of medical emergency it is permitted to open the emergency envelope)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 64, type: ACTUAL, armsInterventionsModule interventions name: Vizol S LIPID BALANCE eye drops, interventions name: ophthalmic saline eye drops, outcomesModule primaryOutcomes measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in the tear film break-up time (TFBUT) from Visit 1 (baseline) to Visit 2 (day 15), secondaryOutcomes measure: 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), secondaryOutcomes measure: Mean change in ocular surface staining score (total corneal and total conjunctival staining score) from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in OSDI score from Visit 1 (baseline) to Visit 3 (day 30), secondaryOutcomes measure: Mean change in Meibomian gland expression from Visit 1 (baseline) to Visit 3 (day 30), otherOutcomes measure: The presence of Adverse Event/ /Serious Adverse Event (AE/ /SAE) throughout the investigation period, otherOutcomes measure: BCVA, otherOutcomes measure: Frequency of ocular signs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Special eye hospital - Beogradski oftalmološki centar, city: Belgrad, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Specialized clinic for eye desease - klinika Veselinović, city: Niš, zip: 18000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, hasResults: False
protocolSection identificationModule nctId: NCT06323382, orgStudyIdInfo id: Liver Project 6, briefTitle: Locoregional Therapy Combined With Bevacizumab and PD1/L1 Inhibitor in Advanced Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Advanced Hepatocellular Carcinoma, conditions: Anti-PD1/PDL1 Antibody, conditions: Bevacizumab, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Locoregional therapy, interventions name: Bevacizumab, interventions name: Atezolizumab, interventions name: Tislelizumab, interventions name: Toripalimab, interventions name: Sintilimab, interventions name: Camrelizumab, outcomesModule primaryOutcomes measure: Progression-Free-Survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chinese PLA hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, contacts name: Qunfang Zhou, Md, role: CONTACT, phone: 8619868000115, email: zhouqun988509@163.com, contacts name: MD, role: CONTACT, phone: 8613910984586, email: duanfeng@vip.sina.com, contacts name: Feng Duan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06323369, orgStudyIdInfo id: SYSKY-2023-1283-02, briefTitle: Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2029-03-25, completionDateStruct date: 2029-09-25, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: Tislelizumab（neoadjuvant）, interventions name: Cisplatin （neoadjuvant）, interventions name: Nab-paclitaxel （neoadjuvant）, interventions name: Surgical resection, interventions name: Cisplatin（adjuvant）, interventions name: Tislelizumab（adjuvant）, interventions name: Radiation, interventions name: Carboplatin（neoadjuvant）, interventions name: Carboplatin（adjuvant）, outcomesModule primaryOutcomes measure: Disease-Free Survival(DFS ), primaryOutcomes measure: Lymph node positivity rate, secondaryOutcomes measure: Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Adverse Events, secondaryOutcomes measure: Pathological complete response (pCR) rate, secondaryOutcomes measure: Major Pathological Response (MPR) rate, secondaryOutcomes measure: lymph node division, secondaryOutcomes measure: Event-free Survival (EFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Disease-Free Survival(DFS ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Ethics Committee of Sun Yat-sen Memorial Hospital, status: RECRUITING, city: Guangzhou, state: Yuexiu, zip: 510120, country: China, contacts name: Song Fan, Doctor, role: CONTACT, phone: 13570536658, phoneExt: +86, email: fansong2@mail.sysu.edu.cn, contacts name: Song Fan, Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06323356, orgStudyIdInfo id: TAK-279-PsO-3005, secondaryIdInfos id: jRCT2031230714, type: REGISTRY, domain: jRCT, briefTitle: A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-03-27, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Generalized Pustular Psoriasis, conditions: Erythrodermic Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: TAK-279, outcomesModule primaryOutcomes measure: 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, primaryOutcomes measure: Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52, secondaryOutcomes measure: 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, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits, secondaryOutcomes measure: Percentage of Participants Achieving PASI-75 at Week 52, secondaryOutcomes measure: Percentage of Participants Achieving PASI-90 at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving PASI-100 at Week 16 and Week 52, secondaryOutcomes measure: Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits, secondaryOutcomes measure: Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits, secondaryOutcomes measure: 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, secondaryOutcomes measure: Change from baseline in ssPGA at Weeks 16 and 52, secondaryOutcomes measure: 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, secondaryOutcomes measure: 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, secondaryOutcomes measure: Change from Baseline in DLQI at Week 16 and Week 52, secondaryOutcomes measure: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline, secondaryOutcomes measure: Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52, secondaryOutcomes measure: 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, secondaryOutcomes measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52, secondaryOutcomes measure: Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52, secondaryOutcomes measure: 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, secondaryOutcomes measure: Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nagoya City University Hospital, status: NOT_YET_RECRUITING, city: Nagoya, state: Aichi, country: Japan, geoPoint lat: 35.18147, lon: 136.90641, locations facility: Fujita Health University Hospital, status: NOT_YET_RECRUITING, city: Toyoake, state: Aichi, country: Japan, geoPoint lat: 35.038, lon: 136.99931, locations facility: Kimitsu Chuo Hospital, status: RECRUITING, city: Kisarazu, state: Chiba, country: Japan, geoPoint lat: 35.38329, lon: 139.93254, locations facility: Juntendo University Urayasu Hospital, status: NOT_YET_RECRUITING, city: Urayasu, state: Chiba, country: Japan, geoPoint lat: 35.67054, lon: 139.88862, locations facility: Hospital of the University of Occupational and Environmental Health, Japan, status: RECRUITING, city: Kitakyushu, state: Fukuoka, country: Japan, geoPoint lat: 33.85181, lon: 130.85034, locations facility: Isesaki Municipal Hospital, status: NOT_YET_RECRUITING, city: Isesaki, state: Gunma, country: Japan, geoPoint lat: 36.31667, lon: 139.2, locations facility: Kobe University Hospital, status: NOT_YET_RECRUITING, city: Kobe, state: Hyogo, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Tokai University Hospital, status: NOT_YET_RECRUITING, city: Isehara, state: Kanagawa, country: Japan, geoPoint lat: 35.39932, lon: 139.31019, locations facility: Mie University Hospital, status: NOT_YET_RECRUITING, city: Tsu, state: Mie, country: Japan, geoPoint lat: 34.73333, lon: 136.51667, locations facility: Kansai Medical University Hospital, status: NOT_YET_RECRUITING, city: Hirakata, state: Osaka, country: Japan, geoPoint lat: 34.81352, lon: 135.64914, locations facility: Saitama Medical University Hospital, status: NOT_YET_RECRUITING, city: Iruma, state: Saitama, country: Japan, locations facility: St.Luke's International Hospital, status: NOT_YET_RECRUITING, city: Chuo City, state: Tokyo, country: Japan, geoPoint lat: 35.57779, lon: 139.71685, locations facility: Teikyo University Hospital, status: NOT_YET_RECRUITING, city: Itabashi-ku, state: Tokyo, country: Japan, geoPoint lat: 35.74893, lon: 139.71497, locations facility: The Jikei University Hospital, status: NOT_YET_RECRUITING, city: Minato-ku, state: Tokyo, country: Japan, geoPoint lat: 34.2152, lon: 135.1501, locations facility: Tokyo Medical University Hospital, status: NOT_YET_RECRUITING, city: Shinjuku-ku, state: Tokyo, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Fukuoka University Hospital, status: NOT_YET_RECRUITING, city: Fukuoka, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: University Hospital, Kyoto Prefectural University of Medicine, status: NOT_YET_RECRUITING, city: Kyoto, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Okayama University Hospital, status: NOT_YET_RECRUITING, city: Okayama, country: Japan, geoPoint lat: 34.65, lon: 133.93333, locations facility: Nippon Life Hospital, status: NOT_YET_RECRUITING, city: Osaka, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, locations facility: Osaka Metropolitan University Hospital, status: NOT_YET_RECRUITING, city: Osaka, country: Japan, geoPoint lat: 34.69374, lon: 135.50218, hasResults: False
protocolSection identificationModule nctId: NCT06323343, orgStudyIdInfo id: 00040976, briefTitle: Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-28, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Medical College of Wisconsin, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Patient Empowerment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 114, type: ESTIMATED, armsInterventionsModule interventions name: Video Intervention, interventions name: Webpage links, outcomesModule primaryOutcomes measure: Parents' communication behaviors measure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323330, orgStudyIdInfo id: I-1623, briefTitle: Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, New Delhi, class: OTHER, collaborators name: Institute of Human Behavior and Allied Sciences, collaborators name: Indian Institute of Technology, New Delhi, collaborators name: Vardhman Mahavir Medical College And Safdarjung Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke Rehabilitation, conditions: Aphasia, Broca, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The MIT- Indian Adaptation will be tested and compared with standard speech rehabilitation in post-stroke non-fluent aphasia, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The outcome assessor will be blinded to the intervention, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Speech rehabilitation, outcomesModule primaryOutcomes measure: Western Aphasia Battery Score, secondaryOutcomes measure: Western Aphasia Battery Score, secondaryOutcomes measure: functional Near Red Spectroscopy measures, secondaryOutcomes measure: modified Rankin Score, secondaryOutcomes measure: Fugl Meyer Assessment Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323317, orgStudyIdInfo id: UW 21-405, briefTitle: A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures, acronym: PREHAB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Coronary Artery Bypass Grafting, conditions: Heart Valve Replacement, conditions: Transcatheter Aortic Valve Implantation, conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The post-intervention data collector (research assistant) will be blinded to the group allocation to avoid performance and detection biases., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Multi-component exercise programme, interventions name: Attention Placebo, interventions name: Structured preoperative education, interventions name: Nutritional optimization, interventions name: Stress management, outcomesModule primaryOutcomes measure: The Short Physical Performance Battery (SPPB), primaryOutcomes measure: Weakness/ Grip Strength (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Slowness (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Low Physical Activity (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Self-reported Exhaustion (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Unintentional Weight Loss (Fried Phenotype Frailty Assessment), primaryOutcomes measure: The Seattle Angina Questionnaire (SAQ), primaryOutcomes measure: The MacNew Heart Disease Health-Related Quality of Life Questionnaire, secondaryOutcomes measure: The Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Biomarkers-Serum albumin, secondaryOutcomes measure: Biomarkers- C-reactive protein, secondaryOutcomes measure: Major adverse cardiac and cerebrovascular events (MACCE), secondaryOutcomes measure: Hospital Length of stay, secondaryOutcomes measure: Hospital Readmissions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Polly Wai Chi, status: RECRUITING, city: Hong Kong, state: Please Select, zip: 00000, country: Hong Kong, contacts name: Polly Wai Chi Li, PhD, role: CONTACT, email: pwcli@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06323304, orgStudyIdInfo id: 701/HDDD-DHYD, briefTitle: Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Medicine and Pharmacy at Ho Chi Minh City, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Itching, conditions: Runny Nose, conditions: Sneezing, conditions: Nasal Congestion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment.The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Auricular acupressure, interventions name: Sham acupressure, interventions name: Standard treatment, outcomesModule primaryOutcomes measure: The change of nasal and non nasal symptom scores, secondaryOutcomes measure: The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, secondaryOutcomes measure: The change of relief medication usage, secondaryOutcomes measure: Proportion of intervention-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Medical Center HCMC - Branch no.3, status: RECRUITING, city: Ho Chi Minh, zip: 700000, country: Vietnam, contacts name: Chau Ngoc Le, MD, role: CONTACT, phone: +84942831722, email: lnchau.ntyhct21@ump.edu.vn, contacts name: Minh-Man Pham Bui, MD, role: CONTACT, phone: +84916080803, email: bpmman@ump.edu.vn, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False
protocolSection identificationModule nctId: NCT06323291, orgStudyIdInfo id: MCC-23077, briefTitle: Cancer Coaching and Remote Education for Self-Empowerment (CARES) Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, collaborators name: Canopy Cancer Collective, descriptionModule briefSummary: This Pilot Study will evaluate a 12-week pilot program that offers digital health coaching for individuals with pancreatic cancer and their caregivers., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Coaching Sessions, outcomesModule primaryOutcomes measure: Recruitment Rate, primaryOutcomes measure: Participant Acceptance of the Digital Health Coaching Program, primaryOutcomes measure: Participant Ease of Usability of the Digital Health Coaching Program, primaryOutcomes measure: Feasibility of Utilizing the Digital Health Coaching Program, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Emma Hume, role: CONTACT, phone: 813-745-6426, email: Emma.Hume@moffitt.org, contacts name: Kea Turner, MPH, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Pamela Hodul, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
protocolSection identificationModule nctId: NCT06323278, orgStudyIdInfo id: PD&REHAB, briefTitle: Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-12-21, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive training, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., secondaryOutcomes measure: The effect of cognitive training on behavioural aspects in PD patients., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, country: Italy, contacts name: Fabiana Ruggiero, MSc in Psychology, role: CONTACT, phone: +390255033621, email: fabiana.ruggiero@policlinico.mi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06323265, orgStudyIdInfo id: ARL-SCLC-001, briefTitle: A Real-world Study of Adebrelimab Combined With Chemotherapy±Chest Radiotherapy in Patients With Extensive Stage Small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Hebei Medical University Fourth Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Extensive Stage Small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Adebrelimab + chemotherapy, interventions name: ±chest radiotherapy, outcomesModule primaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Overall Response（DoR）, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jun Wang, status: RECRUITING, city: Shijiazhuang, state: Hebei, country: China, contacts name: Jun Wang, role: CONTACT, phone: 13931182128, email: wangjunzr@163.com, geoPoint lat: 38.04139, lon: 114.47861, hasResults: False
protocolSection identificationModule nctId: NCT06323252, orgStudyIdInfo id: MastihaOil-HT, briefTitle: A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Harokopio University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Hypertriglyceridemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: MastihaOil, interventions name: nutritional counsel, outcomesModule primaryOutcomes measure: Change in blood triglycerides, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323239, orgStudyIdInfo id: SBRT/LDRT+PD-1+GP for r/mNPC, briefTitle: SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: SBRT, interventions name: Low-dose Radiotherapy (LDRT), interventions name: Toripalimab, interventions name: Gemcitabine, interventions name: Cisplatin, interventions name: IMRT, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: QoL, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06323226, orgStudyIdInfo id: 2024-312-1, briefTitle: The Impact of Sepsis on Long-term Outcomes in Critical Ill Children With Sepsis, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Sepsis, conditions: Children, Only, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: West China Hospital of Sichuan University, status: RECRUITING, city: Chendu, state: Sichuan, country: China, contacts name: Ji Yi, Doctor, role: CONTACT, hasResults: False
protocolSection identificationModule nctId: NCT06323213, orgStudyIdInfo id: SSGJ-610-BA-III-01, briefTitle: Efficacy and Safety Study of 610 in Patients With Severe Asthma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma., conditionsModule conditions: Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 480, type: ESTIMATED, armsInterventionsModule interventions name: 610, interventions name: Placebo, outcomesModule primaryOutcomes measure: Annualized rate of severe exacerbation events, secondaryOutcomes measure: Time to first severe exacerbation event, secondaryOutcomes measure: Annualized rate of severe exacerbation events resulting in hospitalization or emergency room visit, secondaryOutcomes measure: Change from baseline in ACQ score, secondaryOutcomes measure: Change from baseline in ST. GEORGE'S Respiratory Questionnaire(SGRQ), secondaryOutcomes measure: Change in pre-bronchodilator forced expiratory volume (FEV1), secondaryOutcomes measure: Assessment of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323200, orgStudyIdInfo id: 202400221B0, briefTitle: Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA, acronym: LVA, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-09, primaryCompletionDateStruct date: 2023-03, completionDateStruct date: 2023-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Lymphedema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 189, type: ACTUAL, armsInterventionsModule interventions name: lymphaticovenous anastomosis, outcomesModule primaryOutcomes measure: Volume change after LVA., eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06323187, orgStudyIdInfo id: 4656, briefTitle: Optimization of Cervical Collections in Pregnancy, acronym: OCCP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2031-02-28, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Dr. Sascha Drewlo, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cervix; Pregnancy, conditions: Inherited Genetic Conditions (Diagnosis), conditions: Preeclampsia, conditions: Fetal Growth Retardation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 2600, type: ESTIMATED, armsInterventionsModule interventions name: Cervical Sampling, outcomesModule primaryOutcomes measure: Cellular content, primaryOutcomes measure: Cell-free content, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06323174, orgStudyIdInfo id: NN9388-4895, secondaryIdInfos id: 2022-502677-42, type: OTHER, domain: European Medical Agency (EMA), secondaryIdInfos id: U1111-1283-0404, type: OTHER, domain: World Health Organization (WHO), briefTitle: 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, acronym: REIMAGINE 1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-08-12, completionDateStruct date: 2025-11-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in glycated haemoglobin (HbA1c), secondaryOutcomes measure: Relative change in body weight, secondaryOutcomes measure: Number of participants who achieve greater than or equal to (>=) 10% body weight reduction, secondaryOutcomes measure: Number of participants who achieve >=15% body weight reduction, secondaryOutcomes measure: Number of participants who achieve HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]), secondaryOutcomes measure: Number of participants who achieve HbA1c target values of less than or equal to (<=) 6.5% (<= 48 mmol/mol), secondaryOutcomes measure: Change in Fasting Plasma Glucose (FPG), secondaryOutcomes measure: Number of participants who achieve >=5% body weight reduction, secondaryOutcomes measure: Number of participants who achieve >=20% body weight reduction, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in systolic blood pressure (SBP), secondaryOutcomes measure: Change in diastolic blood pressure (DBP), secondaryOutcomes measure: Ratio to baseline in high sensitivity C-reactive protein (hsCRP), secondaryOutcomes measure: Ratio to baseline in lipids: Total cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Triglycerides, secondaryOutcomes measure: Ratio to baseline in lipids: Free fatty acids, secondaryOutcomes measure: Ratio to baseline in lipids: Non-HDL cholesterol, secondaryOutcomes measure: Number of participants who achieve type 2 diabetes (T2D) remission (HbA1c <6.5% and no antidiabetic medication), secondaryOutcomes measure: Ratio to baseline in oral glucose tolerance test (OGTT) based oral glucose disposition index (DIo), secondaryOutcomes measure: Change in experienced level of energy as measured by the SF-36v2 Health Survey Acute (SF-36v2) Vitality score, secondaryOutcomes measure: Change in SF-36v2 score: Physical Component Summary score, secondaryOutcomes measure: Change in SF-36v2 score: Mental Component Summary score, secondaryOutcomes measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score, secondaryOutcomes measure: Change in leptin, secondaryOutcomes measure: Change in soluble leptin receptor, secondaryOutcomes measure: Number of Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol (54 milligrams per deciliter [mg/dL]), confirmed by blood glucose (BG) meter, secondaryOutcomes measure: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Research Institute_Huntington Park, status: RECRUITING, city: Huntington Park, state: California, zip: 90255, country: United States, geoPoint lat: 33.98168, lon: -118.22507, locations facility: Valley Clinical Trials, Inc., status: RECRUITING, city: Northridge, state: California, zip: 91325, country: United States, geoPoint lat: 34.22834, lon: -118.53675, locations facility: Southern California Dermatology, status: RECRUITING, city: Santa Ana, state: California, zip: 92701, country: United States, geoPoint lat: 33.74557, lon: -117.86783, locations facility: Encore Medical Research LLC, status: RECRUITING, city: Hollywood, state: Florida, zip: 33021, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Alliance for Multispec Res, status: NOT_YET_RECRUITING, city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: Brigham & Women's Hospital, status: NOT_YET_RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Arcturus Healthcare, PLC, status: RECRUITING, city: Troy, state: Michigan, zip: 48098, country: United States, geoPoint lat: 42.60559, lon: -83.14993, locations facility: Holston Medical Group, status: RECRUITING, city: Kingsport, state: Tennessee, zip: 37660, country: United States, geoPoint lat: 36.54843, lon: -82.56182, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Northeast Clinical Research of San Antonio, status: RECRUITING, city: San Antonio, state: Texas, zip: 78233, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Consano Clinical Research, LLC, status: RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: Consano Clinical Research, LLC, status: NOT_YET_RECRUITING, city: Shavano Park, state: Texas, zip: 78231, country: United States, geoPoint lat: 29.58495, lon: -98.55252, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Chinese People's Liberation Army General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Jiangsu University_Zhenjiang, status: NOT_YET_RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jinan Central Hospital, status: NOT_YET_RECRUITING, city: Ji'Nan, state: Shandong, zip: 250000, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Belinus Bt., status: NOT_YET_RECRUITING, city: Debrecen, state: Hajdu-Bihar Varmegye, zip: 4025, country: Hungary, geoPoint lat: 47.53333, lon: 21.63333, locations facility: Borbánya Praxis E.Ü. Kft., status: NOT_YET_RECRUITING, city: Nyíregyháza, state: Szabolcs-Szatmar Varmegye, zip: 4405, country: Hungary, geoPoint lat: 47.95539, lon: 21.71671, locations facility: Azienda Ospedaliera Papa Giovanni XXIII, status: NOT_YET_RECRUITING, city: Bergamo, zip: 24127, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, locations facility: Policlinico Mater Domini Università di Catanzaro, status: NOT_YET_RECRUITING, city: Catanzaro, zip: 88100, country: Italy, geoPoint lat: 38.88247, lon: 16.60086, locations facility: IRCCS Ospedale San Raffaele Milano, status: NOT_YET_RECRUITING, city: Milano, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Azienda Ospealiero Universitaria Policlinico Umberto I, status: NOT_YET_RECRUITING, city: Roma, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Centrum Medyczne Medyk Sp. z o.o., status: NOT_YET_RECRUITING, city: Rzeszow, state: Podkarpackie, zip: 35-055, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: Renew Clinic Bialystok, status: NOT_YET_RECRUITING, city: Białystok, zip: 15-794, country: Poland, geoPoint lat: 53.13333, lon: 23.16433, locations facility: Centrum Terapii Wspolczesnej, status: NOT_YET_RECRUITING, city: Lodz, zip: 90-338, country: Poland, geoPoint lat: 51.75, lon: 19.46667, locations facility: NBR Polska Tomasz Klodawski, status: NOT_YET_RECRUITING, city: Warszawa, zip: 00-710, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: King Abdulaziz Hospital-Al Ahsa-National Guard, status: NOT_YET_RECRUITING, city: Al Ahsa, zip: 36428, country: Saudi Arabia, locations facility: National Guard Hospital - Jeddah, status: NOT_YET_RECRUITING, city: Jeddah, zip: 21423, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, locations facility: King Fahad Medical City, status: NOT_YET_RECRUITING, city: Riyadh, zip: 11525, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: King Khaled University Hospital,King Saud Univ. Med. City, status: NOT_YET_RECRUITING, city: Riyadh, zip: 12372, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: King Salman Bin Abdulaziz Hospital, status: NOT_YET_RECRUITING, city: Riyadh, zip: 12769, country: Saudi Arabia, geoPoint lat: 24.68773, lon: 46.72185, locations facility: CHC Zvezdara, Clinical department for endocrinology, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11000, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Clinical Hospital Center Bezanijska Kosa, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11080, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Clinical Hospital Centre Zemun, status: NOT_YET_RECRUITING, city: Belgrade, zip: 11080, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
protocolSection identificationModule nctId: NCT06323161, orgStudyIdInfo id: NN9388-7637, secondaryIdInfos id: U1111-1283-0754, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2022-502679-43, type: OTHER, domain: European Medical Agency (EMA), briefTitle: 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, acronym: REIMAGINE 3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-09-16, completionDateStruct date: 2025-11-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Glycated Haemoglobin (HbA1c), secondaryOutcomes measure: Relative Change in Body Weight, secondaryOutcomes measure: Number of Participants Who Achieve Greater than or Equal to (≥) 10% Body Weight Reduction, secondaryOutcomes measure: Number of Participants Who Achieve ≥15% Body Weight Reduction, secondaryOutcomes measure: Number of Participants Who Achieve HbA1c Target Values of Less than (<) 7.0% (<53 millimole per mole [mmol/mol]), secondaryOutcomes measure: Number of Participants Who Achieve HbA1c Target Values of Less than or Equal to (≤) 6.5% (≤48 mmol/mol), secondaryOutcomes measure: Change in Fasting Plasma Glucose (FPG), secondaryOutcomes measure: Change in Insulin Dose, secondaryOutcomes measure: Number of Participants Who Achieve Insulin Dose Equal to (=) 0 Units, secondaryOutcomes measure: Change in 7-point Self-measured Plasma Glucose (SMPG) Profiles: Mean 7-point profile and Mean postprandial increment (over all meals), secondaryOutcomes measure: Number of Participants Who Achieve ≥5% Body Weight Reduction, secondaryOutcomes measure: Number of Participants Who Achieve ≥20% Body Weight Reduction, secondaryOutcomes measure: Change in Waist Circumference, secondaryOutcomes measure: Change in Systolic Blood Pressure (SBP), secondaryOutcomes measure: Change in Diastolic Blood Pressure (DBP), secondaryOutcomes measure: Ratio to Baseline in High Sensitivity C-reactive Protein (hsCRP), secondaryOutcomes measure: Ratio to Baseline in Lipids: Non-high Density Lipoprotein (Non-HDL) Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Triglycerides, secondaryOutcomes measure: Ratio to Baseline in Lipids: Low-Density Lipoprotein (LDL) Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Very Low-Density Lipoprotein (VLDL) cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: HDL Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Total Cholesterol, secondaryOutcomes measure: Ratio to Baseline in Lipids: Free Fatty Acids, secondaryOutcomes measure: Change in Short Form-36 Version 2.0 Health Survey (SF-36v2): Vitality score, secondaryOutcomes measure: Change in SF-36v2: Physical Component Summary Score, secondaryOutcomes measure: Change in SF-36v2: Mental Component Summary Core, secondaryOutcomes measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, secondaryOutcomes measure: Change in Leptin, secondaryOutcomes measure: Change in Soluble Leptin Receptor, secondaryOutcomes measure: Number of Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Number of Clinically Significant Hypoglycaemic Episodes (level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by Blood Glucose Meter), secondaryOutcomes measure: Number of Clinically Significant Hypoglycaemic Episodes (level 3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Valley Clinical Trials, Inc., status: RECRUITING, city: Northridge, state: California, zip: 91325, country: United States, geoPoint lat: 34.22834, lon: -118.53675, locations facility: Bioclinical Research Alliance, status: RECRUITING, city: Miami, state: Florida, zip: 33155, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Solaris Clinical Research, status: RECRUITING, city: Meridian, state: Idaho, zip: 83646, country: United States, geoPoint lat: 43.61211, lon: -116.39151, locations facility: Iowa Diab & Endo Res Center, status: RECRUITING, city: West Des Moines, state: Iowa, zip: 50265, country: United States, geoPoint lat: 41.57721, lon: -93.71133, locations facility: Alliance for Multispec Res, status: RECRUITING, city: Newton, state: Kansas, zip: 67114, country: United States, geoPoint lat: 38.04668, lon: -97.34504, locations facility: Elite Research Center, status: RECRUITING, city: Flint, state: Michigan, zip: 48532, country: United States, geoPoint lat: 43.01253, lon: -83.68746, locations facility: Palm Research Center Inc., status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89128, country: United States, geoPoint lat: 36.17497, lon: -115.13722, locations facility: University of North Carolina, status: NOT_YET_RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27517, country: United States, geoPoint lat: 35.9132, lon: -79.05584, locations facility: Clinical Research Associates, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Velocity Clinical Res-Dallas, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Synergy Groups Medical, status: RECRUITING, city: Houston, state: Texas, zip: 77061, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: PlanIt Research, PLLC, status: RECRUITING, city: Houston, state: Texas, zip: 77079, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Manassas Clinical Research Center, status: RECRUITING, city: Manassas, state: Virginia, zip: 20110, country: United States, geoPoint lat: 38.75095, lon: -77.47527, locations facility: TPMG Clinical Research, status: RECRUITING, city: Newport News, state: Virginia, zip: 23606, country: United States, geoPoint lat: 37.08339, lon: -76.46965, locations facility: Chinese People's Liberation Army General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100853, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Second Affiliated Hospital of Nanjing Medical University_Nanjing, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210011, country: China, geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Affiliated Hospital of Jiangsu University_Zhenjiang, status: NOT_YET_RECRUITING, city: Zhenjiang, state: Jiangsu, zip: 212001, country: China, geoPoint lat: 32.21086, lon: 119.45508, locations facility: Jinan Central Hospital, status: NOT_YET_RECRUITING, city: Ji'nan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Shanghai Pudong New Area People's Hospital, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 201200, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Manda Memorial Hospital, status: NOT_YET_RECRUITING, city: Sapporo-shi, Hokkaido, state: Hokkaido, Japan, zip: 060-0062, country: Japan, geoPoint lat: 43.06667, lon: 141.35, locations facility: Tsuruma Kaneshiro Diabetes Clinic, status: RECRUITING, city: Yamato-shi, state: Kanagawa, zip: 242-0004, country: Japan, locations facility: Kumanomae Nishimura Internal Medical Clinic, status: RECRUITING, city: Arakawa-ku, Tokyo, zip: 116-0012, country: Japan, locations facility: Akaicho Clinic, status: RECRUITING, city: Chiba-shi, Chiba, zip: 260-0804, country: Japan, locations facility: Futata Tetsuhiro Clinic Meinohama, status: RECRUITING, city: Fukuoka-shi, Fukuoka, zip: 819-0006, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Kunisaki Makoto Clinic, status: RECRUITING, city: Fukuoka-shi, Fukuoka, zip: 819-0168, country: Japan, geoPoint lat: 33.6, lon: 130.41667, locations facility: Sasaki Hospital Internal Medicine, status: RECRUITING, city: Hokkaido, zip: 062-0007, country: Japan, geoPoint lat: 43.41104, lon: 142.88878, locations facility: Naka Kinen Clinic, status: RECRUITING, city: Ibaraki, zip: 311-0113, country: Japan, geoPoint lat: 34.81641, lon: 135.56828, locations facility: H.E.C Science Clinic, status: NOT_YET_RECRUITING, city: Kanagawa, zip: 235-0045, country: Japan, geoPoint lat: 37.58333, lon: 139.91667, locations facility: Minami Akatsuka Clinic, status: RECRUITING, city: Mito-shi, Ibaraki, zip: 311-4153, country: Japan, locations facility: Tokyo-Eki Center-building Clinic, status: RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Tokyo-Eki Center-building Clinic, status: NOT_YET_RECRUITING, city: Tokyo, zip: 103-0027, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Fukuwa Clinic, status: RECRUITING, city: Tokyo, zip: 104-0031, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Kato Clinic of Internal Medicine, status: RECRUITING, city: Tokyo, zip: 125-0054, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Healthcare centre Zvezdara, status: NOT_YET_RECRUITING, city: Belgrade, state: RS, zip: 11050, country: Serbia, geoPoint lat: 44.80401, lon: 20.46513, locations facility: Healthcare centre Kragujevac, status: NOT_YET_RECRUITING, city: Kragujevac, state: RS, zip: 34000, country: Serbia, geoPoint lat: 44.01667, lon: 20.91667, locations facility: University Clinical Centre Nis, status: NOT_YET_RECRUITING, city: Nis, state: RS, zip: 18 000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, locations facility: Healthcare centre Nis, status: NOT_YET_RECRUITING, city: Nis, state: RS, zip: 18000, country: Serbia, geoPoint lat: 43.32472, lon: 21.90333, locations facility: Policlinic for diabetes, status: NOT_YET_RECRUITING, city: Zajecar, zip: 19000, country: Serbia, geoPoint lat: 43.90358, lon: 22.26405, locations facility: MOMED, s.r.o, status: RECRUITING, city: Kralovsky Chlmec, zip: 077 01, country: Slovakia, geoPoint lat: 48.42336, lon: 21.97944, locations facility: DIA - KONTROL s.r.o., status: RECRUITING, city: Levice, zip: 93401, country: Slovakia, geoPoint lat: 48.21563, lon: 18.60705, locations facility: SIN AZUCAR s.r.o., status: RECRUITING, city: Malacky, zip: 901 01, country: Slovakia, geoPoint lat: 48.43604, lon: 17.02188, locations facility: ENRIN, s.r.o., status: RECRUITING, city: Rimavska Sobota, zip: 979 01, country: Slovakia, geoPoint lat: 48.38284, lon: 20.02239, locations facility: LUDIA, s.r.o., status: RECRUITING, city: Spisska Nova Ves, zip: 05201, country: Slovakia, geoPoint lat: 48.94464, lon: 20.56153, locations facility: Vuyo Clinical Research, status: NOT_YET_RECRUITING, city: Bloemfontein, state: Free State, zip: 9323, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Lenasia Clinical Trial Centre, status: NOT_YET_RECRUITING, city: Lenasia, state: Gauteng, zip: 1827, country: South Africa, geoPoint lat: -26.32052, lon: 27.83564, locations facility: Prinshof Medical Campus, status: NOT_YET_RECRUITING, city: Pretoria, state: Gauteng, zip: 0002, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Clinical Trial Systems (CTC), status: NOT_YET_RECRUITING, city: Pretoria, state: Gauteng, zip: 0186, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Ashmed Medi-Centre, status: NOT_YET_RECRUITING, city: Cape Town, state: Western Cape, zip: 7760, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, hasResults: False
protocolSection identificationModule nctId: NCT06323148, orgStudyIdInfo id: ECTOP-1022, briefTitle: Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2029-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Lung Cancer, conditions: EGFR Gene Mutation, conditions: Minimal Residual Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 226, type: ESTIMATED, armsInterventionsModule interventions name: Osimertinib, interventions name: No adjuvant therapy, outcomesModule primaryOutcomes measure: The 3-year Disease-Free Survival (DFS) rate between the observation group and the osimertinib treatment group., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06323135, orgStudyIdInfo id: 2019-725, briefTitle: Nutrition Assessment in Advanced Cancer Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-09-17, primaryCompletionDateStruct date: 2023-09-11, completionDateStruct date: 2023-09-11, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Advanced Cancer, conditions: Nutrition Aspect of Cancer, conditions: Prognostic Cancer Model, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2115, type: ACTUAL, outcomesModule primaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: length of stay in hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Hospital, Sichuan Universit, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06323122, orgStudyIdInfo id: Plating Techniques 2023, briefTitle: A Comparative Study Between Three Different Plating Techniques in Management of Mandibular Parasymphyseal Fractures., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Mandibular Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: 2.0 miniplates, interventions name: 2.3 high profile miniplates, interventions name: 3D miniplates, outcomesModule primaryOutcomes measure: Surgery Time, secondaryOutcomes measure: complication, secondaryOutcomes measure: fracture stability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: October 6U, city: Cairo, zip: 12566, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06323109, orgStudyIdInfo id: 2023-1331, secondaryIdInfos id: A196200, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 12/21/23, type: OTHER, domain: UW Madison, briefTitle: US Imaging for the Assessment of LUTS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, collaborators name: Wisconsin Partnership Program, descriptionModule briefSummary: 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)., conditionsModule conditions: Lower Urinary Tract Symptoms, conditions: BPH, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: MRI-UDS; US-UDS; MCUD, outcomesModule primaryOutcomes measure: MRI Urodynamics - Change in Bladder Volume, primaryOutcomes measure: MRI Urodynamics - Change in Urine Velocity, primaryOutcomes measure: MRI Urodynamics - Change in Pressure, primaryOutcomes measure: Bladder outlet obstruction index (BOOI), primaryOutcomes measure: Bladder contractility index (BOI), primaryOutcomes measure: International Prostate Symptom Score (IPSS), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Wisconsin, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Gemma Gliori, MS, role: CONTACT, email: ggliori@uwhealth.org, contacts name: Suzanne Hanson, BS, role: CONTACT, email: shanson@uwhealth.org, contacts name: Alejandro Roldan-Alzate, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Wade Bushman, MD, PhD, role: SUB_INVESTIGATOR, contacts name: Matt Grimes, MD, role: SUB_INVESTIGATOR, contacts name: Giuseppe Toia, MD, role: SUB_INVESTIGATOR, contacts name: Ivan Rosado-Mendez, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06323096, orgStudyIdInfo id: AR13067824, briefTitle: Development of Clinical Decision Support System for Severe Patients With Polytrauma, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Semey State Medical University, class: OTHER, collaborators name: Ministry of Science and Higher Education of the Republic of Kazakhstan, descriptionModule briefSummary: 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., conditionsModule conditions: Polytrauma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Prediction of SIRS, primaryOutcomes measure: Rate of ATC prediction in the 24 h after admission using the developed CDSS., primaryOutcomes measure: Rate of hemorrage prediction in the 24 h after admission using the developed CDSS., primaryOutcomes measure: Rate of pneumonia prediction using the developed CDSS., eligibilityModule sex: ALL, minimumAge: 28 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emergency Hospital, status: RECRUITING, city: Semey, state: Abai, zip: 071400, country: Kazakhstan, contacts name: Alexander Prokazyuk, MD, role: CONTACT, phone: +77071891849, email: prokazyuk.md@yandex.ru, geoPoint lat: 50.42675, lon: 80.26669, hasResults: False
protocolSection identificationModule nctId: NCT06323083, orgStudyIdInfo id: 006, briefTitle: The Effect of Emotional Freedom Technique on Perceived Stress and General Self-Efficacy in Nursing Students, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-07, primaryCompletionDateStruct date: 2022-11-28, completionDateStruct date: 2023-06-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Emotion Regulation, conditions: Stress, conditions: Self Efficacy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study was designed to be randomly controlled., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Emotional Freedom Technique, outcomesModule primaryOutcomes measure: General Self-Efficacy Scale, primaryOutcomes measure: Perceived Stress Scale, primaryOutcomes measure: The Subjective Units of Distress Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selcuk University, city: Konya, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
protocolSection identificationModule nctId: NCT06323070, orgStudyIdInfo id: HS-2023-0281, briefTitle: Effects of Watermelon or Low-fat Cookie Consumption on Wellness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: San Diego State University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Low-fat cookies, interventions name: Watermelon, outcomesModule primaryOutcomes measure: Change of sexual health questionnaire scores, primaryOutcomes measure: Change of skin hydration scores, primaryOutcomes measure: Change of microbiome diversity, secondaryOutcomes measure: Change of depression questionnaire scores, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: School of Exercise and Nutritional Sciences, status: RECRUITING, city: San Diego, state: California, zip: 92182, country: United States, contacts name: Mee Young Hong, PhD, role: CONTACT, phone: 619-594-2392, email: mhong2@sdsu.edu, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
protocolSection identificationModule nctId: NCT06323057, orgStudyIdInfo id: Pro2022000444_CLFMT, briefTitle: Modulating Reward Learning Using Transcranial Magnetic Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Rutgers, The State University of New Jersey, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Participants will be blinded to the TMS condition (active or sham), whoMasked: PARTICIPANT, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Single pulse TMS to the frontal cortex, outcomesModule primaryOutcomes measure: Event-related Brain Oscillation: Frontal Midline Theta, primaryOutcomes measure: Reward learning, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rutgers University - Newark, status: RECRUITING, city: Newark, state: New Jersey, zip: 07102, country: United States, contacts name: Travis E Baker, PhD, role: CONTACT, phone: 862-250-3351, email: travis.e.baker@rutgers.edu, contacts name: Daniel Robles, PhD, role: CONTACT, phone: 973-353-3509, email: dr1147@newark.rutgers.edu, geoPoint lat: 40.73566, lon: -74.17237, hasResults: False
protocolSection identificationModule nctId: NCT06323044, orgStudyIdInfo id: I-3920723, secondaryIdInfos id: NCI-2024-01734, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: I-3920723, type: OTHER, domain: Roswell Park Cancer Institute, secondaryIdInfos id: R01CA283501, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA283501, briefTitle: MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2029-06-15, completionDateStruct date: 2029-06-15, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Roswell Park Cancer Institute, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Biospecimen Collection, interventions name: Electronic Health Record Review, interventions name: Interview, interventions name: Medical Device Usage and Evaluation, interventions name: Medical Device Usage and Evaluation, interventions name: Survey Administration, outcomesModule primaryOutcomes measure: Medication adherence, eligibilityModule sex: ALL, minimumAge: 365 Days, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Roswell Park Cancer Institute, city: Buffalo, state: New York, zip: 14263, country: United States, contacts name: Kara M. Kelly, role: CONTACT, phone: 716-845-2333, email: Kara.Kelly@RoswellPark.org, contacts name: Kara M. Kelly, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88645, lon: -78.87837, hasResults: False
protocolSection identificationModule nctId: NCT06323031, orgStudyIdInfo id: Blink-DoC, briefTitle: Spontaneous Eye Blinking in Disorders of Consciousness, acronym: Blink-DoC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fondazione Don Carlo Gnocchi Onlus, class: OTHER, collaborators name: Therapiezentrum Burgau, collaborators name: University of Liege, collaborators name: University Hospital Munich, collaborators name: VITHAS Valencia (Spain), collaborators name: Azienda Ospedaliera Universitaria Ferrara, collaborators name: Ludwig-Maximilians - University of Munich, descriptionModule briefSummary: 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., conditionsModule conditions: Disorders of Consciousness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Clinical Diagnosis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Coma Science Group, GIGA-Consciousness, University of Liege, city: Liege, zip: 4000, country: Belgium, contacts name: Olivia Gosseries, PhD, role: CONTACT, email: ogosseries@uliege.be, contacts name: Olivia Gosseries, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Aurore Thibaut, PhD, role: SUB_INVESTIGATOR, contacts name: Youssra Mezoudi, M.Sc., role: SUB_INVESTIGATOR, geoPoint lat: 50.63373, lon: 5.56749, locations facility: Therapiezentrum Burgau, city: Burgau, zip: 89331, country: Germany, contacts name: Andreas Bender, MD, role: CONTACT, email: a.bender@therapiezentrum-burgau.de, contacts name: Andreas Bender, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Martin Rosenfelder, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 48.43159, lon: 10.40989, locations facility: Dipartimento di Neurologia, LMU Hospital, LMU Munich, city: Munich, zip: 81377, country: Germany, contacts name: Konstantinos Dimitriadis, role: CONTACT, email: konstantin.dimitriadis@med.unimuenchen.de, contacts name: Konstantinos Dimitriadis, role: PRINCIPAL_INVESTIGATOR, contacts name: Moritz Schmidbauer, role: SUB_INVESTIGATOR, contacts name: Julia Zibold, role: SUB_INVESTIGATOR, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Polo Specialistico Riabilitativo Fondazione Don Carlo Gnocchi ONLUS, city: Sant'Angelo dei Lombardi, state: AV, zip: 83054, country: Italy, contacts name: Anna Estraneo, PhD, role: CONTACT, phone: 3396418648, phoneExt: 39, email: aestraneo@dongnocchi.it, contacts name: Alfonso Magliacano, PhD, role: CONTACT, phone: 3387389414, phoneExt: 39, email: amagliacano@dongnocchi.it, contacts name: Anna Estraneo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Alfonso Magliacano, PhD, role: SUB_INVESTIGATOR, contacts name: Giovanni Scarano, BS, role: SUB_INVESTIGATOR, geoPoint lat: 40.92937, lon: 15.17535, locations facility: Unità Gravi Cerebrolesioni - Dipartimento Neuroscienze - Azienda Ospedaliera - Universitaria Ferrara, city: Ferrara, zip: 44124, country: Italy, contacts name: Susanna Lavezzi, role: CONTACT, email: s.lavezzi@ospfe.it, contacts name: Susanna Lavezzi, role: PRINCIPAL_INVESTIGATOR, contacts name: Valentina Bonsangue, role: SUB_INVESTIGATOR, contacts name: Sofia Straudi, role: SUB_INVESTIGATOR, geoPoint lat: 44.83804, lon: 11.62057, locations facility: IRCCS Fondazione Don Gnocchi ONLUS, city: Florence, zip: 50143, country: Italy, contacts name: Bahia Hakiki, PhD, role: CONTACT, email: bhakiki@dongnocchi.it, contacts name: Bahia Hakiki, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Andrea Mannini, PhD, role: SUB_INVESTIGATOR, contacts name: Piergiuseppe Liuzzi, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: IRCCS Santa Maria Nascente Fondazione Don Gnocchi ONLUS, city: Milan, zip: 20148, country: Italy, contacts name: Angela Comanducci, PhD, role: CONTACT, email: acomanducci@dongnocchi.it, contacts name: Angela Comanducci, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Tiziana Atzori, role: SUB_INVESTIGATOR, contacts name: Chiara-Camilla Derchi, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Instituto de Rehabilitación Neurológica IRENEA, city: Valencia, zip: 46007, country: Spain, contacts name: Enrique Noé, MD, role: CONTACT, email: enoe@comv.es, contacts name: Enrique Noé, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Roberto Llorens, PhD, role: SUB_INVESTIGATOR, contacts name: Alejandro Galvao, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
protocolSection identificationModule nctId: NCT06323018, orgStudyIdInfo id: 384T-26, briefTitle: Effects of Remote Ischaemic Preconditioning in Cemented Hip Arthroplasty., acronym: PRINCIPAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Tartu, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Osteoarthritis, Hip, conditions: Cardiovascular Diseases, conditions: Bone Cement Implantation Syndrome, conditions: Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization and intervention is done by a dedicated study nurse. Patient, orthopedic surgeon, investigator and outcomes assessor and statistician are all blinded to the study intervention., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Remote Ischemic Preconditioning, interventions name: SHAM, outcomesModule primaryOutcomes measure: Myocardial injury, secondaryOutcomes measure: Cardiovascular injury, secondaryOutcomes measure: Clinical serious complications, secondaryOutcomes measure: Carotid-femoral pulse velocity, secondaryOutcomes measure: Augmentation index, secondaryOutcomes measure: Brain injury, secondaryOutcomes measure: Kidney Injury, secondaryOutcomes measure: Total antioxidative capacity (TAC), secondaryOutcomes measure: Oxidative stress level (total peroxide levels), secondaryOutcomes measure: Inflammation level, secondaryOutcomes measure: Low molecular weight metabolites (uM), eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 90 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Tartu, status: RECRUITING, city: Tartu, state: Tartumaa, zip: 50406, country: Estonia, contacts name: Kaspar Tootsi, MD, PhD, role: CONTACT, phone: +3727318282, email: kaspar.tootsi@kliinikum.ee, geoPoint lat: 58.38062, lon: 26.72509, hasResults: False
protocolSection identificationModule nctId: NCT06323005, orgStudyIdInfo id: 2024-0024, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06322992, orgStudyIdInfo id: R41CA271962, type: NIH, link: https://reporter.nih.gov/quickSearch/R41CA271962, briefTitle: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients - Aim 3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Daynamica, Inc., class: INDUSTRY, collaborators name: Masonic Cancer Center, University of Minnesota, descriptionModule briefSummary: 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., conditionsModule conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: APP satisfaction, primaryOutcomes measure: APP rating, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322979, orgStudyIdInfo id: # R-PED-11-23-3074, briefTitle: Premixed Bioceramic Putty as an Apical Plug in Immature Anterior Permanent Teeth, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Periapical Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Mineral trioxide aggregate, interventions name: Premixed Bioceramic Putty, outcomesModule primaryOutcomes measure: the clinical success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA), primaryOutcomes measure: the radiographic success of apexification after using a new apical plug material (Premixed Bioceramic Putty ) compared to the widely used material (MTA), secondaryOutcomes measure: Change in the periapical index (PAI), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: Tanta University, status: RECRUITING, city: Tanta, state: Gharbia, zip: 6624033, country: Egypt, contacts name: Shaimaa eldesouky, PhD, role: CONTACT, phone: 01008994242, email: shiamaaeldesouky@dent.tanta.edu.eg, contacts name: mohamed ghaly, PhD, role: CONTACT, phone: 01098472899, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
protocolSection identificationModule nctId: NCT06322966, orgStudyIdInfo id: STUDY00017745, secondaryIdInfos id: K99ES034442, type: NIH, link: https://reporter.nih.gov/quickSearch/K99ES034442, briefTitle: Learning and Living With Wildfire Smoke, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2027-05-28, completionDateStruct date: 2028-05-26, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, collaborators name: National Institute of Environmental Health Sciences (NIEHS), descriptionModule briefSummary: 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., conditionsModule conditions: Behavior and Behavior Mechanisms, conditions: Health Knowledge, Attitudes, Practice, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Air Action Curriculum, outcomesModule primaryOutcomes measure: Number of students, staff, teacher and administrators with higher scores on a Likert-style questionnaire for content knowledge learning objectives., primaryOutcomes measure: Scores on Likert-style questionnaire to evaluate behavior change around air quality., primaryOutcomes measure: Change in student exposure to air pollution calculated through measurements of indoor particulate matter and indoor carbon dioxide., eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Washington, status: RECRUITING, city: Seattle, state: Washington, zip: 98195, country: United States, contacts name: Savannah M D'Evelyn, PhD, role: CONTACT, phone: 303-501-6656, email: sdevelyn@uw.edu, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
protocolSection identificationModule nctId: NCT06322953, orgStudyIdInfo id: RG442-21, briefTitle: Timing to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage, acronym: RESTARTtlCrH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-07-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Walton Centre NHS Foundation Trust, class: OTHER, collaborators name: University of Liverpool, collaborators name: National Institute for Health Research, United Kingdom, descriptionModule briefSummary: 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., conditionsModule conditions: Traumatic Intracranial Haemorrhage, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1084, type: ESTIMATED, armsInterventionsModule interventions name: Direct-Acting Oral Anticoagulants (used as per local standard practice), outcomesModule primaryOutcomes measure: Proportion of patients with haemorrhagic or thrombotic event within 12 weeks following tICrH., secondaryOutcomes measure: Time to first haemorrhagic or thrombotic event., secondaryOutcomes measure: Time to first haemorrhagic event, secondaryOutcomes measure: Time to first thrombotic event, secondaryOutcomes measure: Time to death, secondaryOutcomes measure: Functional outcome measured using modified Rankin Scale (mRS), secondaryOutcomes measure: Functional outcome measured using Barthel Index, secondaryOutcomes measure: Functional outcome measured using extended Glasgow Outcome Scale (GOS-E), secondaryOutcomes measure: Overall Quality of Life measured by EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire, secondaryOutcomes measure: Patient/caregiver attitudes to (re)starting OAC, secondaryOutcomes measure: Healthcare resource use, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322940, orgStudyIdInfo id: 2024-10463, briefTitle: Effect of Dairy Product Matrices on Insulin Resistance in People With Overweight and Obesity and Prediabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, collaborators name: Dairy Farmers of Canada, descriptionModule briefSummary: 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., conditionsModule conditions: PreDiabetes, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three treatment groups, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, maskingDescription: Participant's study group will be coded., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: 250 mL serving size, 3.25% fat content, interventions name: 175 g serving size, ≥2% fat content, interventions name: 50 g serving size, ≥28% fat content, outcomesModule primaryOutcomes measure: Change in whole-body insulin sensitivity, secondaryOutcomes measure: Change in glucose tolerance, secondaryOutcomes measure: Change in Matsuda index, secondaryOutcomes measure: Change in Insulinogenic index, secondaryOutcomes measure: Change in oral disposition index, secondaryOutcomes measure: Change in Homeostatic Model Assessment for Insulin Resistance, secondaryOutcomes measure: Change in glycated hemoglobin, secondaryOutcomes measure: Change in total lean body mass, secondaryOutcomes measure: Change in total fat mass, secondaryOutcomes measure: Change in visceral fat mass, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in lipid profile, otherOutcomes measure: Change in resting energy expenditure, otherOutcomes measure: Change in total energy expenditure, otherOutcomes measure: Change in metabolic equivalent of task, otherOutcomes measure: Change in total energy intake, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RI-MUHC, city: Montréal, state: Quebec, zip: H4A 3J1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
protocolSection identificationModule nctId: NCT06322927, orgStudyIdInfo id: CFTsp231, secondaryIdInfos id: 24_CPCR_38, type: OTHER, domain: ChristieNHS, briefTitle: PatIent exPeRiences and prEFerence of trEatment foR Multiple Myeloma, acronym: iPREFER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The Christie NHS Foundation Trust, class: OTHER, collaborators name: CellCentric Ltd., descriptionModule briefSummary: 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., conditionsModule conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Patient Interview, outcomesModule primaryOutcomes measure: Patient Experience and Preference, secondaryOutcomes measure: Treatment and Preference Differences, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Christie NHS Foundation Trust, city: Manchester, state: Greater Manchester, zip: M20 4BX, country: United Kingdom, geoPoint lat: 53.48095, lon: -2.23743, hasResults: False
protocolSection identificationModule nctId: NCT06322914, orgStudyIdInfo id: 029, briefTitle: A Novel Scoring System for Predicting the Success of PCI in Patients With CTO, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01, primaryCompletionDateStruct date: 2023-11, completionDateStruct date: 2023-11, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Total Occlusion (CTO), designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 493, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: PCI technical success, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Nanjing Medical University, city: Nanjing, state: Jiangsu, zip: 210029, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06322901, orgStudyIdInfo id: TDH-2018-7883, briefTitle: The Effect Of Vertical Releasing Incision On Implant Procedures, acronym: Vertikal, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-05, primaryCompletionDateStruct date: 2020-10-02, completionDateStruct date: 2020-10-02, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bone Loss, conditions: Flap Design, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 17, type: ACTUAL, armsInterventionsModule interventions name: Flap, outcomesModule primaryOutcomes measure: Bone loss, otherOutcomes measure: OPG/RANKL, otherOutcomes measure: visual analog scale (VAS), otherOutcomes measure: cortisol levels, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erciyes University Faculty of Dentistry, city: Melikgazi, state: Kayseri, zip: 38039, country: Turkey, hasResults: False
protocolSection identificationModule nctId: NCT06322888, orgStudyIdInfo id: 23-676, briefTitle: Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: Breast Cancer Research Foundation, descriptionModule briefSummary: 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, conditionsModule conditions: Breast Cancer, conditions: Breast Cancer Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Training Program, outcomesModule primaryOutcomes measure: Change in Irisin in Exercise Group, primaryOutcomes measure: Change in Irisin in Control Group, secondaryOutcomes measure: Change in Tissue Markers in Exercise Group, secondaryOutcomes measure: Change in Tissue Markers in Control Group, secondaryOutcomes measure: Change in Biomarkers in Exercise Group - Meso scale, secondaryOutcomes measure: Change in Biomarkers in Exercise Group - Mass cytometry, secondaryOutcomes measure: Change in Biomarkers in Control Group - Meso Scale, secondaryOutcomes measure: Change in Biomarkers in Control Group - Mass cytometry, secondaryOutcomes measure: Change in Participant Weight in Exercise Group, secondaryOutcomes measure: Change in Participant Weight in Control Group, secondaryOutcomes measure: Change in Cardiorespiratory Fitness in Exercise Group, secondaryOutcomes measure: Change in Cardiorespiratory Fitness in Control Group, secondaryOutcomes measure: 10-Repetition Max Test in Exercise Group, secondaryOutcomes measure: 10-Repetition Max Test in Control Group, secondaryOutcomes measure: Change in Minutes of Total Exercise for Exercise Group, secondaryOutcomes measure: Change in Minutes of Total Exercise for Control Group, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Tari King, MD, role: CONTACT, phone: 617-632-3891, email: tking7@bwh.harvard.edu, contacts name: Tari King, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Jennifer Ligibel, MD, role: CONTACT, phone: 617-632-3800, email: Jennifer_Ligibel@dfci.harvard.edu, contacts name: Jennifer Ligibel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06322875, orgStudyIdInfo id: SKCCOL002, briefTitle: A Clinical Study to Evaluate the Efficacy and Satisfaction of RHC Serum Combined With RHC(III) Injection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: DeYi Aesthetic Medical Clinic, class: OTHER, descriptionModule briefSummary: 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), conditionsModule conditions: Facial Wrinkles, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Recombinant type III humanized collagen solution for injection, interventions name: SkinCeuticals recombinant humanized collagen (RHC) serum, interventions name: Regular face cream smear, outcomesModule primaryOutcomes measure: FACE-Q Satisfaction with skin, secondaryOutcomes measure: Investigator Global Aesthetic Improvement Scale (I-GAIS) Rates, secondaryOutcomes measure: Subject Global Aesthetic Improvement Scale (S-GAIS) Rates, secondaryOutcomes measure: Improvement rate assessed by Atlas, secondaryOutcomes measure: Change in Cutometer® dual Analysis Score, secondaryOutcomes measure: Change in VISIA® Skin Analysis Score, secondaryOutcomes measure: FACE-Q Satisfaction with Outcome, secondaryOutcomes measure: FACE-Q Satisfaction with skin, secondaryOutcomes measure: Change of the thickness and density of subjects' facial dermis, otherOutcomes measure: Changes from baseline in skin uniformity and spot area ratio measurements collected by VISIA's face image acquisition instrument., eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322862, orgStudyIdInfo id: H-23042430, briefTitle: Intraoperative Intestinal Perfusion Assessment by Fluorescence Angiography in Emergency Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Bowel; Ischemic, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Indocyanine green, outcomesModule primaryOutcomes measure: Change of strategy, secondaryOutcomes measure: Anastomosis, secondaryOutcomes measure: Quantification using q-ICG, secondaryOutcomes measure: Stomas, secondaryOutcomes measure: Second-look, secondaryOutcomes measure: Anastomotic leaks, secondaryOutcomes measure: Postoperative medical complications, secondaryOutcomes measure: Postoperative surgical complications, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Organ Surgery and Transplantation, status: RECRUITING, city: Copenhagen, state: Hovedstaden, zip: 2100, country: Denmark, contacts name: Sermed Ellebæk Nicolae, MD, role: CONTACT, phone: +4535459666, email: sermed.ellebaek.nicolae@regionh.dk, contacts name: Michael P Achiam, MD, DMSc, role: CONTACT, phone: +45 3545 0441, email: michael.patrick.achiam.01@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Department of Surgery, Bispebjerg Hospital, status: NOT_YET_RECRUITING, city: Bispebjerg, country: Denmark, contacts name: Peter Bonde, MD, role: CONTACT, geoPoint lat: 55.71017, lon: 12.53147, locations facility: Department of Surgery, Herlev Hospital, status: NOT_YET_RECRUITING, city: Herlev, country: Denmark, contacts name: Jakob Burcharth, MD, PhD, role: CONTACT, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Department of Surgery, Nordsjællands Hospital, status: NOT_YET_RECRUITING, city: Hillerød, country: Denmark, contacts name: Mai-Britt Tolstrup, MD, PhD, role: CONTACT, geoPoint lat: 55.92791, lon: 12.30081, locations facility: Department of Surgery, Hvidovre Hospital, status: NOT_YET_RECRUITING, city: Hvidovre, country: Denmark, contacts name: Morten Laksafoss Lauritsen, MD, role: CONTACT, geoPoint lat: 55.65719, lon: 12.47364, hasResults: False
protocolSection identificationModule nctId: NCT06322849, orgStudyIdInfo id: STU00220591, briefTitle: Active Elements of Digital Single-session Interventions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. Participants will be aware that there are other arms of the study to which other participants are randomized, but they will not be aware of what these other arms entail. Additionally, the measures will be self-administered, so there is no scope for evaluator bias., whoMasked: PARTICIPANT, enrollmentInfo count: 880, type: ESTIMATED, armsInterventionsModule interventions name: Psychoeducation, interventions name: Testimonials and Saying is believing exercises, interventions name: Action planning, interventions name: Breathing exercise, outcomesModule primaryOutcomes measure: Patient Health Questionnaire-8, secondaryOutcomes measure: Patient Health Questionnaire-8, secondaryOutcomes measure: Beck Hopelessness Scale-4, secondaryOutcomes measure: Balanced measure of Psychological Needs scale, otherOutcomes measure: Credibility/Expectancy questionnaire, otherOutcomes measure: Intervention satisfaction star rating at post-intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322836, orgStudyIdInfo id: Protocol ID ABR number 83536, briefTitle: A Feasibility Study for Elective Cardioversion of Atrial Fibrillation at Home, acronym: Electra-1, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: RAV Brabant MWN, class: OTHER, collaborators name: Jeroen Bosch Ziekenhuis, descriptionModule briefSummary: 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., conditionsModule conditions: Emergency Medical Services, conditions: Electric Countershock, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a pilot, non-controlled, non-randomised, single centre study. The Electra-1 pilot study is a prospective intervention feasibility study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Duble current electro cardioversion, outcomesModule primaryOutcomes measure: completion of cardioversion to sinus rhythm, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (Safety endpoint a), secondaryOutcomes measure: Incidence of treatment-emergent adverse events (Safety endpoint b), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RAV Brabant MWN, city: 's-Hertogenbosch, state: Noord Brabant, zip: 5212VM, country: Netherlands, geoPoint lat: 51.69917, lon: 5.30417, hasResults: False
protocolSection identificationModule nctId: NCT06322823, orgStudyIdInfo id: 2010.432, briefTitle: Direct Thawing of Vitrified Human Blastocyst, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2022-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: IVF, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 116, type: ACTUAL, armsInterventionsModule interventions name: direct thawing, interventions name: Vitrification, outcomesModule primaryOutcomes measure: blastocysts survival rate, secondaryOutcomes measure: ferilization rate, secondaryOutcomes measure: pregnancy rate, secondaryOutcomes measure: live birth rate, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: David Yiu Leung Chan, city: Hong Kong, zip: 000000, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
protocolSection identificationModule nctId: NCT06322810, orgStudyIdInfo id: ESP vs. PIFB, briefTitle: ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Taichung Veterans General Hospital, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Erector spinae plane block (ESPB), interventions name: Pecto-intercostal fascial plane blok (PIFB), outcomesModule primaryOutcomes measure: 48hr opioid consumption, secondaryOutcomes measure: Postoperative static pain scores-Day 1, secondaryOutcomes measure: Postoperative static pain scores-Day 2, secondaryOutcomes measure: Postoperative dynamic pain scores-Day 1, secondaryOutcomes measure: Postoperative dynamic pain scores-Day 2, secondaryOutcomes measure: postoperative incentive spirometry volume (ml)-Day 1, secondaryOutcomes measure: postoperative incentive spirometry volume (ml)-Day 2, secondaryOutcomes measure: postoperative incentive spirometry volume (ml)-Day 3, secondaryOutcomes measure: QoL15 (pre-op), secondaryOutcomes measure: QoL15 (POD3), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taichung Veterans General Hospital, city: Taichung, zip: 407, country: Taiwan, contacts name: Yi-Ting Chang, MD, role: CONTACT, phone: (+886)4-23592525, phoneExt: 4101, email: taco@vghtc.gov.tw, contacts name: Yi-Ting Chang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06322797, orgStudyIdInfo id: rTMSinStroke, briefTitle: The Safety&Efficacy of Repetitive Transcranial Magnetic Stimulation for Post-Stroke Upper Extremity Function Improvement, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: MinYoung Kim, MD, PhD, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: rTMS, interventions name: rTMS, interventions name: Sham, outcomesModule primaryOutcomes measure: Change of Fugl-Meyer Assessment, secondaryOutcomes measure: Change of Range of motion, secondaryOutcomes measure: Change of Berg Balance Scale, secondaryOutcomes measure: Change of Motor Assessment Scale, secondaryOutcomes measure: Change of Trunk Imbalance Scale, secondaryOutcomes measure: Change of Functional Ambulation Category, secondaryOutcomes measure: Change of Time up and go, secondaryOutcomes measure: Change of Manual muscle Test, secondaryOutcomes measure: Change of Action reach arm test, secondaryOutcomes measure: Change of Jebsen taylor hand function test, secondaryOutcomes measure: Change of Functional Independence Measure, secondaryOutcomes measure: Change of Modified Barthel index, secondaryOutcomes measure: Change of National Institutes of Health Stroke Scale, secondaryOutcomes measure: Change of Korean Mini Mental State Exam, secondaryOutcomes measure: Change of Clinical Dementia Rating, secondaryOutcomes measure: Change of Global Deterioration Scale, secondaryOutcomes measure: Change of Geriatric Depression Scale, secondaryOutcomes measure: Change of Brain imaging, secondaryOutcomes measure: Change of Electroencephalography, secondaryOutcomes measure: Change of Evoked Potential, secondaryOutcomes measure: Changes in test results of WBC(/uL), RBC(/uL),, Hct(%), PLT(/uL), Hgb(g/dL), secondaryOutcomes measure: Changes in test results of CRP (mg/dL), glucose (mg/dL), BUN (mg/dL), creatinine (mg/dL), total cholesterol (mg/dL), secondaryOutcomes measure: Changes in test results of AST(IU/L), ALT(IU/L), secondaryOutcomes measure: Change of Motricity index, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rehabilitation Medicine, CHA Bundang Medical Center, status: RECRUITING, city: Seongnam, zip: 13496, country: Korea, Republic of, contacts name: MinYoung Kim, MD,PhD, role: CONTACT, phone: 82-31-780-2954, phoneExt: 2954, email: parkmijin@chamc.co.kr, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False
protocolSection identificationModule nctId: NCT06322784, orgStudyIdInfo id: LiJingjing, briefTitle: DF(Oat Bran) Intervention on Inflammation, Intestinal Flora, Disease Activity and Quality of Life in Patients With RA, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2024-02-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shenzhen People's Hospital, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental group=1,Control Group=2,, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Researchers set blinding to reduce implementation bias, whoMasked: INVESTIGATOR, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Oat bran (dietary fiber), outcomesModule primaryOutcomes measure: Disease activity score, primaryOutcomes measure: Quality of life score, secondaryOutcomes measure: Compliance of oat bran, secondaryOutcomes measure: Inflammatory indicators :TNF- α, secondaryOutcomes measure: Inflammatory indicators:IL-6, secondaryOutcomes measure: Inflammatory indicators :IL-10, secondaryOutcomes measure: Inflammatory indicators: ESR, secondaryOutcomes measure: Inflammatory indicators :CRP, secondaryOutcomes measure: gut flora, secondaryOutcomes measure: Adjustment of anti rheumatic drugs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jingjing Li, city: Shenzhen, state: Guangdong, zip: 518000, country: China, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False
protocolSection identificationModule nctId: NCT06322771, orgStudyIdInfo id: APHP240376, briefTitle: 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, acronym: RANSPRE-refus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-11, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Pregnancy Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 830, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaire, interventions name: Questionnaire, outcomesModule primaryOutcomes measure: Factors associated with women's refusal, secondaryOutcomes measure: Number of acceptations, secondaryOutcomes measure: Number of refusals, secondaryOutcomes measure: Demographic characteristics, secondaryOutcomes measure: Questionnaire "acceptance", secondaryOutcomes measure: Questionnaire "refusal", eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Port-Royal Maternity, status: RECRUITING, city: Paris, state: IDF, zip: 75014, country: France, contacts name: Yoann Athiel, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06322758, orgStudyIdInfo id: APHP230851, briefTitle: Driving Pressure-guided Tidal Volume Ventilation in the Acute Respiratory Distress Syndrome, acronym: DRIVENT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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), conditionsModule conditions: Acute Respiratory Distress Syndrome ARDS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: comparing ΔP-guided VT to traditional PBW-guided VT during mechanical ventilation of patients with ARDS., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: Tidal volume customization in the acute respiratory distress syndrome, outcomesModule primaryOutcomes measure: Mortality, primaryOutcomes measure: Number of days free from mechanical ventilation, secondaryOutcomes measure: Ventilator parameters, secondaryOutcomes measure: Arterial blood gases, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Number of days alive without ventilation, secondaryOutcomes measure: Sequential Organ Failure Assessment score (SOFA), secondaryOutcomes measure: Number of days alive without catecholamine, secondaryOutcomes measure: Number of days alive without continuous sedation, secondaryOutcomes measure: Number of days alive without neuromuscular blockers, secondaryOutcomes measure: Number of prone position sessions, secondaryOutcomes measure: Use of rescue procedures: inhaled nitric oxide, almitrine, ECMO, ECCO2R, secondaryOutcomes measure: Occurrence of ventilator-associated pneumothorax, secondaryOutcomes measure: Time to pressure support ventilation;, secondaryOutcomes measure: Duration of weaning unreadiness, secondaryOutcomes measure: Duration of weaning, secondaryOutcomes measure: The rate of tracheostomy, secondaryOutcomes measure: Total duration of mechanical ventilation, secondaryOutcomes measure: Length of stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322745, orgStudyIdInfo id: 1986, briefTitle: Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: To compare the outcome of thulium beam coagulation versus suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy., conditionsModule conditions: Renal Tumor, conditions: Renal Malignant Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized prospective comparative study. Two-arm parallel assignment:First Arm: involves cases of laparoscopic partial nephrectomy done with suture renorrhaphy only for hemostasis of the tumor bed.Second Arm: involves cases of laparoscopic partial nephrectomy using thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Suture renorrhaphy only for hemostasis of the tumor bed in laparoscopic partial nephrectomy, interventions name: Thulium beam coagulation and suture renorrhaphy for hemostasis of the tumor bed in laparoscopic partial nephrectomy, outcomesModule primaryOutcomes measure: Intraoperative Warm Ischemia time (WIT) in minutes (time of renal artery clamping)., primaryOutcomes measure: Suture time and operative time in minutes, primaryOutcomes measure: Intraoperative number of sutures for renorraphy, primaryOutcomes measure: Intraoperative Blood loss, primaryOutcomes measure: Blood transfusion rate, primaryOutcomes measure: Renal function: serum creatinine, primaryOutcomes measure: Renal function: estimated GFR (eGFR), primaryOutcomes measure: Transforming growth factor beta (TGF-β) urine level, primaryOutcomes measure: Monocyte chemoattractant protein (MCP-1) urine level, secondaryOutcomes measure: Hospital stay, secondaryOutcomes measure: Post operative pain, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Urology Department, Al-Azhar University Hospitals, status: RECRUITING, city: Cairo, zip: 11511, country: Egypt, contacts name: Malakah Mohammed, Secretary, role: CONTACT, phone: +20225107222, email: urologydepartment@azhar.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06322732, orgStudyIdInfo id: APHP191125, briefTitle: 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, acronym: OptiNeoCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Perinatal Asphyxia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: sub-optimal perinatal care, secondaryOutcomes measure: Frequency of suboptimal care, secondaryOutcomes measure: Relationship, secondaryOutcomes measure: Outcome, secondaryOutcomes measure: Characteristics of suboptimal care, secondaryOutcomes measure: Determinantes of suboptimal care, secondaryOutcomes measure: Ad-hoc survey, eligibilityModule sex: ALL, maximumAge: 1 Month, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322719, orgStudyIdInfo id: INVIBLADE, briefTitle: Hyperangulated vs Macintosh Blades for Intubation With Videolaryngoscopy in ICU, acronym: INVIBLADE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Hospital Clinico Universitario de Santiago, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Respiratory Failure, conditions: Intubation, conditions: Intubation; Difficult or Failed, conditions: Videolaryngoscopy, conditions: Intubation Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1036, type: ESTIMATED, armsInterventionsModule interventions name: Hyperangulated blade videolaryngoscope, interventions name: Macintosh blade videolaryngoscope, outcomesModule primaryOutcomes measure: Difference in the first attempt intubation success rate (percentage), secondaryOutcomes measure: Difference in the overall success rate, secondaryOutcomes measure: Number of intubation attempts, secondaryOutcomes measure: Modified Cormack-Lehane grade of glottic view, secondaryOutcomes measure: Diference in the incidence of "easy intubation", secondaryOutcomes measure: Duration of tracheal intubation, secondaryOutcomes measure: Reason for unsuccessful intubation on the first attempt, secondaryOutcomes measure: Number of videolaryngoscopy attempts, secondaryOutcomes measure: Number of attempts to cannulate the trachea with a bougie or an endotracheal tube, secondaryOutcomes measure: Operator-assessed difficulty of intubation, secondaryOutcomes measure: Need for additional airway equipment, secondaryOutcomes measure: Need to change the device for intubation, secondaryOutcomes measure: Complications of tracheal intubation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Clinical Hospital of Santiago de Compostela, city: Santiago de Compostela, state: A Coruña, zip: 15866, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Complexo Hospitalario Universitario de A Coruña, city: A Coruña, country: Spain, contacts name: Pablo Rama, role: CONTACT, email: Pablo.rama.maceiras@sergas.es, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital General de Albacete, city: Albacete, country: Spain, contacts name: Luisa María Charco, role: CONTACT, geoPoint lat: 38.99424, lon: -1.85643, locations facility: Hospital de la Santa Creu i Sant Pau, Barcelona, city: Barcelona, country: Spain, contacts name: Marta Giné, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario de Cáceres, city: Cáceres, country: Spain, contacts name: Jose Ignacio Hermoso, role: CONTACT, email: nachomartinez@gmail.com, geoPoint lat: 39.47649, lon: -6.37224, locations facility: Hospital de Denia, city: Denia, country: Spain, contacts name: Marta Carrió, role: CONTACT, geoPoint lat: 38.84078, lon: 0.10574, locations facility: Hospital General Universitario de Eche, city: Elche, country: Spain, contacts name: Ana Pérez, role: CONTACT, geoPoint lat: 38.26218, lon: -0.70107, locations facility: Hospital Universitario de Cabueñes, Gijón, city: Gijón, country: Spain, contacts name: Rosaura María Santamarina, role: CONTACT, geoPoint lat: 43.53573, lon: -5.66152, locations facility: Hospital Virgen de las Nieves, Granada, city: Granada, country: Spain, contacts name: Jose Luis Aguilera, role: CONTACT, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Hospital Universitario de Gran Canaria Doctor Negrín, city: Las Palmas De Gran Canaria, country: Spain, contacts name: Angel Becerra, role: CONTACT, geoPoint lat: 28.09973, lon: -15.41343, locations facility: Complejo Asistencial Universitario de León, city: León, country: Spain, contacts name: Inmaculada Fernández, role: CONTACT, geoPoint lat: 42.60003, lon: -5.57032, locations facility: Hospital Universitario Lucus Augusti, Lugo, city: Lugo, country: Spain, contacts name: María Bermúdez, role: CONTACT, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Hospital Gregorio Marañón, Madrid, city: Madrid, country: Spain, contacts name: Mercedes Power, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario 12 de Octubre, Madrid, city: Madrid, country: Spain, contacts name: Raquel García, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario La Paz, Madrid, city: Madrid, country: Spain, contacts name: Irene Vallejo, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario La Princesa, city: Madrid, country: Spain, contacts name: Fernando Ramasco, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Puerta de Hierro, Majadahonda, city: Majadahonda, country: Spain, contacts name: Sara Del Valle, role: CONTACT, geoPoint lat: 40.47353, lon: -3.87182, locations facility: Hospital Universitario de Móstoles, city: Móstoles, country: Spain, contacts name: Raquel Fernández, role: CONTACT, geoPoint lat: 40.32234, lon: -3.86496, locations facility: Complexo Hospitalario Universitario de Ourense, city: Ourense, country: Spain, contacts name: María Concepción Alonso, role: CONTACT, geoPoint lat: 42.33669, lon: -7.86407, locations facility: Hospital Universitario Central de Asturias (HUCA), Oviedo, city: Oviedo, country: Spain, contacts name: María Cristina Iglesias, role: CONTACT, geoPoint lat: 43.36029, lon: -5.84476, locations facility: Clínica Universidad de Navarra, Pamplona, city: Pamplona, country: Spain, contacts name: Marc Vives, role: CONTACT, geoPoint lat: 42.81687, lon: -1.64323, locations facility: Complexo Hospitalario Universitario de Pontevedra, city: Pontevedra, country: Spain, contacts name: Marina Varela, role: CONTACT, geoPoint lat: 42.431, lon: -8.64435, locations facility: Hospital Universitario Donostia, San Sebastián, city: San Sebastián, country: Spain, contacts name: Anxo Rubín, role: CONTACT, geoPoint lat: 43.31283, lon: -1.97499, locations facility: Hospital Universitario Marqués de Valdecilla, Santander, city: Santander, country: Spain, contacts name: Mónica Williams, role: CONTACT, geoPoint lat: 43.46472, lon: -3.80444, locations facility: Complejo Asistencial de Segovia, city: Segovia, country: Spain, contacts name: Francisco Javier García, role: CONTACT, geoPoint lat: 40.94808, lon: -4.11839, locations facility: Hospital Clínico Universitario de Valencia, city: Valencia, country: Spain, contacts name: Sara Martínez, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Hospital Universitario La Fe de Valencia, city: Valencia, country: Spain, contacts name: Azucena Pajares, role: CONTACT, geoPoint lat: 39.46975, lon: -0.37739, locations facility: Complexo Hospitalario Universitario Álvaro Cunqueiro de Vigo, city: Vigo, country: Spain, contacts name: Inés María Rodríguez Naz, role: CONTACT, email: inesnaz@gmail.com, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital Ribera Povisa Vigo, city: Vigo, country: Spain, contacts name: Rafael Cabadas, role: CONTACT, geoPoint lat: 42.23282, lon: -8.72264, hasResults: False
protocolSection identificationModule nctId: NCT06322706, orgStudyIdInfo id: ABSK021-105, briefTitle: A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Abbisko Therapeutics Co, Ltd, class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ABSK021, interventions name: Omeprazole, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: tmax, primaryOutcomes measure: AUC0-∞, primaryOutcomes measure: AUClast, secondaryOutcomes measure: AE, secondaryOutcomes measure: SAE, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: respiratory rate, secondaryOutcomes measure: ECG QT Interval, secondaryOutcomes measure: t1/2, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vz/F, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322693, orgStudyIdInfo id: 213348, secondaryIdInfos id: 2023-507564-39, type: EUDRACT_NUMBER, briefTitle: A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER), statusModule overallStatus: RECRUITING, startDateStruct date: 2016-07-08, primaryCompletionDateStruct date: 2025-08-29, completionDateStruct date: 2027-02-19, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: This is a multi-center, open-label, first-in-human Phase 1 study., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 475, type: ESTIMATED, armsInterventionsModule interventions name: TSR-022, interventions name: Nivolumab, interventions name: TSR-042, interventions name: TSR-033, interventions name: Docetaxel, interventions name: Pemetrexed, interventions name: Cisplatin, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs), primaryOutcomes measure: Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs), primaryOutcomes measure: Part 1 (f,g,h): Number of participants achieving dose limiting toxicity (DLTs), primaryOutcomes measure: 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), primaryOutcomes measure: 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, primaryOutcomes measure: Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, secondaryOutcomes measure: Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : ORR by Immune related RECIST (irRECIST), secondaryOutcomes measure: Part 2: Duration of response (DOR) by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : DOR by irRECIST, secondaryOutcomes measure: Parts 1 and 2: Disease control rate (DCR) by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : DCR by irRECIST, secondaryOutcomes measure: Part 2: Progression-free survival (PFS) by RECIST v 1.1, secondaryOutcomes measure: Part 2 (A, B, C, D) : PFS by irRECIST, secondaryOutcomes measure: Parts 1 and 2 (A, B, C, D, E, F) : Serum concentration of TSR-022, secondaryOutcomes measure: Part 1d: Serum concentration of TSR-033, secondaryOutcomes measure: Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042, secondaryOutcomes measure: Part 2 (A, B, C, D, F): Serum concentration of TSR-042, secondaryOutcomes measure: Part 2: Overall survival (OS), secondaryOutcomes measure: Part 1a: Minimum plasma concentration (Cmin) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: Cmin of TSR-022 in combination with nivolumab, secondaryOutcomes measure: Part 1c: Cmin of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: Cmin of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Area under the concentration × time curve from time 0 to infinity AUC (0-inf) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: AUC (0-inf) of TSR-022 in combination with nivolumab, secondaryOutcomes measure: Part 1c: AUC (0-inf) of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: AUC (0-inf) of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Area under the concentration time curve from time 0 to last assessment (AUC 0-last) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: AUC (0-last) of TSR-022 in combination with nivolumab, secondaryOutcomes measure: Part 1c: AUC (0-last) of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: AUC (0-last) of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Terminal half life (t 1/2) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: t1/2 of TSR-022 and in combination with nivolumab, secondaryOutcomes measure: Part 1c: t1/2 of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: t1/2 of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1a: Area under the concentration × time curve during the dosing interval (AUCtau) of TSR-022 as monotherapy, secondaryOutcomes measure: Part 1b: AUCtau of TSR-022 and in combination with nivolumab, secondaryOutcomes measure: Part 1c: AUCtau of TSR-022 in combination with TSR-042, secondaryOutcomes measure: Part 1d: AUCtau of TSR-022 in combination with TSR-042 and TSR-033, secondaryOutcomes measure: Part 1: Number of participants with anti-drug antibodies (ADAs) to TSR-022, secondaryOutcomes measure: Part 2 (A, B, C, D, E, F): Number of participants with ADA to anti-TSR-022, secondaryOutcomes measure: Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042, secondaryOutcomes measure: Part 2 (A, B, C, D, F): Number of Participants with ADA to TSR-042, secondaryOutcomes measure: Part 1d: Number of participants with ADA to TSR-033, secondaryOutcomes measure: Part 2F: Number of participants with AEs, SAEs, AEs leading to discontinuation, TEAEs, TEAEs leading to death, secondaryOutcomes measure: Part 2F: Percent change from Baseline in Alpha-fetoprotein (AFP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, status: COMPLETED, city: Goodyear, state: Arizona, zip: 85338, country: United States, geoPoint lat: 33.43532, lon: -112.35821, locations facility: GSK Investigational Site, status: COMPLETED, city: Scottsdale, state: Arizona, zip: 85258, country: United States, geoPoint lat: 33.50921, lon: -111.89903, locations facility: GSK Investigational Site, status: COMPLETED, city: Tucson, state: Arizona, zip: 85704, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: GSK Investigational Site, status: COMPLETED, city: Tucson, state: Arizona, zip: 85711, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: GSK Investigational Site, status: RECRUITING, city: Encinitas, state: California, zip: 92024, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Edward F McClay, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.03699, lon: -117.29198, locations facility: GSK Investigational Site, status: RECRUITING, city: Fountain Valley, state: California, zip: 92708, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Haresh S. Jhangiani, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.70918, lon: -117.95367, locations facility: GSK Investigational Site, status: RECRUITING, city: Los Angeles, state: California, zip: 90024, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Antoni Ribas, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: GSK Investigational Site, status: RECRUITING, city: Los Angeles, state: California, zip: 90025, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Peter D Boasberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: GSK Investigational Site, status: RECRUITING, city: San Marcos, state: California, zip: 92069, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Edward F McClay, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.14337, lon: -117.16614, locations facility: GSK Investigational Site, status: RECRUITING, city: Whittier, state: California, zip: 90606, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Paul La Porte, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.97918, lon: -118.03284, locations facility: GSK Investigational Site, status: RECRUITING, city: Aurora, state: Colorado, zip: 80012, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Allen L. Cohn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: GSK Investigational Site, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Theresa Medina, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: GSK Investigational Site, status: COMPLETED, city: Denver, state: Colorado, zip: 80218, country: United States, geoPoint lat: 39.73915, lon: -104.9847, locations facility: GSK Investigational Site, status: RECRUITING, city: Denver, state: Colorado, zip: 80218, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Gerald Falchook, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, locations facility: GSK Investigational Site, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06511, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Patricia M Lorusso, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, locations facility: GSK Investigational Site, status: RECRUITING, city: Washington, state: District of Columbia, zip: 20007, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Michael Pishvaian, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.89511, lon: -77.03637, locations facility: GSK Investigational Site, status: COMPLETED, city: Jacksonville, state: Florida, zip: 32224, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: GSK Investigational Site, status: COMPLETED, city: Miami Beach, state: Florida, zip: 33140, country: United States, geoPoint lat: 25.79065, lon: -80.13005, locations facility: GSK Investigational Site, status: RECRUITING, city: Sarasota, state: Florida, zip: 34232, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Judy S Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.33643, lon: -82.53065, locations facility: GSK Investigational Site, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Zeynep Eroglu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, locations facility: GSK Investigational Site, status: COMPLETED, city: Atlanta, state: Georgia, zip: 30322, country: United States, geoPoint lat: 33.749, lon: -84.38798, locations facility: GSK Investigational Site, status: COMPLETED, city: Augusta, state: Georgia, zip: 30912, country: United States, geoPoint lat: 33.47097, lon: -81.97484, locations facility: GSK Investigational Site, status: RECRUITING, city: Arlington Heights, state: Illinois, zip: 60005, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Richard S Siegel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.08836, lon: -87.98063, locations facility: GSK Investigational Site, status: RECRUITING, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jason J Luke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, locations facility: GSK Investigational Site, status: RECRUITING, city: Niles, state: Illinois, zip: 60714, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Richard S Siegel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.01892, lon: -87.80284, locations facility: GSK Investigational Site, status: RECRUITING, city: Iowa City, state: Iowa, zip: 52242-1009, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mohammed Milhem, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66113, lon: -91.53017, locations facility: GSK Investigational Site, status: COMPLETED, city: Wichita, state: Kansas, zip: 67214, country: United States, geoPoint lat: 37.69224, lon: -97.33754, locations facility: GSK Investigational Site, status: COMPLETED, city: Louisville, state: Kentucky, zip: 40202, country: United States, geoPoint lat: 38.25424, lon: -85.75941, locations facility: GSK Investigational Site, status: RECRUITING, city: Pikeville, state: Kentucky, zip: 41501, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Christopher C. Croot, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.47927, lon: -82.51876, locations facility: GSK Investigational Site, status: RECRUITING, city: Rockville, state: Maryland, zip: 20850, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: John M Wallmark, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.084, lon: -77.15276, locations facility: GSK Investigational Site, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02114, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Keith Flaherty, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: GSK Investigational Site, status: COMPLETED, city: Detroit, state: Michigan, zip: 48202, country: United States, geoPoint lat: 42.33143, lon: -83.04575, locations facility: GSK Investigational Site, status: COMPLETED, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: GSK Investigational Site, status: COMPLETED, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, locations facility: GSK Investigational Site, status: RECRUITING, city: Bronx, state: New York, zip: 10461, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sanjay Goel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.84985, lon: -73.86641, locations facility: GSK Investigational Site, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Janice Mehnert, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: GSK Investigational Site, status: COMPLETED, city: Cincinnati, state: Ohio, zip: 45242, country: United States, geoPoint lat: 39.12713, lon: -84.51435, locations facility: GSK Investigational Site, status: RECRUITING, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: David Bajor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: GSK Investigational Site, status: RECRUITING, city: Toledo, state: Ohio, zip: 43623, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Rex B Mowat, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.66394, lon: -83.55521, locations facility: GSK Investigational Site, status: RECRUITING, city: Eugene, state: Oregon, zip: 97401, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joseph Fiorillo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.05207, lon: -123.08675, locations facility: GSK Investigational Site, status: COMPLETED, city: Portland, state: Oregon, zip: 97213-2982, country: United States, geoPoint lat: 45.52345, lon: -122.67621, locations facility: GSK Investigational Site, status: COMPLETED, city: Bethlehem, state: Pennsylvania, zip: 18015, country: United States, geoPoint lat: 40.62593, lon: -75.37046, locations facility: GSK Investigational Site, status: RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15213-2584, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Diwakar Davar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: GSK Investigational Site, status: RECRUITING, city: Charleston, state: South Carolina, zip: 29425, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Theodore G Gourdin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.77657, lon: -79.93092, locations facility: GSK Investigational Site, status: COMPLETED, city: Greenville, state: South Carolina, zip: 29605, country: United States, geoPoint lat: 34.85262, lon: -82.39401, locations facility: GSK Investigational Site, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jeffrey Roger Infante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: GSK Investigational Site, status: COMPLETED, city: Austin, state: Texas, zip: 78705, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: GSK Investigational Site, status: RECRUITING, city: Dallas, state: Texas, zip: 75246, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Charles L Cowey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: GSK Investigational Site, status: COMPLETED, city: Fort Worth, state: Texas, zip: 76104, country: United States, geoPoint lat: 32.72541, lon: -97.32085, locations facility: GSK Investigational Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Julio Peguero, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: GSK Investigational Site, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Timothy Yap, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: GSK Investigational Site, status: RECRUITING, city: Longview, state: Texas, zip: 75601, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Donald Richards, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.5007, lon: -94.74049, locations facility: GSK Investigational Site, status: RECRUITING, city: McAllen, state: Texas, zip: 78503-1298, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Habib M. H. Ghaddar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.20341, lon: -98.23001, locations facility: GSK Investigational Site, status: COMPLETED, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: GSK Investigational Site, status: COMPLETED, city: Temple, state: Texas, zip: 76508, country: United States, geoPoint lat: 31.09823, lon: -97.34278, locations facility: GSK Investigational Site, status: RECRUITING, city: Tyler, state: Texas, zip: 75702, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Donald Richards, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.35126, lon: -95.30106, locations facility: GSK Investigational Site, status: RECRUITING, city: Weslaco, state: Texas, zip: 78596, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Habib M. H. Ghaddar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.15952, lon: -97.99084, locations facility: GSK Investigational Site, status: RECRUITING, city: Fairfax, state: Virginia, zip: 8613, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Alexander I. Spira, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.84622, lon: -77.30637, locations facility: GSK Investigational Site, status: RECRUITING, city: Kennewick, state: Washington, zip: 99336, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Ying Zhuo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.21125, lon: -119.13723, locations facility: GSK Investigational Site, status: RECRUITING, city: Puyallup, state: Washington, zip: 98373, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Andrea Veatch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.18538, lon: -122.2929, locations facility: GSK Investigational Site, status: RECRUITING, city: Tacoma, state: Washington, zip: 98405, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Andrea Veatch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.25288, lon: -122.44429, locations facility: GSK Investigational Site, status: COMPLETED, city: Madison, state: Wisconsin, zip: 53792, country: United States, geoPoint lat: 43.07305, lon: -89.40123, locations facility: GSK Investigational Site, status: RECRUITING, city: Daegu, zip: 41931, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Sun Hyo Park, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.87028, lon: 128.59111, locations facility: GSK Investigational Site, status: RECRUITING, city: Seongnam-si, Gyeonggi-do, zip: 13620, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Yu Jung kim, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, status: RECRUITING, city: Seoul, zip: 02841, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Yoon Ji Choi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Hye Ryun Kim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Myung-Ju Ahn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, status: RECRUITING, city: Seoul, zip: 7061, country: Korea, Republic of, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jin-Soo Kim, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: GSK Investigational Site, status: RECRUITING, city: Palma de Mallorca, state: Islas Baleares, zip: 07120, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Aitor Azkárate Martínez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.56939, lon: 2.65024, locations facility: GSK Investigational Site, status: RECRUITING, city: Madrid, state: Navarra, zip: 28027, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Eduardo Castanon Alvarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: GSK Investigational Site, status: RECRUITING, city: Barcelona, zip: 08017, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Santiago Viteri Ramírez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: GSK Investigational Site, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Enriqueta Felip, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: GSK Investigational Site, status: RECRUITING, city: Barcelona, zip: 8028, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Andrés Aguilar Hernández, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: GSK Investigational Site, status: RECRUITING, city: Girona, zip: 17007, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Joaquim Bosch Barrera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.98311, lon: 2.82493, locations facility: GSK Investigational Site, status: RECRUITING, city: Jerez de la Frontera, zip: 11407, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jesús Corral Jaime, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.68645, lon: -6.13606, locations facility: GSK Investigational Site, status: RECRUITING, city: L'Hospitalet De Llobregat, zip: 08908, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: María Jové Casulleras, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.35967, lon: 2.10028, locations facility: GSK Investigational Site, status: RECRUITING, city: Las Palmas De Gran Canaria, zip: 35016, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Delvys Rodriguez Abreu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.09973, lon: -15.41343, locations facility: GSK Investigational Site, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Victor Moreno Garcia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: GSK Investigational Site, status: RECRUITING, city: Madrid, zip: 28041, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Luis Paz Ares, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: GSK Investigational Site, status: RECRUITING, city: Madrid, zip: 28046, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Javier De Castro Carpeno, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, locations facility: GSK Investigational Site, status: RECRUITING, city: Majadahonda (Madrid), zip: 28222, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Mariano Provencio Pulla, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, status: RECRUITING, city: Málaga, zip: 29010, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Jose Manuel Trigo Pérez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.72016, lon: -4.42034, locations facility: GSK Investigational Site, status: COMPLETED, city: Pamplona, zip: 31008, country: Spain, geoPoint lat: 42.81687, lon: -1.64323, locations facility: GSK Investigational Site, status: RECRUITING, city: Santander, zip: 39008, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Marta López-Brea Piqueras, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46472, lon: -3.80444, locations facility: GSK Investigational Site, status: RECRUITING, city: Sevilla, zip: 41013, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Amparo Sánchez Gastaldo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.38283, lon: -5.97317, locations facility: GSK Investigational Site, status: RECRUITING, city: Valencia, zip: 46010, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Desamparados Roda Pérez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, locations facility: GSK Investigational Site, status: RECRUITING, city: Valencia, zip: 46026, country: Spain, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Oscar Juan Vidal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
protocolSection identificationModule nctId: NCT06322680, orgStudyIdInfo id: ZSPAC-03, briefTitle: Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Huadong Hospital, collaborators name: RenJi Hospital, collaborators name: The First People's Hospital of Yunnan, collaborators name: First Affiliated Hospital Xi'an Jiaotong University, collaborators name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, descriptionModule briefSummary: 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., conditionsModule conditions: Pancreaticoduodenectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, Multicenter, Controlled, Superiority Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 322, type: ESTIMATED, armsInterventionsModule interventions name: Main pancreatic duct and biliary duct external drainage, interventions name: Main pancreatic duct and biliary duct internal drainage, outcomesModule primaryOutcomes measure: The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery, secondaryOutcomes measure: Surgical Complications: Incidence and grading of complications within 90 days after surgery, secondaryOutcomes measure: Surgical Complications: Clavien-Dindo classification, secondaryOutcomes measure: Surgical Complications: Mortality rate, secondaryOutcomes measure: Surgical Complications: reoperation rate, secondaryOutcomes measure: Surgical Complications: readmission rate, secondaryOutcomes measure: Surgical Complications: rate of digital subtraction angiography for postoperative pancreatic hemorrhage, secondaryOutcomes measure: Surgical Complications: Total cost of perioperative treatment, secondaryOutcomes measure: Surgical Complications: Length of hospital stay, secondaryOutcomes measure: Adjuvant treatment: Proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery, secondaryOutcomes measure: Adjuvant treatment: Interval between the start of adjuvant treatment and surgery, secondaryOutcomes measure: Long-term survival related to malignant tumors: Overall survival (OS), secondaryOutcomes measure: Long-term survival related to malignant tumors: Disease-free survival (DFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, city: Shanghai, state: Shanghai, zip: 200000, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06322667, orgStudyIdInfo id: BAN2401-J081-401, briefTitle: A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-22, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Eisai Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Alzheimer's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention, outcomesModule primaryOutcomes measure: 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), primaryOutcomes measure: Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA, secondaryOutcomes measure: Number of Participants With Infusion Related Reaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eisai trial site 2, status: RECRUITING, city: Hiroshima, country: Japan, geoPoint lat: 34.4, lon: 132.45, locations facility: Eisai trial site 3, status: RECRUITING, city: Kyoto, country: Japan, geoPoint lat: 35.02107, lon: 135.75385, locations facility: Eisai trial site 1, status: RECRUITING, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False
protocolSection identificationModule nctId: NCT06322654, orgStudyIdInfo id: 2023/ABM/01/00004/P/02, briefTitle: A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients, acronym: SMArt, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Wiktor Dega University Orthopedic and Rehabilitation Hospital, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: SMA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: There are two research groups with 100 patients in each group.1. Experimental: Robotically Assisted Locomotion2. Comparison: Robotically Assisted Verticalization, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Patients and their parents will not be blinded by the nature of the therapeutic procedure used after random allocation to the treatment group. Study personnel will be divided into Blinded Team and Unblinded Team to ensure objectivity of the assessment of safety and effectiveness of both strategies., whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Robotically Assisted Locomotion, interventions name: Robotically Assisted Verticalization, outcomesModule primaryOutcomes measure: Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale, primaryOutcomes measure: 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., primaryOutcomes measure: Functional assessment of patients using GMFM (Gross Motor Function Measure) scale, primaryOutcomes measure: X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density, primaryOutcomes measure: Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0, secondaryOutcomes measure: Hospitalization during or between rehabilitations that take place each 6 months, secondaryOutcomes measure: Occurence of discomfort during therapy requiring abrupt interruption or significant modification, secondaryOutcomes measure: Number of fractures, eligibilityModule sex: ALL, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Wiktor Dega University Orthopedic and Rehabilitation Hospital, status: RECRUITING, city: Poznań, zip: 61-545, country: Poland, contacts name: Marek Jóźwiak, role: CONTACT, phone: 696052475, phoneExt: +48, email: sma@orsk.pl, contacts name: Radosław Rutkowski, role: CONTACT, phone: 696052475, email: sma@orsk.pl, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False
protocolSection identificationModule nctId: NCT06322641, orgStudyIdInfo id: DAS-8092, secondaryIdInfos id: U1111-1303-3089, type: OTHER, domain: World Health Organization (WHO), briefTitle: 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, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-04-26, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: 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), conditionsModule conditions: Atherosclerotic Cardiovascular Disease (ASCVD), conditions: Chronic Kidney Disease (CKD), conditions: Systemic Inflammation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: No treatment given, outcomesModule primaryOutcomes measure: Nephrologists' perceptions towards the role of systemic inflammation in the identification, treatment and management of patients with ASCVD and CKD, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KJT Group, Inc., city: Rochester, state: New York, zip: 14623, country: United States, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False
protocolSection identificationModule nctId: NCT06322628, orgStudyIdInfo id: VSA006-2001, briefTitle: A Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of VSA006 in Chinese NASH Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Visirna Therapeutics HK Limited, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Nash, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: VSA006, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving ≥ 1 Stage Improvement in Histological Fibrosis with no Worsening of NASH, primaryOutcomes measure: Percentage of Participants Achieving NASH Improvement with no Worsening of Fibrosis, secondaryOutcomes measure: Compared with placebo, the percentage change in serum alanine aminotransferase (ALT), secondaryOutcomes measure: Compared with placebo, the change in liver fat fraction from baseline and liver fat percentage change from baseline, secondaryOutcomes measure: Compared with placebo, the percentage of participants with a > 30% decrease in liver fat fraction from baseline, secondaryOutcomes measure: 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), secondaryOutcomes measure: Percentage of Participants Achieving NASH Resolution with no Worsening of Fibrosis, secondaryOutcomes measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and their correlation with VSA006, secondaryOutcomes measure: Maximum observed concentration (Cmax) of VSA006, secondaryOutcomes measure: Time of maximum concentration of VSA006 (Tmax), secondaryOutcomes measure: Area under the concentration-time curve from time zero (pre-dose) to the last quantifiable concentration (AUC0-t) of VSA006, secondaryOutcomes measure: anti-drug antibodies (ADAs) of VSA006, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06322615, orgStudyIdInfo id: MC221001, secondaryIdInfos id: NCI-2024-00538, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-004067, type: OTHER, domain: Mayo Clinic Institutional Review Board, secondaryIdInfos id: MC221001, type: OTHER, domain: Mayo Clinic in Rochester, briefTitle: Acupressure for Reducing Anxiety in Patients Undergoing Chemotherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Hematopoietic and Lymphatic System Neoplasm, conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Acupressure Therapy, interventions name: Educational Intervention, interventions name: Electronic Health Record Review, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Number of patients approached about undergoing acupressure intervention (Feasibility), primaryOutcomes measure: Number of patients interested in the initial acupressure intervention in the chemotherapy unit (Feasibility), primaryOutcomes measure: Number of patients interested in the home acupressure intervention (Feasibility), primaryOutcomes measure: Time taken for each nurse-led acupressure intervention in the chemotherapy unit (Feasibility), primaryOutcomes measure: Patient-reported changes in acute anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Laura S. Rhee, D.O., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06322602, orgStudyIdInfo id: 23-009112, secondaryIdInfos id: NCI-2024-01762, type: REGISTRY, domain: CTRP (Clinical Trials Reporting Program), briefTitle: Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Brain Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Intracranial Catheter Placement, interventions name: Lumbar Puncture, interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, outcomesModule primaryOutcomes measure: Feasibility of Ommaya reservoir placement, secondaryOutcomes measure: Utility of Ommaya reservoir, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Terry C. Burns, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06322589, orgStudyIdInfo id: CMUH112-REC3-175, briefTitle: Evaluation of Human Efficacy of SOD Like Super Drink, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: TCI Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human, conditionsModule conditions: Dermatology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: SOD like Super Drink, interventions name: placebo drink, outcomesModule primaryOutcomes measure: the volume of skin wrinkles, primaryOutcomes measure: the roughness of skin texture, primaryOutcomes measure: the change of skin elasticity, primaryOutcomes measure: the change of Total Anti-oxidative Capacity (TAC) of blood, primaryOutcomes measure: the change of Superoxide Dismutase (SOD) of blood, primaryOutcomes measure: the change of Glutathione S-transferase (GST) of blood, primaryOutcomes measure: the change of Glutathione (GSH) of blood, primaryOutcomes measure: the change of Malondialdehyde (MDA) of blood, primaryOutcomes measure: the change of immune-related cytokines of blood, secondaryOutcomes measure: the change of skin surface hydration, secondaryOutcomes measure: the change of skin Transepidermal Water Loss (TEWL), secondaryOutcomes measure: the change of Skin Melanin Index, secondaryOutcomes measure: the change of Skin Erythema Index, otherOutcomes measure: The change of liver function biomarkers (AST, ALT) of blood, otherOutcomes measure: The change of renal function biomarkers (creatinine, BUN) of blood, otherOutcomes measure: The change of self-assessment skin condition and immuno condition, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: China Medical University of department of cosmeceutics, status: RECRUITING, city: Taichung City, zip: 406040, country: Taiwan, contacts name: Hsiu-Mei Chiang, Ph.D., role: CONTACT, phone: +886-04-22053366, phoneExt: 5302, email: hmchiang@mail.cmu.edu.tw, contacts name: Ping Lin, role: CONTACT, phone: +886-02-879778111, email: candice.lin@tci-bio.com, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06322576, orgStudyIdInfo id: IRB00347750, briefTitle: 177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2030-12, completionDateStruct date: 2035-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, class: OTHER, collaborators name: Adenoid Cystic Carcinoma Research Foundation, collaborators name: Progenics Pharmaceuticals, Inc., descriptionModule briefSummary: 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., conditionsModule conditions: Adenoid Cystic Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Cohort 1of this study involves only Dosimetry for (10 patients).(Cohort 2 may be added based on dosimetry analysis of Cohort 1. Planned Treatment for would be for 20 patients, single arm)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: 177Lu-PNT2002, outcomesModule primaryOutcomes measure: Absorbed dose in tumor and normal organs, primaryOutcomes measure: Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC., secondaryOutcomes measure: Stability of Disease: Proportion of patients with Stable Disease, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Xerostomia questionnaire (XQ) score, secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Module (EORTC QLQ-HN43), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
protocolSection identificationModule nctId: NCT06322563, orgStudyIdInfo id: LTC004-202, briefTitle: Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Advanced/Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: LTC004+regorafenib, outcomesModule primaryOutcomes measure: Treatment-Emergent Adverse Events-Safety and Tolerability, primaryOutcomes measure: SAE-Safety and Tolerability, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute and Hospital, city: Tianjin, state: Tianjin, zip: 300060, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
protocolSection identificationModule nctId: NCT06322550, orgStudyIdInfo id: beingapatient, briefTitle: Influence of Role-expectancy on Patient Reported Outcomes Among Patients With Migraine: a Randomized Clinical Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-10-29, primaryCompletionDateStruct date: 2023-02-01, completionDateStruct date: 2023-02-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Role-expectancy on Patient Reported Outcomes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Monocenter, randomized, double blind, three-armed clinical trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Double blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 366, type: ACTUAL, armsInterventionsModule interventions name: cover story, outcomesModule primaryOutcomes measure: self-reported vestibular symptoms, secondaryOutcomes measure: differences in motion sickness susceptibility using a standardized motion sickness questionnaire, secondaryOutcomes measure: differences in disability level using a standardized motion sickness questionnaire, secondaryOutcomes measure: differences in headache days per month, secondaryOutcomes measure: differences in headache burden and migraine disability questionnaires, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: UKE, city: Hamburg, zip: 20246, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
protocolSection identificationModule nctId: NCT06322537, orgStudyIdInfo id: 23-5339, briefTitle: Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective, acronym: AlbACS-1R, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Queen's University, collaborators name: Unity Health Toronto, collaborators name: McMaster University, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: London Health Sciences Centre, collaborators name: The Ottawa Hospital, collaborators name: Vancouver General Hospital, collaborators name: Royal Columbian Hospital, collaborators name: Nova Scotia Health Authority, descriptionModule briefSummary: 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., conditionsModule conditions: Cardiovascular Surgical Procedures, conditions: Albumin, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Albumin, primaryOutcomes measure: Crystalloid, volume dose and type administered, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Royal Columbian Hospital, city: New Westminster, state: British Columbia, zip: V3L 3W7, country: Canada, contacts name: Michael Law, MD FRCPC, role: CONTACT, contacts name: Ramanjot Kaur, MSc, role: CONTACT, geoPoint lat: 49.20678, lon: -122.91092, locations facility: Vancouver General Hospital, city: Vancouver,, state: British Columbia, zip: V5Z 1M9, country: Canada, contacts name: Darren Mullane, MB BCh BAO FRCPC FCAI FJFICM, role: CONTACT, geoPoint lat: 49.24966, lon: -123.11934, locations facility: Nova Scotia Health Authority, city: Halifax, state: Nova Scotia, zip: B3H 3A6, country: Canada, contacts name: Pieter de Jager, role: CONTACT, geoPoint lat: 44.64533, lon: -63.57239, locations facility: McMaster University Medical Centre, city: Hamilton, state: Ontario, country: Canada, contacts name: Michelle Zeller, MD FRCPC, role: CONTACT, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Kingston Health Sciences Centre, city: Kingston, state: Ontario, zip: K7L 3N6, country: Canada, contacts name: Jeannie Callum, MD BA FRCPC, role: CONTACT, geoPoint lat: 44.22976, lon: -76.48101, locations facility: London Health Science Centre, city: London, state: Ontario, zip: N6A 5A5, country: Canada, contacts name: Christopher Harle, MD, role: CONTACT, contacts name: Ziad Solh, MD MSc FRCPC, role: CONTACT, geoPoint lat: 42.98339, lon: -81.23304, locations facility: University of Ottawa Heart Institute, city: Ottawa, state: Ontario, zip: K1Y 4W7, country: Canada, contacts name: Diem Tran, role: CONTACT, contacts name: Bernard McDonald, role: CONTACT, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Sunnybrook Health Sciences Centre, city: Toronto, state: Ontario, zip: M4N 3M5, country: Canada, contacts name: Yulia Lin, MD FRCPC, role: CONTACT, geoPoint lat: 43.70011, lon: -79.4163, locations facility: St. Michael's Hospital, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: Katerina Pavenski, MD, role: CONTACT, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Toronto General Hospital - University Health Network, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
protocolSection identificationModule nctId: NCT06322524, orgStudyIdInfo id: FirstShanxiMU_jsk, briefTitle: Study on Gamma Sensory Flicker for Insomnia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2022-03-30, completionDateStruct date: 2022-12-30, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital of Shanxi Medical University, class: OTHER, collaborators name: Shanxi Medical University, descriptionModule briefSummary: 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., conditionsModule conditions: Sleep Quality, conditions: Sleep Duration, conditions: Sleep Onset Latency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 37, type: ACTUAL, armsInterventionsModule interventions name: Gamma sensory flicker, outcomesModule primaryOutcomes measure: Treatment adherence rate, primaryOutcomes measure: Patient treatment adherence rate, primaryOutcomes measure: Incidence rate of adverse reaction, primaryOutcomes measure: Differences in sleep duration between the first and eighth weeks, primaryOutcomes measure: Differences in sleep onset latencies between the first and eighth weeks, primaryOutcomes measure: Differences in awakening times between the first and eighth weeks, secondaryOutcomes measure: pre-sleep efficiency., secondaryOutcomes measure: post-sleep efficiency., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yong Xu, city: Taiyuan, state: Shanxi, zip: 030000, country: China, geoPoint lat: 37.86944, lon: 112.56028, hasResults: False
protocolSection identificationModule nctId: NCT06322511, orgStudyIdInfo id: HUS/7626/2023, briefTitle: Dialogical Family Guidance PostDoc Study, acronym: DFG II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Tampere University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Family Dynamics, conditions: Family Relations, conditions: Family Support, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Families attending the study Group I: receives Dialogical Family Guidance intervention and they fill questionnaires before and after the intervention.Group II: Families do not receive Dialogical Family Guidance (but belong to the same focus group), primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Families include both parents and children. Parents fill the questionnaires, but all family members attend on the meetings during the intervention (six meetings)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dialogical Family Guidance (DFG), outcomesModule primaryOutcomes measure: FAFHES, secondaryOutcomes measure: DFG-questionnaire, secondaryOutcomes measure: SDQ-p questionnaire (Strengths and difficulties regarding the child), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Helsinki university hospital, status: RECRUITING, city: Helsinki, zip: 00029, country: Finland, geoPoint lat: 60.16952, lon: 24.93545, hasResults: False
protocolSection identificationModule nctId: NCT06322498, orgStudyIdInfo id: INFLAM.UTERUS-HMO-CTIL, briefTitle: Inflammation Markers in Fluid Aspirate From a Scarred Uterine vs. a Normal Uterine Cavity, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-18, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Hadassah Medical Organization, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Infertility Due to Nonimplantation, conditions: Infertility Secondary, conditions: Cesarean Section Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Uterine lavage, outcomesModule primaryOutcomes measure: Inflammatory cell population, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hadassah Medical Organization, status: RECRUITING, city: Jerusalem, country: Israel, contacts name: Hadas Lemberg, PhD, role: CONTACT, phone: 00 972 2 6777572, email: lhadas@hadassah.org.il, contacts name: Chana Adler Lazarovits, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False
protocolSection identificationModule nctId: NCT06322485, orgStudyIdInfo id: P16.230, briefTitle: Online Self-management in Fibromyalgia, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-25, primaryCompletionDateStruct date: 2021-01-26, completionDateStruct date: 2021-01-26, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Leiden University, class: OTHER, collaborators name: Fibrocentrum, descriptionModule briefSummary: 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., conditionsModule conditions: Fibromyalgia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinding of participants and practitioners is not possible due to the nature of the study. However, the statistician who creates the randomization schedule and performs statistical analyses is blinded to group allocation., enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Internet-based self-management intervention, outcomesModule primaryOutcomes measure: Change in pain coping, secondaryOutcomes measure: Change in well-being, secondaryOutcomes measure: Change in illness cognitions, secondaryOutcomes measure: Change in pain coping strategies, secondaryOutcomes measure: Change in Illness Perceptions, secondaryOutcomes measure: Change in pain, secondaryOutcomes measure: Change in pain interference in daily functioning and pain severity, and as exploratory measures support, life control, and affective distress, secondaryOutcomes measure: Change in health-related quality of life, secondaryOutcomes measure: Change in fibromyalgia impact, secondaryOutcomes measure: Change in health-related quality of life, otherOutcomes measure: Economic evaluation: Five-Level Version of the EQ-5D (EQ-5D-5L), otherOutcomes measure: Economic evaluation: iMTA Medical Consumption Questionnaire (iMCQ), otherOutcomes measure: Economic evaluation: iMTA Productivity Cost Questionnaire (iPCQ), otherOutcomes measure: Patient satisfaction, otherOutcomes measure: Expected/perceived patient-provider interaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fibrocentrum, city: Leiden, state: Zuid-Holland, zip: 2321 GL, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, documentSection largeDocumentModule largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2022-07-25, uploadDate: 2023-11-27T05:27, filename: SAP_000.pdf, size: 109827, hasResults: False
protocolSection identificationModule nctId: NCT06322472, orgStudyIdInfo id: 138956, briefTitle: The Relationship Between Phonological Awareness Skills And Home Environment Literacy in Cochlear Implant Users, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-10, primaryCompletionDateStruct date: 2021-05-24, completionDateStruct date: 2022-02-12, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Uskudar University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Cochlear Implants, conditions: Child Language, conditions: Literacy, conditions: Phonological (Speech) Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Descriptive research, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: The Turkish Early Language Development Test (TEDIL), interventions name: The Family Literacy Scale, interventions name: The Early Childhood Phonological Sensitivity Scale (PASECP), interventions name: The Early Literacy Home Environment Scale (ELHES), interventions name: Demographic Questionaries, outcomesModule primaryOutcomes measure: The data the Early Childhood Phonological Sensitivity Scale (PASECP) from children with cochlear implants, primaryOutcomes measure: The data Family Literacy Scale from parents, primaryOutcomes measure: The data Early Literacy Home Environment Scale (ELVES) from parents, eligibilityModule sex: ALL, minimumAge: 5 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Uskudar University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06322459, orgStudyIdInfo id: Junlong Zhang, briefTitle: Effect of Sport Education on Physical Fitness and Learning Attitude Among Junior High School Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-06-29, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Universiti Putra Malaysia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Physical Fitness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Employing a Cluster randomized controlled experiment design, the experimental and control groups were randomly assigned to two different schools. Students participated in the Sport Education Model (experimental group) and traditional teaching (control group)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Sport Education Curriculum, interventions name: Normal teaching, outcomesModule primaryOutcomes measure: Cardiovascular fitness test, primaryOutcomes measure: Flexibility test, primaryOutcomes measure: Speed test, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: The 19th Middle School, status: RECRUITING, city: Qinhuangdao, state: Hebei, zip: 066000, country: China, contacts name: Junlong Zhang, PHD, role: CONTACT, phone: 0397698153, email: zhangjunlong2413@gmail.com, contacts name: Gege Yao, Master, role: CONTACT, contacts name: Junlong Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.93167, lon: 119.58833, hasResults: False

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