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protocolSection identificationModule nctId: NCT06331559, orgStudyIdInfo id: SIM0501-101, briefTitle: Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Jiangsu Simcere Pharmaceutical Co., Ltd., class: INDUSTRY, collaborators name: Shanghai Xianxiang Medical Technology Co., Ltd., descriptionModule briefSummary: This is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: SIM0501 Tablets, interventions name: SIM0501 Tablets, interventions name: SIM0501 in combination with olaparib, interventions name: SIM0501 in combination with olaparib, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: Adverse events will be evaluated according to the CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shandong Cancer Hospital, status: RECRUITING, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Jinming Yu, role: CONTACT, phone: 0531-67626971, email: sdyujinming@126.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06331546, orgStudyIdInfo id: IRB300004693, secondaryIdInfos id: R01DK137784, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK137784, briefTitle: Gut Oxalate Absorption in Calcium Oxalate Stone Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2031-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: University of Texas Southwestern Medical Center, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The goal of this clinical trial study is to test if patients with idiopathic calcium oxalate kidney stones have an increased absorption of dietary oxalate, which would lead to increased urinary excretion of oxalate.The study will recruit adult patients with a history of calcium oxalate kidney stones and healthy volunteers without kidney stones.Participants will* ingest fixed diets containing low and moderately high amounts of oxalate for 5 days at a time* ingest a soluble form of oxalate and sugar preparations to test gut permeability* collect urine, blood, stool and breath sample during the fixed diets and the soluble oxalate test, conditionsModule conditions: Kidney Stone, conditions: Kidney Calculi, conditions: Urolithiasis, conditions: Urolithiasis, Calcium Oxalate, conditions: Nephrolithiasis, conditions: Nephrolithiasis, Calcium Oxalate, conditions: Oxalate Urolithiasis, conditions: Oxaluria, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Low-oxalate diet, interventions name: High-oxalate diet, interventions name: soluble oxalate gut absorption test, outcomesModule primaryOutcomes measure: Net Gastrointestinal absorption of food-bound oxalate, secondaryOutcomes measure: Absorption of soluble 13C2-oxalate, secondaryOutcomes measure: Estimated endogenous oxalate synthesis (oxalate mg/day), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama at Birmingham, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Sonia Fargue, PhD, role: CONTACT, phone: 205-975-6932, email: kidneystone@uabmc.edu, contacts name: Research Coordinator, role: CONTACT, phone: 205-9345712, email: kidneystone@uabmc.edu, contacts name: Sonia Fargue, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: UTSW, status: ACTIVE_NOT_RECRUITING, city: Dallas, state: Texas, zip: 75390, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06331533, orgStudyIdInfo id: IstanbulTRH1, briefTitle: Intradermal BoNT-A Treatment in Erythematotelangiectatic Rosacea, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-06-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Istanbul Training and Research Hospital, class: OTHER_GOV, descriptionModule briefSummary: Investigation of the effectiveness of intradermal botulinum toxin A treatment in the treatment of erythematotelangiectatic rosacea (ETR) using clinical, biophysical, dermatoscopic and videocapillaroscopy., conditionsModule conditions: Erythematotelangiectatic Rosacea, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Randomized, split face, efficacy study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Botulinum toxin will be injected into one randomly selected half of the face, and placebo will be injected into the other half of the face. The patient will not know which half of the face was treated. An independent, blinded dermatologist will evaluate the results of the treatment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Botulinum toxin A, interventions name: Placebo, outcomesModule primaryOutcomes measure: Assessment of erythema with Clinician's Erythema Assessment scale, primaryOutcomes measure: Evaluation of erythema using mexameter, primaryOutcomes measure: Evaluation of erythema by dermatoscopy, secondaryOutcomes measure: Evaluation of the change in vascular structure using videocapillaroscopy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Training and Research Hospital, city: Istanbul, zip: 34098, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06331520, orgStudyIdInfo id: Desineo, briefTitle: NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy., conditionsModule conditions: Chemotherapy-induced Nausea and Vomiting, conditions: Highly Emetogenic Chemotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 627, type: ESTIMATED, armsInterventionsModule interventions name: Netupitant / Palonosetron Oral Capsule [Akynzeo], interventions name: Olanzapine, interventions name: Dexamethasone Oral, outcomesModule primaryOutcomes measure: Percentage of patients with complete response (CR), secondaryOutcomes measure: Percentage of Patients With CR (acute and delayed), secondaryOutcomes measure: Percentage of patients with overall complete protection(OCP), secondaryOutcomes measure: Percentage of patients with overall total control (OTC), secondaryOutcomes measure: incidence of adverse events, secondaryOutcomes measure: quality of life questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331507, orgStudyIdInfo id: HUM00176904, briefTitle: Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips CMR Patch, statusModule overallStatus: TERMINATED, startDateStruct date: 2021-09-02, primaryCompletionDateStruct date: 2023-06-29, completionDateStruct date: 2023-06-29, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Philips Health Care, descriptionModule briefSummary: This study is being done to improve image quality and provide the collaborator with feedback on wide band imaging in patients with cardiac implantable electronic devices (CIED)., conditionsModule conditions: Cardiomyopathies, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 292, type: ACTUAL, armsInterventionsModule interventions name: CMR patch, outcomesModule primaryOutcomes measure: Scan speed:, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Michigan Medicine - University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06331494, orgStudyIdInfo id: SICAS, briefTitle: Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery, acronym: SICAS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis., conditionsModule conditions: Ischemic Stroke, Acute, conditions: Intracranial Atherosclerosis, 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: 140, type: ESTIMATED, armsInterventionsModule interventions name: Butylphthalide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Changes in stenosis degree in the responsible artery, secondaryOutcomes measure: Stroke recurrence, secondaryOutcomes measure: Change in plaque volumes the responsible artery, secondaryOutcomes measure: Changes in hemorrhage and enhancement volumes of atherosclerotic plaque in the responsible artery, secondaryOutcomes measure: Changes in National Institutes of Health Stroke Scale (NIHSS), secondaryOutcomes measure: Proportion of patients with modified Rankin Scale score (mRS) 0-2, secondaryOutcomes measure: Change in the value of cerebral blood flow (CBF) in the responsible artery territory, secondaryOutcomes measure: Change in concentrations of serum lipid profiles, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Jinsheng Zeng, role: CONTACT, phone: +8613322800657, email: zengjs@pub.guangzhou.gd.cn, contacts name: Shihui Xing, role: CONTACT, phone: +8613602755395, email: xingshih@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06331481, orgStudyIdInfo id: 0005-22-HYMC, briefTitle: The Effect of Over Weight on Oocytes Quality in IVF Patients, acronym: IVF, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-02-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hillel Yaffe Medical Center, class: OTHER_GOV, descriptionModule briefSummary: Obesity is an increasing worldwide problem and a risk factor for many diseases. The effect of obesity on female fertility has been extensively tested. Obese women have increased time to pregnancy and remain subfertile even in the absence of ovulatory dysfunction. They present with higher incidence of infertility compared to normal weight women.This study is prospective observational cohort study performed between February 2022 until June 2022 in a single university-affiliated hospital., conditionsModule conditions: IVF, conditions: Overweight, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Fullicular fluid for cytology and biocemical analysis, outcomesModule primaryOutcomes measure: Impact of obesity on oocyte's mtDNA expression in Cumulus Cells, primaryOutcomes measure: Impact of obesity on oocyte quality through levels of protein BMP-15, primaryOutcomes measure: Impact of obesity on oocyte quality through levels of protein HSPG2, secondaryOutcomes measure: Impact of obesity on fertilization and pregnancy rates through analysis of mtDNA expression, secondaryOutcomes measure: Impact of obesity on fertilization and pregnancy rates through levels of protein BMP-15, secondaryOutcomes measure: Impact of obesity on fertilization and pregnancy rates through levels of protein HSPG2, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hillel Yaffe Medical Center - IVF Unit, city: Hadera, zip: 38100, country: Israel, geoPoint lat: 32.44192, lon: 34.9039, hasResults: False
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protocolSection identificationModule nctId: NCT06331468, orgStudyIdInfo id: MCC-23-GYN-10, briefTitle: Hypofractionated Radiochemotherapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Denise Fabian, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are:* What is the MRI-assessed rate of response at 1-month and 3-months post-treatment?* What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy?* What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT?* What is the proportion of patients who complete the treatment in prescribed timeframe?* What the levels of cervix cancer circulating tumor cells pretherapy and after treatment?To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following:* Complete history and physical exam, GOG performance status evaluation* Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions.Treatment will be administered on an outpatient basis.The main difference between the proposed regimen in the trial and standard of care is as follows:1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction.2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2.This protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +/- 2 days of initiation. Computed tomography simulation with the patient in a head-first laying on back-supine position is required. MRI-guided treatment planning and image guidance during treatment for motion management will be used.IMRT will be given once daily Monday-Thursday, four fractions per week. The high-dose-rate (HDR) brachytherapy following institutional protocol. Brachytherapy will be delivered twice per week with a 2-day break in between sessions. A total of four brachytherapy treatments will be delivered.After active therapy is completed, treatment-related toxicity will be assessed at the 1-month post-treatment completion visit and again at the 3-month post-treatment completion. Patients removed from the study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event(s).Routine MRI imaging to assess treatment response to radiotherapy is conducted at Day 15. Treatment response to radiotherapy followed by brachytherapy will be assessed at the 1- month and 3-months post-treatment completion.Following the 3-months post-treatment completion, study participants will be followed for disease progression and survival status until Year 2 post-treatment initiation. NOTE: Cervical cancer patients are routinely followed (clinical surveillance) every 3-months during the first two years post-treatment., conditionsModule conditions: Uterine Cervix Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Cisplatin, interventions name: intensity modulated radiation therapy (IMRT), interventions name: high-dose-rate (HDR) brachytherapy, outcomesModule primaryOutcomes measure: MRI assessed rate of complete response, secondaryOutcomes measure: MRI assessed rate of complete response, secondaryOutcomes measure: progression-free survival (PFS), secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: Treatment Completion, secondaryOutcomes measure: Treatment Tolerability, otherOutcomes measure: Change in levels of uterine cervix cancer circulating tumor cells, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Markey Cancer Center, city: Lexington, state: Kentucky, zip: 40506, country: United States, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False
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protocolSection identificationModule nctId: NCT06331455, orgStudyIdInfo id: 23-5501, briefTitle: Treatment of Pulmonary SUlcus, Pancoast and Chest Wall Non-small Cell Lung Cancer Employing Radiation, Immuno-oncology and Resection, acronym: SUPER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Marc de Perrot, class: OTHER, collaborators name: Ozmosis Research Inc., descriptionModule briefSummary: The SUPER trial is a prospective Phase II trial. It is designed for patients with stage 2 or 3 non-small cell lung cancer (NSCLC) prior to surgery.Patients who are enrolled in this trial will receive combination of Non-ablative oligofractionated radiation (NORT) and two cycles of Durvalumab, an immunotherapy drug before their surgery., conditionsModule conditions: Lung Cancer Patients, conditions: Non-small Cell Lung Cancer (NSCLC), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a multi-centre, phase 2 trial in patients with T2b-3N0-1M0 NSCLC evaluating the biologic efficacy of NORT-Durvalumab administered prior to surgery., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Durvalumab, interventions name: Non-ablative oligofractionated radiation (NORT), outcomesModule primaryOutcomes measure: To Measure CD8 TILs density & Major Pathological Response (MPR), secondaryOutcomes measure: To explore the efficacy and safety of NORT-durvalumab, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331442, orgStudyIdInfo id: 006503905, briefTitle: The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2024-11, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Zagreb, class: OTHER, descriptionModule briefSummary: This randomized controlled trial will be conducted on 40 orthodontic patients at the Department of Orthodontics, University Hospital Centre Zagreb, Croatia. Respondents will be randomly allocated into 4 groups (n=10). The first group will receive photodynamic therapy, the second tricalcium phosphate varnish with 5% NaF (sodium fluoride), the third 1% chlorhexidine varnish, while the fourth group will be the negative control. Before and after the mentioned interventions, the participants will have the amount of plaque measured using the plaque index and the bacteriological composition of the plaque assessed using the mass spectrometry and PCR. The gingival condition will be assessed using the gingival index. Also, the occurrence of white spot lesions will be evaluated on intraoral photographs., conditionsModule conditions: Plaque, Dental, conditions: Dental Plaque Induced Gingivitis, conditions: White Spot Lesion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Photodynamic therapy, interventions name: Tricalcium phosphate (TCP) varnish with 5% NaF, interventions name: Chlorhexidine varnish, outcomesModule primaryOutcomes measure: Assessment of dental plaque accumulation using plaque index, primaryOutcomes measure: Assessment of the bacteriological composition of supragingival plaque using mass spectrometry, secondaryOutcomes measure: Assessment of the bacteriological composition of subgingival plaque using polymerase chain reaction, secondaryOutcomes measure: Assessment of gingival condition using gingival index, secondaryOutcomes measure: Diagnosis of white spot lesions on intraoral photographs, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331429, orgStudyIdInfo id: EmoTiCare, briefTitle: Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, collaborators name: Universitat Politècnica de València, descriptionModule briefSummary: The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness., conditionsModule conditions: Type 1 Diabetes, conditions: Adolescent Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: EmoTiCare, outcomesModule primaryOutcomes measure: Change Quality of Life (Baseline-Pre-Post), primaryOutcomes measure: Change Emotional and Behavioral Problems (Baseline-Pre-Post), primaryOutcomes measure: Change Emotional Competences (Baseline-Pre-Post), primaryOutcomes measure: Change Self-concept (Baseline-Pre-Post), primaryOutcomes measure: Change Coping (Baseline-Pre-Post), primaryOutcomes measure: Change Social Skills (Baseline-Pre-Post), secondaryOutcomes measure: Change Threat of disease(Baseline-Pre-Post), secondaryOutcomes measure: Change Psychoeducation Diabetes, secondaryOutcomes measure: Change Resilience (Baseline-Pre-Post), otherOutcomes measure: Glycaemic control (Baseline-Pre-Post), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Universitat de València, city: Valencia, country: Spain, contacts name: Marián Pérez-Marín, PhD, role: CONTACT, phone: 963983392, email: marian.perez@uv.es, contacts name: Selene Valero Moreno, PhD, role: SUB_INVESTIGATOR, contacts name: Inmaculada Montoya-Castilla, PhD, role: SUB_INVESTIGATOR, contacts name: Javier Martín Ávila, MsC, role: SUB_INVESTIGATOR, contacts name: Esther Rodríguez-Jiménez, MsC, role: SUB_INVESTIGATOR, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06331416, orgStudyIdInfo id: 208_2022H, briefTitle: One-device Multiparametric Home Telemonitoring of Patients With Chronic Obstructive Pulmonary Disease Exacerbation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Trieste, class: OTHER, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD) exacerbations are risk factors for disease progression and short-term re- hospitalizations. We propose a randomized controlled trial to evaluate the efficacy of a one-device multiparameter telemonitoring in reducing functional decline, symptoms, and risk of re-hospitalization of patients discharged after hospitalization for exacerbated COPD., conditionsModule conditions: COPD, conditions: COPD Exacerbation Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Open-label randomized controlled trial, allocation ratio 1:1, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Telemonitoring, outcomesModule primaryOutcomes measure: Re-hospitalization at 90 days, secondaryOutcomes measure: Re-hospitalization at 30 days, secondaryOutcomes measure: Functional decline, secondaryOutcomes measure: Unplanned medical evaluations, secondaryOutcomes measure: Need for mechanical ventilation at 30 days, secondaryOutcomes measure: Need for mechanical ventilation at 90 days, secondaryOutcomes measure: Satisfaction score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331403, orgStudyIdInfo id: 24-009, briefTitle: Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Harvard Medical School (HMS and HSDM), descriptionModule briefSummary: The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit.To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability.As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial.In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being., conditionsModule conditions: Colorectal Cancer, conditions: Anal Cancer, conditions: Sexual Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Mind-Body Group Intervention, outcomesModule primaryOutcomes measure: Feasibility of Intervention, primaryOutcomes measure: Acceptability of Intervention, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331390, orgStudyIdInfo id: 2181-198-03-04-24-0008, briefTitle: Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Split, School of Medicine, class: OTHER, descriptionModule briefSummary: Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days, conditionsModule conditions: Contact Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: niacinamide cosmetic product, interventions name: placebo, outcomesModule primaryOutcomes measure: tewameter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Split School of Medicine, status: RECRUITING, city: Split, country: Croatia, contacts name: Josipa Bukic, role: CONTACT, phone: 00385917933752, email: jbukic@mefst.hr, geoPoint lat: 43.50891, lon: 16.43915, hasResults: False
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protocolSection identificationModule nctId: NCT06331377, orgStudyIdInfo id: 17-004541, secondaryIdInfos id: NCI-2024-01765, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 17-004541, type: OTHER, domain: Mayo Clinic Institutional Review Board, briefTitle: Clinical and Molecular Characteristics of Histiocytic Disorders, statusModule overallStatus: RECRUITING, startDateStruct date: 2017-07-27, primaryCompletionDateStruct date: 2027-07-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study is being done to collect medical and personal histories as well as a samples of blood, other body fluid and/or tumor/disease tissue for current and future research studies on histiocytic disorders., conditionsModule conditions: Histiocytic Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Identify molecular markers, primaryOutcomes measure: Change in PD-L1 and T-cell Bim expression, eligibilityModule sex: ALL, minimumAge: 1 Year, stdAges: CHILD, 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: Ronald S. Go, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06331364, orgStudyIdInfo id: Pro00114347, secondaryIdInfos id: R01AI168420, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AI168420, briefTitle: TREATment of Lower Respiratory Tract Infection in Sri Lanka (TREAT-SL), acronym: TREAT-SL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka.The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group.The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed., conditionsModule conditions: Lower Resp Tract Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: stepped-wedge, cluster randomized, two-arm, open labelThis design combines elements of a cluster randomized trial (intervention is applied in clusters) and a before-after design (each cluster switches to intervention). All 9 pairs of wards (clusters) will start with an initial period of usual care. At intervals of 3-6 months (steps), a set of 3 pairs of wards (clusters) will switch in a randomized order to use the intervention, until all pairs of wards have crossed over., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 765, type: ESTIMATED, armsInterventionsModule interventions name: electronic clinical decision support tool (eCDST) diagnostic plan, outcomesModule primaryOutcomes measure: Total duration of antibacterial prescription for the index visit, primaryOutcomes measure: Composite of adverse outcomes that could be attributed to withholding antibacterials, secondaryOutcomes measure: Proportion of participants using non-invasive ventilation, secondaryOutcomes measure: Proportion of participants using mechanical ventilation, secondaryOutcomes measure: Proportion of participants readmitted to the hospital, secondaryOutcomes measure: Proportion of deaths, secondaryOutcomes measure: Proportion of participants seeking subsequent outpatient care for the LRTI illness and receiving an antibacterial prescription, secondaryOutcomes measure: Proportion of participants admitted to the intensive care unit (ICU) during index hospitalization, secondaryOutcomes measure: Duration of admission to the intensive care unit (ICU) during index hospitalization, secondaryOutcomes measure: Number of participants requiring use of supplemental oxygen by nasal cannula or face mask during index hospitalization, secondaryOutcomes measure: Duration of supplemental oxygen by nasal cannula or face mask during index hospitalization, secondaryOutcomes measure: Duration of non-invasive ventilation during index hospitalization, secondaryOutcomes measure: Duration of mechanical ventilation during index hospitalization, secondaryOutcomes measure: Duration of index hospitalization, secondaryOutcomes measure: Proportion prescribed antibacterials- cumulative, secondaryOutcomes measure: Proportion prescribed antibacterials- at time of assessment, secondaryOutcomes measure: Total antibacterial exposure per patient during hospitalization, secondaryOutcomes measure: Proportion prescribed oseltamivir- cumulative, secondaryOutcomes measure: Proportion prescribed oseltamivir- at time of assessment, secondaryOutcomes measure: Total oseltamivir exposure per patient during hospitalization, secondaryOutcomes measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- cumulative, secondaryOutcomes measure: Proportion prescribed SARS-CoV-2 antivirals during hospitalization- at time of assessment, secondaryOutcomes measure: Physician adherence, as measured by proportion in whom the first recommended diagnostic test (if recommended) was performed, secondaryOutcomes measure: Physician adherence, as measured by the proportion in whom the second recommended diagnostic test (if recommended) was performed, secondaryOutcomes measure: Physician adherence, as measured by proportion in whom the antibacterial treatment recommendation was followed, secondaryOutcomes measure: Physician adherence, as measured by the proportion in whom the oseltamivir treatment recommendation was followed, secondaryOutcomes measure: Physician adherence, as measured by the proportion in whom all treatment recommendations were followed, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331351, orgStudyIdInfo id: A11203001, briefTitle: Effect of Jing Si Herbal Tea Liquid Packets on Chronic Pharyngolaryngitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Dalin Tzu Chi General Hospital, class: OTHER, descriptionModule briefSummary: Chronic pharyngolaryngitis is common and often make people suffer in many aspects. The etiology is numerous, for example, airway hypersensitivity, gastroesophageal acid regurgitation, sicca syndrome, anxiety, etc.The investigators aimed to investigate the effect of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis by a design of randomized, double-blind clinical trial in this study. The subjects who were bed-ridden, without self-care ability, receiving hemodialysis, no idea about the details of this study, poor compliance for this study, alcohol and/or drugs additives, pregnancy and breast-feeding women were excluded from this study.A questionnaire for health and habits was performed at the start of the study, and a questionnaire for Reflux Symptom Index (RSI) was performed at the start and the end of the study. Finally, Student's t-test was used to test the difference between the Jing Si herbal tea group and the control group. And, multivariate linear regression was used to test the violation of clinical factors on the treatment outcome of Jing Si herbal tea liquid packets on chronic pharyngolaryngitis., conditionsModule conditions: Chronic Pharyngitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: control group, interventions name: Jing Si herbal tea liquid packets, outcomesModule primaryOutcomes measure: Health questionnaire, primaryOutcomes measure: Reflux Symptom Index (RSI), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, status: RECRUITING, city: Chiayi City, zip: 66247, country: Taiwan, contacts name: Juen-Haur Hwang, MD, PhD, role: CONTACT, phone: +886-5-2648000, phoneExt: 5239, email: g120796@tzuchi.com.tw, geoPoint lat: 23.47917, lon: 120.44889, hasResults: False
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protocolSection identificationModule nctId: NCT06331338, orgStudyIdInfo id: 202310085RIND, briefTitle: Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Decision Cycle for Person-Centered Glycemic Management, interventions name: Traditional diabetes self-management education, outcomesModule primaryOutcomes measure: glycemic control (HbA1c), secondaryOutcomes measure: Diabetes Self-Care Behavior Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Hsinchu, zip: 302, country: Taiwan, contacts name: Chia-Hui Tsai, role: CONTACT, phone: 886926124093, email: mtsai0322@gmail.com, geoPoint lat: 24.80361, lon: 120.96861, hasResults: False
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protocolSection identificationModule nctId: NCT06331325, orgStudyIdInfo id: 724, briefTitle: Comparison of Frenotomy and Frenectomy Techniques for Management of High Frenum Attachment in Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: October University for Modern Sciences and Arts, class: OTHER, descriptionModule briefSummary: The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:* Does Frenotomy procedure have a lower relapse rate compared to frenectomy?* Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week., conditionsModule conditions: High Frenum Attachment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial. Allocation Ratio: 1:1, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants and outcome assessors will be unaware of the recruitment group. The allocation sequence will be contained within sequentially numbered, opaque, sealed packets that the patients will pull. According to the randomization table, the written number on the paper will allocate the patient to the intervention or control group., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Frenotomy, interventions name: Frenectomy, outcomesModule primaryOutcomes measure: Rebound / Relapse., secondaryOutcomes measure: Postoperative pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: MSA University, status: RECRUITING, city: Giza, zip: 12566, country: Egypt, contacts name: Nada Zazou, role: CONTACT, phone: +201224016945, email: drzazou@hotmail.com, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06331312, orgStudyIdInfo id: CAIN457C22301E1, secondaryIdInfos id: 2023-508077-85-00, type: OTHER, domain: EU CT number, briefTitle: Open-label, Long-term Safety Study of Secukinumab in Polymyalgia Rheumatica (PMR), acronym: REPLENISH-EXT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2028-03-13, completionDateStruct date: 2028-05-08, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this extension study is to assess the safety and tolerability of secukinumab when administered long-term in patients with polymyalgia rheumatica., conditionsModule conditions: Polymyalgia Rheumatica, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Secukinumab, outcomesModule primaryOutcomes measure: Incidences of treatment emergent adverse events (AEs) and serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis Investigative Site, status: RECRUITING, city: Parramatta, zip: 2150, country: Australia, geoPoint lat: -33.81667, lon: 151.0, hasResults: False
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protocolSection identificationModule nctId: NCT06331299, orgStudyIdInfo id: BL013, briefTitle: A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer, acronym: UTOPIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: UroGen Pharma Ltd., class: INDUSTRY, descriptionModule briefSummary: This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC)., conditionsModule conditions: Bladder Cancer, conditions: Urothelial Carcinoma, conditions: Urothelial Carcinoma Bladder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 87, type: ESTIMATED, armsInterventionsModule interventions name: UGN-103, outcomesModule primaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Durable complete response (DCR) rate, secondaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs of special interest, and abnormal clinical laboratory test results (hematology and serum chemistry), secondaryOutcomes measure: Mitomycin plasma concentrations, secondaryOutcomes measure: Mitomycin maximum plasma concentration (Cmax), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331286, orgStudyIdInfo id: IIT20230091C-R1, briefTitle: The Effect of Dulaglutide as an Adjuvant Therapy on Cognitive Function in Bipolar Disorder Patients With Obesity, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Zhejiang University, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to investigate the effect of dulaglutide adjuvant treatment in patients with bipolar disorder with obesity, in addition to exploring the effect of GLP-1RA on cognition of bipolar disorder., conditionsModule conditions: Bipolar Disorder, conditions: Obesity, conditions: Cognition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: dulaglutide injection, outcomesModule primaryOutcomes measure: weight, primaryOutcomes measure: Concentration of blood glucose in blood, primaryOutcomes measure: Concentration of total cholesterol in blood, primaryOutcomes measure: Concentration of high density lipoprotein in blood, primaryOutcomes measure: Concentration of low density lipoprotein in blood, primaryOutcomes measure: Concentration of triglyceride in blood, primaryOutcomes measure: CBCT test results, secondaryOutcomes measure: 17-item Hamilton Depression Rating Scale (HAM-D17) Score, secondaryOutcomes measure: Treatment Emergent Symptom Scale (TESS) Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Psychiatry, First Affiliated Hospital of Zhejiang University, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Hu ShaoHua, role: CONTACT, phone: 13957162903, email: dorhushaohua@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06331273, orgStudyIdInfo id: CT2024-ZJU-OBS3, briefTitle: Impact of "No-touch" Technique on the Outcome of Liver Transplantation for Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Shulan (Hangzhou) Hospital, descriptionModule briefSummary: The "no-touch" technique has been one of the most important principles of oncological surgery and aimed to prevent seeding and tumor cell dissemination. Previous studies in hepatectomy have shown that no-touch technique surgery can reduce HCC recurrence and improve the survival of patients. However, there is no consensus on whether the no-touch technique in LT for HCC improves the outcomes. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant clinical information, post-transplant pathological records and exploring and clarify the correlation between "no-touch" technique and the prognosis of LT patients., conditionsModule conditions: Liver Transplantation, conditions: No-touch Technique, conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Liver transplantation with "No-touch" technique, outcomesModule primaryOutcomes measure: Recurrence free surviavl rate, primaryOutcomes measure: Overall survival rate, primaryOutcomes measure: Tumor recurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06331260, orgStudyIdInfo id: CT2024-ZJU-OBS2, briefTitle: Assessment of AFP and PIVKA-II as Prognostic Indicators in Liver Transplantation for Hepatocellular Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, collaborators name: Shulan (Hangzhou) Hospital, descriptionModule briefSummary: As key biomarkers in HCC, AFP and PIVKA-II reflects biological features of tumor and has been widely applied for clinical diagnosis. Previous studies reported preoperative AFP and PIVKA-II are related to HCC recipient long-term survival after liver transplantation. However, there is no prospective study supporting these conclusions. This study aims to prospective collect liver transplantation cases from multiple transplant centers and further evaluate the prognostic role of preoperative AFP and PIVKA-II in liver transplantation for HCC., conditionsModule conditions: Liver Transplantation, conditions: Hepatocellular Carcinoma, conditions: Alpha-Fetoprotein, conditions: Protein Induced by Vitamin K Absence or Antagonist-II, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Recurrence free survival rate, primaryOutcomes measure: Overall survival rate, primaryOutcomes measure: Tumor recurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06331247, orgStudyIdInfo id: 20230520-2, briefTitle: MIND Diet to Improve Cognitive Function in Mild Stroke Patients (MINDICOMS) II, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: A 6-month pilot randomized controlled trial designed to test the effect of the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet + usual medical care versus usual medical care on cognitive change and several other secondary outcomes through a randomized controlled trial in 60 mild stroke patients aged 35-70 years without dementia., conditionsModule conditions: Dementia, conditions: Stroke, conditions: Cognitive Change, conditions: Cerebrovascular; Disorder, Thrombotic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a two-arm parallel design, with one arm being the control arm (usual medical care) and the other being the intervention arm (MIND diet intervention + usual medical care)., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcome assessors will be masked from the assignment of the participants., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: General dietary advice, interventions name: Localized MIND diet intervention, interventions name: Routine medical care, outcomesModule primaryOutcomes measure: Change in global cognitive function, primaryOutcomes measure: Change in MIND diet score, secondaryOutcomes measure: Change in Montreal Cognitive Assessment (MoCA) score, secondaryOutcomes measure: Change in Mini-Mental State Examination (MMSE) score, secondaryOutcomes measure: Change in brain MRI markers, secondaryOutcomes measure: Change in memory function, secondaryOutcomes measure: Change in language function, secondaryOutcomes measure: Change in executive function, secondaryOutcomes measure: Change in visuospatial function, otherOutcomes measure: Change in the ability of daily life measured using the Activities of Daily Living Scale (ADL), otherOutcomes measure: Change in the ability of daily life measured using the Instrumental Activities of Daily Living Scale (IADL), otherOutcomes measure: Change in depressive status measured using the Patient Health Questionnaire (PHQ-9), otherOutcomes measure: Change in anxiety status measured using the General Anxiety Disorder-7 (GAD-7), otherOutcomes measure: Changes in plasma metabolic profiles measured using metabolome analysis, otherOutcomes measure: Changes in plasma inflammatory biomarker panel, otherOutcomes measure: Changes in the intestinal microbiome, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310058, country: China, contacts name: Lusha Tong, PhD, role: CONTACT, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06331234, orgStudyIdInfo id: VCI, briefTitle: Effects of Vena Cava Inferior Measurements on AKI and Mortality., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: Fluid overload is harmful in critically ill patients; In addition to increasing mortality, it may increase the incidence of acute kidney injury (AKI), length of ICU stay, and duration of mechanical ventilation by causing end-organ damage. (1-3) Mortality attributable to AKI is 20% and is an independent determinant of mortality. (4) Venous load ultrasonography score (VExUS) is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler (PW-Doppler) morphology of the hepatic, portal and renal veins. It has been proposed as a score to assess systemic congestion. When the IVC diameter is \< 2 cm, it means there is no congestion and VEXUS is 0. Mild congestion: In addition to the IVC measuring approximately 2 cm, normal patterns such as the systolic wave being greater than the diastolic wave in the hepatic vein PW-doppler, pulsatility below 30% in the portal vein Doppler, continuous flow in the renal vein PW-doppler, or slightly abnormal patterns, i.e. hepatic The systolic wave in vein PW-doppler is smaller than the diastolic wave, the pulsatility in portal PW-doppler is between 30-50%, and the renal vein PW-doppler is accompanied by biphasic flow, and VEXUS is scored as 1. Moderate congestion is scored as VEXUS 2, which is measured as IVC 2 cm or more, plus inversion of the systolic wave on hepatic vein PW-doppler, pulsatility greater than 50% on portal PW-doppler, and discontinuous monophasic flow with only the diastolic phase on renal vein PW-doppler. It is accompanied by one of the serious abnormal patterns such as There is severe congestion, that is, VEXUS 3: IVC diameter of 2 cm or more and the presence of at least two seriously abnormal PW-Doppler morphologies. (5) The primary aim of this study is to describe the prevalence of venous congestion based on VExUS in general ICU patients. Secondary outcomes were to evaluate the association between VExUS, AKI, and 28-day mortality., conditionsModule conditions: Intensive Care Unit, conditions: Acute Kidney Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Vena cava inferior diameter, outcomesModule primaryOutcomes measure: acute kidney injury, primaryOutcomes measure: mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331221, orgStudyIdInfo id: JSA_Fatigue_FADEUP, briefTitle: Effects of Different Concentric and Eccentric Muscle Fatigue Protocols on the Knee Joint Position Sense, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate the effects of different concentric and eccentric muscle fatigue protocols on the knee joint position sense of healthy individuals., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Muscle fatigue Protocol, outcomesModule primaryOutcomes measure: Absolute angular error, primaryOutcomes measure: Relative angular error, primaryOutcomes measure: Variable angular error, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculdade de Desporto, Universidade do Porto, status: RECRUITING, city: Porto, zip: 4200, country: Portugal, contacts name: Joana Azevedo, MSc, role: CONTACT, phone: +351917910094, email: azevedojoana311@gmail.com, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False
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protocolSection identificationModule nctId: NCT06331208, orgStudyIdInfo id: LUNG-HF:16181/21; G-21-57, briefTitle: Mechanisms of Pulmonary Vascular Dysfunction in Heart Failure, acronym: LUNG-HF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Institute for Clinical and Experimental Medicine, class: OTHER_GOV, descriptionModule briefSummary: Heart failure (HF) patients often develop pulmonary hypertension (PH) that leads to transition into a biventricular HF with poor prognosis.There are two PH components: 1) passive transmission of increased left atrial pressure, 2) heart failure (HF) related pulmonary vascular dysfunction (PVD) with increased vascular resistance. Intriguingly, only some, but not all HF patients develop heart failure-related PVD. The mechanisms and non-invasive detection of HF-PVD are poorly understood and are the focus of the current grant application. Development of PVD is linked to insufficiently characterized metabolic factors that may be mediators of HF-PVD.Untargeted metabolomics is an emerging powerful platform for the discovery of pathways linked to diseases. Its specificity can be further enhanced using transpulmonary gradient sampling.Part A of the project aims to identify novel metabolites associated with the presence of PVD in patients with HF that can serve as biomarkers or targets and will provide biologic insights into PVD. Part C will assess the effects of reverting of metabolic alterations (identified in part A) by a drug/diet on pulmonary vasculature in experimental HF-related PVD. The "gold standard" for the detection of PVD is right heart catheterization, which is invasive and risky. Heart failure-related PVD is therefore often diagnosed late.There is a need for noninvasive tests that may help to detect PVD in early stages and can be done repeatedly. Recent advances in artificial intelligence (AI)-assisted automated quantitative analysis of lung texture from low-dose contrast-free high-resolution CT images allow to quantify lung water content, interstitial changes or vessel volume, and may provide clues for detection of heart failure-related PVD. Such an approach, not tested yet, will be utilized for the detection of HF-PVD (part B). Clinical and functional characteristics of lung circulation (exercise hemodynamics, diffusion capacity, perfusion) will be analyzed in relation to quantitative CT data., conditionsModule conditions: Heart Failure, conditions: Pulmonary Hypertension, conditions: Pulmonary Vascular Resistance Abnormality, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: non-contrast chest CT, interventions name: spirometry with diffusing lung capacity for carbon monoxide (DLCO) analysis, interventions name: Omics analysis of blood plasma obtained from pulmonary artery or peripheral blood, interventions name: supine bike exercise during right heart catheterisation, interventions name: Lung ventilation/perfusion SPECT, outcomesModule primaryOutcomes measure: biomarker of pulmonary vasculopathy in HF, primaryOutcomes measure: CT characteristics of pulmonary vasculopathy in HF, primaryOutcomes measure: CT characteristics of presence of heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Clinical and Experimental Medicine - IKEM, city: Prague, zip: 140 21, country: Czechia, contacts name: Vojtech Melenovsky, MD, PhD, role: CONTACT, phone: 420 236055190, email: vome@ikem.cz, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False
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protocolSection identificationModule nctId: NCT06331195, orgStudyIdInfo id: DICA-HF_MAIN, briefTitle: An Adapted Brazilian Cardioprotective Diet, Phytosterols and Krill Oil in Familial Hypercholesterolemia (DICA-FH), acronym: DICA-FH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hospital do Coracao, class: OTHER, collaborators name: University of Sao Paulo, collaborators name: National Institute of Cardiology, Laranjeiras, Brazil, collaborators name: Instituto Dante Pazzanese de Cardiologia, descriptionModule briefSummary: The main objective of this randomized clinical trial is to evaluate the effects of the adapted Brazilian Cardioprotective Diet (DICA Br) supplemented or not with phytosterols and/or krill oil in patients with a probable or definitive diagnosis of familial hypercholesterolemia (FH) according to the the Dutch Lipid Clinic Network (Dutch MEDPED) criteria. In addition, the following will be considered secondary objectives: to perform participants´ whole genome sequencing (WGS); to evaluate the effects of the interventions on lipid profile biomarkers; to evaluate the frequency of mild, moderate and severe adverse events according to study groups; to identify the prevalence of subclinical atherosclerosis; to perform pharmacogenomic analysis; and to evaluate adherence rates according to study groups. In this study, 300 individuals will be randomly enrolled into four groups: 1) DICA Br adapted to the FH context (DICA-FH) + phytosterol placebo + krill oil placebo (control group); 2) DICA-FH + 2g/day of phytosterol + krill oil placebo; 3) DICA-FH + phytosterol placebo + 2g/day of krill oil; and 4) DICA-FH + 2g/day of phytosterol + 2g/day of krill oil.Primary outcomes will be LDL-cholesterol for groups phytosterol vs. placebo and lipoprotein(a) for groups krill oil vs. placebo after 120 days of follow up., conditionsModule conditions: Familial Hypercholesterolemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Placebo phytosterol, interventions name: Placebo krill oil, interventions name: Phytosterol, interventions name: Krill oil, outcomesModule primaryOutcomes measure: LDL-c, primaryOutcomes measure: Lp(a), secondaryOutcomes measure: TC, secondaryOutcomes measure: HDL-c, secondaryOutcomes measure: TG, secondaryOutcomes measure: VLDL, secondaryOutcomes measure: NHDL, secondaryOutcomes measure: CI I, secondaryOutcomes measure: CI II, secondaryOutcomes measure: TG/HDL-c, secondaryOutcomes measure: AI, secondaryOutcomes measure: ox-LDL, secondaryOutcomes measure: APOAI, secondaryOutcomes measure: APOB100, secondaryOutcomes measure: AE, secondaryOutcomes measure: Adherence, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06331182, orgStudyIdInfo id: 36264PR552/2/24, briefTitle: Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain., conditionsModule conditions: Dexmedetomidine, conditions: Ketamine, conditions: External Oblique Intercostal Plane Block, conditions: Post Thoracotomy Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ketamine, interventions name: Dexmedetomidine, interventions name: Bupivacaine, outcomesModule primaryOutcomes measure: Time to the 1st rescue analgesia, secondaryOutcomes measure: Intraoperative fentanyl consumption, secondaryOutcomes measure: Total morphine consumption in the 1st 24hr and 48 hr, secondaryOutcomes measure: Degree of pain, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial blood, secondaryOutcomes measure: The incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University, status: RECRUITING, city: Tanta, state: ElGharbia, zip: 31527, country: Egypt, contacts name: Mohammed S Elsharkawy, MD, role: CONTACT, phone: 00201148207870, email: mselsharkawy@med.tanta.edu.eg, contacts name: Saad A Moharam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06331169, orgStudyIdInfo id: ALTER-BC-Ib-01, briefTitle: Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: A Prospective Phase Ib Study of Anlotinib with Trastuzumab Deruxtecan for HER2-Low Unresectable and/or Metastatic Breast Cancer, conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Anlotinib, interventions name: Trastuzumab deruxtecan, outcomesModule primaryOutcomes measure: Determination of the RP2D of anlotinib in combination with trastuzumab deruxtecan, primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DCR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Number of Participants With Adverse Events (AEs), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jian Zhang, city: Shanghai, state: Shanghai, zip: 200433, country: China, contacts name: Jian Zhang, MD,PhD, role: CONTACT, phone: +8664175590, phoneExt: 85000, email: syner2000@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06331156, orgStudyIdInfo id: 218485, secondaryIdInfos id: 2022-000708-36, type: EUDRACT_NUMBER, briefTitle: A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-11-19, completionDateStruct date: 2024-11-19, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the immune response and safety of the inactivated poliovirus (IPV) vaccine when co-administered with the human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in healthy Chinese infants 6-10 weeks of age at the time of study enrolment., conditionsModule conditions: Gastroenteritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: HRV PCV-free, interventions name: IPV, outcomesModule primaryOutcomes measure: Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab), secondaryOutcomes measure: Anti-poliovirus types 1, 2 and 3 neutralizing Ab geometric mean titers (GMTs), secondaryOutcomes measure: Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64, secondaryOutcomes measure: Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab, secondaryOutcomes measure: Anti-RV IgA Ab geometric mean concentrations (GMCs), secondaryOutcomes measure: Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL, secondaryOutcomes measure: Percentage of participants reporting solicited systemic events, secondaryOutcomes measure: Percentage of participants reporting unsolicited adverse events (AEs), secondaryOutcomes measure: Percentage of participants reporting serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 6 Weeks, maximumAge: 10 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: GSK Investigational Site, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610041, country: China, 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: Xuecheng Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.66667, lon: 104.06667, locations facility: GSK Investigational Site, status: RECRUITING, city: Guang'an, state: Sichuan, zip: 638300, country: China, 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: Xuecheng Liu, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, status: RECRUITING, city: Neijiang, state: Sichuan, zip: 641200, country: China, 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: Yulin Jing, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.58354, lon: 105.06216, locations facility: GSK Investigational Site, status: RECRUITING, city: Wenshan, state: Yunnan, zip: 663300, country: China, 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: Xiaoqiang Liu, role: PRINCIPAL_INVESTIGATOR, locations facility: GSK Investigational Site, status: RECRUITING, city: Wenshan, zip: 663100, country: China, 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: Xiaoqing Liu, role: PRINCIPAL_INVESTIGATOR, hasResults: False
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protocolSection identificationModule nctId: NCT06331143, orgStudyIdInfo id: 36264PR551/2/24, briefTitle: Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery., conditionsModule conditions: Mid-Transverse Process Block, conditions: Intrathecal Morphine, conditions: Idiopathic Scoliosis, conditions: Posterior Spinal Fusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound-Guided Mid-Transverse Process to Pleura (MTP) Block, interventions name: Morphine, outcomesModule primaryOutcomes measure: Degree of pain, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University, status: RECRUITING, city: Tanta, state: ElGharbia, zip: 31527, country: Egypt, contacts name: Mohammed S Elsharkawy, MD, role: CONTACT, phone: 00201148207870, email: mselsharkawy@med.tanta.edu.eg, contacts name: Saad A Moharam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
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protocolSection identificationModule nctId: NCT06331130, orgStudyIdInfo id: 6363, briefTitle: Mesenteric Infiltration in Ovarian Cancer, acronym: MIO, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, collaborators name: Danube University Krems, collaborators name: Institut du Cancer de Montpellier - Val d'Aurelle, collaborators name: Ente Ospedaliero Cantonale, Ticino, Switzerland, descriptionModule briefSummary: To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents., conditionsModule conditions: Ovary Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: Computed Tomography, outcomesModule primaryOutcomes measure: Preoperative Artificial Intelligence assisted CT-based evaluation, secondaryOutcomes measure: Evaluation of the Radiologist Assessment of the CT, secondaryOutcomes measure: Prediction of Platinum Resistance, secondaryOutcomes measure: Prediction of Progression Free Survival (PFS) and Overall Survival (OS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Radiology Center, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Camilla Panico, MD, role: CONTACT, phone: +390630158637, email: camilla.panico@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06331117, orgStudyIdInfo id: 3776, briefTitle: Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies, acronym: 3776, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-22, primaryCompletionDateStruct date: 2021-12-22, completionDateStruct date: 2026-04-22, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: Costello syndrome (CS) and cardio-facio cutaneous syndrome (CFCS) belongs to RASopathies, a group of multisystemic disorders caused by unregulated signalling through the RAS/MAPK pathway, an intracellular signalling pathway regulating multiple processes such as cellular proliferation, differentiation, survival, apoptosis and also contributing to oncogenesis. They share a recognizable facial appearance, aged appearance, growth delay, muscle-skeletal anomalies, heart defects, neuropsychological features, skin and ocular abnormalities, and cancer predisposition.Even though life expectancy of individuals with CS and CFCS has increased in the last years due to the improvement of patients' care and a more effective prevention of comorbidities, some of the most challenging aspects impacting on everyday living such as growth failure, accelerate senescence and skeletal-muscle defects, still need to be fully understood. This statement underlies the need to improve clinical research protocols with more innovative techniques (multi-omics profiling) in order to better understand the effect of RAS/MAPK pathway hyperactivations on different systems and to define possible personalized treatments., conditionsModule conditions: RASopathy, conditions: Costello Syndrome, conditions: Noonan Syndrome, conditions: Cardio-Facio-Cutaneous Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic test, outcomesModule primaryOutcomes measure: Metabolomic profile of the RASopathies, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Woman and Child Health and Public Health, Fondazione Policlinico A. Gemelli, IRCCS, status: RECRUITING, city: Roma, zip: 00168, country: Italy, contacts name: Chiara Leoni, MD, PhD, role: CONTACT, phone: 0039063381344, email: chiara.leoni@policlinicogemelli.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06331104, orgStudyIdInfo id: ChangyeZou, briefTitle: Network Pharmacology Prediction: Mechanism Study of Puerarin in the Treatment of Giant Cell Tumors of Bone, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-06-14, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Changye Zou, class: OTHER, descriptionModule briefSummary: Based on network pharmacology analysis, this study aims to explore the potential therapeutic targets and molecular mechanisms of puerarin on giant cell tumor of bone (GCTB) genes., conditionsModule conditions: Giant Cell Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 145, type: ACTUAL, armsInterventionsModule interventions name: gene expression levels, outcomesModule primaryOutcomes measure: P27 expression levels, primaryOutcomes measure: ESR1 expression levels, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Churong Yan, city: Guangzhou, state: Guangdong, zip: 518010, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06331091, orgStudyIdInfo id: YuzuncuYıl2022/2, briefTitle: Physiotherapy and Reaction Time in Hemophilia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-10, primaryCompletionDateStruct date: 2024-01-19, completionDateStruct date: 2024-01-19, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Yuzuncu Yıl University, class: OTHER, descriptionModule briefSummary: This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions., conditionsModule conditions: Hemophilia Arthropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised controlled study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ACTUAL, armsInterventionsModule interventions name: Home exercise, interventions name: Manual therapy, interventions name: Neuromuscular electrical stimulation, interventions name: Supervised exercise, outcomesModule primaryOutcomes measure: Hemophilia Joint Health Score, primaryOutcomes measure: Reaction time, eligibilityModule sex: MALE, minimumAge: 10 Years, maximumAge: 32 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Van Yüzüncü Yıl University, city: Van, zip: 65080, country: Turkey, geoPoint lat: 38.49457, lon: 43.38323, hasResults: False
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protocolSection identificationModule nctId: NCT06331078, orgStudyIdInfo id: 29.02.2024/45, briefTitle: Square Step Exercises in Healthy Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fenerbahce University, class: OTHER, descriptionModule briefSummary: This study aims to compare the effectiveness of Square Stepping Exercise and aerobic exercise on cognitive function and physical fitness in young adults. Participants aged 18-30 with low physical activity levels will be randomly assigned to either the Square Stepping Exercise Group or Aerobic Exercise Group. Both interventions will be supervised by a physiotherapist, performed twice a week for 40 minutes over 4 weeks. Cognitive function will be assessed using various tests, including attention, short-term memory, and executive function evaluations. Physical fitness will be evaluated through jump tests and balance assessments. Blinded assessors will conduct evaluations at baseline and post-intervention in both groups to determine the impact of square stepping exercise and aerobic exercise on cognitive and physical health in young adults., conditionsModule conditions: Exercise, conditions: Square Step Exercises, conditions: Aerobic Exercise, conditions: Cognitive Function, conditions: Physical Fitness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Square Stepping Exercise training, interventions name: Aerobic Exercise Training, outcomesModule primaryOutcomes measure: Schulte Grid Test, primaryOutcomes measure: Stroop Test, primaryOutcomes measure: Verbal Fluency Test, primaryOutcomes measure: Digit Span Test, primaryOutcomes measure: Vertical jump test, primaryOutcomes measure: Horizontal jump test, primaryOutcomes measure: Y Balance Test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Marmara University, city: Maltepe, country: Turkey, geoPoint lat: 40.93567, lon: 29.15507, hasResults: False
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protocolSection identificationModule nctId: NCT06331065, orgStudyIdInfo id: 69HCL21_1180, secondaryIdInfos id: ID-RCB, type: OTHER, domain: 2023-A01756-39, briefTitle: Promoting Mental Health at Work Among Hospital Professionals, acronym: PROMIND, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Mental health is a state of well-being in which a person can realize his/her potential, cope with the normal stresses of life, work productively and contribute to his/her community. It refers to a continuum that extends from the promotion of well-being and the prevention of mental disorders to the treatment and rehabilitation of people suffering from these disorders.Healthcare professionals face major mental health challenges, due to the demands of their profession, which is characterized by heavy workloads and confrontation with human distress. The frequency of mental health problems among hospital staff is high, at all stages (malaise, distress, pathologies). A meta-analysis found that caregivers suffer from around 30% anxiety, 30% depression, 30% psychotrauma and 45% sleep disorders.According to the French Labor Code, employers are responsible for the physical and mental health of their employees. The Hospices Civils de Lyon establishment project includes a section on the prevention of psycho-social risks, quality of working life and management.Healthcare professionals, like the general population, have high expectations of non-medication treatments. These non-medication interventions aim to prevent, treat, or cure a health problem. They are non-invasive and non-pharmacological, with certain observable impacts supported by scientific evidence.Mindfulness meditation is one of the most extensively studied non-medication interventions in mental health. Declined in different modalities, its effects focus on improving resilience with efficacy on physical and mental well-being (stress, anxiety, burnout, affect), and their physiological corollary (cardiac and respiratory rhythms), acceptance of reality in stressful situations, reduced interpersonal conflict in emergencies and, more broadly, impact on relational behaviours (anti- and pro-social), teamwork. Managers also benefit, with a strengthening of the aspiration to lead, in a vision fully at the disposal of others.Mindfulness meditation appears to be a practice that promotes mental well-being and could contribute to fulfilment at work.The challenge is to offer a mindfulness meditation program in a hospital department for individual and collective benefit.The main objective is to evaluate the evolution of psychological fulfilment in the workplace of hospital healthcare professionals in a 5-month meditation program between the baseline and the end of the program, in comparison with the evolution over the same period of a control group.The expected outcome is to show that it is possible to implement a mindfulness meditation intervention for hospital staff in care departments, whatever their status or profession, with individual and collective benefits for mental health, psycho-social risks (stress, violence, etc.) and work organization. If it proves to be effective and acceptable, this intervention could be offered more widely within the institution and beyond., conditionsModule conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Information session on mindfulness meditation and questionnaires, interventions name: Mindfulness meditation experimentation, practice program, questionnaires, individual interview and focus group, outcomesModule primaryOutcomes measure: Psychological fulfilment at work, secondaryOutcomes measure: Psychological fulfilment at work, secondaryOutcomes measure: Mindful state, secondaryOutcomes measure: Aggressiveness, secondaryOutcomes measure: Impulsivity, experience of being disturbed by conflict, and psychological safety., secondaryOutcomes measure: Occupational stress, secondaryOutcomes measure: Collective activity, secondaryOutcomes measure: Organizational leeway, secondaryOutcomes measure: Evolution of participants' representation of mindfulness meditation, secondaryOutcomes measure: The representation of mindfulness meditation among professionals, secondaryOutcomes measure: The representation of mindfulness meditation among professionals, secondaryOutcomes measure: The representation of mindfulness meditation among professionals, secondaryOutcomes measure: Fidelity and adherence to the mindfulness meditation intervention, secondaryOutcomes measure: Fidelity and adherence to the mindfulness meditation intervention, secondaryOutcomes measure: Barriers and facilitators to the implementation, secondaryOutcomes measure: Barriers and facilitators to the implementation, secondaryOutcomes measure: Mechanisms of the intervention effects, secondaryOutcomes measure: Mechanisms of the intervention effects, secondaryOutcomes measure: Mechanisms of the intervention effects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurology Department, Pierre Wertheimer Hospital (Hospices Civils de Lyon), city: Bron, zip: 69677, country: France, contacts name: Sandra Vukusic, role: CONTACT, phone: +33 4 72 35 72 16, email: sandra.vukusic@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Pediatric Intensive Care Unit - Continuous Monitoring, Femme Mère Enfant Hospital (Hospices Civils de Lyon), city: Bron, zip: 69677, country: France, contacts name: Etienne Javouhey, role: CONTACT, phone: +33 4 27 85 61 56, email: etienne.javouhey@chu-lyon.fr, geoPoint lat: 45.73333, lon: 4.91667, locations facility: Department of Geriatrics, Edouard Herriot Hospital (Hospices Civils de Lyon), city: Lyon, zip: 69003, country: France, contacts name: Géraldine Martin-Gaujard, role: CONTACT, phone: +33 4 72 11 95 31, email: geraldine.martin-gaujard@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Neonatology and neonatal intensive care unit, Croix-Rousse Hospital (Hospices Civils de Lyon), city: Lyon, zip: 69004, country: France, contacts name: Olivier Claris, role: CONTACT, phone: +33 4 27 85 53 48, email: olivier.claris@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Department of Anesthesia and Intensive Care, Edouard Herriot Hospital (Hospices Civils de Lyon), city: Lyon, zip: 69437, country: France, contacts name: Jullien Crozon-Clauzel, role: CONTACT, phone: +33 4 72 11 02 72, email: jullien.crozon-clauzel@chu-lyon.fr, geoPoint lat: 45.74848, lon: 4.84669, locations facility: Anaesthesia - Intensive Care and Perioperative Medicine Department, Lyon South Hospital (Hospices Civils de Lyon), city: Pierre-Bénite, zip: 69495, country: France, contacts name: Arnaud Friggeri, role: CONTACT, phone: +33 4 78 86 14 76, email: arnaud.frigerri@chu-lyon.fr, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Department of Physical Medicine and Neurological Rehabilitation, Henry Gabrielle Hospital (Hospices Civils de Lyon), city: Saint-Genis Laval, zip: 69230, country: France, contacts name: Jacques Luauté, role: CONTACT, phone: +33 4 72 35 71 69, email: jacques.luaute@chu-lyon.fr, geoPoint lat: 45.69558, lon: 4.7934, locations facility: Department of Geriatrics, Charpennes Hospital (Hospices Civils de Lyon), city: Villeurbanne, zip: 69100, country: France, contacts name: Clémence Grange, role: CONTACT, phone: +33 4 72 43 23 24, email: clemence.grange@chu-lyon.fr, geoPoint lat: 45.76667, lon: 4.88333, hasResults: False
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protocolSection identificationModule nctId: NCT06331052, orgStudyIdInfo id: 23-2431, secondaryIdInfos id: 1R01NS125386-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R01NS125386-01, briefTitle: 3-D Tractography FUS Ablation for Essential Tremor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2028-02-28, completionDateStruct date: 2028-02-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Texas Tech University Health Sciences Center, El Paso, collaborators name: University of Pittsburgh, collaborators name: National Institute of Neurological Disorders and Stroke (NINDS), descriptionModule briefSummary: The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes., conditionsModule conditions: Essential Tremor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: MR-guided Focused Ultrasound Ablation, outcomesModule primaryOutcomes measure: Number of Participants without Side Effects, primaryOutcomes measure: Absolute Change in Tremor, primaryOutcomes measure: Relative Change in Tremor, secondaryOutcomes measure: Number of Participants with Procedure-Related Side Effects, secondaryOutcomes measure: Relative Change in Tremor-Related Quality of Life, secondaryOutcomes measure: Number of Participants Who Are Satisfied with Treatment, otherOutcomes measure: Change in Tremor Based on Video Assessment, otherOutcomes measure: Change in Gait Based on Video Assessment, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, status: RECRUITING, city: Chapel Hill, state: North Carolina, zip: 27999, country: United States, contacts name: Mary Ann Barnett, MLS, role: CONTACT, phone: 919-966-8804, email: mary-ann_barnett@med.unc.edu, contacts name: Vibhor Krishna, MD, SM, role: CONTACT, phone: 919-445-2410, email: vibhor_krishna@med.unc.edu, contacts name: Vibhor Krishna, MD, SM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
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protocolSection identificationModule nctId: NCT06331039, orgStudyIdInfo id: CelalBayarU-5, briefTitle: The Effects of Pelvic Floor Muscle Training and Balance Exercises in Elderly People With Incontinence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-04-05, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Celal Bayar University, class: OTHER, collaborators name: Dokuz Eylul University, collaborators name: Saglik Bilimleri Universitesi, descriptionModule briefSummary: Pelvic floor muscle weakness is one of the most important causes of incontinence. There are many studies supporting that pelvic floor muscle training prevents incontinence and reduces symptom severity, and with A level of evidence, it is among the first in the conservative treatment of incontinence. Functional status and balance problems are common in elderly people with incontinence, and it is known that functional type incontinence is common. Elderly people with incontinence most often fall while trying to get to the toilet. Balance exercises are recommended for falls and balance problems.The aim of this study is to examine the effects of pelvic floor muscle training and balance exercises on ankle muscle function, joint range of motion and balance in individuals aged 65 and over with urinary incontinence., conditionsModule conditions: Urinary Incontinence, conditions: Pelvic Floor Muscle Weakness, conditions: Muscle Weakness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: PFMT, interventions name: PFMT+Balance, outcomesModule primaryOutcomes measure: ankle muscle function, primaryOutcomes measure: ankle range of motion, primaryOutcomes measure: muscle strength, primaryOutcomes measure: incontinence symptoms and severity, primaryOutcomes measure: incontinence symptoms and severity, primaryOutcomes measure: balance, primaryOutcomes measure: bladdery diary, primaryOutcomes measure: functional performance, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Melda BAŞER SEÇER, city: Mani̇sa, state: Yunusemre, zip: 45000, country: Turkey, contacts name: Melda BAŞER SEÇER, PhD, role: CONTACT, phone: +905547285453, email: melda.secer@cbu.edu.tr, contacts name: Özge ÇELİKER TOSUN, Assos. Prof., role: CONTACT, phone: +905055252029, email: ozge.tosun@deu.edu.tr, geoPoint lat: 38.61202, lon: 27.42647, hasResults: False
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protocolSection identificationModule nctId: NCT06331026, orgStudyIdInfo id: GenSci004-106, briefTitle: A Bioequivalence Study of Two Different PEG-rhGH Preparations., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-07, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Changchun GeneScience Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation., conditionsModule conditions: Pediatric Growth Hormone Deficiency (PGHD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 87, type: ESTIMATED, armsInterventionsModule interventions name: PEG-rhGH with new preparation (T), interventions name: PEG-rhGH with present preparation (R), outcomesModule primaryOutcomes measure: Pharmacokinetics (Peak Plasma Concentration (Cmax) ) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Pharmacokinetics (Area under the concentration-time curve from time zero to time infinity (AUC0-inf)) of PEG-rhGH with present and new preparation, primaryOutcomes measure: Pharmacokinetics (Area under the concentration-time curve from time zero to the time of the last quantifiable (AUC0- last )) of PEG-rhGH with present and new preparation, secondaryOutcomes measure: Safety and tolerability（Number of participants with treatment-related adverse events）, otherOutcomes measure: Anti-drug antibody (Number of Participants with positive ADA), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chengdu Xinhua Hospital, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Xiaolan Yong, Doctor, role: CONTACT, phone: +86-28-60212136, email: yongxlan@126.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06331013, orgStudyIdInfo id: IEO 1872, briefTitle: CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr, acronym: PRO-SPEED, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CyberKnife ultra-hypofractionated SBRT, outcomesModule primaryOutcomes measure: Number of Participants with Acute GU and GI toxicities (RTOG), primaryOutcomes measure: Number of Participants with Late GU and GI toxicities (RTOG), primaryOutcomes measure: Evaluation of patient-reported toxicity, primaryOutcomes measure: Evaluation of patient-reported quality of life, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Barbara Alicja Jereczek, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06331000, orgStudyIdInfo id: 9248, briefTitle: Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment, acronym: DIATRIM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and the reduction of pulmonary exacerbations should have a considerable impact on the quality of life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance abnormalities are still very fragmentary. The investigators can think that their use, earlier and earlier in the history of the disease, will transform the evolutionary trajectories of patients on the respiratory, nutritional and metabolic levels.Diabetes represents a major challenge in the management of pwCF because it is a factor in morbidity and mortality at all stages of the disease, from children to patients with terminal respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance observed in childhood, before the stage of diabetes, are also associated with poor pulmonary and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin secretion. However, investigators do not currently know the impact of CFTRm in patients with very early glucose disorders or at the stage of diabetes treated with insulin. Recently continuous glucose measurement (CGM) devices represent very effective tools for assessing abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients treated with insulin., conditionsModule conditions: Cystic Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: elexacaftor-tezacaftor-ivacaftor treatment, outcomesModule primaryOutcomes measure: Evaluate time in range of blood glucose variation >140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor, secondaryOutcomes measure: Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl, secondaryOutcomes measure: Marker of metabolic status: HbA1c (mmol/l), secondaryOutcomes measure: Marker of metabolic status: HbA1c (%), secondaryOutcomes measure: Marker of metabolic status: C-Peptid (µg/L), secondaryOutcomes measure: Marker of metabolic status: C-Peptid (nmol/L), secondaryOutcomes measure: Markers of nutritional status: Evaluation of weight monitoring (kg), secondaryOutcomes measure: Markers of nutritional status: Body Mass Index (BMI), secondaryOutcomes measure: Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl), secondaryOutcomes measure: Assessment of respiratory function parameters : number of IV antibiotics, secondaryOutcomes measure: Number patients with severe hypoglycaemia and serious adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330987, orgStudyIdInfo id: 15110_MANNELLA, briefTitle: Fetal Autonomic Nervous sysTem Evaluation, acronym: FANTE, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-08-13, primaryCompletionDateStruct date: 2025-09-28, completionDateStruct date: 2025-12-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Pisa, class: OTHER, collaborators name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, descriptionModule briefSummary: The autonomic nervous system (ANS) is involved in cardiovascular, metabolic and cognitive processes, so its study in the fetus can provide relevant functional diagnostic and prognostic information. In particular, the study of the fetal ANS allows us to understand the degree of nervous maturation reached by the fetus and any developmental disorders that could have an impact on the cardiovascular characteristics of the fetus.The goal of this open-label, non-randomized, prospective observational study is to study the fetal ANS in pregnant women between 23 and 40 weeks of gestation.The objetives are:* To Evaluate Fetal Autonomic Nervous System (FANTE) through the analysis of maternal electrocardiogram (ECG) and others clinical parameters usually used in pregnancy monitoring.* To identify any variations in the fetal ECG in the event of developmental or pathological maternal and/or fetal pregnancy.Participants will be recruited during ultrasound visits, information sessions, and hospitalizations after signing informed consent., conditionsModule conditions: Pregnancy Related, conditions: Pregnancy Disease, conditions: Pregnancy Complications, conditions: Pre-Eclampsia, conditions: Gestational Diabetes, conditions: ECG Electrode Site Reaction, conditions: Fetal Growth Retardation, conditions: Fetal Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 186, type: ESTIMATED, armsInterventionsModule interventions name: electrocardiograph, outcomesModule primaryOutcomes measure: Fetal Autonomic Nervous sysTem Evaluation (FANTE), secondaryOutcomes measure: Maternal Assesment, secondaryOutcomes measure: Obstetric Complications and mode of Delivery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Universitaria Pisana, status: RECRUITING, city: Pisa, zip: 56126, country: Italy, contacts name: Paolo Mannella, MD. PhD., role: CONTACT, phone: 0039.050.993523, email: paolo.mannella@unipi.it, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
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protocolSection identificationModule nctId: NCT06330974, orgStudyIdInfo id: FinnATOPY, briefTitle: Allergy, Asthma, and Atopic Eczema in Finland, acronym: FinnATOPY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2032-12, completionDateStruct date: 2034-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Tampere University, class: OTHER, collaborators name: Professor Lauri Lehtimäki, collaborators name: Professor Mika Mäkelä, collaborators name: Professor Sanna Toppila-Salmi, collaborators name: Professor Ilkka Junttila, descriptionModule briefSummary: The summary is available at --\> https://www.finnatopy.fi/summary, conditionsModule conditions: Asthma, conditions: Asthma in Children, conditions: Allergy, conditions: Rhinitis, Allergic, conditions: Atopic Dermatitis, conditions: Allergen Immunotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 2000000, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Epidemiology of atopic diseases and allergic sensitization profiles in Finland, primaryOutcomes measure: Burden of atopic diseases (allergies, asthma, and atopic eczema) as well as comorbidities in Finland, primaryOutcomes measure: Evaluate and improve the current use of diagnostic tests for atopic diseases, primaryOutcomes measure: Use and effectiveness of allergen immunotherapy in real world setting, primaryOutcomes measure: Direct and indirect costs related to atopic diseases and comorbidities, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tampere University, city: Tampere, country: Finland, geoPoint lat: 61.49911, lon: 23.78712, hasResults: False
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protocolSection identificationModule nctId: NCT06330961, orgStudyIdInfo id: 2023-MED-2756299, briefTitle: Effects of Different Kinds of Exercise in Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Valencia, class: OTHER, descriptionModule briefSummary: Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics.The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:* Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?* Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?* Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?* Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded.Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Isometric exercise, interventions name: Aerobic exercise, interventions name: Placebo intervention, outcomesModule primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Pain-pressure thresholds, primaryOutcomes measure: Trunk flexion-extension electromyography (EMG), primaryOutcomes measure: Flexion-extension ratio (EMG), primaryOutcomes measure: Maximum ranges of lumbar and pelvic flexion, primaryOutcomes measure: Trunk flexion-extension percentages of motion, primaryOutcomes measure: Time of maximum flexion, primaryOutcomes measure: Fear-avoidance beliefs, primaryOutcomes measure: Pain distribution and supra-threshold stimulation, secondaryOutcomes measure: Anthropometric data: height, secondaryOutcomes measure: Anthropometric data: weight, secondaryOutcomes measure: Date of birth/ age, secondaryOutcomes measure: Sex/ gender, secondaryOutcomes measure: Basic clinical history and occupational data, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València, status: RECRUITING, city: Valencia, zip: 46010, country: Spain, contacts name: Daniel Sánchez-Zuriaga, PhD, MD, role: CONTACT, phone: +343983522, phoneExt: 83522, email: daniel.sanchez@uv.es, geoPoint lat: 39.46975, lon: -0.37739, hasResults: False
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protocolSection identificationModule nctId: NCT06330948, orgStudyIdInfo id: NYCU112183AEF, briefTitle: Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: National Yang Ming University, class: OTHER, descriptionModule briefSummary: Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement., conditionsModule conditions: PreDiabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: SugarCut® Unripe Guava Fruit Extract, interventions name: Placebo group, outcomesModule primaryOutcomes measure: GLUT4 gene expression, primaryOutcomes measure: Hematology Test, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Yang Ming Chiao Tung University, status: RECRUITING, city: Taipei, state: Beitou Dist., zip: 112, country: Taiwan, contacts name: Tze-Fang Wang, Ph.D., role: CONTACT, phone: +886-2-28267907, email: tzefang@nycu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06330935, orgStudyIdInfo id: 192-2023, briefTitle: Evaluating the Effect of Tranexamic Acid on the Clinical Outcomes in Patients With Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Evaluate the effect of tranexamic acid on mortality in pediatric patients with traumatic brain injury. This could potentially lead to improved treatment protocols and better outcomes for this vulnerable population., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Tranexamic Acid (TXA), interventions name: Normal saline, outcomesModule primaryOutcomes measure: The early traumatic brain injury-related death in the hospital, primaryOutcomes measure: The difference between treatment group in the Intracranial haemorrhage growth, primaryOutcomes measure: The difference between the treatment groups in the incidence of mortality, secondaryOutcomes measure: Need for neurosurgical management, secondaryOutcomes measure: Days in the intensive care unit, secondaryOutcomes measure: Need for blood transfusion, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Pediatric Quality of Life (PedsQL), secondaryOutcomes measure: Pediatric Glasgow Outcome Scale Extended (GOS-E) Peds), eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330922, orgStudyIdInfo id: 10.55776/V992, briefTitle: Muscle-tendon Pathology and Metabolic Dysregulation in CP, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Graz, class: OTHER, collaborators name: Medical University of Graz, collaborators name: Karolinska Institutet, descriptionModule briefSummary: The main aim of this project is to gain knowledge about the muscle-tendon pathology of moderately to severely affected young people with cerebral palsy and their risk for cardiometabolic diseases and chronic inflammation. Furthermore, it will be investigated whether there are associations between the existing pathophysiology as well as inactivity and muscle function, cardiometabolic risk factors and inflammation. Moreover, the potential of the target group for adaptation of its muscular, cardiorespiratory, and endocrine system will be investigated.The study parameters will be determined in adolescents and young adults aged 14 to 25 years with moderate to severe spastic cerebral palsy and compared with those of their less severely affected and healthy peers (cross-sectional study). In addition, the more affected individuals will participate in a 12-week training intervention (longitudinal study) performed with special tricycles (i.e., Frame Runners).To measure the study parameters, ultrasound, strength tests, near-infrared spectroscopy, blood analyses, and spiroergometry will be used. The fitness training will be performed two times a week for 12 weeks with the Frame Runners., conditionsModule conditions: Cerebral Palsy, Spastic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cardiorespiratory fitness training, outcomesModule primaryOutcomes measure: Muscle fascicle length and muscle thickness, primaryOutcomes measure: Muscle fascicle pennation angle, primaryOutcomes measure: Passive muscle stiffness, primaryOutcomes measure: Isometric muscle strength, primaryOutcomes measure: Muscle tissue oxygenation, primaryOutcomes measure: Exosome size, primaryOutcomes measure: Exosome content, primaryOutcomes measure: Micro ribonucleic acid (RNA) cargo, secondaryOutcomes measure: Metabolic parameters, secondaryOutcomes measure: Pro-inflammatory cytokines, secondaryOutcomes measure: Resting, mean, and peak heart rate, secondaryOutcomes measure: Resting blood pressure, secondaryOutcomes measure: Distance covered, secondaryOutcomes measure: Peak oxygen uptake (VO2peak), Peak ventilation (VEpeak), secondaryOutcomes measure: Peak respiratory frequency, secondaryOutcomes measure: Respiratory exchange ratio, secondaryOutcomes measure: VEpeak/VO2peak, secondaryOutcomes measure: VEpeak/VCO2peak, secondaryOutcomes measure: Perceived exertion, secondaryOutcomes measure: Well-being and quality of life, secondaryOutcomes measure: Total physical activity, time spent in different intensities, secondaryOutcomes measure: Passive range of motion (sagittal plane) of hip, knees, ankles, secondaryOutcomes measure: Step count, otherOutcomes measure: Body height, otherOutcomes measure: Body weight, otherOutcomes measure: Body mass index (BMI), otherOutcomes measure: Modified Ashworth Scale Score of the Plantar flexors, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Institute of Human Movement Science, Sport and Health, University of Graz, status: RECRUITING, city: Graz, zip: 8010, country: Austria, contacts name: Sebastian Ruin, Univ.-Prof., role: CONTACT, phone: 00433163802336, email: sebastian.ruin@uni-graz.at, geoPoint lat: 47.06667, lon: 15.45, hasResults: False
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protocolSection identificationModule nctId: NCT06330909, orgStudyIdInfo id: P003103, secondaryIdInfos id: DRKS00022915, type: OTHER, domain: Deutsches Register Klinische Studien, briefTitle: Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt, acronym: HypoF-SBRT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-18, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2030-02, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University Hospital Freiburg, class: OTHER, collaborators name: German Federal Ministry of Education and Research, descriptionModule briefSummary: Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy.Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 374, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT, interventions name: Radiotherapy (RT) Arm B - IMRT/IGRT, outcomesModule primaryOutcomes measure: Relapse free survival, secondaryOutcomes measure: Time to local failure after randomization, secondaryOutcomes measure: Metastatic free survival after randomization, secondaryOutcomes measure: Overall (OS) and prostate cancer specific (PCSS) survival after randomization, secondaryOutcomes measure: Time to biochemical failure (phoenix definition) after randomization, secondaryOutcomes measure: Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26), secondaryOutcomes measure: Patient reported late quality of life (QOL), secondaryOutcomes measure: Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria, secondaryOutcomes measure: Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria, secondaryOutcomes measure: Dose constraints and prescription doses / recruited patients, secondaryOutcomes measure: Characterization of safety: adverse events, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center - University of Freiburg, status: RECRUITING, city: Freiburg, state: Baden-Württemberg, zip: 79106, country: Germany, geoPoint lat: 47.9959, lon: 7.85222, hasResults: False
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protocolSection identificationModule nctId: NCT06330896, orgStudyIdInfo id: 346/2566(IRB3), briefTitle: Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing, acronym: genetics MM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2028-04-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:* genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing* genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.* disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.* correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing., conditionsModule conditions: Plasma Cell Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 498, type: ESTIMATED, outcomesModule primaryOutcomes measure: genetic landscape of PCD, secondaryOutcomes measure: genetic correlation, secondaryOutcomes measure: genetic landscape of relapse MM patients, secondaryOutcomes measure: overall survival, secondaryOutcomes measure: progression free survival, secondaryOutcomes measure: factor of genetic landscape differentiation, secondaryOutcomes measure: gender, secondaryOutcomes measure: age, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330883, orgStudyIdInfo id: 2021/507, briefTitle: Determining the Prevalence of Frailty and Evaluating Its Relationship With Mortality., statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-01-01, completionDateStruct date: 2023-01-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: Covid-19 patients admitted to the intensive care unit of Selcuk University Hospital were included in the study. Clinical frailty score was given during admission to the intensive care unit. Demographic data, laboratory data, radiological imaging and vital signs of the patients were recorded. Treatment and patient positions were recorded during the intensive care follow-up of the patients. Mortality status of the patients 6 months after admission to the ICU was recorded., conditionsModule conditions: Frailty, conditions: Mortality, conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 148, type: ACTUAL, armsInterventionsModule interventions name: Prognosis, outcomesModule primaryOutcomes measure: Mortality, secondaryOutcomes measure: The Sequential Organ Failure Assessment Score, The Acute Physiology and Chronic Health Evaluation II Score, secondaryOutcomes measure: Thorax computed tomography (CT) imaging, secondaryOutcomes measure: Laboratory values, secondaryOutcomes measure: Respiratory support, secondaryOutcomes measure: Vasoactive drugs administered, secondaryOutcomes measure: Renal replacement therapy, secondaryOutcomes measure: Patient positions, secondaryOutcomes measure: Length of stay in the intensive care unit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Selcuk University Hospital, city: Konya, state: Selçuklu, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
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protocolSection identificationModule nctId: NCT06330870, orgStudyIdInfo id: BCBM_Breast, briefTitle: Brain Metastasis Development Mechanism in BCBM Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-06, primaryCompletionDateStruct date: 2025-02-05, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, descriptionModule briefSummary: This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis, conditionsModule conditions: Breast Cancer, conditions: Brain Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: WGS/TME evaluation, outcomesModule primaryOutcomes measure: Intracranial disease free survival, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ji-Yeon Kim, status: RECRUITING, city: Seoul, zip: 06351, country: Korea, Republic of, contacts name: Ji-Yeon Kim, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06330857, orgStudyIdInfo id: Dnr2021-06921-02, briefTitle: Recurrence and Bowel Function After Laparoscopic Vaginorectopexy, a Modified Anterior Rectopexy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2002-05-28, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Sahlgrenska University Hospital, Sweden, class: OTHER, descriptionModule briefSummary: Several pelvic prolapses can render defecation difficulties and they are often treated with different surgical techniques. This study will evaluate a novel variation of a laparoscopic technique used to treat rectal prolapse that is modified to treat multiple pelvic prolapses. 25 women with symptoms of obstructed defecation and multiple pelvic prolapses are assessed before and after surgery with clinical examination, defecography and a questionnaire for bowel function and quality of life. Follow up was scheduled after three and twelve months and at long term (minimum ten years)., conditionsModule conditions: Rectal Prolapse, conditions: Fecal Incontinence, conditions: Defecation Disorder, conditions: Enterocele, conditions: Rectocele, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Evaluation of recurrence with clinical examination and defecography. Evaluation of bowel function with a questionnaire., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Laparoscopic vaginorectopexy, outcomesModule primaryOutcomes measure: Recurrence, primaryOutcomes measure: Bowel function, primaryOutcomes measure: Bowel related quality of life, secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Peroperative complications, secondaryOutcomes measure: Operative time, secondaryOutcomes measure: Conversions to open surgery, secondaryOutcomes measure: Hospital days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330844, orgStudyIdInfo id: RBSEF-MCI-CCT, briefTitle: Race-Based Stress and Cognitive Training for MCI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2026-09-15, completionDateStruct date: 2027-03-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Rosalind Franklin University of Medicine and Science, class: OTHER, descriptionModule briefSummary: This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group.Following the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group.Hypothesis: Participation in this newly developed/updated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups assignment - One group will complete the original ME-CCT training program. The other group will complete the newly developed RBSE-CCT-MCI., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment (RBSEF-CCT-MCI), interventions name: Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT), outcomesModule primaryOutcomes measure: Verbal learning and memory, primaryOutcomes measure: Basic auditory attention and working memory, primaryOutcomes measure: Psychomotor processing speed, primaryOutcomes measure: Psychomotor processing speed; executive functioning, primaryOutcomes measure: Self-report of prospective and retrospective memory, primaryOutcomes measure: Self-report of cognitive concerns, primaryOutcomes measure: The Patient Health Questionnaire-9, primaryOutcomes measure: Self-report symptoms of anxiety, primaryOutcomes measure: Self-reported daily functioning, primaryOutcomes measure: The Racial Microaggressions Scale, primaryOutcomes measure: The Trauma Symptoms of Discrimination Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rosalind Franklin University of Medicine and Science, city: Chicago, state: Illinois, zip: 60064, country: United States, contacts name: Rachael Ellison, PhD, role: CONTACT, contacts name: Rachael Ellison, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06330831, orgStudyIdInfo id: x2ghr8pc, briefTitle: Intensive Group Based CIMT for Young Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-05-09, primaryCompletionDateStruct date: 2023-06-28, completionDateStruct date: 2023-07-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Rockhurst University, class: OTHER, collaborators name: Ability KC, descriptionModule briefSummary: This project aims to investigate the effectiveness of an intensive, group-based Constraint Induced Movement Therapy (CIMT) program for young children ages 2-6 years with unilateral hemiparesis, or weakness on one side of the body. This project involves two studies. Study 1 investigates the effect of one dosage of a 1-month, intensive group based CIMT summer program. Study 2 investigates the effect of a repeated, consecutive episode of the intensive, group based CIMT program for children who attended the program the following summer., conditionsModule conditions: Hemiplegic Cerebral Palsy, conditions: Non-Accidental Traumatic Head Injury to Child, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Study 1 is a single group pre-post study of children who received 1 episode of the intensive, group based CIMT intervention (2 data points- pre CIMT 1 and post CIMT1). Study 2 is a repeated measures design to evaluate the long-term effects of the first episode and the effects of the second episode of intensive group based CIMT (4 data points- pre CIMT1; post CIMT1 (at the end of 1 month intervention); pre CIMT 2- 11 months after post of CIMT1; post CIMT 2- 12 months post CIMT 1), primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: No masking occurred for the participants or care providers since all parents/caregivers consented to have their children participate in the intensive group based CIMT intervention. The parents/ care providers knew who the interventionists were. The principal investigator was aware of all participants' assignment to the study. The principal investigator also delivered the intervention to the 2-3-year-old group and also served as the assessor of outcomes along with trained student investigators. The principal investigator attempted to limit bias by having all students achieve an inter-rater reliability level of 90% or above (intra-class correlation coefficient ICC\>.90) on the QUEST and by not allowing the student investigators or herself to consult the pre-intervention assessment outcome scores until after post-intervention outcome assessment scoring was completed., enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: Intensive, Group Based Constraint Induced Therapy (CIMT), outcomesModule primaryOutcomes measure: Quality Upper Extremity Skills Evaluation Test (QUEST), primaryOutcomes measure: Assisting Hand Assessment (AHA), primaryOutcomes measure: Canadian Occupational Performance Measure (COPM), primaryOutcomes measure: Pediatric Evaluation Disability Inventory (PEDI), eligibilityModule sex: ALL, minimumAge: 20 Months, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330818, orgStudyIdInfo id: IMAGINE Moyamoya, secondaryIdInfos id: 528291394, type: OTHER_GRANT, domain: German Research Council (DFG), briefTitle: Imaging in Moyamoya Disease - Study to Investigate Different Imaging Technologies for a Better Understanding of Various Imaging Techniques to Evaluate Cerebral Hemodynamics, Disease-activity and Possibly the Etiology in Moyamoya Patients, acronym: IMAGINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-30, completionDateStruct date: 2027-05-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University Hospital Tuebingen, class: OTHER, collaborators name: University Hospital Freiburg, descriptionModule briefSummary: Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression.Main tasks are:* Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT* Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling* Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients, conditionsModule conditions: Moyamoya Disease, conditions: Moyamoya, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: MRI, interventions name: H2 15O PET/CT, interventions name: Biosampling, outcomesModule primaryOutcomes measure: Value of CO2-triggered BOLD MRI compared to PET/CT, secondaryOutcomes measure: Vessel-Wall contrast enhancement, secondaryOutcomes measure: Circulating endothelial cells, secondaryOutcomes measure: PCR-based virus sampling, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330805, orgStudyIdInfo id: OSU-23069, secondaryIdInfos id: NCI-2024-00705, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, collaborators name: Pfizer, collaborators name: Myovant Sciences GmbH, collaborators name: Sumitomo Pharmaceuticals America, descriptionModule briefSummary: This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:1. Comprehensive cardiac and exercise testing before and after starting ADT2. Completion of quality-of-life questionnaires at specific intervals during the study period3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers, conditionsModule conditions: Prostate Adenocarcinoma, conditions: Stage IIB Prostate Cancer AJCC v8, conditions: Stage IIC Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Contrast Agent, interventions name: Leuprolide, interventions name: Magnetic Resonance Imaging, interventions name: Physical Performance Testing, interventions name: Relugolix, outcomesModule primaryOutcomes measure: Physiologic alterations in cardiopulmonary function - Myocardial perfusion, primaryOutcomes measure: Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption, secondaryOutcomes measure: Quality of life using EPIC-26, secondaryOutcomes measure: Quality of life using EORTC QLQ-C30, secondaryOutcomes measure: Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L), secondaryOutcomes measure: Quality of life using PROMIS, secondaryOutcomes measure: Functional tests of strength and balance using Timed Up-and-Go, secondaryOutcomes measure: Functional tests of strength and balance using 10-meter walk time, secondaryOutcomes measure: Functional tests of strength and balance using Grip strength, secondaryOutcomes measure: Changes in body composition, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Shang-Jui Wang, role: CONTACT, phone: 614-366-9306, email: Shang-Jui.Wang@osumc.edu, contacts name: Shang-Jui Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06330792, orgStudyIdInfo id: mechanical low back pain, briefTitle: Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-04, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: investigate the effect of bio-mechanical awareness and core stability exercises on mechanical low back pain among Egyptian Physiotherapists, conditionsModule conditions: Mechanical Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Physiotherapists will be randomly subdivided into two equal groups in number. Group (A) (Experimental Group): This group will receive biomechanical awareness advices while working and core stability exercises.Group (B) (Control Group): This group will receive core stability exercises only., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: bio-mechanical awareness, interventions name: core stability exercises, outcomesModule primaryOutcomes measure: intensity of low back pain, secondaryOutcomes measure: back muscle endurance, secondaryOutcomes measure: level of function (disability) associated with mechanical Low Back Pain, secondaryOutcomes measure: Fatigue Severity, secondaryOutcomes measure: psycho-social factors at work, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330779, orgStudyIdInfo id: UWest, briefTitle: Trauma-adapted Yoga in Child & Adolescent Psychiatry., acronym: TAY-CAP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University West, Sweden, class: OTHER, collaborators name: Västra Götalands Region, collaborators name: Region Stockholm, collaborators name: Region Skåne, collaborators name: Region Värmland, collaborators name: Region Östra Gotland, collaborators name: Region Örebro, descriptionModule briefSummary: The goal of this randomized clinical trial is to evaluate the efficacy of trauma-adapted yoga as a complementary intervention to care as usual in child and adolescents psychiatry clinics, in the population of adolescents with the diagnosis of ADHD and/or PTSD. We hypothesize that trauma-adapted yoga (TAY) is an effective non-pharmacological intervention for adolescent with ADHD and/or PTSD. Aims: (1) Validate the impact of TAY on the mental health \& quality of life of adolescents with ADHD and/or PTSD. (2) Investigate the feasibility of online TAY for continued self-care. (3) Explore adolescents' experiences \& parental perspectives on TAY in their treatment. (4) Explore healthcare professionals' experience on the integration of TAY into clinical practice.Within and between group (yoga group vs waiting list) analyses will be performed., conditionsModule conditions: ADHD, conditions: PTSD, conditions: Quality of Life, conditions: Self-Control, conditions: Pain, conditions: Affect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Trauma-adapted yoga, outcomesModule primaryOutcomes measure: Negative experience score CPSS-5-S, primaryOutcomes measure: Inattention, impulsivity score, primaryOutcomes measure: Resilience score, secondaryOutcomes measure: Pain frequency and intensity, secondaryOutcomes measure: affect, secondaryOutcomes measure: Self-directednes, secondaryOutcomes measure: Quality of life score, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330766, orgStudyIdInfo id: PET24, briefTitle: Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients, acronym: DENTAVI, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, descriptionModule briefSummary: In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023., conditionsModule conditions: Transcatheter Aortic Valve Implantation, conditions: Dental, conditions: Endocarditis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: No preoperative dental screening, outcomesModule primaryOutcomes measure: Number of Participants with Infectious Endocarditis, secondaryOutcomes measure: Number of Participants undergoing Oral surgical procedure at dental screening, secondaryOutcomes measure: Number of Participants undergoing Tooth extraction at dental screening, secondaryOutcomes measure: The different Bacteria types causing the infectious endocarditis assessed by blood culture, secondaryOutcomes measure: Number patients with Bacteremia assessed by positive blood culture, secondaryOutcomes measure: Number of Participants with IE caused by bacteria from oral foci, secondaryOutcomes measure: Number of Participants with Cardiac implantable electronic device risk of IE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Odense University Hospital, Cardiology Department, status: RECRUITING, city: Odense, zip: 5000, country: Denmark, contacts name: Jordi S Dahl, MD,PhD,DMSc, role: CONTACT, phone: 004524638899, email: Jordi.Sanchez.Dahl@rsyd.dk, contacts name: Lytfi Krasniqi, MD, role: CONTACT, phone: 004524638899, email: Lytfi.Krasniqi@rsyd.dk, contacts name: Jordi S Dahl, MD,PhD,DMSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Lytfi Krasniqi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False
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protocolSection identificationModule nctId: NCT06330753, orgStudyIdInfo id: 2024P000682, briefTitle: Synergy Between Patient and Clinician: Using a Trauma-Informed Care Plan, acronym: TICP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, descriptionModule briefSummary: The goal of this prospective study is to test the: acceptability of trauma-informed care plans; the intervention appropriateness; and the feasibility of the trauma-informed care plans in the electronic health care record. Patient seen in various health care settings and how have complex health care needs will be invited to participate in this study. The aims to are:Aim 1: Explore the acceptability of trauma-informed care plans, the appropriateness of trauma-informed care plans, and the feasibility of Trauma-Informed Care Plans(TICP) when used by clinicians on the health care team (HCTC). Hypothesis 1: HCTC using the TICP will report its acceptability, feasibility, satisfaction and ease of use. Hypothesis 2: HCTC will report heightened awareness of intersection of trauma and social determinants of health. Hypothesis 3: HCTC will report more awareness of the patient's unique preferences and will be better informed regarding the unique plan of care for their patient.Aim 2: Explore the impact of having a TICP by patients understanding how the TICP may have improved their experience around care and treatment. Hypothesis 1: patients will report: improved satisfaction with their care. Hypothesis 2: patients will report feeling better known by HCT. Hypothesis 3: will report less stress and anxiety related to health care encounters., conditionsModule conditions: Trauma and Stressor Related Disorders, conditions: Violence, Structural, conditions: Violence, Domestic, conditions: Violence, Sexual, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a prospective study designed to explore the acceptability, intervention appropriateness of trauma-informed care plans and the feasibility of trauma-informed care plans by patients and members of the health care team, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Participants (patients and providers) will be de-identified, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Trauma-informed Care Plan-, outcomesModule primaryOutcomes measure: Acceptability of Trauma Informed Care Plans, secondaryOutcomes measure: Intervention Appropriateness of Trauma-Informed Care plans, secondaryOutcomes measure: Feasibility of the trauma-informed care plans, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330740, orgStudyIdInfo id: AAAU3416, briefTitle: Evaluations of CDS Systems, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: New York Presbyterian Hospital, class: OTHER, descriptionModule briefSummary: Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors., conditionsModule conditions: Safety Issues, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Clinical Decision Support, outcomesModule primaryOutcomes measure: The combined rate of Wrong Drug, Wrong Duration, Wrong Dose and Wrong Frequency Retract-And-Reorder (RAR) events will be combined to create an overall rate of near-miss ordering errors in the control and intervention arm., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330727, orgStudyIdInfo id: KY20231109-09, briefTitle: Effects of Coffee Consumption on Metabolic Markers in Adults With Prediabetes and Obesity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Epidemiological studies have shown an inverse association between coffee consumption and risk of type 2 diabetes. However, the randomized controlled trials in prediabetes are limited to evaluate the effects of coffee. The purpose of this study is to investigate the effects of coffee on metabolic factors and inflammation in individuals with prediabetes and obesity. A double-blind, randomized controlled trial is designed to explore the effects of coffee consumption on participants with prediabetes and obesity. A total of 100 eligible participants with prediabetes and obesity will be recruited from the Health Management Center of Nanjing First Hospital. These participants are randomly assigned in a 1:1 ratio to either the coffee capsule group or the control group. The coffee capsule group will be instructed to consume 3.6 g of coffee capsules per day (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). The control group will be asked to consume 3.6 g of cornstarch capsules (0.3 g per capsule, 6 capsules per serving, twice a day, once in the morning and once in the middle of the day). 75 g oral glucose tolerance test, 2-week blinded continuous glucose measurement and others will be performed before and after the 3-month intervention. During the three months of intervention, the information on dietary intake, physical activity and sleep of participants will be systematically collected. To comprehensively assess the impact of coffee intake on prediabetes and obesity, we will analyze the effects of coffee capsules on various metabolic and inflammatory markers, including glucose metabolism, lipid profiles, blood pressure, adiponectin, high sensitivity C-reactive protein, interleukin-6, body mass index, body composition, the degree of hepatic steatosis and so on. We will further adjust for potential confounding factors such as lifestyle factors to better understand the underlying biological mechanisms driving this association., conditionsModule conditions: Prediabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Coffee capsule, interventions name: Corn starch capsule, outcomesModule primaryOutcomes measure: Continuous glucose monitoring parameters, primaryOutcomes measure: glucose from a 75 g-oral glucose tolerance test （mmol/L）, primaryOutcomes measure: insulin from a 75 g-oral glucose tolerance test （pmol/L）, primaryOutcomes measure: C-peptide from a 75 g-oral glucose tolerance test (ng/ml), primaryOutcomes measure: glucagon from a 75 g-oral glucose tolerance test（pmol/L）, primaryOutcomes measure: Glycated hemoglobin (HbA1c) ( % ), primaryOutcomes measure: Fasting total cholesterol (mmol/L), primaryOutcomes measure: Fasting high-density lipoprotein-cholesterol (mmol/L), primaryOutcomes measure: Fasting low-density lipoprotein-cholesterol (mmol/L), primaryOutcomes measure: Fasting triglycerides (mmol/L), secondaryOutcomes measure: C-reactive protein, secondaryOutcomes measure: Interleukin-6, secondaryOutcomes measure: Body mass index ( kg/m^2), secondaryOutcomes measure: Fat mass (FM), secondaryOutcomes measure: body fat percentage (BF), secondaryOutcomes measure: visceral fat, secondaryOutcomes measure: skeletal muscle mass (SMM), secondaryOutcomes measure: fat-free mass (FFM), secondaryOutcomes measure: Adiponectin, secondaryOutcomes measure: Systolic blood pressure（mmHg）, secondaryOutcomes measure: Diastolic blood pressure（mmHg）, secondaryOutcomes measure: Heart rate （bpm）, secondaryOutcomes measure: Controlled attenuation parameter (CAP), secondaryOutcomes measure: Standard deviation of heart rate variability (SDNN), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nanjing First Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210006, country: China, contacts name: Jun Wang, M.D., PhD., role: CONTACT, phone: 8613382079966, email: wangjun868@163.com, contacts name: Lin Li, PhD., role: CONTACT, phone: 8615380998768, email: guobaolimu@126.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06330714, orgStudyIdInfo id: AV.RMH.v01-01, briefTitle: Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements, acronym: REMOTE-HUB-1, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-07-01, primaryCompletionDateStruct date: 2018-11-30, completionDateStruct date: 2018-12-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Aventyn, Inc., class: INDUSTRY, collaborators name: Intel Corporation, descriptionModule briefSummary: This is planned as a feasibility study.The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction.The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device, conditionsModule conditions: Chronic Disease of Cardiovascular System, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Symptoms of chronic illness., outcomesModule primaryOutcomes measure: Mobile Home Device Hub Data Resiliency, secondaryOutcomes measure: Patient Self Monitoring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Liver Health, city: Chandler, state: Arizona, zip: 85248, country: United States, geoPoint lat: 33.30616, lon: -111.84125, hasResults: False
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protocolSection identificationModule nctId: NCT06330701, orgStudyIdInfo id: 2023URO0001, briefTitle: Stone Access and Removal (STAR) Study, acronym: STAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Auris Health, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology., conditionsModule conditions: Kidney Calculi, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Robotic-assisted mini-PCNL, outcomesModule primaryOutcomes measure: Percentage of Robotic-assisted mini-Percutaneous Nephrolithotomy (PCNL) Kidney Stone Removal Procedure Completed, secondaryOutcomes measure: Stone Free Rate (%), secondaryOutcomes measure: Number of Adverse Events, secondaryOutcomes measure: Number of Procedure Conversions to Conventional Treatment Methods due to study device-related safety event, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indiana University, status: RECRUITING, city: Bloomington, state: Indiana, zip: 47401, country: United States, geoPoint lat: 39.16533, lon: -86.52639, locations facility: UW School of Medicine and Public Health, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53705, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
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protocolSection identificationModule nctId: NCT06330688, orgStudyIdInfo id: ΕΒΔ 53/25.01.2024, briefTitle: Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Attikon Hospital, class: OTHER, descriptionModule briefSummary: The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside., conditionsModule conditions: Cholecystitis, Acute, conditions: Cholecystitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: percutaneous cholecystostomy, outcomesModule primaryOutcomes measure: Technical success, primaryOutcomes measure: Procedure-related complications, secondaryOutcomes measure: duration of the procedure, secondaryOutcomes measure: intraprocedural and post-procedural pain, secondaryOutcomes measure: clinical success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Attikon University Hospital, status: RECRUITING, city: Chaïdári, state: Athens, zip: 12461, country: Greece, contacts name: Stavros Spiliopoulos, MD, Associate Professor, role: CONTACT, phone: +302105831812, email: stavspiliop@gmail.com, geoPoint lat: 38.01135, lon: 23.66597, hasResults: False
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protocolSection identificationModule nctId: NCT06330675, orgStudyIdInfo id: 2022-01820, briefTitle: Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Caporali Elena, class: OTHER, collaborators name: Cardiocentro Ticino, descriptionModule briefSummary: Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure., conditionsModule conditions: Pacemaker, conditions: Defibrillators, Implantable, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 558, type: ESTIMATED, armsInterventionsModule interventions name: Early mobilization, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion, secondaryOutcomes measure: Post-operative pain, secondaryOutcomes measure: Sleep disturbance, secondaryOutcomes measure: Postoperative urinary retention, secondaryOutcomes measure: Delirium, secondaryOutcomes measure: Orthostatic intolerance, secondaryOutcomes measure: Quality of recovery, secondaryOutcomes measure: Pressure ulcer, otherOutcomes measure: Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cardiocentro Ticino Institute - EOC, status: RECRUITING, city: Lugano, zip: 6900, country: Switzerland, contacts name: Elena Caporali, MD, role: CONTACT, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False
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protocolSection identificationModule nctId: NCT06330662, orgStudyIdInfo id: 05-PA-30-19-6/2023., briefTitle: Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Andelina Sekelja, class: OTHER, descriptionModule briefSummary: The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a coronally advanced flap (CAF+HA). The main question it aims to answer is: is there any difference in the reduction of multiple gingival recessions between the control (CAF) and the test group (CAF + HA)? The research would be conducted on subjects referred for specialist treatment at the Department of Periodontology (Faculty of dental medicine, University of Zagreb). A record would be kept of all patients who underwent a detailed clinical examination, those who did not meet the criteria for inclusion in the study and those who refused to participate in it. Participants who meet the inclusion criteria will undergo a detailed clinical examination and if they agree to participate in the research, they will sign the informed form. During the pre-treatment, patients will receive instructions and a demonstration on proper maintenance of oral hygiene as well as a teeth cleaning. In addition to the informed form, they will fill out the OHIP-14 questionnaire, and the researcher will measure the periodontal indices at the very beginning before the operation, as well as the Schiff index. Patients will be photographed at the baseline as well as at follow-up examinations. The total number of subjects would be 42, or 21 patients in the 2 observed groups. The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA)., conditionsModule conditions: Gingival Recession, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA)., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Randomization would first be generated using a computer-selected program, and then the protocol itself would be placed in opaque sealed envelopes and handed to the operator immediately before the procedure with a decision as to whether or not hyaluronic acid (HA) would be applied. In treated areas where HA will not be applied, the operative site will be treated only with saline. The patient as well as the researcher and the outcomes assesssor will not be informed which patient belongs to which group. Randomization and allocation of envelopes as well as allocation of patients to groups will be determined by a fourth party., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only, outcomesModule primaryOutcomes measure: The effect of hyaluronic acid on recession reduction, secondaryOutcomes measure: To examine the effect of tissue thickness on recession coverage (KTt), secondaryOutcomes measure: To examine keratinized gingiva width (KTw), secondaryOutcomes measure: To examine changes in periodontal clinical parameters: PPD, secondaryOutcomes measure: To examine changes in periodontal clinical parameters: CAL, secondaryOutcomes measure: To examine changes in periodontal clinical parameters: REC, secondaryOutcomes measure: To examine changes in periodontal clinical parameters: FMPS (full mouth plaque score), secondaryOutcomes measure: To examine changes in periodontal clinical parameters: FMBS (full mouth bleeding score), secondaryOutcomes measure: Assess the healing quality of the operated area by using a RES scale, secondaryOutcomes measure: Schiff test tooth examination, secondaryOutcomes measure: To examine the impact of oral health on quality of life, secondaryOutcomes measure: To evaluate the level of pain postoperatively during the healing of the surgical wound, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zagreb - School of dental medicine, city: Zagreb, state: Hrvatska, zip: 10 000, country: Croatia, geoPoint lat: 45.81444, lon: 15.97798, hasResults: False
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protocolSection identificationModule nctId: NCT06330649, orgStudyIdInfo id: 2024-0095, briefTitle: The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy Metabolism, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The University of Texas at Arlington, class: OTHER, descriptionModule briefSummary: The objective of this protocol is to investigate the effect of consumption of a commercially available energy drink beverage on blood pressure, heart rate, and energy metabolism, conditionsModule conditions: Cardiovascular Diseases, conditions: Hypertension, conditions: Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Individuals will be randomly assigned to either an experimental or a control condition., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Energy Drink, interventions name: Water Control, outcomesModule primaryOutcomes measure: Peripheral blood pressure in millimeters of mercury, primaryOutcomes measure: Oxygen consumption milliliters per kilogram of body weight per minute, primaryOutcomes measure: Heart rate in beats per minute, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: UT Arlington - Science and Engineering Innovation and Research Building, status: RECRUITING, city: Arlington, state: Texas, zip: 76019, country: United States, contacts name: Robert M Brothers, PhD, role: CONTACT, phone: 817-272-3288, email: matthew.brothers@uta.edu, contacts name: Alison Mancera, BS, role: CONTACT, phone: 8172723288, email: alison.mancera@mavs.uta.edu, geoPoint lat: 32.73569, lon: -97.10807, hasResults: False
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protocolSection identificationModule nctId: NCT06330636, orgStudyIdInfo id: 336-0723, briefTitle: The Acute Effect of D-allulose Consumption on Postprandial Glycaemia, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2024-03-28, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Nottingham, class: OTHER, descriptionModule briefSummary: The rare sugar D-Allulose, when consumed in a drink before eating has been shown to reduce the blood glucose response to high carbohydrate drinks or meals in people who are healthy, or have elevated fasting blood glucose concentration. However, the effectiveness of D-allulose to suppress blood glucose concentration when added into carbohydrate containing food products has not been previously reported and as the potential use of allulose is as a sucrose replacer in foods, rather than drinks, it is important that effects and efficacy are tested in this format. The study aimed to extend understanding of the acute effects of D-allulose consumption in humans by testing whether post-eating blood glucose concentration can be modified by the presence of D-allulose in a high carbohydrate breakfast and collecting data on any adverse gastrointestinal effects of consuming D-allulose., conditionsModule conditions: Sugar; Blood, High, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Randomised, placebo controlled cross over design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Allocation coded A and B, with independent researcher determining allocation and making up the test breakfasts for the study team., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: D-Allulose, interventions name: Sodium Saccharin, outcomesModule primaryOutcomes measure: Incremental area under the curve (iAUC) 180 Glucose Test, primaryOutcomes measure: iAUC 180 Glucose Placebo, secondaryOutcomes measure: Glycaemia Test, secondaryOutcomes measure: Glycaemia Placebo, secondaryOutcomes measure: Insulinemia Test, secondaryOutcomes measure: Insulinemia Placebo, secondaryOutcomes measure: iAUC 180 Insulin Test, secondaryOutcomes measure: iAUC 180 Insulin Placebo, secondaryOutcomes measure: iCAS Test, secondaryOutcomes measure: iCAS Placebo, secondaryOutcomes measure: abdominal discomfort test, secondaryOutcomes measure: abdominal discomfort placebo, secondaryOutcomes measure: Dietary Fibre, secondaryOutcomes measure: Carbohydrate %, secondaryOutcomes measure: Fat %, secondaryOutcomes measure: Protein %, secondaryOutcomes measure: Sugars %, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: David Greenfield Human Physiology Laboratories, city: Nottingham, state: Notts, zip: NG72UH, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False
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protocolSection identificationModule nctId: NCT06330623, orgStudyIdInfo id: 0929, secondaryIdInfos id: 321895, type: OTHER, domain: HRA, briefTitle: Developing Personalised Relative Physical Activity Thresholds in COPD., acronym: IMPACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-22, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of Leicester, class: OTHER, descriptionModule briefSummary: The aim of this observational study is to translate the principle of individualised exercise prescription into the evaluation of daily absolute and relative intensity physical activity.The main questions this study aims to answer are:* Phase 1: What does physical activity (intensity) mean to people with COPD?* Phase 2: Are there differences between time spent in absolute and relative physical activity for people with COPD?Phase 1 Participants will take part in semi-structured interview (30-45 minutes) about living with COPD and perceptions of physical activity and how they perceive intensity. This will also include photovoice and photo-elicitation. Demographic information will be recorded and participants will also complete several respiratory symptom questionnaires.Phase 2:Participants will take part in physical activity testing before and after pulmonary rehabilitation while wearing physical activity monitors. Demographic information will be recorded and participants will also complete several respiratory symptom and physical activity questionnaires. Participants will also wear the physical activity monitors for 8 days after the pre-testing sessions and after their final pulmonary rehabilitation class.Sub-study:Participants will be asked to take images of barriers during physical activity, facilitators during physical activity, feelings during physical activity and types of physical activity they take part in for 8 days after their final pulmonary rehabilitation class. Participants will then take part in a semi-structured interview about the images their have taken while doing physical activity., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Phase 1 - Semi-structured Interviews, primaryOutcomes measure: Phase 2 - Differences between time spent in PA intensity expressed in absolute and relative intensity., secondaryOutcomes measure: Phase 1 - Medical Research Council (MRC) Dyspnoea Scale, secondaryOutcomes measure: Phase 1 - COPD Assessment Test (CAT), secondaryOutcomes measure: Phase 1 - Chronic Respiratory Questionnaire (CRQ-SR), secondaryOutcomes measure: Phase 1 - Photovoice and photo-elicitation, secondaryOutcomes measure: Phase 2 - Medical Research Council (MRC) Dyspnoea Scale, secondaryOutcomes measure: Phase 2 - COPD Assessment Test (CAT), secondaryOutcomes measure: Phase 2 - Chronic Respiratory Questionnaire (CRQ-SR), secondaryOutcomes measure: Phase 2 - Gait Analysis, secondaryOutcomes measure: Phase 2 - Exercise Capacity (ISWT), secondaryOutcomes measure: Phase 2 - Exercise Capacity (ESWT), secondaryOutcomes measure: Daily PROactive Physical Activity instrument in COPD (D-PPAC), secondaryOutcomes measure: Phase 2 - Photovoice and photo-elicitation, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NIHR Leicester Biomedical Research Centre - Respiratory, status: RECRUITING, city: Leicester, state: Leicestershire, zip: LE67 2DU, country: United Kingdom, contacts name: Phoebe H Lloyd-Evans, role: CONTACT, phone: +441162502758, email: phile1@leicester.ac.uk, contacts name: Mark W Orme, role: CONTACT, email: mwo4@leicester.ac.uk, contacts name: Mark W Orme, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.6386, lon: -1.13169, hasResults: False
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protocolSection identificationModule nctId: NCT06330610, orgStudyIdInfo id: 2021/0378/HP, briefTitle: Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit, acronym: ENNUT-CI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficiency of intermittent enteral nutrition versus continuous enteral nutrition to prevent from organ failures for patients at the acute phase of sepsis shock with mechanical ventilation in ICU., conditionsModule conditions: Intermittent Fasting, conditions: Septic Shock, conditions: Organ Failure, Multiple, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent enteral nutrition, outcomesModule primaryOutcomes measure: Evolution of variation of the SOFA (Sepsis-related organ failure assessment) score., secondaryOutcomes measure: evaluation of caloric intake, secondaryOutcomes measure: evaluation of protein intake, secondaryOutcomes measure: Measurement of nutritionnal status, secondaryOutcomes measure: Evaluation of the digestive symptoms, secondaryOutcomes measure: Evaluation of the nosocomial infections, secondaryOutcomes measure: Evaluation of the metabolic response, secondaryOutcomes measure: Evaluation of the duration of hospitalisation, secondaryOutcomes measure: Evaluation of the intensive care neuromuscular weakness, secondaryOutcomes measure: Evaluation of death, secondaryOutcomes measure: Evaluation of quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330597, orgStudyIdInfo id: 21-5196, briefTitle: NIVIA-Hemodynamics, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-07-17, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: This is an investigator-initiated, single-center, single-arm prospective study to compare non-invasive hemodynamic assessment using transthoracic echocardiography (TTE) and lung ultrasound (LUS) and hemodynamic assessment using PAC. Patients who have been hemodynamically assessed using PAC will be invited to participate. Each patient will undergo TTE and LUS immediately after first invasive assessment, and again daily after PAC assessments., conditionsModule conditions: Cardiogenic Shock, conditions: Heart Failure, conditions: Shock, conditions: Hemodynamic Instability, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Echocardiography and lung ultrasound, outcomesModule primaryOutcomes measure: Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP., secondaryOutcomes measure: Correlation between cardiac output measured by echocardiography (using LVOT diameter and VTI) and by PAC (using thermodilution), secondaryOutcomes measure: Correlation between right atrial pressure assessed by echocardiography (using IVC diameter and respiratory variation) and by PAC, secondaryOutcomes measure: Correlation between pulmonary pressure assessed by echocardiography (using TR max velocity and estimated RAP) and by PAC, secondaryOutcomes measure: Correlation between pulmonary pressure assessed by echocardiography (using PAT) and by PAC, secondaryOutcomes measure: Correlation between PVR assessed by echocardiography (using PAT) and by PAC, secondaryOutcomes measure: Correlation between right ventricular function assessed by echocardiography (using TAPSE and S') and by PAC (using PAPI and RVSWI), secondaryOutcomes measure: Correlation between E/e' ratio and PCWP vs. correlation between lung ultrasound score and PCWP., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 2N2, country: Canada, contacts name: Yishay Szekely, MD, role: CONTACT, phone: 4163404800, email: Yishay.szekely@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06330584, orgStudyIdInfo id: AIM Care Study, briefTitle: Administration of Intranasal Midazolam for Anxiety in Palliative Care, acronym: AIM Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: University Hospital, Basel, Switzerland, collaborators name: University Hospital, Zürich, collaborators name: Stadtspital Zürich, descriptionModule briefSummary: The goal of this double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study (three study arms) is to describe effects and safety of different doses of intranasal midazolam to treat acute anxiety in palliative care patients, while providing pharmacokinetic and pharmacodynamic data., conditionsModule conditions: Anxiety, conditions: Acute Anxiety, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-blind, randomized, placebo-controlled parallel-group multicenter exploratory pilot study with 3 study arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All study personnel except the personnel at the facility preparing the investigational medicinal product (IMP) (Hospital Pharmacy, University Hospital Basel), and all patients will be blinded to the assigned treatment. Allocation will be concealed using sequentially coded drug packs (using consecutive patient identification numbers from 1 to at least 30) containing the IMP that are otherwise identical. Each drug pack will contain two nasal sprays of identical appearance. Patients and all trial personnel involved in recruitment and care of patients, trial assessment, monitoring, and analyses will be blinded to the assigned trial arm. Blinding will be upheld until the last patient (at least 30 patients, i.e., at least 10 per study arm) has completed the pilot study and data entry into the trial database has been completed.To safeguard blinding, placebo formulation will be produced with the same pH as the active study drug formulations to mimic nasal irritation induced by verum sprays., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Placebo Nasal Spray 0 mg/spray, interventions name: Midazolam Nasal Spray 0.45 mg/spray, interventions name: Midazolam Nasal Spray 0.9 mg/spray, outcomesModule primaryOutcomes measure: Change from baseline in anxiety levels, measured by Visual Analogue Scale (VAS), primaryOutcomes measure: Change from baseline in anxiety levels, measured by Numerical Rating Scale (NRS), secondaryOutcomes measure: Sedation, secondaryOutcomes measure: Oxygen saturation SaO2 (percent %), secondaryOutcomes measure: Heart rate (bpm), secondaryOutcomes measure: Cortisol levels in oral fluid, secondaryOutcomes measure: Time to first requested additional dose, secondaryOutcomes measure: Cumulative number of doses over 24 hours, secondaryOutcomes measure: Number of patients with adverse drug events (ADEs), secondaryOutcomes measure: Peak plasma concentration (Cmax), secondaryOutcomes measure: Time to reach the peak plasma concentration (Tmax), secondaryOutcomes measure: Elimination half-life (t1/2), secondaryOutcomes measure: Area under the curve (AUC0-Τ, AUC0-∞), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inselspital, Universitätsspital Bern, city: Bern, zip: 3010, country: Switzerland, contacts name: Manuel Haschke, MD, role: CONTACT, phone: +41 (0)31 632 67 93, email: manuel.haschke@insel.ch, contacts name: Manuel Haschke, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Universitäres Zentrum für Palliative Care (UZP), city: Bern, country: Switzerland, contacts name: Steffen Eychmüller, MD, role: CONTACT, phone: +41 (0)31 632 51 07, email: steffen.eychmueller@insel.ch, geoPoint lat: 46.94809, lon: 7.44744, locations facility: Zentrum für Palliative Care, Stadtspital Zürich, city: Zürich, zip: 8037, country: Switzerland, contacts name: Andreas Major, MD, role: CONTACT, phone: +41 (0)44 417 29 26, email: andreas.major@stadtspital.ch, geoPoint lat: 47.36667, lon: 8.54999, locations facility: Kompetenzzentrum Palliative Care, Universitätsspital Zürich, city: Zürich, zip: 8091, country: Switzerland, contacts name: Caroline Hertler, MD, role: CONTACT, phone: +41 (0)44 255 29 34, email: caroline.hertler@usz.ch, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
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protocolSection identificationModule nctId: NCT06330571, orgStudyIdInfo id: Aligners in distalization, briefTitle: The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial., acronym: Aligner, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-27, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization., conditionsModule conditions: Orthodontic Aligners, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Molar distalization by aligners with attachment, outcomesModule primaryOutcomes measure: Efficiency of aligners in molar distalization, secondaryOutcomes measure: Amount of anchorage loss, secondaryOutcomes measure: Amount of molar tipping, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ainshams university, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06330558, orgStudyIdInfo id: pheos, briefTitle: Side-specific Factors for Conversion in Adrenalectomy for Pheochromocytoma., statusModule overallStatus: COMPLETED, startDateStruct date: 2016-09-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Context: Adrenalectomy for pheochromocytoma (PHEO) poses difficulties due to the elevated chance of conversion. The objective of this study was to conduct a comparative analysis of the occurrence and determinants of conversion in left-sided abdominal laparoscopic adrenalectomy (LLA) and right-sided abdominal laparoscopic adrenalectomy (RLA).Methods: A retrospective analysis was conducted to include a total of 271 patients diagnosed with PHEO. These patients were separated into two groups: LRA (N=121) and LLA (N=150). The study period spanned from September 2016 to September 2023., conditionsModule conditions: Adrenal Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 271, type: ACTUAL, armsInterventionsModule interventions name: laparoscopic right adrenalectomy, outcomesModule primaryOutcomes measure: conversion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330545, orgStudyIdInfo id: STUDY02002161, briefTitle: Radiation Therapy for Dupuytren's Contracture Following Non-Surgical Release, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2032-04, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Dartmouth-Hitchcock Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this study is to learn about preventing recurrence of Dupuytren's Contracture. The main question it aims to answer are:• Does targeted radiation therapy decrease recurrence of Dupuytren's contracture after treatment with Collagenase Clostridium Histolyticum?Participants will undergo:* Release of Dupuytren's Contracture after Collagenase Clostridium Histolyticum injection* Daily radiation therapy treatment for 5 days followed by 6-8 week rest period and then another course of 5 days of radiation therapy, conditionsModule conditions: Dupuytren Contracture, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a prospective phase II trial where patients diagnosed with late/advanced stage Dupuytren's Contracture (DC) who undergo successful CCH injection and release will receive a standardized regimen of radiotherapy (RT). The study will be powered to assess the outcome in patients undergoing the combination of successful release followed by RT. Patients will be monitored for acute and late toxicities while we evaluate disease recurrence defined as a \> 20 degree worsening of contracture in the presence of a palpable cord, or the need for medical/surgical intervention to correct the new or worsening contracture., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: Radiation therapy, outcomesModule primaryOutcomes measure: Recurrence of Dupuytren's Contracture, secondaryOutcomes measure: Radiation Toxicity, secondaryOutcomes measure: Patient Reported Outcomes after Radiation Treatment (RT), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330532, orgStudyIdInfo id: 4-2023-1526, briefTitle: Impact of Preoperative Frailty and Cognitive Impairment on Postoperative Outcomes in Elderly Cardiac Surgery Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: This is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between March 5, 2021 and October 12, 2022 in the operating room of Severance Cardiovascular Hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. Physical frailty will be determined by the Clinical Frailty Scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the K-MMSE and K-MoCA administered at the preoperative interview, and emotional dysregulation will be determined using the SGDS-K. These were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. Nutritional status will be analyzed based on blood test values measured within one month of surgery., conditionsModule conditions: Cardiovascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: postoperative all cause mortality, primaryOutcomes measure: major composite morbidity, secondaryOutcomes measure: the number of days not in hospital, secondaryOutcomes measure: The number of participants who die, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Health system, Severance Hospital, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06330519, orgStudyIdInfo id: Ainshams University Dentistry, briefTitle: Impact of Different Techniques on The Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-25, primaryCompletionDateStruct date: 2024-02-21, completionDateStruct date: 2024-02-21, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess the effect of* Preoperative intraligamentary corticosteroids injection* Cryotherapy which is cold application on : * Hard tooth structure ( crown of the tooth ) * Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication.Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment.Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block., conditionsModule conditions: Pulpitis - Irreversible, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Dexamethasone sodium phosphate injection, interventions name: 1,1,1,2 tetrafluoroethane, interventions name: intraoral soft tissue cryotherapy, outcomesModule primaryOutcomes measure: The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06330506, orgStudyIdInfo id: 123456123456, briefTitle: The Effect of Pressure Ulcer Care Package on the Risk of Pressure Ulcer Development, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-08-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Cukurova University, class: OTHER, descriptionModule briefSummary: This study aimed to determine the effect of pressure ulcer care package use on the risk of pressure ulcer development due to surgery in patients undergoing orthopedic surgery. It was planned as a randomized controlled study. The population of the study will consist of patients who underwent surgery in the Orthopaedics and Traumatology Clinic of Doğubayazıt Dr.Yaşar Eryılmaz State Hospital Hospital Hospital of Ağrı Provincial Health Directorate. The sample of the study will consist of patients who volunteered to participate in the study that meets the inclusion criteria. To obtain research data, the Personal Information Form developed by the researcher in line with the literature, 3S Operating Theatre Pressure Wound Risk Assessment Scale, Pressure Wound Regions and Stages Monitoring Form prepared according to NPUAP (2016) Pressure Wound Staging System Form will be used. Statistical analysis of the data obtained from the study will be performed using the SPSS 25 (Statistical Package of Social Science) package program., conditionsModule conditions: Pressure Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Pressure ulcer prevention pack, outcomesModule primaryOutcomes measure: Evaluation of pressure ulcer formation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330493, orgStudyIdInfo id: AcoArt BTK Global Trial, briefTitle: AcoArt Litos PCB Below-the-knee Global Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2030-12, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Acotec Scientific Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5), conditionsModule conditions: Chronic Limb-Threatening Ischemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 288, type: ESTIMATED, armsInterventionsModule interventions name: PCB, interventions name: PTA, outcomesModule primaryOutcomes measure: Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency, primaryOutcomes measure: Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death), secondaryOutcomes measure: Composite of Limb Salvage and Primary Patency, secondaryOutcomes measure: Patency rate, secondaryOutcomes measure: Freedom from CD-TLR, secondaryOutcomes measure: Re-occlusion rate of target lesion, secondaryOutcomes measure: Rate of Major adverse events(MAE), secondaryOutcomes measure: Rate of target limb major amputation, secondaryOutcomes measure: Rate of all-cause death, secondaryOutcomes measure: Amputation free survival rate, secondaryOutcomes measure: Change in ankle-brachial index(ABI), secondaryOutcomes measure: Change in toe-brachial index(TBI), secondaryOutcomes measure: Change in Rutherford category, secondaryOutcomes measure: Change in EQ-5D, secondaryOutcomes measure: Change in VascuQol, secondaryOutcomes measure: Primary sustained clinical improvement, secondaryOutcomes measure: Secondary sustained clinical improvement, secondaryOutcomes measure: Wound healing, secondaryOutcomes measure: Rate of Device Success, secondaryOutcomes measure: Rate of Technical Success, secondaryOutcomes measure: Rate of Procedure Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06330480, orgStudyIdInfo id: Check@Home, briefTitle: Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-11-01, completionDateStruct date: 2028-11-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Prof. Dr. Folkert W. Asselbergs, class: OTHER, collaborators name: Dutch Cardiovascular Alliance, collaborators name: University Medical Center Groningen, collaborators name: Dutch Heart Foundation, collaborators name: Dutch Kidney Foundation, collaborators name: Dutch Diabetes Research Foundation, collaborators name: Maastricht University, collaborators name: AstraZeneca BV, collaborators name: UMC Utrecht, collaborators name: Radboud University Medical Center, collaborators name: Siemens Healthineers Nederland BV, collaborators name: University of Twente, collaborators name: Roche Diagnostics Nederland BV, collaborators name: Luscii healthtech BV, collaborators name: Happitech BV, collaborators name: Stichting Radboud Universiteit, collaborators name: Stichting Netherlands Heart Institute, descriptionModule briefSummary: The aim of the Check@Home consortium is to set up a roadmap and infrastructure for a program to early detect atrial fibrillation and chronic kidney disease in the general population.This will be a population-based screening with a phased implementation and an iterative design in four regions in the Netherlands (Breda, Utrecht, Arnhem, Eindhoven). In total, a random sample of 160,000 people (aged 50-75 years) will be invited to participate in the study and another random sample of 160,000 people with the same characteristics will be included in the control group in which no screening will be offered.The overall screening program will consist of three phases: a home-based testing phase, diagnostic screening phase, and a treatment phase:* Phase 1: Subjects will be invited for a home-based screening that includes home-based testing; urine collection for detection of elevated albuminuria, and a heart rhythm measurement using a smartphone app for detection of atrial fibrillation.* Phase 2: Depending on the results on these home-based tests, subjects will be invited for further screening in a diagnostic screening facility. During this visit, physical data will be collected (height, weight, waist circumference, blood pressure, heart rhythm), blood will be drawn, and urine will be collected for the assessment of parameters that are indicative of a cardiovascular disease, chronic kidney disease, type 2 diabetes or their risk factors. Participants will receive a questionnaire that include questions on demographics, educational level, disease history, medication use, health literacy, and quality of life.* Phase 3: Based on the results of the diagnostic screening, participants may be referred to their general practitioner for appropriate treatment (lifestyle advice/medication) according to the prevailing guidelines.The primary study outcomes are:Overall effectiveness of population based screening on atrial fibrillation and chronic kidney disease in subjects aged 50-75 years, based on:* Participation rate of different screening strategies and phases;* Yield of the screening (number of subjects with (newly) diagnosed disease and risk factors);* Effectiveness of the atrial fibrillation screening, compared with standard care, based on the incidence of ischemic stroke);* Effectiveness of the albuminuria screening, compared with standard care, based on the incidence of kidney failure events and Major Adverse Cardiovascular Events (MACE)., conditionsModule conditions: Atrial Fibrillation, conditions: Chronic Kidney Diseases, conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Check@Home is a population-based screening with a phased assessment and implementation using an iterative design executed consecutively in four regions in the Netherlands., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 320000, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group, outcomesModule primaryOutcomes measure: Participation rate of the atrial fibrillation and albuminuria screening, primaryOutcomes measure: Yield of the atrial fibrillation and albuminuria screening, primaryOutcomes measure: Effectiveness of the atrial fibrillation screening, primaryOutcomes measure: Effectiveness of the albuminuria screening, secondaryOutcomes measure: Effectiveness of the atrial fibrillation screening based on incidence of MACE events, secondaryOutcomes measure: Effectiveness of the albuminuria screening based on incidence each individual MACE component, secondaryOutcomes measure: Safety of the atrial fibrillation screening, secondaryOutcomes measure: Cost-effectiveness of screening strategies compared with standard of care: treatment effectiveness based on literature., secondaryOutcomes measure: Cost-effectiveness of screening strategies compared to standard of care: treatment effectiveness based on actual observed event rates, otherOutcomes measure: False-positive rate, false-negative rate, sensitivity, specificity, positive predictive screening on atrial fibrillation and albuminuria screening., otherOutcomes measure: Characteristics of responders and non-responders, otherOutcomes measure: Effectiveness of the atrial fibrillation screening based on incidence each individual MACE component, otherOutcomes measure: Overall effectiveness of broader population-based screening strategies applied to screening on heart failure, coronary artery disease, and type 2 diabetes., eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330467, orgStudyIdInfo id: 2023-A02442-43, secondaryIdInfos id: RIPH 2023-02, type: REGISTRY, domain: sponsor's internal reference, briefTitle: Prevalence of Dissociative Identity Disorder in At-risk Outpatient Groups Reporting Childhood Trauma., acronym: IDENTITY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Centre Psychothérapique de Nancy, class: OTHER, descriptionModule briefSummary: The investigators will study the prevalence of dissociative identity disorder (DID) in three populations at risk in cases of childhood psychotrauma : patients with a diagnosis of borderline personality, patients with a diagnosis of functional dissociative crises (FDC) and patients with early psychosis.The investigators will also study the prevalence of other dissociative disorders and the frequency of complex post-traumatic stress disorder.The investigators will also look for correlations between the type of maltreatment in childhood, the age of onset of trauma and the type of diagnosis of dissociative disorders.The investigators hope to include 150 borderline patients, 150 FDC patients and 50 early psychosis patients.Data collection will be done via a psychometric administration of 7 self-completion questionnaires as well as the completion of the SCID-D semi-structured interview., conditionsModule conditions: Dissociative Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 3 groups : borderline, early psychosis and FDC., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: psychometric assessment, interventions name: semi-structured clinical interview, outcomesModule primaryOutcomes measure: SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders / DSM = Diagnostic and Statistical Manual of Mental Disorders / ICD = International Classification of Diseases, secondaryOutcomes measure: SCID-D : Semi-structured Clinical Interview for diagnosing DSM-5 and ICD-11 Dissociative Disorders, secondaryOutcomes measure: CTQ-28 : Childhood Trauma Questionnaire, secondaryOutcomes measure: life events inventory DSM-5, secondaryOutcomes measure: PCL-5 : Posttraumatic stress disorder CheckList-5, secondaryOutcomes measure: ITQ : International Trauma Questionnaire, secondaryOutcomes measure: SDQ-20 : Somatoform Dissociative questionnaire, secondaryOutcomes measure: DIS-Q : Dissociation Questionnaire, secondaryOutcomes measure: DES : Dissociative Experience Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre Psychothérapique de Nancy - CLIP, city: Nancy, country: France, contacts name: Vincent LAPRÉVOTE, role: CONTACT, email: vincent.laprevote@cpn-laxou.com, contacts name: Vincent LAPRÉVOTE, role: PRINCIPAL_INVESTIGATOR, contacts name: Lori PETROCELLI, role: SUB_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: Centre Psychothérapique de Nancy - CMP Jacquard et Des Près, city: Nancy, country: France, contacts name: Coraline HINGRAY, role: CONTACT, email: coraline.hingray@cpn-laxou.com, contacts name: Coraline HINGRAY, role: PRINCIPAL_INVESTIGATOR, contacts name: Lori PETROCELLI, role: SUB_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, locations facility: CHRU Nancy - Neurology department, city: Nancy, country: France, contacts name: Coraline HINGRAY, role: CONTACT, email: coraline.hingray@cpn-laxou.com, contacts name: Coraline HINGRAY, role: PRINCIPAL_INVESTIGATOR, contacts name: Alexis TARRADA, role: SUB_INVESTIGATOR, contacts name: Séverine CONRADI, role: SUB_INVESTIGATOR, contacts name: Lori PETROCELLI, role: SUB_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
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protocolSection identificationModule nctId: NCT06330454, orgStudyIdInfo id: 483/2020/Disp/AOUFe, briefTitle: Painful Total Knee Replacement (TKA) and I-one Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-22, primaryCompletionDateStruct date: 2025-10-21, completionDateStruct date: 2025-10-21, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: University Hospital of Ferrara, class: OTHER, descriptionModule briefSummary: Arthroplasty operations are very frequent and their number is constantly increasing. The success of prosthetic surgery is linked to surgical factors (prosthesis type, prosthesis design, prosthesis material, surgical hand) and 'biological' factors (inflammation, pain, oedema, impingement). It is well known that important functional limitations may result mainly from an overreaction involving the peri-articular tissues. This is particularly true after total knee arthroplasty (TKA) surgery, during which a large part of the bone tissue and part of the peri-articular tissues (joint capsule, ligaments, synovium) are dislodged or removed. In the days following arthroplasty operations, the presence of a strong local inflammatory component is associated with pain and functional limitation, which usually resolves within a few months; however, it can sometimes take longer, and sometimes result in a chronic, albeit modest, inflammatory condition that lasts for years. There is still a percentage of 11-25% of patients who remain not completely satisfied with the result achieved with prosthetic surgery . Baker et al. state that 19.8% of patients experience pain one year after arthroplasty . Beswick et al. report that many patients (10-34%) continue to experience significant pain and functional limitation after arthroplasty even years later., conditionsModule conditions: Knee Pain Swelling, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 237, type: ESTIMATED, armsInterventionsModule interventions name: I-ONE, outcomesModule primaryOutcomes measure: Evaluate pain resolution after treatment with I-ONE® therapy in patients with painful TKA at least 1 month after surgery., secondaryOutcomes measure: reduced NSAID intake, secondaryOutcomes measure: improved recovery of joint function, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: BO, country: Italy, contacts name: Francesco Traina, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Poliambulanza Brescia, status: RECRUITING, city: Brescia, state: BS, country: Italy, contacts name: Francesco Benazzo, role: CONTACT, geoPoint lat: 45.53558, lon: 10.21472, locations facility: Policlinico San Matteo Pavia, status: RECRUITING, city: Pavia, state: PV, country: Italy, contacts name: Mario Mosconi, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Ospedale Mauriziano Torino, status: RECRUITING, city: Torino, state: TO, country: Italy, contacts name: Roberto Rossi, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Ospedale Sacro Cuore Don Calabria Negrar Verona, status: RECRUITING, city: Negrar, state: VR, country: Italy, contacts name: Claudio Zorzi, role: CONTACT, geoPoint lat: 45.52918, lon: 10.93899, locations facility: Policlinico di Bari, status: RECRUITING, city: Bari, country: Italy, contacts name: Biagio Moretti, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale Santo Spirito in Sassia/Ospedale San Filippo Neri Roma, status: RECRUITING, city: Roma, country: Italy, contacts name: Francesco Falez, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
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protocolSection identificationModule nctId: NCT06330441, orgStudyIdInfo id: MOU-2021-01, briefTitle: Pancreatic Cancer Screening in a Population at High Risk, acronym: ScrePan, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-07, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2028-01-06, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Masaryk Memorial Cancer Institute, class: OTHER, collaborators name: Masaryk University, descriptionModule briefSummary: Pancreatic cancer is one of the diseases with the worst prognosis, which is mainly due to the initial asymptomatic prognosis. Unfortunately, the incidence of this disease in the Czech Republic is still increasing. In a certain proportion of patients, it is possible to predict the disease, e.g. due to family burdens. Regular follow-up of such individuals is the subject of the SCREPAN study: "Pancreatic Cancer Screening in High-Risk Persons"., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, conditions: Hereditary Diseases, conditions: Pancreatitis, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: endoscopic ultrasonography, interventions name: magnetic resonance, interventions name: laboratory examination, outcomesModule primaryOutcomes measure: Number of participants with newly diagnosed pancreatic ductal adenocarcinoma, secondaryOutcomes measure: Methods yield comparison, secondaryOutcomes measure: Screening methods cost-effectiveness, secondaryOutcomes measure: KRAS mutation status evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Masaryk Memorial Cancer Institute, status: RECRUITING, city: Brno, zip: 65653, country: Czechia, contacts name: Martina Lojova, Ph.D., role: CONTACT, phone: +420543136232, email: martina.lojova@mou.cz, contacts name: Dita Kozakova, Ing., role: CONTACT, phone: +420543136236, email: dita.kozakova@mou.cz, contacts name: Petr Karasek, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jana Halamkova, MD, role: SUB_INVESTIGATOR, contacts name: Helena Coupkova, MD, role: SUB_INVESTIGATOR, contacts name: Anna Ondrackova, MD, role: SUB_INVESTIGATOR, contacts name: Marketa Palacova, MD, role: SUB_INVESTIGATOR, contacts name: Radim Nemecek, MD, role: SUB_INVESTIGATOR, contacts name: Lumir Kunovsky, MD, role: SUB_INVESTIGATOR, contacts name: Jan Trna, MD, role: SUB_INVESTIGATOR, contacts name: Lenka Foretova, MD, role: SUB_INVESTIGATOR, contacts name: Zdenka Cermakova, MD, role: SUB_INVESTIGATOR, contacts name: Jan Kristek, MD, role: SUB_INVESTIGATOR, contacts name: Roman Hrstka, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 49.19522, lon: 16.60796, hasResults: False
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protocolSection identificationModule nctId: NCT06330428, orgStudyIdInfo id: MU-Ebe-ZDKY-02, briefTitle: Investigation of the Effect of Sexuality-Based Family Planning Education Given to Women Via Podcast on Contraceptive Method Selection and Sexual Life Quality, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-08-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Marmara University, class: OTHER, descriptionModule briefSummary: In this study, it was aimed to examine the effect of Sexuality-Based Family Planning Education given to women of childbearing age via Podcast on contraceptive method selection and sexual life quality.Accordingly, the hypotheses of the study are as follows:Hypotheses of the Project H1: Sexuality-based family planning education via podcast has an effect on women's conscious and appropriate contraceptive method selection.H2: Sexuality-based family planning education via podcast has a positive effect on women's sexual life quality.H3: Sexuality-based family planning education via podcast has a positive effect on the quality of sexual life of women by increasing their level of contraceptive knowledge.H4: Sexuality-based family planning education via podcast has a positive effect on women's attitudes towards family planning., conditionsModule conditions: Contraception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One control group, one experimental group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: The experimental group will receive sexuality-based family planning education via podcast and outcome assessment will be performed by an investigator who was blinded to group assignment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 176, type: ESTIMATED, armsInterventionsModule interventions name: Sexuality-Based Family Planning Education via Podcast, outcomesModule primaryOutcomes measure: Contraceptive Knowledge Assessment Scale-Turkish Form, secondaryOutcomes measure: Sexual Quality of Life Scale-Female, otherOutcomes measure: Family Planning Attitudes Scale, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Marmara University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Meltem Demirgöz Bal, role: CONTACT, phone: +905056482983, email: meltemdemirgoz@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06330415, orgStudyIdInfo id: 25603, briefTitle: Effect and Process Evaluation of the SME Tool, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, collaborators name: ZonMw: The Netherlands Organisation for Health Research and Development, descriptionModule briefSummary: A web-based tool has been developed to help small and medium-sized businesses support employees returning to work after sick-leave. A six-month trial is conducted, randomly assigning employer-employee dyads to either use the tool or receive standard care. The primary aim is to evaluate its impact on employee satisfaction with return-to-work support., conditionsModule conditions: Sick-listed Employees, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 404, type: ESTIMATED, armsInterventionsModule interventions name: The SME tool, outcomesModule primaryOutcomes measure: Satisfaction with the RTW support of employer assessed by the employee, secondaryOutcomes measure: Social support, secondaryOutcomes measure: Total number of sick-leave days, secondaryOutcomes measure: Work performance, secondaryOutcomes measure: Quality of working Life, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Satisfaction with the resumption of work of the respective employee, otherOutcomes measure: Recruitment, otherOutcomes measure: Use of the SME tool, otherOutcomes measure: Perceived usefulness of the SME tool, otherOutcomes measure: Components of the logic model of change, otherOutcomes measure: Experiences, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330402, orgStudyIdInfo id: N-20220063, briefTitle: Exploration of Gait Biomechanics and Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-26, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kristian Kjær Petersen, class: OTHER, descriptionModule briefSummary: This interventional study aims to test gait biomechanics in healthy individuals with and without experimental knee pain. The main questions it aims to answer are:* How do gait patterns change during painful walking?* Can pain sensitivity testing and gait biomechanics predict experimental knee pain intensity?Participants will receive two knee injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition)., conditionsModule conditions: Pain, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Hypertonic saline injection, interventions name: Isotonic saline injection, outcomesModule primaryOutcomes measure: Infrared marker XYZ coordinates, primaryOutcomes measure: Pain sensitivity., secondaryOutcomes measure: The Pittsburgh Sleep Quality Index score, secondaryOutcomes measure: The Pain catastrophizing Scale score, secondaryOutcomes measure: The Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Knee symptoms, secondaryOutcomes measure: Ground reaction forces, secondaryOutcomes measure: Ground reaction moments, secondaryOutcomes measure: Ground contact XZ location, secondaryOutcomes measure: Muscle activation, otherOutcomes measure: Pain intensity (NRS 0-10), otherOutcomes measure: Pain distribution, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aalborg University, status: RECRUITING, city: Aalborg, state: Nordjylland, zip: 9000, country: Denmark, contacts name: Kristian K Petersen, Dr. Med, role: CONTACT, phone: (+45) 31697510, email: kkp@hst.aau.dk, contacts name: Emma Hertel, M. Sc., role: CONTACT, phone: (+45) 60887473, email: eh@hst.aau.dk, geoPoint lat: 57.048, lon: 9.9187, hasResults: False
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protocolSection identificationModule nctId: NCT06330389, orgStudyIdInfo id: MRC-01-20-1074, briefTitle: Burn Injuries During COVID-19 Pandemic and Its Influence on Length of Stay, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2021-03-01, completionDateStruct date: 2021-06-25, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Hamad Medical Corporation, class: INDUSTRY, descriptionModule briefSummary: Burn injuries were thought to be difficult to treat during the new corona virus epidemic. Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic., conditionsModule conditions: SARS-CoV-2 Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Burn Injuries Graft Surgery, outcomesModule primaryOutcomes measure: Our goal is to determine the risk factors that influence length of hospital stay (LOS) of burn injured patients during COVID -19 pandemic., secondaryOutcomes measure: Clinical diffreneces between burn injuries with positive vs negative COVID-19 status, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: HAMAD Medical Corporation- Al Wakra Hospital, city: Doha, zip: 82228, country: Qatar, geoPoint lat: 25.28545, lon: 51.53096, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2020-05-30, uploadDate: 2021-09-07T14:07, filename: Prot_SAP_000.pdf, size: 273860, hasResults: False
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protocolSection identificationModule nctId: NCT06330376, orgStudyIdInfo id: PT-2022-30735, briefTitle: Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are critical illness myopathy, ventilator-induced diaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to line placement, post-infectious inflammatory neuropathy of the phrenic nerve, or possibly direct neuromuscular involvement of the SARS- CoV-2 virus given expression of the angiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system and skeletal muscle. The use of diaphragmatic ultrasound has been widely used to assess diaphragmatic function is well known in patients following prolonged mechanical ventilation. Prolonged mechanical ventilation leads to contractile dysfunction of respiratory muscles, in particular the diaphragm, causing a so-called ventilator-induced diaphragm dysfunction. The latter is defined as a loss of diaphragm force-generating capacity specifically related to the use of mechanical ventilation. However, the use of diaphragmatic Ultrasound to assess its function in Long COVID patients has not been noted and is a gap in the work up of these patients.The purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seen in patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness of breath/chest tightness and subsequent fatigue. Targeting shortness of breath and subsequent fatigue as a central symptom of PASC will alleviate long term sequelae for the patients with PASC. DD will be addressed by a unique intervention of physical therapy. The goal of this prospective randomized clinical study will be to evaluate the comparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walk test, depression/anxiety, and quality of life (QoL)., conditionsModule conditions: Post-Acute Sequelae of COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective randomized clinical study with 2 arms, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Usual care of traditional treatment, interventions name: Specific DB program/Diaphragmatic manipulation program, outcomesModule primaryOutcomes measure: 6-minute walk test (6MWT), secondaryOutcomes measure: PHQ9: Patient health questionnaire 9, secondaryOutcomes measure: GAD7: Generalized anxiety disorder 7-item, secondaryOutcomes measure: PROMIS score: Patient-Reported Outcomes Measurement Information System, secondaryOutcomes measure: QoL scale: Quality of life scale, secondaryOutcomes measure: FACIT fatigue scale 's Fatigue score, secondaryOutcomes measure: Modified Borg dyspnea scale, secondaryOutcomes measure: RR; respiratory rate with 6 min walk test, secondaryOutcomes measure: PR: pulse rate with 6 min walk test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55414, country: United States, contacts name: Farah Ikramuddin, role: CONTACT, email: ikram002@umn.edu, geoPoint lat: 44.97997, lon: -93.26384, hasResults: False
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protocolSection identificationModule nctId: NCT06330363, orgStudyIdInfo id: METC 23-049, briefTitle: The Impact of Low Level Laser Treatment on Skeletal Muscle and Skin Tissue, acronym: LASER, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: Rationale: Low level laser therapy, or photobiomodulation, is getting more attention as a non-invasive treatment strategy for numerous conditions. Phototherapy has been applied for more than 40 years for the treatment of musculoskeletal and neurological conditions. Low level laser therapy generally applies red or near-infrared lasers with a wavelength between 600 and 1000 nm and low power wattage from 5 to 500 mW and a power density between 1 and 5 W/cm2. The laser light is absorbed by the skin without thermal damage and penetrates deeply into tissues where it is supposed to induce its physiological effects at the cellular level. Laser therapy has been hypothesized to stimulate mitochondrial respiration, increase tissue oxygenation, and support tissue regeneration. Despite supportive research data on in vitro cell and in vivo animal data, there are surprisingly few data on the proposed impact of low level laser treatment (LLLT) on tissue metabolism in vivo in humans.Objective: To assess the impact of acute laser treatment on muscle tissue mitochondrial respiration in vivo in healthy, young adults. Secondary objectives include the in vivo assessment of cellular energy, anabolic, angiogenic and inflammatory pathways, along with enzyme activity within muscle and skin.Study design: Within-subject study.Study population: 12 healthy (BMI 18.5-30 kg/m2) young (age: 18-35 y) adults (6 men and 6 women).Intervention: One leg of the subjects will receive LLLT, while the other leg will receive no treatment. After the treatment muscle and skin biopsy samples will be taken from both legs.Main study parameters/endpoints: The primary outcome will be mitochondrial respiration of the LLLT treated and non-treated leg based on muscle samples. Secondary study parameters are muscle and skin gene expression, protein signalling and enzyme activity., conditionsModule conditions: Muscles Metabolism, conditions: Skin Metabolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Within-subject study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: One let will receive the laser therapy, the other one will get a sham laser. The person analyzing the samples will be blinded to legs., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Laser therapy, interventions name: Sham, outcomesModule primaryOutcomes measure: Muscle mitochondrial respiration, secondaryOutcomes measure: Gene expression (mRNA) via real-time PCR, secondaryOutcomes measure: Protein expression via western blotting, secondaryOutcomes measure: Skin mitochondrial respiration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Maastricht University Medical Centre, status: RECRUITING, city: Maastricht, country: Netherlands, contacts name: Luc JC van Loon, PhD, role: CONTACT, phone: +31-43-3881397, email: l.vanloon@maastrichtuniversity.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
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protocolSection identificationModule nctId: NCT06330350, orgStudyIdInfo id: METC 2023-0193, briefTitle: Qualitative Study in Patients With Genodermatoses and Healthcare Professionals on Reproductive Counselling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to understand the perspectives and needs of patients with genodermatoses and their partners who wish to have children, regarding their decision-making process and their consideration of reproductive options. Additionally, the investigators aim to investigate the level of knowledge and perspectives of healthcare professionals (such as clinical geneticists, dermatologists and other clinicians involved), and want to explore to what extent patients and their partners are well informed about these reproductive options. To achieve this, the investigators will conduct individual semi-structured qualitative interviews with participants affected by genodermatoses (and their partners) and with healthcare professionals., conditionsModule conditions: Quality of Life, conditions: Ichthyosis, conditions: Palmoplantar Keratoses, conditions: Epidermolysis Bullosa, conditions: Ectodermal Dysplasia, conditions: Basal Cell Nevus Syndrome, conditions: Birt-Hogg-Dube Syndrome, conditions: Tuberous Sclerosis, conditions: Cutis Laxa, conditions: Albinism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Qualitative interview, outcomesModule primaryOutcomes measure: Assessment of perspectives of affected patients + partners and of healthcare professionals concerning reproductive decision-making, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, status: RECRUITING, city: Maastricht, state: Limburg, zip: 6202 AZ, country: Netherlands, contacts name: Fauve C van Veen, role: CONTACT, phone: +31433877293, email: genodermatose@mumc.nl, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
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protocolSection identificationModule nctId: NCT06330337, orgStudyIdInfo id: ZSLL-KY-2024-010-01, briefTitle: Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, collaborators name: Zhejiang University, descriptionModule briefSummary: Gliomas are the most common type of primary brain tumors, with surgery followed by radiotherapy and chemotherapy as the main treatment modalities. However, they are highly prone to recurrence, presenting significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel, a common chemotherapeutic agent, exhibits antitumor effects in vitro that are 1400 times stronger than those of temozolomide (the first-line chemotherapy drug for gliomas). However, due to its large molecular weight (approximately 893 Da), it cannot cross the blood-brain barrier, precluding its use as a first-line treatment for gliomas. Preliminary research by our team has demonstrated that Specific Mode Electroacupuncture Stimulation (SMES) can open the blood-brain barrier, enhancing the concentration of albumin-bound paclitaxel (ABX) in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Consequently, this study aims to observe the safety and efficacy of SMES combined with ABX in treating patients with recurrent high-grade gliomas postoperatively, to explore its mechanisms of action, extend survival, improve quality of life, and forge new theories and methods for the integrative treatment of brain tumors combining traditional Chinese and Western medicine., conditionsModule conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Temozolomide（TMZ） injection or oral administration, interventions name: Albumin-Bound Paclitaxel(ABX) intravenous drip, interventions name: Specific mode electroacupuncture stimulation(SMES) intervention, outcomesModule primaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Head MRI (plain and enhanced), secondaryOutcomes measure: he Karnofsky Performance Score (KPS), secondaryOutcomes measure: The Eastern Cooperative Oncology Group (ECOG), secondaryOutcomes measure: The Quality of Life (QOL), secondaryOutcomes measure: The Neurological Assessment for Neuro-Oncology (NANO), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Zhejiang, country: China, contacts name: Xianming Lin, PHD, role: CONTACT, phone: +86-13858028101, email: linxianming1966@163.com, contacts name: Zhaoxing Jia, PHD, role: CONTACT, phone: +86-18356130598, email: zhenxinzhenyi183@163.com, hasResults: False
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protocolSection identificationModule nctId: NCT06330324, orgStudyIdInfo id: METC 2023-0182, briefTitle: Reproductive Options in Inherited Skin Diseases, acronym: REPRO-ISD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Maastricht University Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children.To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe., conditionsModule conditions: Ichthyosis, conditions: Palmoplantar Keratoses, conditions: Epidermolysis Bullosa, conditions: Ectodermal Dysplasia, conditions: Basal Cell Nevus Syndrome, conditions: Birt-Hogg-Dube Syndrome, conditions: Tuberous Sclerosis, conditions: Xeroderma Pigmentosum, conditions: Cutis Laxa, conditions: Albinism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 650, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of clinical outcomes of reproductive options, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maastricht University Medical Center, city: Maastricht, state: Limburg, zip: 6202AZ, country: Netherlands, geoPoint lat: 50.84833, lon: 5.68889, hasResults: False
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protocolSection identificationModule nctId: NCT06330311, orgStudyIdInfo id: 20/551-EC, briefTitle: Effectiveness of Whole-Body Vibration, acronym: WBVibration, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-09-29, completionDateStruct date: 2024-09-29, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Universidad Complutense de Madrid, class: OTHER, collaborators name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain, descriptionModule briefSummary: Cerebral Palsy is the most common cause of severe physical disability in childhood and may present difficulties and limitations that will have an impact on their independence and integration in all social areas.Within interventions aiming to manage CP Whole-Body Vibration (WBV) has shown some benefits such as reducing spasticity or improving strength and functionality of the lower limbs.The aim of this study is to assess the effectiveness on motor function and spasticity of the lower limbs by adding an intervention with WBV to an evidence-based multimodal physiotherapy treatment in children with CP., conditionsModule conditions: Spastic Cerebral Palsy, conditions: Physical Therapy Modalities, conditions: Vibration; Exposure, conditions: Lower Extremity Weakness, Spastic, conditions: Muscle Spasticity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The participants will be randomly allocated to experimental or control group, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The principal investigator will be blinded to the randomization, patient assessment, and data analysis., whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Physiotherapy, outcomesModule primaryOutcomes measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions), primaryOutcomes measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions), primaryOutcomes measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions), primaryOutcomes measure: GROSS MOTOR FUNCTION MEASURE 88 (D and E dimensions), primaryOutcomes measure: Modified Ashworth Scale (MAS), primaryOutcomes measure: Modified Ashworth Scale (MAS), primaryOutcomes measure: Modified Ashworth Scale (MAS), primaryOutcomes measure: Modified Ashworth Scale (MAS), secondaryOutcomes measure: 6 Minute Walking Test (6MWT), secondaryOutcomes measure: 6 Minute Walking Test (6MWT), secondaryOutcomes measure: 6 Minute Walking Test (6MWT), secondaryOutcomes measure: 6 Minute Walking Test (6MWT), secondaryOutcomes measure: Dynamometry, secondaryOutcomes measure: Dynamometry, secondaryOutcomes measure: Dynamometry, secondaryOutcomes measure: Dynamometry, secondaryOutcomes measure: Mini-Balance Evaluation System Test, secondaryOutcomes measure: Mini-Balance Evaluation System Test, secondaryOutcomes measure: Mini-Balance Evaluation System Test, secondaryOutcomes measure: Mini-Balance Evaluation System Test, secondaryOutcomes measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL), secondaryOutcomes measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL), secondaryOutcomes measure: Cerebral Palsy Quality of Life questionnaire (CP-QOL), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: María José Díaz Arribas, city: Madrid, zip: 28040, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06330298, orgStudyIdInfo id: 202000479, briefTitle: Improving Social Cognition and Social Behaviour in Various Brain Disorders, acronym: T-ScEmo4ALL, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time., conditionsModule conditions: Stroke, conditions: Multiple Sclerosis, conditions: Brain Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatmentWaiting list condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatmentThe participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition.In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The neuropsychologist who leads T1 and T2 measurements will be masked for the fact of which patient will be draw in which clinical condition (experimental group or control group), however this cannot be guaranteed since patients may talk about their experience., whoMasked: INVESTIGATOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Treatment social cognition and emotion regulation (T-ScEmo), outcomesModule primaryOutcomes measure: Change in social behaviour examined by proxy, secondaryOutcomes measure: Social cognition: Emotion recognition as assessed using the Eckman-60 faces test, secondaryOutcomes measure: Social cognition: Theory of Mind as assessed using the Happé cartoons test, secondaryOutcomes measure: Social cognition: Theory of Mind as assessed using the Faux Pas test, secondaryOutcomes measure: Social cognition: assessed using the Hailing Sentence Completion Test, secondaryOutcomes measure: Demographic information, secondaryOutcomes measure: Self-rated social behaviour as assessed using the Dysexecutive questionnaire Social Scales., secondaryOutcomes measure: Self-rated social behaviour as assessed using the Interpersonal Reactivity Index, secondaryOutcomes measure: Self-rated social behaviour as assessed using The Dutch version of the BAFQ social scales, secondaryOutcomes measure: Proxy-rated social behaviour as assessed using the Interpersonal Reactivity Index, secondaryOutcomes measure: Proxy-rated social behaviour as assessed using the Socioemotional Dysfunction Scale, secondaryOutcomes measure: Proxy-rated social behaviour as assessed using the Dutch version of the BAFQ social scales, secondaryOutcomes measure: Alexithymia, secondaryOutcomes measure: Life satisfaction, secondaryOutcomes measure: (Social) participation as assessed using the Utrecht Scale for Evaluation of Rehabilitation, secondaryOutcomes measure: (Social) participation as assessed using the Impact on Participation and Autonomy scale, secondaryOutcomes measure: Mood and anxiety, secondaryOutcomes measure: Caregiving burden, secondaryOutcomes measure: Goal attainment, otherOutcomes measure: Executive functioning as assessed using the Controlled Oral Word Association Test, otherOutcomes measure: Executive functioning assessed using the Key Search Test, otherOutcomes measure: Verbal memory, otherOutcomes measure: Working memory, otherOutcomes measure: Language, otherOutcomes measure: Mental speed and attention as assessed using the Trail Making Test, otherOutcomes measure: Mental speed and attention as assessed using the Symbol Digit Modalities Test, otherOutcomes measure: Premorbid intelligence, otherOutcomes measure: Fatigue, otherOutcomes measure: Health limitations, otherOutcomes measure: Coping, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Deventer Hospital, status: RECRUITING, city: Deventer, state: Overijssel, zip: 7416SE, country: Netherlands, contacts name: M.J.J. Gerritssen, dr., role: CONTACT, geoPoint lat: 52.255, lon: 6.16389, locations facility: University Medical Center Groningen, status: RECRUITING, city: Groningen, zip: 9700VB, country: Netherlands, contacts name: Amber Heegers, MSc., role: CONTACT, phone: +3150 361 4666, email: a.heegers@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
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protocolSection identificationModule nctId: NCT06330285, orgStudyIdInfo id: e learning pgme/cpet, briefTitle: Comparison of E-Learning and Face-to-Face Learning in Cardiopulmonary Exercise Test Training, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, collaborators name: TC Erciyes University, descriptionModule briefSummary: The main purpose of this study is to compare the effect of teaching Cardiopulmonary Exercise Test (CPET) via e-learning and face-to-face to doctors receiving postgraduate medical education (PGME)., conditionsModule conditions: Exercise Test, conditions: Learning, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: e-learning, interventions name: face to face learning, outcomesModule primaryOutcomes measure: Open-Ended Achievement Test, primaryOutcomes measure: Adult Motivation Scale, primaryOutcomes measure: Distance Education Attitude Scale in Lifelong Learning, primaryOutcomes measure: Cognitive Flexibility Scale, primaryOutcomes measure: State and Trait Anxiety Scale, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06330272, orgStudyIdInfo id: UCeuma, briefTitle: Accuracy of Spectrophotometry in Hypomineralized Lesions Treated With CPP-ACPF Dental Mousse: Clinical Study, acronym: ASHLTDMCS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Meire Coelho Ferreira, class: OTHER, collaborators name: Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão, descriptionModule briefSummary: MIH is a condition with considerable prevalence in the child population. This structural defect, represented by a change in the color of the enamel, can be accompanied by structural loss and great sensitivity. Remineralizing agents have been used to strengthen compromised enamel. The objective of the study will be to measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse., conditionsModule conditions: Molar Incisor Hypomineralization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: MIH lesions will receive prophylaxis with pumice stone before application of CPP-ACPF-based dental foam (Tooth Mousse PlusTM, GC Corporation, Tokyo, Japan).The application of Tooth Mousse Plus to the MIH lesion will be carried out under relative isolation and with the aid of a microbrush. The cream will remain on the surface for 1 minute. The application will be carried out once a week, for four consecutive weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Application of dental mousse based on CPP-ACPF, outcomesModule primaryOutcomes measure: To measure the accuracy of a spectrophotometer (VITA Easyshade V) in determining the mineralization of IMH lesions by a CPP-ACPF dental mousse, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: Josue Montello, Universidade Ceuma, city: São Luis, state: Maranhão, zip: 65075-120, country: Brazil, geoPoint lat: -2.52972, lon: -44.30278, hasResults: False
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