Datasets:

hackint0sh

/

small-data

like 0

protocolSection identificationModule nctId: NCT06388772, orgStudyIdInfo id: HJG-CZQH-QHRD106, briefTitle: Study to Assess PK, Safety and Tolerability Early in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-05, primaryCompletionDateStruct date: 2022-07-22, completionDateStruct date: 2023-01-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Changzhou Qianhong Bio-pharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of QHRD106 early in Chinese healthy subjects with single doses., conditionsModule conditions: Acute Ischemic Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule interventions name: QHRD106 Injection, interventions name: placebo, outcomesModule primaryOutcomes measure: Safety as assessed by incidence, severity, and causality of adverse events, primaryOutcomes measure: Plasma measurements of QHRD106, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nanjing Drum Tower Hospital, city: Nanjing, state: Jiangsu, zip: 210008, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False

protocolSection identificationModule nctId: NCT06388759, orgStudyIdInfo id: TQ05105-Ib-03, briefTitle: TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-08-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis., conditionsModule conditions: Myelofibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ACTUAL, armsInterventionsModule interventions name: TQ05105 Tablets, outcomesModule primaryOutcomes measure: Spleen volume reduction (SVR35)≥35% from baseline, secondaryOutcomes measure: Optimum effective rate, secondaryOutcomes measure: Onset time of splenic response, secondaryOutcomes measure: Duration of maintenance of spleen response (DoMSR) ≥35% reduction, secondaryOutcomes measure: Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) : ≥ 50% Reduction from Baseline, secondaryOutcomes measure: The total symptom score of MPN-SAF TSS decreased compared with baseline, secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Leukemia free survival (LFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Severity of AEs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230001, country: China, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The First Affiliated Hospital of Wannan Medical College, city: Wuhu, state: Anhui, zip: 241001, country: China, geoPoint lat: 31.33728, lon: 118.37351, locations facility: Union Hospital Tongji College Huazhong University of Science And Technology, city: Wuhan, state: Hubei, zip: 430071, country: China, geoPoint lat: 30.58333, lon: 114.26667, locations facility: The Affiliated Hospital of Xuzhou Medical University, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, geoPoint lat: 34.18045, lon: 117.15707, locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130021, country: China, geoPoint lat: 43.88, lon: 125.32278, locations facility: Shanghai Sixth People's Hospital, city: Shanghai, state: Shanghai, zip: 200233, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06388746, orgStudyIdInfo id: NKUA, briefTitle: Arresting Carious Lesions With Minimal Intervention Techniques, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National and Kapodistrian University of Athens, class: OTHER, descriptionModule briefSummary: A single-blinded randomized clinical trial with a split-mouth design that will assess the 12-month clinical and radiographic success of two minimally invasive treatment techniques, one using a chemo-mechanical caries removal agent and one using a caries arresting agent, for the treatment of deep caries in primary molars., conditionsModule conditions: Caries,Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: BRIX3000®, interventions name: Riva Star Aqua, SDI Limited, Australia, outcomesModule primaryOutcomes measure: clinical success, primaryOutcomes measure: radiographic success, secondaryOutcomes measure: Longevity and the quality of the final restoration, secondaryOutcomes measure: Patient's acceptance, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388733, orgStudyIdInfo id: IVY P3-24-021, briefTitle: A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ivy Brain Tumor Center, class: OTHER, collaborators name: GlaxoSmithKline, descriptionModule briefSummary: The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:Does niraparib improve progression-free survival (PFS) compared to TMZ?Does niraparib improve overall survival (OS) compared to TMZ?Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.* study drug (Niraparib) or* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.Participants' tasks will include:* Complete study visits as scheduled* Complete a diary to record study medication, conditionsModule conditions: Glioblastoma, conditions: GBM, conditions: Brain Neoplasms, Adult, Malignant, conditions: Brain Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Blinded Independent Central Review is composed of independent radiologists and will be utilized to assess progression of disease, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Niraparib, interventions name: Temozolomide, outcomesModule primaryOutcomes measure: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale), secondaryOutcomes measure: Compare symptoms, function, and Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-BN20-item Core module (EORTC QLQ-BN20) (Scores on a scale), secondaryOutcomes measure: Changes from baseline in neurocognitive function assessed by Hopkins Verbal Learning Test, secondaryOutcomes measure: Changes from baseline in neurocognitive function assessed by Controlled Oral Word Association, secondaryOutcomes measure: Changes from baseline in neurocognitive function assessed by Trail Making Test Parts A and B, secondaryOutcomes measure: Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), secondaryOutcomes measure: Number of treatment discontinuations, dose interruptions, and dose reductions due to AEs, SAEs, or AESIs, changes in Karnofsky performance status, changes in clinical laboratory results, and vital sign measurements, secondaryOutcomes measure: Frequency and severity of symptomatic AEs based on PRO-CTCAE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388720, orgStudyIdInfo id: NCC2024-0026, briefTitle: The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy, acronym: IMGeS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: National Cancer Center, Korea, class: OTHER_GOV, descriptionModule briefSummary: The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml, outcomesModule primaryOutcomes measure: Recurrent free survival in sequential treatment group., secondaryOutcomes measure: Progression free survival in sequential treatment group., secondaryOutcomes measure: Cystectomy free survival in sequential treatment group., secondaryOutcomes measure: cancer specific survival in sequential treatment group., secondaryOutcomes measure: Overall survival in sequential treatment group., secondaryOutcomes measure: Safety of sequential treatment., eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, status: RECRUITING, city: Goyang-si, country: Korea, Republic of, contacts name: Ho Kyung Seo, role: CONTACT, phone: 82-31-920-1678, email: seohk@ncc.re.kr, contacts name: Ho Kyung Seo, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eui Hyun Jung, Ph.D, role: SUB_INVESTIGATOR, geoPoint lat: 37.65639, lon: 126.835, hasResults: False

protocolSection identificationModule nctId: NCT06388707, orgStudyIdInfo id: NF-2022-01, briefTitle: A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NaviFUS Corporation, class: INDUSTRY, collaborators name: NaviFUS US LLC, descriptionModule briefSummary: This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE)., conditionsModule conditions: Drug Resistant Epilepsy, conditions: Epilepsy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: NaviFUS System, outcomesModule primaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Change from baseline in seizure frequency, secondaryOutcomes measure: Change from baseline in electroencephalography (EEG) epileptiform discharges, secondaryOutcomes measure: Days of seizure-free, secondaryOutcomes measure: Changes from baseline in Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Changes from baseline in Beck Depression Inventory (BDI-II), secondaryOutcomes measure: Changes from baseline in Personal Impact of Epilepsy Scale (PIES), otherOutcomes measure: Change from baseline in subjective seizure strength, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University School of Medicine, city: Palo Alto, state: California, zip: 94305, country: United States, contacts name: Robert Fisher, M.D., Ph.D., role: CONTACT, geoPoint lat: 37.44188, lon: -122.14302, locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Ellen Bubrick, M.D., role: CONTACT, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Virginia School of Medicine, city: Charlottesville, state: Virginia, zip: 22903, country: United States, contacts name: Nathan Fountain, M.D., role: CONTACT, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False

protocolSection identificationModule nctId: NCT06388694, orgStudyIdInfo id: RDO KPNC 24-056, briefTitle: Pharmacist Management of Attention Deficit Hyperactivity Disorder Medication Refill Requests, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kaiser Permanente, class: OTHER, descriptionModule briefSummary: This cluster randomized trial will compare pharmacist management of secure message requests for refills of attention deficit hyperactivity medications with primary care physician management regarding quality of care, timeliness of service, and parent care experience., conditionsModule conditions: Attention-deficit Hyperactivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 315, type: ESTIMATED, armsInterventionsModule interventions name: Pharmacist Care, interventions name: Primary Care Physician Care, outcomesModule primaryOutcomes measure: Percentage of participants appropriately referred for a follow-up weight check, secondaryOutcomes measure: Timeliness of care, secondaryOutcomes measure: Parent perception of effectiveness of care, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Kaiser Permanente Northern California, city: Oakland, state: California, zip: 94612, country: United States, geoPoint lat: 37.80437, lon: -122.2708, hasResults: False

protocolSection identificationModule nctId: NCT06388681, orgStudyIdInfo id: HMKU-KMY-SA-02, briefTitle: Stress Ball Use in Patients Undergoing Coronary Angiography, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-04-26, completionDateStruct date: 2024-06-26, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mustafa Kemal University, class: OTHER, descriptionModule briefSummary: One of the nonpharmacologic interventions included in the NIC-Nursing Interventions Classification is the use of stress balls. Stress balls are one of the cognitive distraction methods used especially in reducing pain and increasing the comfort level of patients. On the other hand, there are studies showing that stress balls have a positive effect not only on pain but also on vital signs, anxiety and comfort level of the patient., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: The Effect of Stress Ball Use on Immobilization Comfort, Pain Level and Vital Signs in Patients Undergoing Coronary Angiography, outcomesModule primaryOutcomes measure: Patient Identifying Information Form, primaryOutcomes measure: Immobilization Comfort Scale, otherOutcomes measure: Visual Benchmarking Scale, otherOutcomes measure: Vital Signs Monitoring Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hatay Mustafa Kemal University, status: RECRUITING, city: Hatay, country: Turkey, contacts name: SÜMEYYE AKÇOBAN, role: CONTACT, geoPoint lat: 38.40227, lon: 27.10486, hasResults: False

protocolSection identificationModule nctId: NCT06388668, orgStudyIdInfo id: ICM 2025-3428, briefTitle: Lipid Testing After Myocardial Infarction at the Montreal Heart Institute, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Montreal Heart Institute, class: OTHER, collaborators name: Novartis Pharmaceuticals, descriptionModule briefSummary: Because treatment decisions are usually based on a single measurement of the lipid panel at the time of an admission for an MI, the overarching objective of this project is to evaluate whether the measurement of LDL, non-HDL, and apoB values are reliable through all the duration of the hospitalization.It will be a single-center, prospective, observational study will be conducted, including consecutive patients hospitalized for myocardial infarction at the Montreal Heart Institute.Every patient at the Cardiac Care Unit will undergo non-fasting lipid panel testing at day 0 of their admission for Myocardial Infarction during the study period. Patients who consent to participate will have a 2nd non-fasting lipid panel drawn at day 2 of their admission.Thereafter, the levels of the different lipid values from the panel will be compared between day 0, day 2, and 4-6 weeks after discharge., conditionsModule conditions: Dyslipidemias, conditions: Lipid Testing, conditions: Myocardial Infarction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Lipid panel, outcomesModule primaryOutcomes measure: Variation in LDL, secondaryOutcomes measure: Variation in non-HDL and apoB, secondaryOutcomes measure: Evaluation of intensification threshold, otherOutcomes measure: Repeat lipid panel after discharge, otherOutcomes measure: Evaluation of intensification threshold after discharge, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Montreal Heart Institute, city: Montréal, state: Quebec, zip: H1T 1C8, country: Canada, contacts name: Guillaume Marquis-Gravel, MD, MSc, role: CONTACT, phone: (514) 376-3330, email: guillaume.marquis.gravel@umontreal.ca, contacts name: Guillaume Marquis-Gravel, MD, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Jean Grégoire, MD, role: SUB_INVESTIGATOR, contacts name: François Simard, MD, role: SUB_INVESTIGATOR, contacts name: Rafaël Monet-Alarcia, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False

protocolSection identificationModule nctId: NCT06388655, orgStudyIdInfo id: MDCR-19-007, briefTitle: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-06-10, primaryCompletionDateStruct date: 2022-06-30, completionDateStruct date: 2022-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Daegu Catholic University Medical Center, class: OTHER, descriptionModule briefSummary: The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations., conditionsModule conditions: Internet Addiction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 61, type: ACTUAL, armsInterventionsModule interventions name: mobile neurofeedback, interventions name: sham mobile neurofeedback, outcomesModule primaryOutcomes measure: Comparisons of the means of children's self-scale variables, secondaryOutcomes measure: Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II), secondaryOutcomes measure: Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV), secondaryOutcomes measure: Comparisons of the means of children's Stroop, secondaryOutcomes measure: Comparisons of the means of children's ATA(Advanced Test of Attention), secondaryOutcomes measure: Comparisons of the means of children's CCTT(Children's Color Trails Test), eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Daegu Catholic University Medical Center, city: Daegu, state: Nam-gu, zip: 42471, country: Korea, Republic of, geoPoint lat: 35.87028, lon: 128.59111, hasResults: False

protocolSection identificationModule nctId: NCT06388642, orgStudyIdInfo id: CUV052, briefTitle: Pharmacokinetics of Afamelanotide in EPP Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Clinuvel Europe Limited, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients., conditionsModule conditions: Erythropoietic Protoporphyria, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Afamelanotide 16mg implant, outcomesModule primaryOutcomes measure: Cmax (maximum Plasma Concentration), primaryOutcomes measure: AUC(0-t) (area under the curve from administration to last observed concentration at time t), secondaryOutcomes measure: AUC(0-∞) (area under the curve extrapolated to infinite time), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus Medical Center, status: RECRUITING, city: Rotterdam, country: Netherlands, contacts name: Erasmus Medical Centre, role: CONTACT, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False

protocolSection identificationModule nctId: NCT06388629, orgStudyIdInfo id: M064-066 Rev 00, briefTitle: Epicardial Access Study With Rook, acronym: EASY-R, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-17, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Circa Scientific, Inc., class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to test how how effective the Circa Scientific Rook® Epicardial Access Kit is at gaining guidewire access to the outside surface of the heart (epicardium). In addition the safety of the device will be compared to the available data for alternative methods of epicardial access.Participants will receive treatment with the subject device during the course of a typical epicardial electrophysiology procedure., conditionsModule conditions: Arrythmia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective, non-randomized, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Rook Epicardial Access Kit, outcomesModule primaryOutcomes measure: Successful Epicardial Access, secondaryOutcomes measure: Speed of Access, secondaryOutcomes measure: Rate of Use Errors, otherOutcomes measure: Rate of Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Na Homolce Hospital, status: RECRUITING, city: Prague, zip: 15030, country: Czechia, contacts name: Petr Neuzil, MD, PhD, role: CONTACT, phone: +420257272211, geoPoint lat: 50.08804, lon: 14.42076, hasResults: False

protocolSection identificationModule nctId: NCT06388616, orgStudyIdInfo id: D6402C00013, briefTitle: Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of balcinrenone in patients with mild and moderate hepatic impairment in comparison to a matched healthy control group., conditionsModule conditions: Hepatic Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Three cohorts (two hepatic impairment cohorts and controls with normal hepatic function) will be enrolled into this study.All subjects will receive the study intervention:* Cohort 1 will enroll 8 participants with mild hepatic impairment* Cohort 2 will enroll 8 participants with moderate hepatic impairment* Cohort 3 will enroll 8-12 healthy participants matched on a group level regarding age, BMI and sex, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Balcinrenone, outcomesModule primaryOutcomes measure: Area under plasma concentration-time curve from time zero to the last measurable concentration (AUClast), primaryOutcomes measure: Area under plasma concentration-time curve from zero to infinity (AUCinf), primaryOutcomes measure: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: AEs and SAEs up to the follow-up telephone call (Day 10 [± 3 days]), secondaryOutcomes measure: Number of participants with abnormal Vital signs, abnormal ECGs, and abnormal physical examination findings, secondaryOutcomes measure: Number of participants with abnormal laboratory tests results, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Hialeah, state: Florida, zip: 33014, country: United States, geoPoint lat: 25.8576, lon: -80.27811, locations facility: Research Site, city: Orlando, state: Florida, zip: 32809, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Research Site, city: San Antonio, state: Texas, zip: 78215, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False

protocolSection identificationModule nctId: NCT06388603, orgStudyIdInfo id: DFORCT012023, briefTitle: RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT), acronym: DFORCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: ASST Ovest Milanese, class: OTHER, collaborators name: Hippocrates Research, collaborators name: Bonalive Biomaterials Ltd, descriptionModule briefSummary: The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.Participants will randomized into two groups:* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible., conditionsModule conditions: Osteomyelitis - Foot, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: Bioactive Glass, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: healing rate, secondaryOutcomes measure: Duration of antibiotic therapy, secondaryOutcomes measure: Rate of recurrences, secondaryOutcomes measure: Number of re-interventions because of the same lesion, secondaryOutcomes measure: Timing of re-interventions because of the same lesion, secondaryOutcomes measure: Proportion of patients undergoing amputations, secondaryOutcomes measure: Patients' Quality of Life, secondaryOutcomes measure: Patients' Quality of Life, secondaryOutcomes measure: Time back to walk, secondaryOutcomes measure: Characteristics of surgery, secondaryOutcomes measure: Length of surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASUGI Azienda Sanitaria Universitaria Giuliano Isontina - Ospedale Monfalcone, status: NOT_YET_RECRUITING, city: Monfalcone, state: Gorizia, zip: 34074, country: Italy, contacts name: Dr. Roberto Da Ros, Med Doctor, role: CONTACT, phone: +39 3470606008, email: roberto.daros@aas2.sanita.fvg.it, contacts name: Dr. Roberto Da Ros, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.80463, lon: 13.53292, locations facility: ASST Ovest Milanese - Ospedale di Abbiategrasso, status: RECRUITING, city: Abbiategrasso, state: Milano, zip: 20081, country: Italy, contacts name: Dr. Roberto De Giglio, Med Doctor, role: CONTACT, phone: +39 331 6989775, email: roberto.degiglio@asst-ovestmi.it, contacts name: Dr. Roberto De Giglio, Med Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Ilaria Formenti, Med Doctor, role: SUB_INVESTIGATOR, contacts name: Dr. Vincenzo Curci, Med Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 45.39821, lon: 8.91678, locations facility: Casa di Cura Abano Terme - POLICLINICO ABANO TERME, status: NOT_YET_RECRUITING, city: Abano Terme, state: Padova, zip: 35031, country: Italy, contacts name: Dr. Christine Whisstock, Med Doctor, role: CONTACT, phone: +39 338 8924624, email: cwhisstock@casacura.it, contacts name: Dr. Christine Whisstock, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.35753, lon: 11.78725, locations facility: USL Sud Est Toscana - Ospedale San Donato, status: NOT_YET_RECRUITING, city: Arezzo, zip: 52100, country: Italy, contacts name: Dr. Alessia Scatena, Med Doctor, role: CONTACT, phone: +39 328 3281501, email: alessia.scatena@uslsudest.toscana.it, contacts name: Dr. Alessia Scatena, Med Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Matteo Apicella, Med Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 43.46276, lon: 11.88068, locations facility: AUSL Romagna - Ospedale Morgagni Pierantoni, status: NOT_YET_RECRUITING, city: Forlì, zip: 47121, country: Italy, contacts name: Dr. Silvia Acquati, Med Doctor, role: CONTACT, phone: +39 335 1239344, email: silvia.acquati@auslromagna.it, contacts name: Dr. Silvia Acquati, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.22177, lon: 12.04144, locations facility: Azienda USL Toscana Nord Ovest - Ospedale Campo di Marte, status: NOT_YET_RECRUITING, city: Lucca, zip: 55100, country: Italy, contacts name: Dr. Ilaria Casadidio, Med. Doctor, role: CONTACT, phone: +39 3284882078, email: ilaria.casadidio@uslnordovest.toscana.it, contacts name: Dr. Ilaria Casadidio, Med Doctor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.84369, lon: 10.50447, locations facility: AOU Pisana - Ospedale di Cisanello, status: NOT_YET_RECRUITING, city: Pisa, zip: 5612, country: Italy, contacts name: Prof. Alberto Piaggesi, Med Doctor, role: CONTACT, phone: +39 3473331949, email: alberto.piaggesi@med.unipi.it, contacts name: Dr. Chiara Goretti, Med Doctor, role: CONTACT, phone: +39 3294125791, email: chiara.goretti@gmail.com, contacts name: Prof. Alberto Piaggesi, Med Doctor, role: PRINCIPAL_INVESTIGATOR, contacts name: Dr. Chiara Goretti, Med Doctor, role: SUB_INVESTIGATOR, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False

protocolSection identificationModule nctId: NCT06388590, orgStudyIdInfo id: MOMMC.2024.0029, briefTitle: Acupuncture for Chronic Pelvic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: David Moss, class: FED, descriptionModule briefSummary: The objective of this study is to determine if alternative pain management strategies, namely acupuncture, may help reduce intensity of female pelvic pain compared to other pain control modalities. This research study will focus specifically on the Dragon's protocol of acupuncture which will seek to alleviate chronic non-endometriosis pelvic pain for women both with and without a history of sexual assault.This study may support evidence for an inexpensive alternative means of treatment for patients with or without traumatic sexual history and chronic pelvic pain., conditionsModule conditions: Pelvic Pain, conditions: Acupuncture, conditions: Gynecology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patient sample will be both control and treatment groups. Individuals will not be divided into distinct groups. Patients will serve as their own controls. Control patients will be participating in standard of care therapies including physical therapy, psychotherapy, behavioral health, typical primary care management, etc. as deemed appropriate by the primary care provider for 4 weeks prior to study intervention. The same patients will then be re-evaluated and will be offered Acupuncture with Dragon technique (see attachment Protocol for Needle Insertion) as a means of pain control once per week for 4 weeks., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Dragons, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Defense and Veterans Pain Rating Scale (DVPRS), primaryOutcomes measure: Defense and Veterans Pain Rating Scale (DVPRS), primaryOutcomes measure: Defense and Veterans Pain Rating Scale (DVPRS), primaryOutcomes measure: Defense and Veterans Pain Rating Scale (DVPRS), primaryOutcomes measure: Defense and Veterans Pain Rating Scale (DVPRS), primaryOutcomes measure: Defense and Veterans Pain Rating Scale (DVPRS), primaryOutcomes measure: Female Genitourinary Pain Index (GUPI), primaryOutcomes measure: Female Genitourinary Pain Index (GUPI), primaryOutcomes measure: Female Genitourinary Pain Index (GUPI), primaryOutcomes measure: Female Genitourinary Pain Index (GUPI), primaryOutcomes measure: Female Genitourinary Pain Index (GUPI), primaryOutcomes measure: Female Genitourinary Pain Index (GUPI), secondaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), secondaryOutcomes measure: PTSD Checklist for DSM-5 (PCL-5), eligibilityModule sex: FEMALE, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mike O'Callaghan Military Medical Center, status: RECRUITING, city: Nellis Air Force Base, state: Nevada, zip: 89191, country: United States, contacts name: Amanda J Crawford, MSHS, role: CONTACT, phone: 702-653-3583, email: amanda.j.crawford.ctr@health.mil, geoPoint lat: 36.24607, lon: -115.05721, hasResults: False

protocolSection identificationModule nctId: NCT06388577, orgStudyIdInfo id: MEU-HEM-SY-189, briefTitle: The Effect of the Training Programme Based on the Health Promotion Model Given to Parents, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-13, primaryCompletionDateStruct date: 2024-06-13, completionDateStruct date: 2024-09-13, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mersin University, class: OTHER, descriptionModule briefSummary: This randomised controlled study evaluates the effect of a training programme based on the Health Promotion Model developed for parents of children diagnosed with epilepsy on parents' level of knowledge about epilepsy, parents' general self-efficacy level, parents' health promoting and protective behaviours and the number of hospital admissions of their children. The hypothesis of this study is that education has an effect on these., conditionsModule conditions: Parents, conditions: Epilepsy in Children, conditions: Disease Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, single-centre, randomised controlled, single-blind interventional study in parallel groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participants and the person who will perform the statistical analysis will be blinded. Participants will be assigned to intervention and control groups coded as A and B. Afterwards, it will be determined which of the A and B groups belong to the control and intervention groups by drawing lots.It will not be explained to the parents which group they are in, and it will be stated that education about epilepsy will be given. While entering the data, the researcher will enter the data encrypted as A and B in order to prevent measurement bias, the statistical analysis of the data will be carried out according to this encryption and the report of the study will be written in encrypted form. After the statistical analyses of the research are carried out and the research report is written as a result of the data found, it will be explained which of the groups the individuals are included in., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Parents' level of knowledge about epilepsy evaluated using the Form for the Evaluation of Parents' Level of Knowledge about Epilepsy, primaryOutcomes measure: Self-efficacy evaluated using the General Self-Efficacy Scale, primaryOutcomes measure: Health Promoting and Protective Behaviors evaluated using the Health Promoting and Protective Behaviors Scale, secondaryOutcomes measure: Number of Hospital Admissions for Children evaluated using the Evaluation Form for the Number of Hospital Admissions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Turkey, Mersin University, city: Mersin, country: Turkey, contacts name: Sümerya YASTI, MASTER, role: CONTACT, email: 2204160171012@mersin.edu.tr, contacts name: Hacer ÇETİN, PROFESSOR, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.79526, lon: 34.61792, hasResults: False

protocolSection identificationModule nctId: NCT06388564, orgStudyIdInfo id: INCA34176-254, secondaryIdInfos id: 2022-502168-19-00, type: REGISTRY, domain: EU CT Number, briefTitle: A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-08, primaryCompletionDateStruct date: 2027-03-05, completionDateStruct date: 2028-09-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Incyte Corporation, class: INDUSTRY, descriptionModule briefSummary: This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD., conditionsModule conditions: Chronic Graft-versus-host-disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Axatilimab, interventions name: Ruxolitinib, interventions name: Corticosteroids, outcomesModule primaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Number of participants with Treatment-emergent Adverse Events (TEAEs), secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score, secondaryOutcomes measure: Best overall response in the first 6 months, secondaryOutcomes measure: OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD., secondaryOutcomes measure: Proportion of participants who remain corticosteroid-free, secondaryOutcomes measure: Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD., secondaryOutcomes measure: Failure-free Survival (FFS), secondaryOutcomes measure: Axatilimab pharmacokinetic (PK) in Plasma, secondaryOutcomes measure: Ruxolitinib PK in Plasma, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388551, orgStudyIdInfo id: LY03017/CT-CHN-101, briefTitle: A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Luye Pharma Group Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a phase 1，randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects., conditionsModule conditions: Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, conditions: Hallucinations and Delusions Associated With Parkinson Disease Psychosis, conditions: Negative Symptoms of Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: LY03017, interventions name: LY03017-Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Maximum observed concentration (Cmax) of LPM526000133 in plasma, secondaryOutcomes measure: Time to maximum observed concentration (Tmax) of LPM526000133 in plasma, secondaryOutcomes measure: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma, secondaryOutcomes measure: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma, secondaryOutcomes measure: Apparent terminal elimination half-life (t1/2) of LPM526000133 in plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shanghai Mental Health Center, city: Shanghai, country: China, contacts name: Huafang Li, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06388538, orgStudyIdInfo id: Carlo Bergamini, briefTitle: The COLD2B Multicenter, Two-arm Prospective Cohort Study, acronym: COLD2B, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Azienda Sanitaria di Firenze, class: OTHER, descriptionModule briefSummary: Since it is still debated whether 2b acute diverticulitis (AD), according to the World Society of Emergency Surgery (WSES) classification, should be initially treated surgically or conservatively, we launched the COLD2B study to compare the clinical results of both therapeutic regimens in a multi-institutional cohort of prospectively enrolled patients.The primary aim of the COLD2B (Conservative vs surgical (either Open or Laparoscopic) approach in the emergency management of acute Diverticulitis WSES 2B) study is to develop a model able to predict the length of hospitalization, comparing the management of WSES 2b AD in the emergency setting (conservative versus surgical approach) (primary endpoint of the first arm of the study).Moreover, the two groups will be compared regarding mortality and morbidity (secondary end-point).The second arm of the study will consider the population undergoing surgery, develop a model able to predict the length of hospitalization, and compare the open vs laparoscopic approach (primary end-point), and mortality, morbidity, and surgical outcome indices (secondary end-point)., conditionsModule conditions: Acute Diverticulitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Conservative treatment (non-operative treatment), interventions name: Surgical treatment (operative treatment), outcomesModule primaryOutcomes measure: Length of hospital stay in the overall population, secondaryOutcomes measure: Morbidity rate for both arms, secondaryOutcomes measure: Mortality rate for both arms, secondaryOutcomes measure: Surgical complications rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dipartimento di Medicina di Precisione e Rigenerativa e Area Jonica (DiMePRe-J), Universita' di Bari, city: Bari, country: Italy, contacts name: Francesco Paolo Prete, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: Department of Emergency and Acceptance, Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy, city: Florence, zip: 50134, country: Italy, contacts name: Carlo Bergamini, MD, role: CONTACT, phone: +39(0)557949173, email: drcarlobergamini@gmail.com, contacts name: Carlo Bergamini, role: PRINCIPAL_INVESTIGATOR, contacts name: Alessio Giordano, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Department of Medicine, Surgery and Health Sciences, University of Trieste, city: Trieste, country: Italy, contacts name: Manuela Mastronardi, role: CONTACT, geoPoint lat: 45.64953, lon: 13.77679, locations facility: Department of General Surgery, PO di Vittorio Veneto (TV), ULSS2 Marca Trevigiana, city: Vittorio Veneto, country: Italy, contacts name: Giulia Montori, role: CONTACT, geoPoint lat: 45.98026, lon: 12.30065, hasResults: False

protocolSection identificationModule nctId: NCT06388525, orgStudyIdInfo id: PostERCPLC, briefTitle: Post-ERCP Cholecystectomy. How ERCP and ERCP-related Variables Effect the Outcomes?, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2020-01-01, completionDateStruct date: 2020-01-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Kanuni Sultan Suleyman Training and Research Hospital, class: OTHER, descriptionModule briefSummary: In this retrospective study, we aimed to detect of effects of ERCP on outcomes of Laparoscopic Cholecystectomy. Patients underwent elective cholecystectomy surgery with a diagnosis of symptomatic cholelithiasis were identified and divided into two main groups regarding to have a ERCP procedure prior to surgery or not. To eliminate possible differences in baseline characteristics, patients in ERCP and non-ERCP groups were propensity score-matched 1:1 using nearest-neighbor matching without replacement based on age, sex and ASA score. Following propensity score matching (PSM), the ERCP and non-ERCP groups were first compared to detect effects of the ERCP procedure itself. After comparison of two main groups, subgroup analyzes performed for the ERCP group to detect effect of ERCP-related variables (indication for ERCP procedure, time between last ERCP procedure and surgery, number of preoperative ERCPs, stone extractions, and biliary stent use), conditionsModule conditions: Endoscopic Retrograde Cholangiopancreatography, conditions: ERCP-Laparoscopic Cholecystectomy Interval, conditions: Number of Preoperative ERCPs, conditions: Stone Extraction Status in ERCP Procedures, conditions: Biliary Stents, conditions: Mechanical Lithotripsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 426, type: ACTUAL, armsInterventionsModule interventions name: Endoscopic Retrograde Cholangiopancreatography, outcomesModule primaryOutcomes measure: Conversion to open, primaryOutcomes measure: Subtotal Cholecystectomy, primaryOutcomes measure: Postoperative Complications, primaryOutcomes measure: Adhesion levels, primaryOutcomes measure: Operative time, primaryOutcomes measure: Length of hospital stay, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bakirkoy Dr. Sadi Konuk Training and Research Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06388512, orgStudyIdInfo id: STUDY00160044, briefTitle: iMRI Prone Positioning Frame Design Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, collaborators name: Continuum Educational Technologies, descriptionModule briefSummary: The goal of this study is to learn if the prototype adjustable prone positioning frame is a feasible design for use during neurosurgical procedures which utilize intraoperative magnetic resonance imaging (iMRI). The main questions it aims to answer are:* Is the prototype prone positioning device design feasible for use during neurosurgical procedures which utilize intraoperative MRI?* Does use of the prototype device place the patient at increased risk of complications compared to the standard positioning pads? Researchers will place patients in the prone position on the prototype device during neurosurgical procedures that utilize intraoperative MRI and observe for any problems with the positioning device or complications attributable to the positioning device., conditionsModule conditions: Epilepsy, conditions: Pulmonary Embolism, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: prototype prone positioning device, outcomesModule primaryOutcomes measure: Number of devices that meet functional requirements, primaryOutcomes measure: Number of devices that are damaged during use, secondaryOutcomes measure: Number of patients with skin complications, secondaryOutcomes measure: Number of patients with thromboembolic complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, contacts name: Andrew Guillotte, MD, role: CONTACT, phone: 309-648-7036, email: aguillotte@kumc.edu, contacts name: Anand Dharia, MD, role: SUB_INVESTIGATOR, contacts name: Jennifer Cheng, MD, role: SUB_INVESTIGATOR, contacts name: Michael Kinsman, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Christopher Miller, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False

protocolSection identificationModule nctId: NCT06388499, orgStudyIdInfo id: GOIPG/2022/1854, briefTitle: A Physiotherapy-led Disease-agnostic Telerehabilitation Programme for People With Chronic Health Conditions, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-07-22, completionDateStruct date: 2024-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Limerick, class: OTHER, descriptionModule briefSummary: This protocol outlines a planned mixed methods feasibility trial which will be conducted to examine the feasibility and acceptability of a physiotherapy-led exercise-based telerehabilitation programme for groups of people with mixed chronic health conditions., conditionsModule conditions: Chronic Conditions, Multiple, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: TECC (Telerehabilitation and Exercise for Chronic Conditions), outcomesModule primaryOutcomes measure: Recruitment rate assessed by number of participants recruited during recruitment period., primaryOutcomes measure: Retention rate assessed by the proportion of enrolled participants who complete post-intervention assessments., primaryOutcomes measure: Adherence rate assessed by the attendance at synchronous group exercise sessions, primaryOutcomes measure: Satisfaction with the intervention as assessed by the Client-Satisfaction Questionnaire 8 (CSQ-8), primaryOutcomes measure: Satisfaction with individual intervention components assessed by Numerical Rating Scales (NRS), primaryOutcomes measure: Adverse events assessed via self-report questionnaire, primaryOutcomes measure: Intervention acceptability as assessed by qualitative feedback from participants via focus groups, secondaryOutcomes measure: Physical function assessed by the 30-second chair stand test (30CST)., secondaryOutcomes measure: Quality of life assessed by the Euro-QoL 5 Dimension 5 Level (Euro-QoL-5D-5L)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Tipperary Chronic Disease Management Hub, St. Brigid's Hospital, Carrick-on-Suir, status: RECRUITING, city: Tipperary, country: Ireland, contacts name: Niamh Julian, BSc, role: CONTACT, geoPoint lat: 52.47333, lon: -8.15583, hasResults: False

protocolSection identificationModule nctId: NCT06388486, orgStudyIdInfo id: UMCGoettingen9/9/16, briefTitle: Cytokine-Induced Transcription in Depressed Inpatients Undergoing Psychotherapy, acronym: CitDip, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-01, primaryCompletionDateStruct date: 2022-03-09, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Medical Center Goettingen, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to measure the levels of cytokine-induced transcription factor activation in a cohort of depressed inpatients undergoing psychotherapy. The study aims to answer the following main questions:* Do psychological traits (i.e.: social inhibition, negative affectivity, ...) affect the activation of immunomodulatory transcription factors (STAT3, NFkB) in depressed patients?* Are subjects with these psychological traits affected differently by psychotherapeutic intervention?Study subjects are assessed for their psychological and behavioral traits and receive psychotherapeutic care over several weeks during hospital treatment. Peripheral blood mononuclear cells are isolated from the study subjects, and activation of transcription factors is measured by flow cytometry., conditionsModule conditions: Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 63, type: ACTUAL, armsInterventionsModule interventions name: Psychotherapy, outcomesModule primaryOutcomes measure: Change in depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06388473, orgStudyIdInfo id: NMRR-20-2188-56086 IIR, briefTitle: Implementation of a Web-based App for Screening in Men in a Malaysian Primary Care Setting, acronym: iScreenMen, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-14, primaryCompletionDateStruct date: 2021-06-06, completionDateStruct date: 2021-06-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Malaya, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine how to successfully implement ScreenMen in the primary care setting. ScreenMen is a mobile web-based app that has been developed to increase the uptake of screening in men. ScreenMen undertook a vigorous and systematic approach in its development. It was developed based on theories, evidence and needs of men. ScreenMen particularly target men in the age group of 20 to 50 years as this group of men usually do not attend any health screening. This research is necessary because ScreenMen has yet to be implemented in the primary care setting. The study will last about five months and your participation will be about five months., conditionsModule conditions: Men's Health Screening, conditions: Implementation, conditions: Web-based Application, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 101, type: ACTUAL, armsInterventionsModule interventions name: Tailored implementation intervention, outcomesModule primaryOutcomes measure: Reach, primaryOutcomes measure: Reach, primaryOutcomes measure: Adoption of ScreenMen using qualitative methods, primaryOutcomes measure: Implementation of ScreenMen using qualitative methods, primaryOutcomes measure: Maintenance of ScreenMen using qualitative methods, secondaryOutcomes measure: Impact of COVID-19 on the clinic using qualitative methods, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Klinik Kesihatan Cheras Baru, city: Kuala Lumpur, zip: 56100, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False

protocolSection identificationModule nctId: NCT06388460, orgStudyIdInfo id: STUDY00001015, secondaryIdInfos id: R01HL169229, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL169229, briefTitle: Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2028-01, completionDateStruct date: 2028-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Massachusetts, Worcester, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of this cluster RCT is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14., conditionsModule conditions: Childhood Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Asthma Link, interventions name: Enhanced Usual Care, outcomesModule primaryOutcomes measure: Improving Asthma Symptoms, secondaryOutcomes measure: Improving Medication Adherence, secondaryOutcomes measure: Improving Healthcare Utilization, secondaryOutcomes measure: Reducing Parental Lost Workdays, secondaryOutcomes measure: Reducing School Absences, secondaryOutcomes measure: Improving Quality of Life, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Massachusetts Chan Medical School, status: RECRUITING, city: Worcester, state: Massachusetts, zip: 01655, country: United States, contacts name: Michelle Spano, role: CONTACT, phone: 508-856-2990, email: michelle.spano@umassmed.edu, contacts name: MIchelle Trivedi, MD MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.26259, lon: -71.80229, hasResults: False

protocolSection identificationModule nctId: NCT06388447, orgStudyIdInfo id: UCMSC1, briefTitle: Reconstruction of Deficient Interdental Papilla Using Stem Cells vs Physiological Saline: a RCT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Malaya, class: OTHER, descriptionModule briefSummary: The goal of this study is to assess the reconstruction of interdental papilla following the injection of UC-MSCs or physiological saline in patients with interdental papilla deficiency. Participants will be randomised into 2 groups (intervention vs placebo) to receive the treatment., conditionsModule conditions: Gingival Recession, Localized, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Umbilical cord-mesenchymal stem cells, outcomesModule primaryOutcomes measure: Reconstruction of the deficient interdental papilla with soft tissue, primaryOutcomes measure: Reconstruction of the deficient interdental papilla with bone, primaryOutcomes measure: Reconstruction of the deficient interdental papilla with bone, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Orthodontic Postgraduate Clinic, city: Kuala Lumpur, state: Wilayah Persekutuan Kuala Lumpur, zip: 50603, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False

protocolSection identificationModule nctId: NCT06388434, orgStudyIdInfo id: HP-00100309, briefTitle: Protective Arm Balance Responses, acronym: PAT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Maryland, Baltimore, class: OTHER, descriptionModule briefSummary: The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults.Participants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training., conditionsModule conditions: Old Age; Debility, conditions: Peripheral Neuropathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: The study will include two groups (older adults and people with peripheral neuropathy) which will be assessed pre- and post-intervention, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Protective Arm Balance Response Training, outcomesModule primaryOutcomes measure: Grasp Accuracy, primaryOutcomes measure: In-task falls incidence, secondaryOutcomes measure: Electromyography (EMG) of the shoulder muscles, secondaryOutcomes measure: Physiological responses (heart rate variability), secondaryOutcomes measure: Physiological responses (electrodermal activity), secondaryOutcomes measure: Activity specific balance confidence scale, secondaryOutcomes measure: Stait Trait Anxiety Inventory, secondaryOutcomes measure: Subjective Units of Distress Scale, secondaryOutcomes measure: Mini Mental State Examination (MMSE), secondaryOutcomes measure: Beck Anxiety Inventory, secondaryOutcomes measure: Somatosensation, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 88 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Allied Health Research Building, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Kelly P Westlake, PhD, role: CONTACT, phone: 410-706-5919, email: kwestlake@som.umaryland.edu, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False

protocolSection identificationModule nctId: NCT06388421, orgStudyIdInfo id: GMS-PH-401, briefTitle: DeciPHer-ILD: A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2030-08-01, completionDateStruct date: 2030-11-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: United Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a prospective, non-interventional, multicenter, registry of patients with pulmonary associated with interstitial lung disease (PH-ILD)., conditionsModule conditions: Pulmonary Hypertension Due to Lung Diseases and Hypoxia, conditions: Pulmonary Hypertension, conditions: Interstitial Lung Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Prospective study assessments, outcomesModule primaryOutcomes measure: Baseline characteristics as described by demographics, medical history, ILD history, PH history, family history (comorbidities), and diagnostic right heart catheterization values, secondaryOutcomes measure: Changes in clinical features relating to patients' interstitial lung disease and pulmonary hypertension, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388408, orgStudyIdInfo id: SufMAST, briefTitle: Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Padova, class: OTHER, descriptionModule briefSummary: Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil., conditionsModule conditions: Anesthesia Brain Monitor, conditions: Sufentanil, conditions: Target Controlled Infusion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia, primaryOutcomes measure: Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia, primaryOutcomes measure: Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia, secondaryOutcomes measure: Analgesia Nociception Index (ANI) values and postoperative pain, secondaryOutcomes measure: Patient State Index (PSi) values and postoperative delirium, secondaryOutcomes measure: Analgesia Nociception Index (ANi) values and postoperative delirium, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Treviso Regional Hospital, city: Treviso, state: TV, zip: 31100, country: Italy, geoPoint lat: 45.66673, lon: 12.2416, hasResults: False

protocolSection identificationModule nctId: NCT06388395, orgStudyIdInfo id: REC-23-05-12-02-F, briefTitle: Clinical Performance of All-on-4 PEEK and Conventional Prostheses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-08-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Sharjah, class: OTHER, descriptionModule briefSummary: The all-on-4 treatment approach for completely edentulous mandible is a proven concept. However, there are still issues regarding the use of metal substructure to support the prostheses such as allergy, metallic taste, and aesthetic. Therefore, other materials such as polyetheretherketone (PEEK) are being tested for its suitability and is showing good potential. However, available evidence is limited regarding its clinical performance. Thus, the aim of this study is to compare clinical performance of all-on-4 treatment concept utilizing PEEK versus conventional metal framework as substructure in fully edentulous mandible. Thirty suitable patients will receive either PEEK or conventional all-on-4 prostheses for fully edentulous mandible. The prostheses will be retained by four implants utilizing the all-on-4 principle. Clinical performance will be assessed during the follow up period of up 3 years concerning screw loosening, material chipping or fracture, wear or staining, prosthesis survival and success, implant survival and success., conditionsModule conditions: Failure, Prosthesis, conditions: Dental Prosthesis, Implant-Supported, conditions: Survival, Prosthesis, conditions: Complete Edentulism, conditions: Complication;Prostheses, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups will be provided with two types of implant-supported prostheses, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Block randomization will be used to randomly assign participants. The sequences will be concealed in opaque, consecutively numbered envelopes for each block. One envelope will be obtained for each participant, corresponding to the assignment of the protocol (conventional versus PEEK). The outcome assessor will be independent and not involved in any treatment procedure, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Accuracy of full-arch surgical guides, interventions name: Survival and complications of the prostheses, interventions name: Survival and complications of the implants, interventions name: Conventional (metal-resin) implant-supported prosthesis, interventions name: PEEK implant-supported prosthesis, outcomesModule primaryOutcomes measure: Accuracy of full-arch surgical guides, primaryOutcomes measure: Survival rate of implants, primaryOutcomes measure: Success rates of the Prostheses, primaryOutcomes measure: Pain level, secondaryOutcomes measure: Marginal bone loss, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Pocket depth, secondaryOutcomes measure: Bleeding index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Sharjah, city: Sharjah, zip: 7724, country: United Arab Emirates, geoPoint lat: 25.33737, lon: 55.41206, hasResults: False

protocolSection identificationModule nctId: NCT06388382, orgStudyIdInfo id: UKKx2024, briefTitle: Investigation of the Audible ICD Alert Tone, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-05-15, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Köln, class: OTHER, descriptionModule briefSummary: Ability of ICD patients to hear the audible ICD alert is being assessed., conditionsModule conditions: Implantable Defibrillator User, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Alert tone demonstration, outcomesModule primaryOutcomes measure: Alert tone audible, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Cologne, city: Cologne, zip: 50937, country: Germany, geoPoint lat: 50.93333, lon: 6.95, hasResults: False

protocolSection identificationModule nctId: NCT06388369, orgStudyIdInfo id: CA184-608, briefTitle: Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer, acronym: NEPI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, collaborators name: Advanced Accelerator Applications, collaborators name: Bristol-Myers Squibb, descriptionModule briefSummary: A randomized, open-label Phase I/II study of neoadjuvant treatment with \[177Lu\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy., conditionsModule conditions: Very High Risk Prostate Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The first patients are enrolled - without randomization - into the Safety Cohort to assess whether the treatment regime under investigation, i.e. Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq), is appropriately tolerated as per dose escalation algorithm.If it is established that Ipilimumab (3mg/kg) + \[177Lu\]Lu-PSMA-617 RLT (7,4 GBq) is appropriately tolerated, patients will be randomized into the two arms of the Analysis Cohort:* Arm A: Ipilimumab + \[177Lu\]Lu-PSMA-617 RLT* Arm B: \[177Lu\]Lu-PSMA-617 RLT, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: [177Lu]Lu-PSMA-617, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: Feasibility to perform prostatectomy on time, primaryOutcomes measure: Clinical activity: Proportion of participants in the full analysis set who achieve a pCR, secondaryOutcomes measure: Safety Profile of neoadjuvant treatment before radical prostatectomy, secondaryOutcomes measure: Safety Profile of neoadjuvant treatment before radical prostatectomy, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Essen, Clinic of Urology, city: Essen, zip: 45147, country: Germany, contacts name: PD Dr. med. Ulrich Krafft, role: CONTACT, email: ulrich.krafft@uk-essen.de, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False

protocolSection identificationModule nctId: NCT06388356, orgStudyIdInfo id: 042024, briefTitle: Patient's Informational Privacy in Prehospital Emergency Care - Educational Intervention Study for the Paramedics, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-05-19, completionDateStruct date: 2024-06-16, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Eini Koskimies, class: OTHER, descriptionModule briefSummary: The main goal of this educational intervention study about patient's informational privacy (IP) is to evaluate the effect of the educational intervention into the paramedics' knowledge and attitude regarding patient's IP. The study also investigates the usability and the feasibility of the educational intervention.The main questions it aims to answer are:1. What is the effect of the educational intervention on the 1. theoretical knowledge of paramedics' regarding IP? 2. the paramedics' attitude towards patient's IP?2. What is the usability and feasibility of the intervention being evaluated according to the respondents?, conditionsModule conditions: Knowledge, conditions: Attitude of Health Personnel, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups, intervention and control group. Only intervention group is receiveing the intervention., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Educational intervention - Yksityisyyttä ensihoitoon / Informational privacy for preospital emergency care, outcomesModule primaryOutcomes measure: Paramedics' knowledge about patient's informational privacy, secondaryOutcomes measure: paramedics' attitude towards patient's informational privacy., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Turku, city: Turku, zip: 20520, country: Finland, geoPoint lat: 60.45148, lon: 22.26869, hasResults: False

protocolSection identificationModule nctId: NCT06388343, orgStudyIdInfo id: S68485, briefTitle: Causes of Listening Difficulties in Children, acronym: CLINIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, collaborators name: Universitair Ziekenhuis Brussel, descriptionModule briefSummary: Many children experience listening and processing difficulties (LiD), especially in background noise, despite normal hearing sensitivity. The prevalence of these problems is estimated at 0.5-1% in the general population. Listening difficulties are associated with developmental disorders (DD) such as specific language disorders, autism spectrum disorder (ASD), ADHD and learning disabilities. Many children with developmental problems are easily distracted by sounds, have difficulty concentrating for long periods, processing language, remembering and summarizing oral information, and can experience academic difficulties (reading, writing). Early identification, differential diagnosis and intervention are important to help children overcome these difficulties and reach their full potential. Some concerns about these listening and processing problems, such as the lack of a gold standard to diagnose LiD and age-appropriate reference data, led to the initiation of this study.CLINIC aims to develop a new approach to diagnose the causes of listening difficulties in children. This is accomplished through (1) a validated parent questionnaire and (2) a multidisciplinary behavioral assessment tool. Data from these combined measures will lead to evidence-based profiles of children with LiD, which in turn will help streamline their referral pathways and care pathways., conditionsModule conditions: Listening Difficulties, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation of Children's Listening and Processing Skills, interventions name: Multidisciplinary behavioral assessment, outcomesModule primaryOutcomes measure: ECLiPS questionnaire, primaryOutcomes measure: Behavioral measures, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388330, orgStudyIdInfo id: s61692, briefTitle: The Effect of a Low FODMAP Diet in Functional Dyspepsia Patients With Meal Related Symptoms, acronym: FFD, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-04-26, primaryCompletionDateStruct date: 2022-03-08, completionDateStruct date: 2022-03-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: In this study, the investigators will evaluate the FODMAP diet as an alternative treatment for functional dyspepsia and explore its effect on different aspects of the pathophysiology of FD., conditionsModule conditions: Functional Dyspepsia, conditions: FODMAP Diet, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: open label strict diet phase blinded participant during reintroduction, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: low FODMAP diet, outcomesModule primaryOutcomes measure: Improvement on gastrointestinal symptoms, secondaryOutcomes measure: Reintroduction period, secondaryOutcomes measure: Evaluation of the low FODMAP diet on IBS related symptoms, secondaryOutcomes measure: Evaluation of the low FODMAP diet on symptom response and quality of life, secondaryOutcomes measure: Evaluation of the low FODMAP diet on depression, somatization, secondaryOutcomes measure: Evaluation of the low FODMAP diet on duodenal barrier function, secondaryOutcomes measure: Evaluation of the low FODMAP diet on gastric emptying, secondaryOutcomes measure: Evaluation of the low FODMAP diet on gastric accommodation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KU Leuven, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06388317, orgStudyIdInfo id: 123632, briefTitle: Machine-based Algorithm for Increased Physical Activity and Sustained User Engagement, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Western University, Canada, class: OTHER, descriptionModule briefSummary: This 12-week study compares the effectiveness of personalized daily step goals generated by a machine learning algorithm in the Sprout app versus fixed daily step goals of 10,000 steps among adults. Participants will be recruited through the Sprout app, and after a 1-week run-in period, they will be assigned to either the intervention or control group. The intervention group will receive adaptive goals based on their historical step data, while the control group will have a fixed goal. Both groups will receive financial incentives. This study aims to inform future interventions measuring changes in daily steps and app engagement levels (i.e., time spent on app, number of app opens) by studying how using financial incentives and an adaptive goal-setting design can improve physical activity levels of app users, informed by a machine learning algorithm., conditionsModule conditions: Health Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Retrospective, quasi-experimental study., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants are unaware of the other intervention arm (i.e., adaptive step goals versus static step goals)., whoMasked: PARTICIPANT, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Adaptive Step Goal (Intervention), interventions name: Static Step Goal (Control), outcomesModule primaryOutcomes measure: Step count, secondaryOutcomes measure: Number of app opens, total time spent on app, number of pages opened, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Western University, city: London, state: Ontario, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False

protocolSection identificationModule nctId: NCT06388304, orgStudyIdInfo id: 23-0556, briefTitle: THRIVE Study: Positive Affect Training for Endocrine Therapy Medication Adherence, acronym: THRIVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-10-12, completionDateStruct date: 2024-12-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Joanna Arch, class: OTHER, descriptionModule briefSummary: The purpose of this study is to pilot and refine an online behavioral intervention based on Positive Affect Training (PAT) that aims to increase positive emotional attitudes and decrease negative emotional attitudes toward endocrine therapy (ET, i.e., anti-hormonal medication) and to increase positive affect and decrease negative affect more generally, among post-treatment breast cancer survivors who are prescribed ET to prevent recurrence of breast cancer., conditionsModule conditions: Breast Cancer, conditions: DCIS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: THRIVE Online PAT Program, outcomesModule primaryOutcomes measure: Acceptability of THRIVE intervention (AIM), primaryOutcomes measure: Feasibility of THRIVE intervention, primaryOutcomes measure: Client Satisfaction Survey, eligibilityModule sex: FEMALE, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Boulder, status: RECRUITING, city: Boulder, state: Colorado, zip: 80309, country: United States, contacts name: Sienna Russel, role: CONTACT, phone: 720-897-1850, email: archlab@colorado.edu, contacts name: Madeline Nealis, MPH, role: CONTACT, phone: 720-897-1850, email: archlab@colorado.edu, contacts name: Joanna Arch, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.01499, lon: -105.27055, hasResults: False

protocolSection identificationModule nctId: NCT06388291, orgStudyIdInfo id: CTU/2018/321, briefTitle: Deep Brain Stimulation in Tourette Syndrome, acronym: Op-TICS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: National Institute for Health Research, United Kingdom, collaborators name: University College London Hospitals, collaborators name: Northern Care Alliance NHS Foundation Trust, collaborators name: St George's University Hospitals NHS Foundation Trust, collaborators name: Royal Devon and Exeter NHS Foundation Trust, collaborators name: University of Bristol, collaborators name: University of Dundee, collaborators name: London School of Hygiene and Tropical Medicine, collaborators name: King's College London, collaborators name: University Hospital, Rouen, collaborators name: Imperial College London, descriptionModule briefSummary: Op-TICS is a clinical investigation of the use of Deep Brain Stimulation (DBS), with a CE marked implantable device, to reduce severe motor and vocal tics in patients who suffer from Tourette Syndrome (TS).It is a randomised, double-blind, crossover clinical investigation for 20 patients. Op-TICS will be performed at the National Hospital for Neurology \& Neurosurgery.Following DBS surgery, participants will first enter an open adjustment phase, of 6 months, where the electrical stimulation settings of the device are optimised. Participants will then enter the double-blind phase that will include successively up to 2 weeks with stimulation on and up to 2 weeks with the stimulation off in a randomised order.The primary outcome measure is the tic severity score measured by the Yale Global Tic Severity Scale -Total Tic Score after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase, conditionsModule conditions: Tourette Syndrome, conditions: Deep Brain Stimulation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants will have electrodes implanted in the globus pallidus interna and connected to a subcutaneous pulse generator.This will be followed by a 6 months open-phase period of stimulation for electrical parameter adjustment.Following these 6 months, participants will be randomised into two groups by the order of treatment condition (ON/OFF-stimulation vs OFF/ON-stimulation): one group will be kept with the stimulation on ("ON-stimulation") and the other switched off ("OFF-stimulation") for up to two weeks. Tic severity will be assessed and all participants will enter a 2-day interval, in the ON state, before switching to the other treatment condition for another two weeks., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double Blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Deep Brain Stimulation, outcomesModule primaryOutcomes measure: Tic severity score measured by the YGTSS-TTS (total tic) after two weeks OFF-stimulation versus two weeks ON-stimulation in the double-blind randomised crossover phase, secondaryOutcomes measure: MRVRS at the end of the OFF-stimulation state versus the end of the ON-stimulation state in the blinded, randomised crossover phase., secondaryOutcomes measure: Change in the MRVRS between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the YGTSS (global) between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the GTS-QOL questionnaire measures at baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the YBOCS between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the BDI scale between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the BAI scale between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Change in the BAARS-IV between baseline 0 and the end of the open-phase (Baseline 1), secondaryOutcomes measure: Safety of DBS as indicated by the number of participants with any adverse events and number with any serious adverse events, otherOutcomes measure: A mechanistic part of the study will look at possible explanations of differing responses in both the open and randomised phase., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Hospital of Neurology & Neurosurgery, status: RECRUITING, city: London, country: United Kingdom, contacts name: Patricia Limousin, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False

protocolSection identificationModule nctId: NCT06388278, orgStudyIdInfo id: NET-2018-12366982-4/ASP_LOMB, briefTitle: Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018), acronym: RF-net2018, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-04-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, collaborators name: Regione Lombardia, collaborators name: Ministero della Salute, Italy, descriptionModule briefSummary: Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "RF-net2018" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms)., conditionsModule conditions: Antimicrobial Stewardship, conditions: Cost-effectiveness Analysis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50000, type: ESTIMATED, outcomesModule primaryOutcomes measure: evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection, primaryOutcomes measure: evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria., primaryOutcomes measure: compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Fondazione Policlinico of Milan, status: RECRUITING, city: Milan, zip: 20135, country: Italy, contacts name: GIULIA dr RENISI, Doctor, role: CONTACT, phone: 3887429609, email: giulia.renisi@policlinico.mi.it, contacts name: Alessandra dr Bandera, Doctor, role: CONTACT, phone: 0255034770, email: alessandra.bandera@unimi.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False

protocolSection identificationModule nctId: NCT06388265, orgStudyIdInfo id: 18/2018, Acta 26-6-2018, briefTitle: Emotional and Oral Characteristics of Patients That Attend a Dental Consultation for the Extraction of Third Molars, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-09, primaryCompletionDateStruct date: 2023-07-31, completionDateStruct date: 2023-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Barcelona, class: OTHER, descriptionModule briefSummary: Analyze the level of anxiety, hemodynamic parameters, oral status, and satisfaction among patients undergoing third molar extraction, we will assess those who attend the Master of Oral Medicine, Surgery, and Implantology program at the University of Barcelona., conditionsModule conditions: Anxiety and Fear, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: Trifold information, outcomesModule primaryOutcomes measure: Changes in STAI-S, primaryOutcomes measure: Changes in MDAS, secondaryOutcomes measure: Changes in blood pressure, secondaryOutcomes measure: Changes in Heart rate, secondaryOutcomes measure: Changes in Oxygen saturation, secondaryOutcomes measure: Patient Satisfaction of procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Odontològic Universitat de Barcelona, city: L'Hospitalet De Llobregat, state: Barcelona, zip: 08907, country: Spain, geoPoint lat: 41.35967, lon: 2.10028, hasResults: False

protocolSection identificationModule nctId: NCT06388252, orgStudyIdInfo id: ERID-KSOPR-0049/2023, secondaryIdInfos id: 0120-297/2023/3, type: OTHER, domain: National Medical Ethics Committee of the Republic of Slovenia, briefTitle: Electrochemotherapy Induces Changes in the Tumor Microenvironment of Cutaneous and Subcutaneous Metastases in Patients With Cutaneous Melanoma, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-11-10, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Institute of Oncology Ljubljana, class: OTHER, collaborators name: Slovenian Research and Innovation Agency, descriptionModule briefSummary: In the last 10 years, the treatment of metastatic cutaneous melanoma has changed dramatically. The new systemic treatment with immunotherapy has led to a dramatic improvement in quality of life and overall survival. Systemic treatment means that the patient receives the drug as an infusion into a vein. Unfortunately, we know that immunotherapy is not equally successful in all patients. Recent studies have shown that the success of the treatment is not only influenced by the cellular composition of the metastasis, but also by its surroundings. This is called tumor microenvironment. Depending on the differences in the composition of this microenvironment, some metastases can be described as immunologically hot and others as immunologically cold. Immunologically hot metastases respond better to immunotherapy than immunologically cold metastases.Studies have shown that with some interventions we can change the tumor microenvironment from being immune-cold to being immune-hot. Electrochemotherapy is one of the interventions that might improve the efficacy of immunotherapy in cutaneous melanoma. Electrochemotherapy is an established method for the local treatment of tumors, in which only a certain tumor is treated with special electrodes, to which a weak electric current is applied. We hypothesize that electrochemotherapy stimulates the body's own immune response and enables more effective treatment. Since immunotherapy also stimulates the body's own immune response to cutaneous melanoma cells, the interaction of the two drugs could be even more successful. Recent research results support this assumption.The primary objective is to evaluate the changes in the tumor microenvironment of cutaneous and subcutaneous melanoma metastases induced by electrochemotherapy, based on the histologic analysis of treated and untreated metastases before and after treatment. The secondary aim is to determine whether the changes in the tumor microenvironment differ depending on the chemotherapeutic agent used.The results will help us to better understand the synergistic effects of electrochemotherapy and immunotherapy on cutaneous melanoma metastases. The combination of systemic immunotherapy and electrochemotherapy could become an important treatment method for patients with metastatic melanoma., conditionsModule conditions: Cutaneous Malignant Melanoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: Electrochemotherapy with intratumoural cysplatin is recommended for smaller (less than 3 cm) and fewer tumours (up to 10 lesions), while electrochemotherapy with intravenous bleomycin is preferable for multiple and larger tumours., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Electrochemotherapy with Intratumoral Cysplatin, interventions name: Electrochemotherapy with Intravenous Bleomycin, outcomesModule primaryOutcomes measure: Changes in the tumor microenvironment of cutaneoys and subcutaneousm melanoma metastases induced by electrochemotherapy, secondaryOutcomes measure: Diferrent changes in the tumor microenvironment induced by electrochemotherapy with bleomycin or cysplatin, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Oncology Ljubljana, city: Ljubljana, zip: 1000, country: Slovenia, geoPoint lat: 46.05108, lon: 14.50513, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-10, uploadDate: 2024-03-20T00:20, filename: ICF_000.pdf, size: 356929, hasResults: False

protocolSection identificationModule nctId: NCT06388239, orgStudyIdInfo id: BE24-006, briefTitle: Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-26, primaryCompletionDateStruct date: 2024-09-14, completionDateStruct date: 2024-09-23, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: International Bio service, class: NETWORK, descriptionModule briefSummary: The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Apixaban 5MG, interventions name: ELIQUIS, outcomesModule primaryOutcomes measure: Plasma Area Under the Curve (AUC(0 to 36hr)) for Apixaban, primaryOutcomes measure: Peak Plasma Concentration (Cmax) of Apixaban, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388226, orgStudyIdInfo id: IRB # 16143, briefTitle: Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: Purdue University, descriptionModule briefSummary: The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Leg heat therapy, interventions name: Leg sham therapy, outcomesModule primaryOutcomes measure: Change in time to exhaustion during treadmill exercise, secondaryOutcomes measure: Change in maximal pulmonary oxygen uptake during treadmill exercise, secondaryOutcomes measure: Change in triceps surae microvascular oxygenation during treadmill exercise, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Change in diastolic blood pressure, secondaryOutcomes measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score, secondaryOutcomes measure: Change in triceps surae microvascular oxygenation during reactive hyperemia, secondaryOutcomes measure: Change in triceps surae volume, secondaryOutcomes measure: Change in triceps surae intramuscular fat content, secondaryOutcomes measure: Change in the time constant for phosphocreatine recovery after dynamic exercise, secondaryOutcomes measure: Change in maximal plantar flexor strength, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388213, orgStudyIdInfo id: GLP-1 RA patients GE by GUS, briefTitle: Investigation of the Evolution of Gastric Emptying by Gastric Ultra Sonography in Patients Treated With GLP-1 Receptor Agonists on a 7 Days Pausing Period., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Geneva, class: OTHER, descriptionModule briefSummary: Glucagon-like-peptide-1 is a hormone released by the gut enteroendocrine cells. Its secretion occurs after each meal to enable production of insulin and inhibits the production of glucagon to lower after meal glycemia. It also inhibits gastric emptying and food intake. GLP-1 RA plays a role on GLP-1 receptors present on islet beta cells and delta cells of the pancreas to control insulin. GLP-1 receptors are also present in multiple region of the central nervous system such as the hypothalamus and hindbrain where it results in reducing food intake. For anesthesiologist it is important to understand how GLP-1 RA influence gastric emptying. Indeed, respecting a fasting period (6 hours for solid and 2 hours for liquid) before each surgery is one of the cornerstones of anesthesiology to significantly reduce the risk of pulmonary aspiration. One of the side effects of GLP-1 RA is slowing gastric emptying and increasing the risk of regurgitation in patient that observed a recommended fasting period. During 2023 a lot of cases reports have emerged of pulmonary aspiration or the presence of a full stomach in patient treated by GLP-1 RA for a type 2 diabetes. Despite recommendations made by the American Society of Anesthesiology, it is still unkown what is the best fasting period and how long patients should pause a long acting GLP-1 RA before surgery. In this observational study, we would like to determine the effect of GLP-1 RA on gastric emptying in patient scheduled for general anesthesia. We will measure and compare residual gastric content with gastric ultrasonography in patients treated by GLP-1 RA and in those who are not. We will also do these comparisons in a group of patients with type 2 diabetes treated by weekly GLP-1 RA at different days after the injection of the medication. Our hypothesis is that we will observe a reduction in gastric residue in patients who stopped weekly GLP-1 RA 7 days prior the examination compared to those who have stopped less days considering the same fasting period. This would lead us to propose an optimal duration of stopping time for GLP-1 inhibitors in the preoperative period., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Anesthesia, conditions: Pulmonary Aspiration of Gastric Contents, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Gastric Ultrasonography, outcomesModule primaryOutcomes measure: Reduction of 5.5 cm2 of the CSA in patients pausing 7 days their GLP-1 RA treatment., secondaryOutcomes measure: Correlation between a full stomach evaluated on gastric ultrasonography and gastric symptoms such as nausea and bloating., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388200, orgStudyIdInfo id: OCU400-301, briefTitle: A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa, acronym: liMeliGhT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-10-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ocugen, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 3 study to Assess the Efficacy, Safety and Tolerability of OCU400 in patients with retinitis pigmentosa (RP) associated with RHO mutations and patients with any other RP associated mutation with a clinical phenotype of RP.This is a multicenter, assessor blinded and randomized study which will enroll 150 subjects., conditionsModule conditions: Retinitis Pigmentosa, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This is outcome assessor blinded study, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Sub-Retinal Administration of OCU400-301, outcomesModule primaryOutcomes measure: Number of participants with change in functional vision in the study eye of RP subjects as assessed by LDNA, primaryOutcomes measure: Number of participants with change in functional vision in the study eye in Gene Agnostic group as assessed by LDNA, secondaryOutcomes measure: Number of participants with change in functional vision in the all treated eyes of RP subjects as assessed by LDNA, secondaryOutcomes measure: Number of participants with change in functional vision in the all treated eyes of subjects in Gene Agnostic Arm as assessed by LDNA, secondaryOutcomes measure: Number of participants with change in visual function in subjects with RHO mutation as assessed by LLVA letter score, secondaryOutcomes measure: Number of participants with change in visual function in Gene Agnostic Arm as assessed by LLVA letter scores, secondaryOutcomes measure: Ocular and non-ocular Events, otherOutcomes measure: Patients Global Impression of Change (PGIC) score, eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Associated Retina Consultants, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85020, country: United States, contacts name: Mallory Mintert, MS, role: CONTACT, phone: 480-999-5458, email: Mallory.mintert@doctrials.com, contacts name: Jillian Bollinger, BS, role: CONTACT, phone: 480-999-5458, email: Jillian.bollinger@doctrials.com, contacts name: Benjamin Bakall, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Retina Consultants of Texas, status: NOT_YET_RECRUITING, city: Bellaire, state: Texas, zip: 77401, country: United States, contacts name: Rebbeca C Taing, role: CONTACT, phone: 713-524-3434, email: rebbecca.taing@retinaconsultantstexas.com, contacts name: Kenneth C Fan, M.D, MBA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.70579, lon: -95.45883, hasResults: False

protocolSection identificationModule nctId: NCT06388187, orgStudyIdInfo id: NN9838-7749, secondaryIdInfos id: U1111-1298-3451, type: OTHER, domain: World Health Organization (WHO), secondaryIdInfos id: 2023-509273-24, type: OTHER, domain: European Medical Agency (EMA), briefTitle: A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-24, primaryCompletionDateStruct date: 2026-02-27, completionDateStruct date: 2026-04-10, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Placebo, outcomesModule primaryOutcomes measure: Relative change in body weight, primaryOutcomes measure: Achievement of ≥5% weight reduction, secondaryOutcomes measure: Achievement of ≥10% weight reduction, secondaryOutcomes measure: Achievement of ≥15% weight reduction, secondaryOutcomes measure: Achievement of ≥20% weight reduction, secondaryOutcomes measure: Change in waist circumference, secondaryOutcomes measure: Change in systolic blood pressure, secondaryOutcomes measure: Ratio to baseline in lipids: Total cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol, secondaryOutcomes measure: Ratio to baseline in lipids: Triglycerides, secondaryOutcomes measure: Ratio to baseline in lipids: Free fatty acids, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aurora FDRC Inc., city: Costa Mesa, state: California, zip: 92627, country: United States, geoPoint lat: 33.64113, lon: -117.91867, locations facility: Clinical Trial Res Assoc,Inc, city: Plantation, state: Florida, zip: 33324, country: United States, geoPoint lat: 26.13421, lon: -80.23184, locations facility: Midwest Inst For Clin Res, city: Indianapolis, state: Indiana, zip: 46260, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: Accellacare, city: Wilmington, state: North Carolina, zip: 28401, country: United States, geoPoint lat: 34.22573, lon: -77.94471, locations facility: Velocity Clinical Res-Dallas, city: Dallas, state: Texas, zip: 75230, country: United States, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Washington Cntr Weight Mgmt, city: Arlington, state: Virginia, zip: 22206, country: United States, geoPoint lat: 38.88101, lon: -77.10428, locations facility: Capital Clin Res Ctr,LLC, city: Olympia, state: Washington, zip: 98502, country: United States, geoPoint lat: 47.03787, lon: -122.9007, locations facility: Ocean West Research Clinic, city: Surrey, state: British Columbia, zip: V3Z 2N6, country: Canada, geoPoint lat: 49.10635, lon: -122.82509, locations facility: Nova Scotia Health Authority, city: Halifax, state: Nova Scotia, zip: B3H 1V7, country: Canada, geoPoint lat: 44.64533, lon: -63.57239, locations facility: Wharton Med Clin Trials, city: Hamilton, state: Ontario, zip: L8L 5G8, country: Canada, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Hospices Civils de Lyon-Hopital Lyon Sud-1, city: Pierre-Benite, zip: 69310, country: France, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1, city: Saint Herblain, zip: 44800, country: France, geoPoint lat: 47.21765, lon: -1.64841, locations facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1, city: Toulouse Cedex 9, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: InnoDiab Forschung GmbH, city: Essen, zip: 45136, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, locations facility: Wendisch/Dahl Hamburg, city: Hamburg, zip: 22607, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, locations facility: AmBeNet GmbH, city: Leipzig, zip: 04107, country: Germany, geoPoint lat: 51.33962, lon: 12.37129, locations facility: Institut für Diabetesforschung GmbH Münster - Dr. med. Rose, city: Münster, zip: 48145, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann, city: Witten, zip: 58455, country: Germany, geoPoint lat: 51.44362, lon: 7.35258, locations facility: The Health Centre, city: Bradford-on-Avon, zip: BA15 1DQ, country: United Kingdom, geoPoint lat: 51.34772, lon: -2.25065, locations facility: Southmead Hospital, city: Bristol, zip: BS10 5NB, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Addenbrooke's Hospital_Cambridge, city: Cambridge, zip: CB2 0QQ, country: United Kingdom, geoPoint lat: 52.2, lon: 0.11667, locations facility: WISDEM Centre, city: Coventry, zip: CV2 2DX, country: United Kingdom, geoPoint lat: 52.40656, lon: -1.51217, locations facility: The Staploe Medical Centre, city: Soham, zip: CB7 5JD, country: United Kingdom, geoPoint lat: 52.33543, lon: 0.33654, locations facility: Joint Clinical Research Facility - Swansea, city: Swansea, zip: SA2 8PP, country: United Kingdom, geoPoint lat: 51.62079, lon: -3.94323, hasResults: False

protocolSection identificationModule nctId: NCT06388174, orgStudyIdInfo id: S2022-0336, briefTitle: Idiopathic Generalized Epilepsy Syndromes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2033-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis., conditionsModule conditions: Epilepsy, conditions: Epilepsy, Idiopathic Generalized, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: The proportion of drug-resistent epilepsy, primaryOutcomes measure: The proportion of seizure freedom, secondaryOutcomes measure: The proportion of psychiatric comorbidity, secondaryOutcomes measure: The proportion of psychosocial outcome, secondaryOutcomes measure: The proportion of seizure relapse after antiseizure medication withdrawn, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, status: RECRUITING, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: Chunhong Shen, role: CONTACT, phone: +86 0571 87783872, email: shen_neurology@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06388161, orgStudyIdInfo id: Yan2022-0336, briefTitle: Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, collaborators name: Sir Run Run Shaw Hospital, collaborators name: Ningbo Medical Center Lihuili Hospital, collaborators name: Shaoxing People's Hospital, descriptionModule briefSummary: Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies. Interestingly, some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis, particularly in the early stage.It is essential to recognize these patients early and to perform antibody testing, as studies have reported early immunotherapy can improve their clinical outcomes. At the same time, it is important to limit the number of patients who require testing, for the sake of specificity and cost effectiveness. Thus, this prospective, multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology, and to create a score to preselect patients requiring autoantibody testing., conditionsModule conditions: Epilepsy, conditions: Encephalitis Autoimmune, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, outcomesModule primaryOutcomes measure: Detectable serum neural autoantibodies, primaryOutcomes measure: Neuronal surface antibodies-mediated autoimmune- encephalitis, secondaryOutcomes measure: The proportion of seizure freedom, secondaryOutcomes measure: The proportion of drug-resistent epilepsy, secondaryOutcomes measure: Clinical severity and recovery, eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 100 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Chun-Hong Shen, role: CONTACT, phone: +86 0571 87783872, email: shen_neurology@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06388148, orgStudyIdInfo id: XL STROKE-2, briefTitle: Endovascular Treatment for eXtra-Large Ischemic Stroke, acronym: XL STROKE-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2027-01-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Zhongming Qiu, class: OTHER, collaborators name: The First Affiliated Hospital, University of South China, collaborators name: Xiangtan Central Hospital, collaborators name: Zhejiang University, collaborators name: Longyan First Affiliated Hospital of Fujian Medical University, descriptionModule briefSummary: The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion., conditionsModule conditions: Stroke, Acute Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 286, type: ESTIMATED, armsInterventionsModule interventions name: Medical management, interventions name: Endovascular thrombectomy, outcomesModule primaryOutcomes measure: Modified Rankin Scale score, secondaryOutcomes measure: Rate of successful reperfusion, secondaryOutcomes measure: Rate of excellent outcome, secondaryOutcomes measure: Rate of functional independence, secondaryOutcomes measure: Rate of independent ambulation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangtan Central Hospital, city: Xiangtan, state: Hunan, zip: 421001, country: China, geoPoint lat: 27.85, lon: 112.9, locations facility: Xingguo County People's Hospital, city: Ganzhou, state: Jiangxi, country: China, hasResults: False

protocolSection identificationModule nctId: NCT06388135, orgStudyIdInfo id: SNC-01, briefTitle: Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Yang Jianjun, PhD, class: OTHER, descriptionModule briefSummary: Abstract Objective: This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma (ESCC).The efficacy and safety of combining the programmed death 1 (PD-1) inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated. Methods and analysis: A prospective, single-center, open-label cohort study will enroll 80 patients, with 40 patients allocated to the experimental group and 40 patients to the control group. Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab, cisplatin, and nab-paclitaxel, while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel. The primary efficacy endpoint will be the assessment of pathological complete response (pCR) following neoadjuvant therapy. Secondary efficacy endpoints will include major pathological response (MPR), disease-free survival, objective response rate (ORR), and monitoring of adverse events (AEs).Ethics: Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital (Xijing Hospital) of Air force Military Medical University (KY20242052-C-1)., conditionsModule conditions: Esophageal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Serplulimab Combined With Nab-paclitaxel and Cisplatin, interventions name: nab-paclitaxel，Cisplatin, outcomesModule primaryOutcomes measure: pCR, secondaryOutcomes measure: MPR, secondaryOutcomes measure: DFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: AEs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388122, orgStudyIdInfo id: 23-009689, secondaryIdInfos id: NCI-2024-03405, type: REGISTRY, domain: CTRP (Clinical Trials Reporting Program), secondaryIdInfos id: MC240301, type: OTHER, domain: Mayo Clinic, briefTitle: DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2026-06-15, completionDateStruct date: 2026-06-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to explore the clinical utility of routinely measuring thymidine kinase activity (TKa) in HR+ metastatic breast cancer patients receiving treatment with any approved endocrine therapy either alone or in combination with any approved CDK4/6 inhibitor., conditionsModule conditions: HER2-negative Breast Cancer, conditions: Hormone-receptor-positive Breast Cancer, conditions: Metastatic Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, outcomesModule primaryOutcomes measure: DiviTum®TKa assay as an early predictor of primary treatment resistance, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Pooja Advani, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False

protocolSection identificationModule nctId: NCT06388109, orgStudyIdInfo id: IRB15-00741, briefTitle: Positive Peers Intervention Clinical Trial, acronym: PoPIT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: MetroHealth Medical Center, class: OTHER, collaborators name: Kent State University, descriptionModule briefSummary: The goal of this clinical trial is to learn if the Positive Peers mobile app intervention increases rates of viral suppression in young (13-34 y/o) persons with HIV.Does use of the Positive Peers app improve viral suppression among young minority persons with HIV? What user characteristics are associated with a) viral suppression, b) retention in care, and c) perceived HIV-related stigma?Participants will:* download the mobile app onto their personal smartphone* Use the mobile app as they find useful* complete online surveys at enrollment, 3 mo, 6, mo, 9 mo and 12 months., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized control trial with observational cohort for eligible patients who decline participation, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Positive Peers mobile app, outcomesModule primaryOutcomes measure: Viral suppression, secondaryOutcomes measure: Correlates of app use and viral suppression, secondaryOutcomes measure: Correlates of app use and retention in care, secondaryOutcomes measure: Correlates of app use and HIV related perceived stigma, eligibilityModule sex: ALL, minimumAge: 13 Years, maximumAge: 34 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Northeast Valley Health Corporation, city: Van Nuys, state: California, zip: 91405, country: United States, contacts name: Edgar Banuelos, role: CONTACT, email: edgarbanuelos@nevhc.org, contacts name: Herberth Osorio, MPH, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.18667, lon: -118.44897, locations facility: Infectious Disease Practice- Rutgers University, city: Newark, state: New Jersey, zip: 07103, country: United States, contacts name: Jared Khan, role: CONTACT, email: khanjj@njms.rutgers.edu, contacts name: Shoba Swaminathan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.73566, lon: -74.17237, locations facility: Equitas Health, city: Cincinnati, state: Ohio, zip: 45206, country: United States, contacts name: Tania Slack-Peterson, role: CONTACT, email: TaniaSlack@equitashealth.com, contacts name: Kelly Wesp, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Equitas Health, city: Columbus, state: Ohio, zip: 43203, country: United States, contacts name: Tania Slack-Peterson, role: CONTACT, email: TaniaSlack@equitashealth.com, contacts name: Kelly Wesp, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Thomas Street Clinic, city: Houston, state: Texas, zip: 77004-8004, country: United States, contacts name: Ernesto Linares Pineda, role: CONTACT, email: Ernesto.LinaresPineda@bcm.edu, contacts name: Shital Patel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: UW Madison Clinic at Harborview, city: Seattle, state: Washington, zip: 98104, country: United States, contacts name: Tala Mahmoud, role: CONTACT, email: talam2@uw.edu, contacts name: H Nina Kim, MD, MPH, role: PRINCIPAL_INVESTIGATOR, contacts name: Raaka Kumbhakar, MD, role: SUB_INVESTIGATOR, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False

protocolSection identificationModule nctId: NCT06388096, orgStudyIdInfo id: PERGCLAD001, briefTitle: CLAD Deconvolved PERG Responses in Glaucoma Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Jorvec Corp., class: INDUSTRY, collaborators name: University of Miami, descriptionModule briefSummary: Glaucoma is a progressive disease resulting in blindness. Determining the onset of the disease is critical so patients may obtain treatment to preserve useful vision. This study will collect data from a population of glaucoma suspects (with positive factors for the disease but with normal vision) along with a population of age matched controls using the pattern electroretinogram (PERG) and other standard eye tests for glaucoma. The PERG measures the function of retinal ganglion cells (RGCs) which come together to form the optic nerve. RGCs may become dysfunctional before dying. The Continuous loop deconvolution technique (CLAD) will be used to extract transient PERG responses in both glaucoma suspects and age matched controls. All patients will be monitored with PERG, Optic Coherence Tomography (OCT) and other ancillary tests over 2 years. CLAD will be compared with conventional techniques of monitoring glaucoma (standard PERG, OCT, visual field etc) to see if the CLAD is better at distinguishing between glaucoma suspects and controls., conditionsModule conditions: Glaucoma, Suspect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: No Intervention Provided, outcomesModule primaryOutcomes measure: PERG Amplitude, primaryOutcomes measure: PERG Latency, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, Bascom Palmer Eye Institute 900 NW 17th Street, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Vittorio Porciatti, MD/PhD, role: CONTACT, email: vporciatti@med.miami.edu, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False

protocolSection identificationModule nctId: NCT06388083, orgStudyIdInfo id: LBS-008-CT07, briefTitle: A Phase 2/3 Study to Evaluate the Efficacy and Safety of Tinlarebant in Subjects With Stargardt Disease, acronym: DRAGON II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Belite Bio, Inc, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of tinlarebant in subjects with Stargardt Disease, conditionsModule conditions: STGD1, conditions: Stargardt Disease 1, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Tinlarebant, interventions name: Placebo, outcomesModule primaryOutcomes measure: To measure the annualized rate of change from baseline lesion size in aggregate area of atrophy, secondaryOutcomes measure: To measure the annualized rate of change in total area of atrophy, secondaryOutcomes measure: Change in BCVA measured by the ETDRS method, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 20 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Belite Study Site, city: Dallas, state: Texas, zip: 75231, country: United States, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False

protocolSection identificationModule nctId: NCT06388070, orgStudyIdInfo id: HUC3-053, briefTitle: To Evaluate the Efficacy and Safety of HUC3-053 in Patients With Dry Eye Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Huons Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a multi-center, randomized, double-blinded, non-inferiority study to evluate the efficacy and safety of HUC3-053 in patients with dry eye syndrome.After a 2-week run-in period, patients will be randomized equally to the HUC3-053 or Hyalein Mini Drops administered bilaterally five to six times a day for 12 weeks., conditionsModule conditions: Dry Eye Syndromes, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: HUC3-053, interventions name: Hyalein Mini Drops, outcomesModule primaryOutcomes measure: Change from Baseline in Corneal staining score, secondaryOutcomes measure: Change from Baseline in Corneal staining score, secondaryOutcomes measure: Change from Baseline in Conjunctival staining score, secondaryOutcomes measure: Change from Baseline in Schirmer test, secondaryOutcomes measure: Change from Baseline in Tear film break-up time, secondaryOutcomes measure: Change from Baseline in Ocular surface disease index, secondaryOutcomes measure: Change from Baseline in Soreness after eye drop assessed by NRS, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06388057, orgStudyIdInfo id: 5836, briefTitle: Intraoperative Ultrasound in Crohn's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: To study the role of intraoperative ultrasound of small bowel as a possible tool that can reduce the rate of histologically involved resection margins from Crohn's Disease., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients with Crohn's disease with an indication for surgery, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Intraoperative Small Bowel Ultrasonography, outcomesModule primaryOutcomes measure: Specificity and sensibility of intraoperative ultrasound of small bowel in identifying resection margins histologically involved by Crohn's disease, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06388044, orgStudyIdInfo id: PRO00115010, briefTitle: ACT for Infertility: Case Series, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT., conditionsModule conditions: Infertility, conditions: Psychological Distress, conditions: Acceptance and Commitment Therapy, conditions: Psychological Flexibility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Acceptance and Commitment Therapy, outcomesModule primaryOutcomes measure: Acceptability of the Intervention, secondaryOutcomes measure: Change in Fertility Problem Inventory (FPI), secondaryOutcomes measure: Change in Patient Health Questionnaire 9 (PHQ-9), secondaryOutcomes measure: Change in Patient Health Questionnaire 2 (PHQ-2), secondaryOutcomes measure: Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7), secondaryOutcomes measure: Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2), secondaryOutcomes measure: Change in Modified Differential Emotions Scale (mDES), secondaryOutcomes measure: Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15), secondaryOutcomes measure: Change in Intolerance of Uncertainty (IUS), secondaryOutcomes measure: Change in Valuing Questionnaire (VQ), secondaryOutcomes measure: Change in Values-Based Behavior, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke North Pavilion, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Francesca Scheiber, PhD, role: CONTACT, phone: 919-668-8696, email: fs158@duke.edu, contacts name: Julia Woodward, PhD, role: SUB_INVESTIGATOR, contacts name: Ashley Moskovich, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False

protocolSection identificationModule nctId: NCT06388031, orgStudyIdInfo id: CAPTRAL2024v1, briefTitle: ICI Rechallenge for Advanced NSCLC With Long-Term Response to First-Line ICI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-10, primaryCompletionDateStruct date: 2027-01-10, completionDateStruct date: 2027-12-10, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: An exploratory phase II trial of immune checkpoint inhibitors (ICIs, anti-PD-1/anti-PD-L1) as second-line treatment with advanced non-small cell lung cancer (NSCLC) who had long-term response to first-line immunotherapy (with or without chemotherapy).This study aims to evaluate efficacy and safety of ICI rechallenge in long-term responders to prior ICI. Furthermore, it seeks to identify biomarkers capable of predicting the efficacy of immunotherapy and prognosis., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Immune checkpoint inhibitor, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Progression Free Survival 2 (PFS 2), otherOutcomes measure: Safety profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, zip: 100730, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06388018, orgStudyIdInfo id: NRG-GY032, secondaryIdInfos id: NCI-2023-09355, type: REGISTRY, domain: CTRP, secondaryIdInfos id: CCTG EN.10, type: OTHER, domain: CCTG, secondaryIdInfos id: U10CA180868, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180868, briefTitle: Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer, statusModule overallStatus: SUSPENDED, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-01-09, completionDateStruct date: 2025-01-09, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: NRG Oncology, class: OTHER, collaborators name: National Cancer Institute (NCI), collaborators name: Canadian Cancer Trials Group, descriptionModule briefSummary: This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended., conditionsModule conditions: Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC V8, conditions: Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC V8, conditions: Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC V8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 325, type: ESTIMATED, armsInterventionsModule interventions name: Clinical Observation, interventions name: External Beam Radiation Therapy, interventions name: High-Dose-Rate Vaginal Brachytherapy, interventions name: Computed Tomography, interventions name: Positron Emission Tomography, interventions name: X-Ray Imaging, interventions name: Magnetic Resonance Imaging, interventions name: Questionnaire Administration, outcomesModule primaryOutcomes measure: Time to pelvic recurrence, secondaryOutcomes measure: Time to isolated vaginal recurrence, secondaryOutcomes measure: Recurrence-free survival, secondaryOutcomes measure: Endometrial cancer-specific survival, secondaryOutcomes measure: Fear of recurrence, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False

protocolSection identificationModule nctId: NCT06388005, orgStudyIdInfo id: 2021-060, briefTitle: The Application of Emotion Release Technology in Anxiety Patients Before Daytime Thyroid Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2022-07-31, completionDateStruct date: 2022-07-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Yantai Yuhuangding Hospital, class: OTHER, descriptionModule briefSummary: Research methods1 Data collection and evaluation tools1. The general data record sheet was self-designed by the research team, and the collected content included age, gender, BMI, occupation, general family status, economic situation, history of hypertension and cardiovascular diseases, history of anxiety and depression, self-rating anxiety scale (SAS) score, blood pressure and heart rate before and after intervention, disease diagnosis and severity, etc.2. The anxiety was self-scored using the VAS-A (0-10 points), with 0 point as no anxiety and 10 as severe anxiety.3. Negative emotional intensity was scored using the subjective unit of disturbance scale (SUDS, 0-10 points), with 0 point as no and 10 points as severe.4. Nursing satisfaction was scored by the self-designed questionnaire (1-5 points): 5 points, very satisfied; 4 points, relatively satisfied; 3 points, satisfied; 2 points, medium; 1 point, dissatisfied.2 Intervention method of the control group The control group was given routine nursing. After entering the pre-anesthesia room, the patients were scored using the VAS-A, and those with VAS-A score ≥ 5 were considered to meet the inclusion criteria. After identity authentication, the preoperative precautions and reasons for waiting in the pre-anesthesia room were explained to the patients, and answers were provided to the questions raised by the patients. After routine nursing, VAS-A score was recorded, blood pressure and heart rate were monitored, and nursing satisfaction was inquired. The survey of patient satisfaction with nursing was completed before entering the operating room.3 Intervention method of the experimental group 3.1 Researcher training Before intervention, 4 nurses were trained for 5 d by a nurse with EFT qualification certificate, 1 h per day. The training content included: theoretical knowledge of EFT, tapping techniques, etc. After training, two assessments were conducted. Only those who scored above 90 points in both assessments could participate in the study.3.2 Operating instructions The acupoint diagram was distributed to the experimental group by nurses, and the essentials and precautions of acupoint tapping were explained. The nurses demonstrated and tapped the acupoints on the patients while explaining, and then instructed them to tap on their own until they were able to complete the task independently and proficiently. For patients with upper limb vein puncture, proper fixation and close observation were needed, and the flexible nature of the puncture needle that would not affect operations was explained to the patients to eliminate their concerns.3.3 Intervention content After routine nursing, the patients received EFT intervention. In addition, subjective anxiety was scored, blood pressure and heart rate were monitored, and nursing satisfaction was surveyed after admission and intervention. The specific methods are as follows.1. Preparation stage The patients with VAS-A score ≥ 5 meeting the inclusion criteria were in a comfortable position with eyes closed, and adopted breathing exercise to relax their whole body. The patients were guided to summarize the main current distresses, such as fear, tension, pain, surgical prognosis, economic burden, etc., name the caused negative emotions, and use the SUDS to evaluate the intensity of negative emotions. The patients were asked to recite silently the prompt "Although I am very \*\* (a negative emotional word) now, I still deeply and completely love and accept myself" while tapping.2. Tapping stage The patients were guided to gently massage the sore points on both sides of the body (2-3 fingers below the midpoint of the clavicle) with their five fingers together in a clockwise direction, while silently reciting the prompt 3 times. Then, the patients were guided to close their index and middle fingers together and gently tap the Zanzhu, Tongziliao, Chengqi, Renzhong, Chengjiang, Shufu, Dabao and Baihui acupoints successively with their fingertips at 2-3 times/s and the force they can bear. The prompt was recited silently when tapping each acupoint. After 3-5 rounds of tapping, 3 deep breaths were taken to re-evaluate the intensity of negative emotions.3. Feedback stage After tapping, the patients communicated with the nurses at least once about their evaluated negative emotional intensity score and whether the score was accepted. If the tapping effect was not obvious, the evaluation was conducted by nurses, and the patients were guided to massage the sore points while silently reciting the prompt 3 times. To relieve reverse psychological drive, tapping was continued until the intensity of negative emotions reduced., conditionsModule conditions: Anxiety, conditions: Day Surgery, conditions: Preoperative Nursing Care, conditions: Emotional Freedom Technique, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 237, type: ACTUAL, armsInterventionsModule interventions name: emotional freedom technique (EFT), outcomesModule primaryOutcomes measure: VAS-A score, primaryOutcomes measure: hemodynamic and endocrine indicators, primaryOutcomes measure: nursing satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Yantai Yuhuangding Hospital, city: Yantai, state: Shandong, zip: 264000, country: China, geoPoint lat: 37.47649, lon: 121.44081, hasResults: False

protocolSection identificationModule nctId: NCT06387992, orgStudyIdInfo id: PP24023, briefTitle: Evaluation of the Agreement Between a Consultation With a Nurse Acquiring Three-dimensional Intraoral Images Made With a 3D Intraoral Camera and the Standard Consultation With a Dental Surgeon, in Institutionalized Elderly Subjects, acronym: GEROdonto3D, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: CHU de Reims, class: OTHER, descriptionModule briefSummary: The primary objective of this study will be to assess the agreement between a dental consultation with a nurse acquiring intraoral images, using a 3D intraoral camera, and a standard consultation with a dental surgeon, in institutionalized elderly subjects Institutionalized subjects planned to have a dental consultation and eligible will be included once written informed consent is signed. Their dental consultation will start with a consultation with a nurse to record 3D intraoral images, then a consultation with a dental surgeon for standard dental care, blinded from the nurse consultation will be performed. Thereafter, 3D images will be analyzed by another dental surgeon blinded from the results of both consultations. Agreement on different outcomes between the analysis of the images acquired by the nurse and the standard dental evaluation by a dental surgeon will be assessed.Agreement on the results between the interpretation of the 3D images acquired by a nurse and the standard consultation by a dental surgeon could lead, in the long term, to a significant step forward in dental care of institutionalized patients.Indeed, training nursing home nurses to acquire 3D dental images would enable the identification of patients in need of immediate dental care and thus extend the possibilities of access to consultations with a dentist for these patients. This would increase the efficiency of care., conditionsModule conditions: Dental Care for Institutionalized Elderly Persons, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Three-dimensional dental acquisition, outcomesModule primaryOutcomes measure: DMFT index, secondaryOutcomes measure: Plaque control record, secondaryOutcomes measure: General Oral Health Assessment Index (GOHAI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Damien JOLLY, city: Reims, country: France, contacts name: Carole ETIENNOT, role: CONTACT, phone: 03 10 73 66 79, phoneExt: 0033, email: cetiennot@chu-reims.fr, geoPoint lat: 49.25, lon: 4.03333, hasResults: False

protocolSection identificationModule nctId: NCT06387979, orgStudyIdInfo id: 19-010725, secondaryIdInfos id: NCI-2024-01000, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 19-010725, type: OTHER, domain: Mayo Clinic in Florida, secondaryIdInfos id: P30CA015083, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA015083, secondaryIdInfos id: R33CA240181, type: NIH, link: https://reporter.nih.gov/quickSearch/R33CA240181, briefTitle: Advanced Development of Desorption Electrospray Ionization Mass Spectrometry for Intraoperative Molecular Diagnosis of Brain Cancer Using Pathology Biopsies, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-10-26, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2025-10-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study explores whether DESI-MS can be used to identify cancerous vs. noncancerous tissue during brain tumor surgery., conditionsModule conditions: Glioma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 185, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Pathological state of the tissue, primaryOutcomes measure: Percentage of tumor infiltration, primaryOutcomes measure: Presence of IDH mutations, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Florida, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32224-9980, country: United States, contacts name: Clinical Trials Referral Office, role: CONTACT, phone: 855-776-0015, email: mayocliniccancerstudies@mayo.edu, contacts name: Alfredo Quinones-Hinojosa, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.33218, lon: -81.65565, hasResults: False

protocolSection identificationModule nctId: NCT06387966, orgStudyIdInfo id: H-FNTN-PI-Ia, briefTitle: A Randomized, Double-blind,Dose-escalating, Single-dose, Oral Phase I Clinical Study of Flunotinib Healthy People, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-08-29, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Chengdu Zenitar Biomedical Technology Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: Evaluate the safety and tolerability of a single increasing dose of Flibanserin Maleate tablets administered orally to healthy adult Chinese subjects; preliminarily assess the pharmacokinetic characteristics of a single dose of oral Flibanserin Maleate tablets, conditionsModule conditions: Healthy Person, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: flunotinib, interventions name: flunotinib placebo, outcomesModule primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：Cmax, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：Tmax, primaryOutcomes measure: The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144h) and excretion rate (Ae%);, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：AUC0-∞, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：MRT, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：Vd, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：t1/2, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：CLz/F, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：Vz/F, primaryOutcomes measure: Prilinostat Mesylate Pharmacokinetics (PK)：Ke, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chengdu Xinhua Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Xiaolan Yong, bachelor, role: CONTACT, phone: 13568843829, email: yongxlan@126.com, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False

protocolSection identificationModule nctId: NCT06387953, orgStudyIdInfo id: STUDY00019480, briefTitle: Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Washington, class: OTHER, descriptionModule briefSummary: This is a randomized, prospective, double-blinded (patient and outcome-assessor) trial. Our goal is to assess efficacy of Bridge Therapy (versus sham bridge therapy) to prevent emergence agitation following general anesthesia.Primary Objective: Activation of Bridge Therapy from the time of the pre incision "time out" until 24 hours after admission to the PACU (Post Anesthesia Care Unit) is associated with reduced frequency and intensity of emergence agitation.Secondary Objective: Bridge Therapy activation will also result in a lower incidence of rescue pharmacologic treatment of agitation.Tertiary Objective: Activation of Bridge Therapy during a stable anesthetic state is associated with a reduced Patient State Index as measured on Sedline, conditionsModule conditions: Emergence Delirium, conditions: Agitation, Emergence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Bridge Therapy, interventions name: Sham Therapy, outcomesModule primaryOutcomes measure: Emergence agitation, primaryOutcomes measure: Emergence agitation, secondaryOutcomes measure: Rescue pharmacologic treatment of agitation, otherOutcomes measure: Patient State Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387940, orgStudyIdInfo id: UEC 2019 008 FHMS, briefTitle: Acute Metabolic Effects of Carbohydrate Restriction at Varying Energy Levels, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-05, primaryCompletionDateStruct date: 2020-04-01, completionDateStruct date: 2022-11-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Surrey, class: OTHER, descriptionModule briefSummary: This study investigates how different low-carbohydrate diets affect metabolism and hunger in overweight adults. We will measure metabolic rates and blood metabolites., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: nEB Diet, followed for 36 hours, interventions name: LC25 Diet, followed for 36 hours, interventions name: LCEB Diet, followed for 36 hours, outcomesModule primaryOutcomes measure: Biomarkers in blood Measured, primaryOutcomes measure: Resting metabolic rate, secondaryOutcomes measure: Perceived Appetite Scores, secondaryOutcomes measure: Food intake, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Surrey, city: Guildford, zip: GU2 7XH, country: United Kingdom, geoPoint lat: 51.23536, lon: -0.57427, hasResults: False

protocolSection identificationModule nctId: NCT06387927, orgStudyIdInfo id: PT-NEUR-10/2023-520, briefTitle: Effect of Home-exercise Programs Versus Supervised Core Stability Exercises on Hypertensive Patient With Low Back Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ahram Canadian University, class: OTHER, descriptionModule briefSummary: Thirty male and female hypertension patients with chronic mechanical non-specific low back pain were included in this randomized controlled study conducted at the Ababa Private Physical Therapy Center in Beni-Seuf, Egypt. They were randomly assigned into two equal groups; the study group A control (n = 15) had a supervised conventional core stability, while the study group B (n = 15) received a home exercise program. In both groups' patients had evaluations before and after their six-week course of therapy. Modified-modified Schober test was used to assess the active back range of motion (ROM), Arabic version of Oswestry disability index (ODI) was utilized to evaluate functional disability, and visual analog scale (VAS) was used to measure pain., conditionsModule conditions: Hypertension, conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: home exercise program, interventions name: the core stability exercise, outcomesModule primaryOutcomes measure: Assessment of pain, primaryOutcomes measure: Assessment of lumbar flexion range of motion, primaryOutcomes measure: Assessment of functional disability, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of physical therapy, city: Giza, zip: 3387722, country: Egypt, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06387914, orgStudyIdInfo id: PID 16707, secondaryIdInfos id: 23/WM/0219, type: OTHER, domain: Ethics Committee (South Birmingham REC) UK, briefTitle: Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation, acronym: EPIONE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2026-05-02, completionDateStruct date: 2027-05-02, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, collaborators name: Jon MoultonTrust, collaborators name: Placito Bequest, collaborators name: Bioinduction, descriptionModule briefSummary: The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are:* Does DBS lower the pain score in these participants.* What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain.Participants will:* Undergo baseline screening procedures and have an MRI scan.* Have neurosurgery to put the DBS system in* Have follow up for 10 months* Visit the clinic at least 5 times in the study for check-ups and tests* Fill in questionnaires about pain and mood and have check ups remotely, conditionsModule conditions: Central Post Stroke Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Double-blind trial, within subject randomisation and cross-over., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Blinding maintained using the hand held controller (shows ON at all times) and programs which ensure equivalent battery drain at all stimulation settings.Pseudo-ON =high frequency, low amplitude stimulation. Frequency up to 250 Hertz(Hz), Amplitude less than 0.5 milliamps(mA), Pulse Width 500 microseconds(uS)., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Stimulation ON, interventions name: Stimulation Pseudo-ON, outcomesModule primaryOutcomes measure: McGill Pain Questionnaire V2.0 -Short Form - Present Pain Intensity (MQ-SF-PPI) score, secondaryOutcomes measure: Numerical Rating Scale (NRS), secondaryOutcomes measure: McGill Pain Questionnaire V2.0 short form (MPQ-SF) McGill Pain Questionnaire V2.0 short form) MPQ-SF (McGill Pain Questionnaire V2.0 short form), secondaryOutcomes measure: Brief Pain Inventory (BPI) - Short Form, secondaryOutcomes measure: Beck Depression Inventory (BDI II), secondaryOutcomes measure: Patients' Global Impression of Change (PGIC), secondaryOutcomes measure: EuroQol Quality of life (EQ5D-5L), secondaryOutcomes measure: Healthy Days Measures (HDM), secondaryOutcomes measure: Adverse Events (AEs), otherOutcomes measure: Heart rate variability (HRV), otherOutcomes measure: Client Service Receipt Inventory (CSRI), otherOutcomes measure: MRI, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387901, orgStudyIdInfo id: PABTOX - part 1, briefTitle: Investigating Paclitaxel Toxicity in Breast Cancer: The Roles of Physical Activity and Body Composition., acronym: PABTOX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-05-06, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universitair Ziekenhuis Brussel, class: OTHER, collaborators name: Vrije Universiteit Brussel, collaborators name: University Ghent, descriptionModule briefSummary: This study looks into how a common breast cancer treatment, paclitaxel, can sometimes cause severe side effects that make it hard for patients to continue treatment. These side effects can significantly affect a patient's quality of life and even impact their recovery and overall health costs. What's interesting about this research is that it considers how a patient's lifestyle, specifically their physical activity levels and body makeup (like how much muscle and fat they have), might influence these side effects.The researchers are doing a detailed study with 40 women receiving paclitaxel treatment, tracking how the drug is processed in their bodies and how their body composition and physical activity might play a role in the side effects they experience. They are using a special method to monitor drug levels in the blood and are also keeping tabs on the patients' health and physical activity through questionnaires and modern tracking devices.The goal here is twofold: first, to better understand why these side effects happen to some people and not others, and second, to develop a model that can predict who might be at higher risk for these side effects based on their body composition, lifestyle, and how their body handles the drug. This could lead to more personalized treatment plans that could help reduce the risk of severe side effects and improve the overall treatment experience for patients with breast cancer.In simpler terms, this research is trying to find a way to make breast cancer treatment with paclitaxel safer and more comfortable by considering how a person's lifestyle and body type might affect their reaction to the drug. This could make a big difference in helping patients complete their treatment successfully and with a better quality of life., conditionsModule conditions: Breast Cancer, conditions: Paclitaxel Adverse Reaction, conditions: Chemotherapeutic Toxicity, conditions: Chemotherapeutic Agent Toxicity, conditions: Body Weight, conditions: Physical Inactivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Paclitaxel Chemotherapy, outcomesModule primaryOutcomes measure: Identification of Body Composition Parameter (Muscle mass) Related to Dose-Limiting Toxicities (DLTs), primaryOutcomes measure: Identification of Body Composition Parameters (Fat %) Related to Dose-Limiting Toxicities (DLTs), primaryOutcomes measure: Identification of Physical Activity Parameters Related to Dose-Limiting Toxicities (DLTs), secondaryOutcomes measure: Paclitaxel Exposure Analysis (Cmax), secondaryOutcomes measure: Paclitaxel Exposure Analysis (AUC), secondaryOutcomes measure: Number and Type of Dose-Limiting Toxicities, otherOutcomes measure: Treatment-Related Adverse Events, otherOutcomes measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (muscle mass), otherOutcomes measure: Body Composition Measurement via Bioelectrical Impedance Analysis (BIA) (fat %), otherOutcomes measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (muscle mass), otherOutcomes measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (fat mass), otherOutcomes measure: Body Composition Measurement via Dual X-ray Absorptiometry (DEXA) (extracellular fluid), otherOutcomes measure: The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30), otherOutcomes measure: EORTC QLQ-BR45 Breast (BR) Cancer Module, otherOutcomes measure: EORTC QLQ- Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20, otherOutcomes measure: European Health Interview Survey Physical Activity Questionnaire (EHIS PAQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vrije Universiteit Brussel, city: Brussel, state: Jette, zip: 1090, country: Belgium, contacts name: Nele Adriaenssens, role: CONTACT, phone: +32 2 476 36 23, email: Nele.Adriaenssens@vub.be, contacts name: Len De Nys, role: CONTACT, phone: +32 472 99 49 48, email: Len.de.nys@vub.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False

protocolSection identificationModule nctId: NCT06387888, orgStudyIdInfo id: E-31034136-302.08.01-4221, briefTitle: The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns, acronym: Newborn, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-01, primaryCompletionDateStruct date: 2021-09-01, completionDateStruct date: 2022-04-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools., conditionsModule conditions: Newborns, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Listening to mother's voice, outcomesModule primaryOutcomes measure: Neonatal Comfort Behavior Scale, secondaryOutcomes measure: Neonatal Comfort Behavior Scale (COMFORTneo):, eligibilityModule sex: ALL, minimumAge: 3 Weeks, maximumAge: 41 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Istanbul Medipol University Hospital, city: Istanbul, state: Beykoz, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06387875, orgStudyIdInfo id: Hangzhou Bay Cohort, briefTitle: Cohort in Qianwan New District, Ningbo, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Ningbo Hangzhou Bay Hospital, descriptionModule briefSummary: Our objective is to carry out research on prevention and control of noncommunicable chronic diseases, and establish a risk prediction mechanism for chronic diseases to promote early detection, early diagnosis and early treatment of chronic diseases in natural population in Qianwan District of Ningbo, significantly reduce medical costs and extend population life span., conditionsModule conditions: Cardiovascular Diseases, conditions: Stroke, conditions: Non-Communicable Chronic Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30000, type: ESTIMATED, outcomesModule primaryOutcomes measure: death, primaryOutcomes measure: incidence of cardio-cerebrovascular diseases, primaryOutcomes measure: incidence of other non-communicable chronic diseases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, country: China, contacts name: Jun Pu, MD,PHD, role: CONTACT, phone: 86-21-68383477, email: pujun310@hotmail.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06387862, orgStudyIdInfo id: 2022SIMBIOV, briefTitle: Pharmacokinetics of Inhaled Levosimendan, acronym: Symbiov, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Universitair Ziekenhuis Brussel, class: OTHER, descriptionModule briefSummary: Determination of biological availability, time-to-peak and elimination half-life of inhaled levosimendan by administration of an inhaled- and intravenous dose of levosimendan., conditionsModule conditions: Left Ventricular Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Inhaled, interventions name: Levosimendan 2.5 milligram/milliliter Injectable Solutiondose Intravenous, outcomesModule primaryOutcomes measure: Bioavailability of inhaled levosimendan, primaryOutcomes measure: Time-to-peak of inhaled levosimendan, primaryOutcomes measure: Elimination half-life of inhaled levosimenan, secondaryOutcomes measure: Effect of inhaled levosimendan on MAP, secondaryOutcomes measure: Effect of inhaled levosimendan on TVR, secondaryOutcomes measure: Effect of inhaled levosimendan on CO, secondaryOutcomes measure: Effect of inhaled levosimendan on LVOT VTI, secondaryOutcomes measure: Effect of inhaled levosimendan on FAC of the right vetricle, secondaryOutcomes measure: Effect of inhaled levosimendan on S', secondaryOutcomes measure: Effect of inhaled levosimendan on SPAP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Brussel, city: Brussel, zip: 1090, country: Belgium, contacts name: Matthias Raes, MD, role: CONTACT, phone: 024749872, email: matthias.raes@uzbrussel.be, contacts name: Marie-Claire Van Malderen, SC, role: CONTACT, phone: 024763110, email: marieclaire.vanmalderen@uzbrussel.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False

protocolSection identificationModule nctId: NCT06387849, orgStudyIdInfo id: 03/2023, briefTitle: Aromatherapy Effect on Pain and Anxiety After C-section, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-21, primaryCompletionDateStruct date: 2023-08-31, completionDateStruct date: 2023-08-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women., conditionsModule conditions: Post-operative Pain, conditions: Post-operative Anxiety, 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: 100, type: ACTUAL, armsInterventionsModule interventions name: Aromatherapy, interventions name: Placebo, outcomesModule primaryOutcomes measure: Post-operative pain level, primaryOutcomes measure: Post-operative anxiety level, secondaryOutcomes measure: Heart Rate (HR), secondaryOutcomes measure: Systolic Blood Pressure (SBP), secondaryOutcomes measure: Diastolic Blood Pressure (DBP), secondaryOutcomes measure: Respiratory Rate (RR), secondaryOutcomes measure: Pulsatile Oxygen Saturation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ben Arous Regional Hospital, city: Ben Arous, country: Tunisia, geoPoint lat: 36.75306, lon: 10.21889, hasResults: False

protocolSection identificationModule nctId: NCT06387836, orgStudyIdInfo id: B2024-063, briefTitle: LINC01844 as a Diagnostic Biomarker for POCD in Elderly Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-02-21, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Postoperative cognitive dysfunction (POCD) is a common complication after surgery that is associated with more adverse events and death. The goal of this observational study is to learn about the diagnosis performance of long intergenic non-coding RNA(LINC01844) level in blood of older people for POCD. The main question it aims to answer is:Does the relative level of LINC01844 in blood help diagnose POCD of older people after surgery? Participants undergoing elective lumbar decompression and fusion will finish neuropsychological evaluations one day before and 1st, 3rd and 5th day after surgery. At the same timepoint, the relative level of LINC01844 in blood will also be tested., conditionsModule conditions: Postoperative Cognitive Dysfunction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 63, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: relative level of LINC01844, secondaryOutcomes measure: serum reactive protein-C, secondaryOutcomes measure: serum interleukin-6, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Danfeng Jin, M.D., role: CONTACT, phone: +8613795306154, email: jindanfeng0506@163.com, contacts name: Shengjin Ge, Ph.D., role: CONTACT, phone: +8613601926171, email: ge.shengjin@zs-hospital.sh.cn, contacts name: Shengjin Ge, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06387823, orgStudyIdInfo id: K5321, briefTitle: Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS, acronym: STAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-27, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, collaborators name: Peking University, collaborators name: Shanghai Huilun Pharmaceutical Co., Ltd., descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are:* Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo?* Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo., conditionsModule conditions: Acute Respiratory Distress Syndrome, 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: 300, type: ESTIMATED, armsInterventionsModule interventions name: Sivelestat sodium, interventions name: Dexamethasone, interventions name: Sivelestat sodium placebo, interventions name: Dexamethasone placebo, outcomesModule primaryOutcomes measure: 28-day ventilator-free days, primaryOutcomes measure: Informed consent rate, primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Recruitment compliance rate, primaryOutcomes measure: Protocol adherence rate, primaryOutcomes measure: Completion of follow-up visits, secondaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: 90-day mortality, secondaryOutcomes measure: 28-day length of stay, secondaryOutcomes measure: 28-day organ support free day, secondaryOutcomes measure: Sequential organ failure assessment (SOFA), secondaryOutcomes measure: Murray's acute lung injury score, secondaryOutcomes measure: C-reactive protein (CRP), secondaryOutcomes measure: Interleukin-6 (IL-6), secondaryOutcomes measure: Interleukin-8 (IL-8), secondaryOutcomes measure: Procalcitonin (PCT), secondaryOutcomes measure: Neutrophil-to-lymphocyte Ratio (NLR), secondaryOutcomes measure: Neutrophil elastase, secondaryOutcomes measure: New-onset infection rate, secondaryOutcomes measure: Re-intubation rate, secondaryOutcomes measure: Adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387810, orgStudyIdInfo id: MA-PC-II-010, briefTitle: Irinotecan Liposome II in Combination With 5-FU/LV and Oxaliplatin in Perioperative Treatment of Borderline Resectable Pancreatic Cancer, acronym: undetermined, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, single-arm, phase II study to evaluate the efficacy and safety of irinotecan liposome II in combination with oxaliplatin and 5-FU/LV in perioperative treatment of borderline resectable pancreatic cancer in 45 patients., conditionsModule conditions: Borderline Resectable Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: irinotecan liposome II combined with 5-FU/LV and oxaliplatin, outcomesModule primaryOutcomes measure: event free survival, secondaryOutcomes measure: overall survival, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: R1 excision rate, secondaryOutcomes measure: adverse event, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387797, orgStudyIdInfo id: UNLV-2023-321, briefTitle: Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Nevada, Las Vegas, class: OTHER, collaborators name: University of Nevada, Reno, descriptionModule briefSummary: This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior)., conditionsModule conditions: At Risk for Type 2 Diabetes Mellitus, conditions: Pre Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to one of two parallel study arms.1. Cooking Matters for Adults (CMA) Curriculum Delivery over 6 weeks2. CMA + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM. (6 weeks), primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Because of the parallel arm differences, it would not be possible to mask the arm assignment for the participant or investigator. However, we will mask the arm assignment for the outcomes assessor, in particular for the HbA1c% assessment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Cooking Matters for Adults (CMA+), interventions name: Cooking Matters for Adults (CMA), outcomesModule primaryOutcomes measure: Feasibility of conducting the intervention, primaryOutcomes measure: Acceptability of the intervention, primaryOutcomes measure: Acceptability of each cooking class, secondaryOutcomes measure: Knowledge about the importance of produce consumption, secondaryOutcomes measure: Attitudes toward produce consumption, secondaryOutcomes measure: Intentions to consume recommended amounts of produce during and after intervention, secondaryOutcomes measure: Changes in fruit and vegetable consumption in servings per day, secondaryOutcomes measure: HbA1c%, secondaryOutcomes measure: Body weight in kg, secondaryOutcomes measure: Gut Microbiota composition, secondaryOutcomes measure: waist circumference in cm, secondaryOutcomes measure: body fat percentage (%), secondaryOutcomes measure: non fat mass in kg, otherOutcomes measure: blood pressure in mmHg, otherOutcomes measure: fasting blood glucose in mg/dL, otherOutcomes measure: fasting total cholesterol in mg/dL, otherOutcomes measure: fasting LDL cholesterol in mg/dL, otherOutcomes measure: fasting HDL cholesterol in mg/dL, otherOutcomes measure: fasting triglyceride level in mg/dL, otherOutcomes measure: Usual dietary quality, otherOutcomes measure: Week 6 dietary quality, otherOutcomes measure: physical activity energy expenditure average kcals per day, otherOutcomes measure: Time spent in sedentary behavior in minutes per day, otherOutcomes measure: physical activity intensity distribution as minutes per day and average percentage of day, otherOutcomes measure: sleep quantity in hours per day, otherOutcomes measure: sleep quality, otherOutcomes measure: stress levels, otherOutcomes measure: Nutrition Security, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Nevada, Las Vegas, city: Las Vegas, state: Nevada, zip: 89154, country: United States, contacts name: Sara K Rosenkranz, PhD, role: CONTACT, phone: 702-895-0938, email: Sara.Rosenkranz@unlv.edu, contacts name: Richard Rosenkranz, PhD, role: CONTACT, phone: 702-895-5198, email: Richard.Rosenkranz@unlv.edu, contacts name: Keren Morales, B.S., RD, role: SUB_INVESTIGATOR, contacts name: Donya Shahamati, B.S., role: SUB_INVESTIGATOR, contacts name: Laura Kruskall, PhD, RD, role: SUB_INVESTIGATOR, contacts name: Elika Nematian, M.S., role: SUB_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, hasResults: False

protocolSection identificationModule nctId: NCT06387784, orgStudyIdInfo id: 2024/823, briefTitle: Acute Beetroot Juice Supplementation in Pre-eclampsia Pregnancies, acronym: BEET_PE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo, class: OTHER, collaborators name: Hospital das Clínicas de Ribeirão Preto, collaborators name: Universidade Estadual Paulista Júlio de Mesquita Filho, descriptionModule briefSummary: Pre-eclampsia is a serious condition that typically affects pregnant women after the 20th week of pregnancy, characterized by high blood pressure and damage to organs such as the kidneys and liver. Currently, treatment options are limited, which has prompted researchers to explore alternative approaches. One such promising alternative is dietary nitrate found in vegetables like beetroot, as nitrate can be converted into nitric oxide in the body, which helps lower blood pressure. This study aims to determine the acute effects of nitrate-rich beetroot juice on blood pressure, several blood and salivary markers in pregnant women with pre-eclampsia. Furthermore, the study will assess fetal blood flow using Doppler ultrasound. The investigators want to understand the kinetics of nitrate and nitric oxide metabolites and assess the temporal dependency of the hypotensive response. Through this investigation, the investigators seek evidence of nitrate-enriched beetroot juice as an adjunct therapy in managing pre-eclampsia., conditionsModule conditions: Pre-Eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, placebo-controlled, single-blind, parallel-group study assessing acute rich-nitrate juice on pregnant women diagnosed with early and late-onset pre-eclampsia. Participants will be divided into four distinct groups: two groups for each onset category. Within each group, participants will be further divided into a control group and a treated group. The assignment of participants to these groups will be randomized using an online program., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Beetroot juice, interventions name: Placebo juice, outcomesModule primaryOutcomes measure: Acute Effect of Beetroot Juice Supplementation on Blood Pressure, secondaryOutcomes measure: Plasma Concentrations of Nitric Oxide Metabolites, secondaryOutcomes measure: Concentration of Salivary Nitrate Reductase Enzyme, secondaryOutcomes measure: Plasma Lipid Peroxidation Levels, secondaryOutcomes measure: Concentration of Total Antioxidant Capacity in Plasma, secondaryOutcomes measure: Maternal Blood Flow Velocity, secondaryOutcomes measure: Fetal Heart Rate, secondaryOutcomes measure: Umbilical Arterial Pulsatility Index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387771, orgStudyIdInfo id: rs4680-tolcapona, briefTitle: Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia, statusModule overallStatus: RECRUITING, startDateStruct date: 2014-09-22, primaryCompletionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Clinica Universidad de Navarra, Universidad de Navarra, class: OTHER, descriptionModule briefSummary: Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Tolcapone, outcomesModule primaryOutcomes measure: Efficacy: Change from baseline in cognitive test scores at day 8, primaryOutcomes measure: Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8, secondaryOutcomes measure: Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8, secondaryOutcomes measure: Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8, secondaryOutcomes measure: Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8, secondaryOutcomes measure: Change from baseline in plasmatic homocysteine (umol/L), otherOutcomes measure: Patient Reported Outcome: change from baseline in the Profile of Mood States (POMS) scores at day 8, otherOutcomes measure: Patient Reported Outcome: change from baseline in the mood state Visual Analogue Scale (VAS) scores at day 8, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Universidad de Navarra, status: RECRUITING, city: Pamplona, state: Navarra, zip: 31008, country: Spain, contacts name: Jose Maria Galindo, role: CONTACT, phone: 34 948 255400, phoneExt: 2725, email: ucicec@unav.es, geoPoint lat: 42.81687, lon: -1.64323, hasResults: False

protocolSection identificationModule nctId: NCT06387758, orgStudyIdInfo id: UMMC-IRB-2022-473, briefTitle: Low Systemic/High Local Exercise Load in Peds SCD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-19, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Mississippi Medical Center, class: OTHER, collaborators name: University of Alabama at Birmingham, descriptionModule briefSummary: This research study wants to learn about what kind of exercise is best for kids with sickle cell disease. Participating children will have a small amount of blood drawn one time at the beginning of the study. Children will then complete some questionnaires that measure pain, physical function, and emotions (depression, anxiety) and complete some tests that measure physical fitness at the beginning and end of the study. Children will be randomized to either a home-based telehealth (1) walking or (2) strengthening exercise program that lasts for 8-weeks, 3-x week, for 45 minutes each session. Children's participation will last up to 10 weeks., conditionsModule conditions: Sickle Cell Anemia in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Low systemic strength training, interventions name: Moderate systemic exercise, outcomesModule primaryOutcomes measure: Demographics and medical history (parents), primaryOutcomes measure: Pediatric Pain Questionnaire, primaryOutcomes measure: Functional Disability Inventory, primaryOutcomes measure: NIH PROMIS 2582, primaryOutcomes measure: Heart Rate Variability, primaryOutcomes measure: Heart Rate, primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Bruininks-Oseretsky Test of Motor Proficiency, primaryOutcomes measure: American Thoracic Society 6-minute walk test, primaryOutcomes measure: Actigraphy, primaryOutcomes measure: Daily diaries, primaryOutcomes measure: Biomarkers, primaryOutcomes measure: Medical Chart Review, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Mississippi Medical Center, status: RECRUITING, city: Jackson, state: Mississippi, zip: 39216, country: United States, contacts name: Cynthia Karlson, PhD, role: CONTACT, phone: 601-984-2723, email: ckarlson@umc.edu, geoPoint lat: 32.29876, lon: -90.18481, hasResults: False

protocolSection identificationModule nctId: NCT06387745, orgStudyIdInfo id: US-REFERRAL, briefTitle: Referral of Patients to Hepatology With Hepatoscope, acronym: US-REFERRAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, collaborators name: E-Scopics, descriptionModule briefSummary: Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center., conditionsModule conditions: Chronic Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Hepatoscope, outcomesModule primaryOutcomes measure: Positive Predictive Value for significant fibrosis, secondaryOutcomes measure: Correlation of stiffness measurements, secondaryOutcomes measure: Concordance of stiffness measurements, secondaryOutcomes measure: Diagnostic performance of liver stiffness measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387732, orgStudyIdInfo id: 161223, briefTitle: Mechanisms Underlying Antidepressant Effects of Physical Activity, acronym: LIFE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University College, London, class: OTHER, collaborators name: King's College London, collaborators name: Queen Mary University of London, collaborators name: University of Dublin, Trinity College, descriptionModule briefSummary: It is well established that any level of physical activity can help prevent and treat depression, with more strenuous activity having a greater effect. Understanding the mechanisms driving this antidepressant effect is important because it could allow exercise programmes to be made more effective, accessible, and targeted. Such knowledge could contribute to social prescribing, increasingly a priority for mental healthcare. Importantly, physical activity is highly scalable, low cost, well suited to early intervention, and has beneficial impacts on physical health co-morbidities. This trial may provide initial indications of whether there are sub-groups of depressed individuals who are particularly likely to benefit from physical activity, lead to strategies to personalise physical activity prescription based on motivational factors, and pave the way for augmentative approaches, for example combining physical activity with psychological interventions.To date the mechanisms driving the antidepressant effects of physical activity in humans are poorly understood. Building on links between depressive symptoms, reward processing and dopamine, plus evidence from animal studies that physical activity is anti-inflammatory and boosts both dopamine and reward processing, the overarching aim of this trial is to understand the mechanisms underlying the effects of physical activity in depression, focusing on the concept of motivation.The key objective is to conduct a randomised controlled trial (RCT) in N=250 depressed participants comparing aerobic exercise to a stretching/relaxation control condition, examining a range of mechanistic factors. The proposed trial will examine the impact of physical activity at multiple, linked potential levels of explanation: (1) immune-metabolic markers; (2) dopamine synthesis capacity; (3) activation in the brain's reward and effort processing circuitry;(4) effort-based decision making incorporating computational analysis; and (5) symptom networks based on fine-grained, daily measurements., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial will use a single-site parallel group design with depressed participants randomised to eight weeks of either 45 minutes of aerobic exercise of moderate-to-vigorous activity (experimental group: three times per week, N=125) or 45 minutes of non-aerobic stretching/guided relaxation (control group: three times per week, N=125)., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The control arm is stretching and relaxation. Prior research indicates that participants have similar efficacy expectations regarding mild stretching and aerobic exercise, which will help to improve masking. Due to the nature of the interventions, it is not possible for the participants to be masked as to the intervention they are undergoing, but all study information will be agnostic about which intervention we expect to be more effective, and all analysis will be performed by blinded staff. The trial will assess expectations and preferences about the intervention conditions, allowing for sensitivity analyses., whoMasked: PARTICIPANT, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise, interventions name: Stretching and relaxation, outcomesModule primaryOutcomes measure: Patient Health Questionnaire-9 score, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Aerobic capacity: CPET, secondaryOutcomes measure: Ecological Momentary Assessment, secondaryOutcomes measure: Inflammatory response (cytokines), secondaryOutcomes measure: Inflammatory response (genetic markers), secondaryOutcomes measure: Inflammatory response (flow cytometry immunophenotype), secondaryOutcomes measure: Neuroendocrine system, secondaryOutcomes measure: Metabolic function, secondaryOutcomes measure: Dopamine synthesis capacity, secondaryOutcomes measure: Functional magnetic resonance imaging (fMRI) during cognitive tasks, secondaryOutcomes measure: Online cognitive tasks, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Anxiety (GAD7 score), secondaryOutcomes measure: Anxiety (STAI score), secondaryOutcomes measure: Anhedonia (SHAPS score), secondaryOutcomes measure: Anhedonia (DARS score), secondaryOutcomes measure: Apathy, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Cognitive impairment, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Self-esteem, secondaryOutcomes measure: Sleep quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387719, orgStudyIdInfo id: PREC-BED Study, briefTitle: Precursors of Binge Eating Disorder in a Clinical Sample of Adolescents With Obesity, acronym: PREC-BED, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-21, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Fundació Sant Joan de Déu, class: OTHER, collaborators name: Instituto de Salud Carlos III, descriptionModule briefSummary: BACKGROUND: Binge eating disorder (BED) is the worldwide most-prevalent eating disorder. It is associated with psychiatric comorbidities and obesity, a high impact in life functioning, and high morbidity and mortality. First symptoms appear frequently in youths, who most commonly present incomplete (subthreshold) criteria for BED (precursor forms, PREC-BED). While some subjects will evolve from PREC-BED to BED, there is no gold standard to identify the clinical evolution. Information from prior studies suggest early alterations in reward and inhibitory brain circuits in PREC-BED may predict increased vulnerability or resilience to develop BED. Tools based on MRI brain connectivity analyses (MRI-BC), built on robust and interpretable connectivity whole-brain models, have proven successful in diagnostic classification and predicting certain clinical outcomes. OBJECTIVES: To study MRI-BC diagnostic markers of PREC-BED and to explore prognosis at 1 year of follow-up in a sample of adolescents with obesity (12-17 years old). METHODS: A) Transversal analytical design: 3-group (n=34 per group) comparison of neuroimaging (MRI-BC), neurocognitive and clinical markers in adolescents with obesity and i) BED, ii) PREC-BED, iii) no BED nor PREC-BED (Healthy group, HC). B) Longitudinal analytical design, pilot, exploratory: adolescents with PREC-BED will be evaluated in clinical and neurocognitive variables at 1 year. Baseline brain neuroimaging variables (alone and in combination with clinical and neurocognitive variables) will be analyzed as predictors of clinical prognosis, including conversion to BED., conditionsModule conditions: Binge-Eating Disorder, conditions: Obesity, conditions: Eating Disorders, conditions: BED, conditions: Other Specified Feeding or Eating Disorder, conditions: Eating Disorder Nos, conditions: Emotion Regulation, conditions: Food Addiction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic resonance imaging, outcomesModule primaryOutcomes measure: Neuroimaging assessment, primaryOutcomes measure: Neuroimaging assessment, secondaryOutcomes measure: Height, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Waist perimeter, secondaryOutcomes measure: BMI, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Fasting glucose, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: HDL cholesterol, secondaryOutcomes measure: Developmental Tanner stage, secondaryOutcomes measure: Adherence to Mediterranean diet, secondaryOutcomes measure: Diagnosis of BED, and PREC-BED or exclusion of other DMS-5 diagnosis., secondaryOutcomes measure: Functioning, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Emotion Regulation, secondaryOutcomes measure: Eating symptomatology, secondaryOutcomes measure: Eating symptomatology, secondaryOutcomes measure: Temperamental tendencies for sensitivity to punishment and sensitivity to reward., secondaryOutcomes measure: Food Addiction, secondaryOutcomes measure: Food intake, secondaryOutcomes measure: General Intelligence, secondaryOutcomes measure: Attention ability, secondaryOutcomes measure: Visuo-constructional ability and visual memory, secondaryOutcomes measure: Executive function: cognitive flexibility, alternating attention, sequencing, visual search, and motor speed., secondaryOutcomes measure: Executive function: working memory ability, secondaryOutcomes measure: Executive function: decision-making abilities reward based, secondaryOutcomes measure: Executive function: ability to inhibit cognitive interference, secondaryOutcomes measure: Executive function: planning and strategic organisation, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hospital Sant Joan de Déu, status: RECRUITING, city: Esplugues De Llobregat, state: Barcelona, zip: 08950, country: Spain, contacts name: ESTHER VIA VIRGILI, role: CONTACT, phone: 34 + 673342094, email: esther.via@sjd.es, contacts name: ESTHER VIA VIRGILI, role: PRINCIPAL_INVESTIGATOR, contacts name: EDUARDO SERRANO, role: SUB_INVESTIGATOR, contacts name: RAQUEL CECILIA, role: SUB_INVESTIGATOR, contacts name: SILVIA MARÍN, role: SUB_INVESTIGATOR, contacts name: MARINA LLOBET, role: SUB_INVESTIGATOR, contacts name: LAURA MARITZA ASTIASUAINZARRA VILLA, role: SUB_INVESTIGATOR, contacts name: LILIANA SZEGHALMI, role: SUB_INVESTIGATOR, contacts name: ANTONIO PÉREZ, role: SUB_INVESTIGATOR, contacts name: MATTHIEU GILSON, role: SUB_INVESTIGATOR, contacts name: MANEL VILA-VIDAL, role: SUB_INVESTIGATOR, contacts name: GUIDO FRANK, role: SUB_INVESTIGATOR, contacts name: CHRISTIAN STEPHAN OTTO, role: SUB_INVESTIGATOR, geoPoint lat: 41.37732, lon: 2.08809, hasResults: False

protocolSection identificationModule nctId: NCT06387706, orgStudyIdInfo id: GAP, briefTitle: The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction.Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation.Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness., conditionsModule conditions: Chronic Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: Gamified web-based pain management Program, outcomesModule primaryOutcomes measure: Pain Relief, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hong Kong Metropolitan University, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Mimi Mun Yee Tse, PhD., role: CONTACT, phone: (852)39708764, email: mmytse@hkmu.edu.hk, contacts name: Mimi Mun Yee Mimi Mun Yee, PhD., role: PRINCIPAL_INVESTIGATOR, contacts name: Tyrone Tai On Kwok, PhD., role: SUB_INVESTIGATOR, contacts name: Timothy Chung Ming Wu, Master, role: SUB_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06387693, orgStudyIdInfo id: 24U-1359, briefTitle: Artificial Intelligence in ANOCA, acronym: (AI)NOCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, descriptionModule briefSummary: Angina pectoris is diagnosed in \>180.000 people in the Netherlands each year. Diagnosis in angina pectoris focuses on epicardial coronary stenosis, the identification of which may lead to guideline-directed medical therapy or revascularization. However, no such stenosis is identified in 40-70% of patients. This condition, angina with no obstructed coronary artery (ANOCA), is more prevalent in women and is related to poor quality of life, high medical expenses, and a higher incidence of adverse events.The origin of ANOCA can be evaluated during invasive coronary angiography by coronary function testing (CFT) to identify coronary vasomotor disorders. This relates to vasospasm of the coronary artery and microcirculation, or to impaired microvascular vasodilation. For the diagnosis of vasospasm, CFT needs to result in electrocardiographic signs of myocardial ischemia as part of the diagnostic criteria. This is a critical point in the diagnosis of vasospasm, as these signs can be subtle and can vary, and are therefore prone to misinterpretation. Apart from this caveat, the diagnosis approach therefore currently requires an invasive procedure for the diagnosis. This limits the broad application and hampers early identification and treatment of ANOCA.During CFT, a coronary guide wire is routinely advanced in the coronary artery which also allows obtaining an intracoronary ECG by attaching a sterile alligator clamp to a standard electrocardiogram lead. This allows continuous recording of intracoronary ECG throughout CFT on the same monitor as the routine ECG. This technique can increase sensitivity for myocardial ischemia during CFT. Further, Holter ECG monitoring allows the identification of ischemic changes in the ECG in the outpatient setting. Evidence is lacking on the patterns of myocardial ischemia that occur during spontaneous angina pectoris symptoms in ANOCA patients, and on the sensitivity of Holter ECG for this purpose. Finally, the interpretation of ischemic patterns on ECG tracings can be cumbersome, especially when changes are subtle or change from beat to beat. The use of deep learning techniques allows to automate the interpretation of ECG traces and may improve the standardized diagnosis in ANOCA., conditionsModule conditions: Angina, Stable, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Holter monitoring, intracoronary ECG, outcomesModule primaryOutcomes measure: Prevalence of myocardial ischemia in patients with equivocal coronary function test results, primaryOutcomes measure: Diagnostic accuracy of perprocedural Holter ECG monitoring to diagnose coronary vasomotor disorders, primaryOutcomes measure: Diagnostic ccuracy of outpatient Holter monitoring for coronary vasomotor disorders, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387680, orgStudyIdInfo id: 2022/187, briefTitle: The Peanut Ball Use on Labor, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores., conditionsModule conditions: Birth Outcome, Adverse, conditions: Birth, First, conditions: Labor Long, conditions: Apgar; 4-7 at 1 Minute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial, outcomesModule primaryOutcomes measure: Comparison of sociodemographic of pregnant women., primaryOutcomes measure: Comparison of obstetric characteristics of pregnant women, primaryOutcomes measure: Comparison of postpartum characteristics of pregnant women, primaryOutcomes measure: Comparison of duration of 1st and 2nd stage of labor by group, primaryOutcomes measure: Comparison of 1st and 5th minute APGAR scores of newborns by group, primaryOutcomes measure: Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups, primaryOutcomes measure: Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Selcuk University, city: Konya, zip: 42250, country: Turkey, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False

protocolSection identificationModule nctId: NCT06387667, orgStudyIdInfo id: FIRTI, briefTitle: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: New Valley University, class: OTHER, descriptionModule briefSummary: Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance., conditionsModule conditions: Immunocompromised ICU Patients With Respiratory Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Immunocompromised ICU Patients with Respiratory tract infections, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Complete blood count, interventions name: C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT), interventions name: CT chest, interventions name: Microscopic examination, interventions name: culture and sensitivity, outcomesModule primaryOutcomes measure: Number of fungal species causing pneumonia in immunocompromised ICU patients, secondaryOutcomes measure: Determine the antifungal susceptibility profiles of the identified fungal isolates., secondaryOutcomes measure: Number of associated specific patient factors with the type or antifungal resistance of fungal infections, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387654, orgStudyIdInfo id: RC31/23/0361, briefTitle: Clinico-biological Collection of Autoimmune, Dysimmune or Auto-inflammatory Dermatological Diseases, acronym: TekAPo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2034-04, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: The aim of this project is to start a biological and clinical collection of patients presenting autoimmune, dysimmune or auto-inflammatory dermatological diseases. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies., conditionsModule conditions: Autoimmune Bullous Dermatosis, conditions: Systemic Autoimmune Diseases With Dermatological Presentation, conditions: Dysimmune Dermatological Diseases, conditions: Auto-inflammatory Dermatological Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: Blood sampling, interventions name: Remainders of samples taken as part of the treatment, outcomesModule primaryOutcomes measure: Building a collection of biological samples and clinical-biological data from patients with autoimmune, dysimmune or auto-inflammatory dermatological disease, secondaryOutcomes measure: Identification of new autoantibodies, secondaryOutcomes measure: Identification of biomarkers regarding the severity (such as cytokines, survival factors) in order to help the therapeutic decisions, secondaryOutcomes measure: Exploration of the pathophysiological mechanisms of rare autoimmune dermatological pathologies, secondaryOutcomes measure: Comparison of blood cells populations determinants with flow cytometry, before and after cell therapy and in patients responder or not responder to cell therapy, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Purpan University Hospital, city: Toulouse, zip: 31059, country: France, contacts name: Chloé BOST, MD, PhD, role: CONTACT, phone: 5 61 77 61 44, phoneExt: 0033, email: bost.c@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False

protocolSection identificationModule nctId: NCT06387641, orgStudyIdInfo id: 2024004, briefTitle: Effects of Life Review Intervention on Meaning in Life Among Older Adults With Disabilities, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Bao Huimin, class: OTHER, descriptionModule briefSummary: The goal of this interventional study is to learn if life review works to improve the sense of meaning in life in older adults with disabilities who live at home. The main questions it aims to answer are:Does life review enhance the sense of meaning in life of participants? Dose life reviews enhance the life satisfaction of participants. Dose life reviews enhance the quality of life of participants?Researchers will compare the life review program to routine community health services to see if the life review intervention program is effective in enhancing the sense of meaning in life of older adults with disabilities who live at home.Participants will:Take face-to-face life review interview or routine community health service every week for 6 weeks.Take the the questionnaire survey before and after the six-week life review intervention., conditionsModule conditions: Disabilities, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Life review, interventions name: Routine community health services, outcomesModule primaryOutcomes measure: Change from Baseline in Meaning in life on the Meaning in Life Questionnaire (MLQ) at Week6, secondaryOutcomes measure: Change from Baseline in Life satisfaction on the Life Satisfaction In-dex A (LSIA) at Week6, secondaryOutcomes measure: Change from Baseline in Quality of life on the 12-Item Short Form Survey (SF-12) at Week6, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xixi Street Community Health Service Center, city: Hanzhou, state: Zhejiang, zip: 310012, country: China, geoPoint lat: 26.4965, lon: 99.437, locations facility: Gongchenqiao Street Community Health Service Centre, city: Hanzhou, state: Zhejiang, zip: 310015, country: China, geoPoint lat: 26.4965, lon: 99.437, locations facility: Baiyang Street Wenchao Community Health Centre, city: Hanzhou, state: Zhejiang, zip: 310018, country: China, geoPoint lat: 26.4965, lon: 99.437, locations facility: School of Nursing, Hangzhou Normal University, city: Hanzhou, state: Zhejiang, zip: 311121, country: China, geoPoint lat: 26.4965, lon: 99.437, hasResults: False

protocolSection identificationModule nctId: NCT06387628, orgStudyIdInfo id: LM108-IIT-202, briefTitle: LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or eribulin as first-line or post-line treatment in patients with metastatic triple-negative breast cancer., conditionsModule conditions: TNBC - Triple-Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: LM-108, interventions name: Toripalimab, interventions name: Eribulin, interventions name: Nab paclitaxel, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: DoR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Biyun Wang, role: CONTACT, phone: 18017312387, email: pro_wangbiyun@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False

protocolSection identificationModule nctId: NCT06387615, orgStudyIdInfo id: H22086, secondaryIdInfos id: 1R21HD108576-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21HD108576-01A1, briefTitle: Impact of Non-invasive Brain Stimulation on Learning Novel Spoken Words, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Georgia State University, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: The purpose of the proposed study is to use transcranial magnetic stimulation (TMS) to evaluate a neurobiological model of spoken word learning in older youth. Specifically, it is hypothesized that: (1) inhibition of the left dorsal stream will impact subsequent learning, processing, and retention of phonologically similar pseudowords; (2) the impact of dorsal stream inhibition on word learning will be associated with baseline levels of variability in neural activity, indicative of underlying differences in cortical excitability., conditionsModule conditions: Dyslexia, conditions: Dyslexia, Developmental, conditions: Learning; Developmental Disorder, Reading, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Active cTBS, interventions name: Sham, outcomesModule primaryOutcomes measure: Novel Word Learning Task, primaryOutcomes measure: Pseudoword Discrimination Task, secondaryOutcomes measure: MRI Scan, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 24 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Georgia State University/Georgia Tech Center for Advanced Brain Imaging (CABI), status: RECRUITING, city: Atlanta, state: Georgia, zip: 30318, country: United States, contacts name: C.Nikki Arrington, PhD, role: CONTACT, phone: 404-385-8621, geoPoint lat: 33.749, lon: -84.38798, hasResults: False

protocolSection identificationModule nctId: NCT06387602, orgStudyIdInfo id: FUI/CTR/2024/6, briefTitle: Comparison Between Effects of Active Release Technique and Post Isometric Relaxation on Adductor Strain in Mixed Martial Arts Fighters, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Foundation University Islamabad, class: OTHER, descriptionModule briefSummary: This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and post-isometric relaxation on adductor strain in mixed martial arts fighters., conditionsModule conditions: Adductor Strain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cryotherapy, interventions name: Strengthening of adductors, interventions name: Active release technique, interventions name: Post-Isometric Relaxation, outcomesModule primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Range of motion, primaryOutcomes measure: Functionality, primaryOutcomes measure: Flexibility, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Foundation University College of Physical Therapy, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, contacts name: Furqan Yaqoob, MS-OMPT,PHD*, role: CONTACT, phone: 03465333101, email: furqan.yaqoob@fui.edu.pk, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False

protocolSection identificationModule nctId: NCT06387589, orgStudyIdInfo id: FUI/CTR/2024/5, briefTitle: Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2023-11-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Foundation University Islamabad, class: OTHER, descriptionModule briefSummary: This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain", conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Core stability exercises, interventions name: Static Stretching of Iliopsoas, interventions name: Post Facilitation Stretch of Iliopsoas, outcomesModule primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Level of disability, primaryOutcomes measure: Lumbar Range of motion, primaryOutcomes measure: Hip Range of motion, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Foundation University College of Physical Therapy, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, contacts name: Sana Khalid, MSNMPT,PHD, role: CONTACT, phone: 03315050460, email: sana.khalid@fui.edu.pk, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False

protocolSection identificationModule nctId: NCT06387576, orgStudyIdInfo id: Post-discharge Appointments, briefTitle: Post-Discharge Follow-up Appointment Scheduling, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: This is a prospective clinical trial evaluating whether a behaviorally informed intervention (pre-discharge iPad video scheduling) increases post-discharge primary care physician (PCP) appointment completion compared to the status-quo scheduling process (post-discharge via phone), with the ultimate goal of improving patient health outcomes., conditionsModule conditions: Appointments and Schedules, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel-arm control trial, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Behaviorally informed pre-discharge iPad video scheduling, outcomesModule primaryOutcomes measure: Post-discharge follow-up PCP appointment completion rate within 7 days, secondaryOutcomes measure: Post-discharge follow-up PCP appointment completion rate within 14 days, secondaryOutcomes measure: Post-discharge follow-up PCP appointment scheduling rate within 7 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA Santa Monica Medical Center, status: RECRUITING, city: Santa Monica, state: California, zip: 90404, country: United States, contacts name: Rich Leuchter, MD, role: CONTACT, phone: 310-825-9111, email: rleuchter@mednet.ucla.edu, geoPoint lat: 34.01945, lon: -118.49119, hasResults: False

protocolSection identificationModule nctId: NCT06387563, orgStudyIdInfo id: FUI/CTR/2024/4, briefTitle: Effects of Abdominal Muscle Activation Training, Using Pressure Biofeedback in Comparison With Surface Electromyography, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-06, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Foundation University Islamabad, class: OTHER, descriptionModule briefSummary: This study is a randomized control trial and the purpose of this study to determine the effects of abdominal muscle activation training on non-specific low back pain; using pressure biofeedback in comparison with surface electromyography biofeedback: a randomized control trial., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized control trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Abdominal activation using pressure biofeedback, interventions name: Abdominal activation using SEMG biofeedback, outcomesModule primaryOutcomes measure: Pain Intensity, primaryOutcomes measure: Level of Disability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 44 Years, stdAges: ADULT, contactsLocationsModule locations facility: Foundation University College of Physical Therapy, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, contacts name: Anam Rehman, MS-OMPT, role: CONTACT, phone: 03355082299, email: anam.rehman@fui.edu.pk, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False

protocolSection identificationModule nctId: NCT06387550, orgStudyIdInfo id: FUI/CTR/2024/3, briefTitle: Effects of Eccentric Training on Glycemic Control and Quality of Life in Patients With Type II Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Foundation University Islamabad, class: OTHER, descriptionModule briefSummary: Diabetes is defined by the level of hyperglycemia its a metabolic chronic disorder that furthur lead to life threatning medical conditions however, the prevalence of diabetes is rapidly increasing day by day in both developed and developing countries making it global pandemic and type II is more prevalent. Life dependency is increased due to long term effects of diabetes in specifically older individuals. Physical activity and exercise improves glucose tolerance and also reduces other life threatening diabetic complications, improving the quality of life in diabetic population., conditionsModule conditions: Type II Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a pre-post quasi experimental study having one group analysis.Participants will be selected through inclusion and exclusion criteria then pre assessment would be done that include HBA1C and EQ5DL QOL tool, followed by intervention and post assessment., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Eccentric Training, outcomesModule primaryOutcomes measure: Glycemic control, primaryOutcomes measure: Patient's quality of life, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation University College of Physical Therapy, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, contacts name: Zara Khalid, PhD*, role: CONTACT, phone: +923335415822, email: zara.khalid@fui.edu.pk, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False

protocolSection identificationModule nctId: NCT06387537, orgStudyIdInfo id: FUI/CTR/2024/2, briefTitle: Effects of Scapular Mobilization on Shoulder Proprioception and Pain in Patients With Adhesive Capsulitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Foundation University Islamabad, class: OTHER, descriptionModule briefSummary: Adhesive capsulitis is a common musculoskeletal condition. Painful gradual loss of both active and passive gleno-humeral motion resulting from progressive fibrosis and ultimate contracture of the gleno-humeral joint capsule.Scapular position and movement perception both effected by shoulder adhesive capsulitis, change in the scapular kinematics in the form of an increase in scapular lateral rotation, and reduced joint sense for shoulder movements in adhesive capsulitis. Physiotherapists have a wide range of options in managing Adhesive capsulitis including Electrotherapeutic modalities, kaltenborn mobilization, Maitland's mobilization,Mulligan's mobilization and Manipulation. So far studies have shown the efficacy of different treatments in combination or in isolation.Few studies on proprioception in rotator cuff tear, sub acromial impingment syndrome, but no obseved effects of scapular mobilization on shoulder proprioception in patients with adhesive capsulitis.Physical therapist focus on lowering pain and ROM limitations in the shoulder,but often neglect to evaluate proprioception/joint position sense as well as the roleof scapula in adhesive capsulitis during treatment.If found effective,this study can help in probviding treatment protocols for improving proprioception in patients with adhesive capsulits., conditionsModule conditions: Adhesive Capsulitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the second will receive conventional physical therapy along with scapular mobilization. Both groups will be recruited concurrently., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Conventional physical therapy, interventions name: Scapular mobilization., outcomesModule primaryOutcomes measure: Shoulder Proprioception, primaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Shoulder Range of motion, secondaryOutcomes measure: Shoulder Disability, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation University College of Physical Therapy, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 460000, country: Pakistan, contacts name: Zara Khalid, DPT, MS-CPPT,PHD*, role: CONTACT, phone: +923335415822, email: zara.khalid@fui.edu.pk, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False

protocolSection identificationModule nctId: NCT06387524, orgStudyIdInfo id: FUI/CTR/2024/1, briefTitle: Effects of Eccentric Exercises on Gait Parameters in Patellofemoral Pain Syndrome: A Quasi-Experimental Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-15, primaryCompletionDateStruct date: 2024-11-20, completionDateStruct date: 2024-11-20, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Foundation University Islamabad, class: OTHER, descriptionModule briefSummary: This study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study, conditionsModule conditions: Patellofemoral Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Quasi experimental study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: McConnell Taping, interventions name: ECCENTRIC EXERCISES:, outcomesModule primaryOutcomes measure: Dynamic knee valgus angle, primaryOutcomes measure: Hip Range of Motion, primaryOutcomes measure: Knee Range of Motion, primaryOutcomes measure: Pain intensity, primaryOutcomes measure: Gait Speed, primaryOutcomes measure: Cadence, primaryOutcomes measure: Stride length, primaryOutcomes measure: Step length, primaryOutcomes measure: Cycle length, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Foundation University College of Physical Therapy, status: RECRUITING, city: Rawalpindi, state: Punjab, zip: 46000, country: Pakistan, contacts name: Qurat ul Ain Saeed, MS-OMPT,PHD*, role: CONTACT, phone: 03315562889, email: quratulain.saeed@fui.edu.pk, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False

protocolSection identificationModule nctId: NCT06387511, orgStudyIdInfo id: NutriVax-Measles, briefTitle: Increasing Measles Vaccination Coverage Through Supplementation With an SQ-LNS Incentive in Children Aged 6-23 Months, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-06-15, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Alliance for International Medical Action, class: OTHER, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, collaborators name: Programme PAC-CI, Site ANRS-MIE de Côte d'Ivoire, collaborators name: Yobe State Ministry of Health, Nigeria, collaborators name: Eleanor Crook Foundation, collaborators name: Gavi, The Vaccine Alliance, descriptionModule briefSummary: Provision of SQ-LNS also holds promise in incentivizing vaccination as well as other health services.We will estimate 1) the effectiveness of a SQ-LNS mass supplementation program added to routine immunization program compared to routine immunization program alone in terms of measles vaccine coverage, after 12 months of program implementation, 1) in children aged 12-23 months in the endline cross-sectional household survey, 2) in children aged 6-12 months at inclusion in a longitudinal 12 months follow-up survey.Secondary objectives are to assess the barriers and facilitators from the perspectives of parents/legal guardian of children, health care providers and community health workers and to assess the cost-efficiency of theThis study will implrmented in 20 wards covering the Karasuwa and Nguru Local Government Areas (LGAs) in Yobe state, Northeast Nigeria.This is a pragmatic parallel cluster randomized trial (PCT) with baseline measure with different populations and data collection modes: 1) baseline and endline cross-sectional household surveys of children aged 12-23 months, 2) a longitudinal follow-up survey (LS) of children aged 6-12 months at inclusion, 3) a qualitative feasibility and acceptability survey of parents of children aged 6-23 months, of health providers, of community health workers and community representatives and 4) a cost survey of parents/legal guardian of children from the longitudinal follow-up cohort, and 5) a health facility cost survey of a randomized sub-sample of health facilities.Clusters will be randomly allocated at a ratio of 1:1 either to the standard arm or to the NutriVax arm:* The standard Expanded Program on Immunization (EPI) in children aged 6-23 months delivered according to the Ministry of Health's routine plans in the community and at health centres and health posts, named the standard EPI arm;* The NutriVax program combining the EPI in children aged 6-23 months according to the Ministry of Health's routine plans in the community and at health centres (i.e. PHCCs) and health posts associated with SQ-LNS mass supplementation integrated into pre-existing services delivered at health centres (i.e. PHCCs) for children 6-23 months of age, named the NutriVax arm., conditionsModule conditions: Immunization Coverage Improvment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two arms opened pragmatic parallel cluster-randomized controlled trial with baseline measure, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: No possible to mask intervention due to the specifity of the intervention tested, enrollmentInfo count: 3720, type: ESTIMATED, armsInterventionsModule interventions name: Small-quantity lipid-based nutrition supplements (SQ-LNS) NutriVax, outcomesModule primaryOutcomes measure: Measles vaccine coverage in children aged 12-23 months, primaryOutcomes measure: Measles vaccine coverage in children 6-12 months at inclusion, secondaryOutcomes measure: Measles vaccine coverage: at least one dose, secondaryOutcomes measure: Measles vaccine coverage : two doses, secondaryOutcomes measure: Timeliness of measles 1 vaccination, secondaryOutcomes measure: Other infant vaccines coverage, secondaryOutcomes measure: Zero-dose, secondaryOutcomes measure: Fully immunization, secondaryOutcomes measure: Acceptability, secondaryOutcomes measure: Cost-efficiency, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 23 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06387498, orgStudyIdInfo id: 20-2286, briefTitle: Testicular Tissue Cryopreservation (TTC), acronym: TTC, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-09-28, primaryCompletionDateStruct date: 2027-12-30, completionDateStruct date: 2027-12-30, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, descriptionModule briefSummary: The "Testicular Tissue Cryopreservation" study is open to a subset of patients facing disease or treatment regimens that could lead to infertility (gonadotoxic therapies). For some of these patients, experimental testicular tissue cryopreservation is the only fertility preservation option available. The overall objective of this study is to determine the feasibility and acceptability of testicular tissue cryopreservation in male patients of all ages who have a condition or will undergo a treatment that can cause infertility., conditionsModule conditions: Fertility Issues, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Testicular tissue biopsy and cryopreservation, outcomesModule primaryOutcomes measure: Feasibility, as Assessed via the Percentage of Eligible Patients who do a Procedure, primaryOutcomes measure: Feasibility, as Assessed via Percentage of Patients who Attempted a Procedure who were able to Cryopreserve, primaryOutcomes measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event, primaryOutcomes measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified Adverse Event, primaryOutcomes measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified, primaryOutcomes measure: Safety, as Assessed via the Number of Participants with At Least One Pre-specified, secondaryOutcomes measure: Acceptability, as Assessed via Annual Survey Regret Score, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Jocelyn Phipers, RN, role: CONTACT, phone: 303-724-7807, email: jocelyn.phipers@cuanschutz.edu, contacts name: Leslie Appiah, MD, role: CONTACT, email: LESLIE.APPIAH@CUANSCHUTZ.EDU, contacts name: Leslie Appiah, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, hasResults: False

protocolSection identificationModule nctId: NCT06387485, orgStudyIdInfo id: SR-001, briefTitle: A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Ricoh USA, Inc., class: INDUSTRY, descriptionModule briefSummary: This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across 3 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.Primary endpoint: Operative time of surgical procedure.Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction., conditionsModule conditions: Sarcoma, Ewing, conditions: Chondrosarcoma, conditions: Osteosarcoma, conditions: Fibrous Histiocytoma, conditions: Fibrosarcoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: 3D Printed Anatomic Model, interventions name: CT/MRI, outcomesModule primaryOutcomes measure: Operative time, secondaryOutcomes measure: Blood loss, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Tumor margin status, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: William Beaumont University Hospital, status: RECRUITING, city: Royal Oak, state: Michigan, zip: 48073, country: United States, contacts name: Pamela Sloan, RN, CCRP, role: CONTACT, phone: 248-551-6059, email: Pamela.Sloan@corewellheath.org, geoPoint lat: 42.48948, lon: -83.14465, locations facility: The Ohio State University Wexner Medical Center, status: RECRUITING, city: Columbus, state: Ohio, zip: 43212, country: United States, contacts name: Rachel Herster, BS, role: CONTACT, phone: 248-514-4490, email: rachel.herster@osumc.edu, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False