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protocolSection identificationModule nctId: NCT06289933, orgStudyIdInfo id: BR-EMC-CT-103, briefTitle: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Boryung Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers, conditionsModule conditions: Type2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: BR3005, interventions name: BR3005-1, interventions name: BR3005-2, outcomesModule primaryOutcomes measure: AUCτ, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center, H PLUS Yangji Hospital, status: RECRUITING, city: Seoul, state: Gwanakgu, zip: 08779, country: Korea, Republic of, contacts name: Seunghyun Kang, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06289920, orgStudyIdInfo id: BR-EMC-CT-102, briefTitle: A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fasting Conditions in Healthy Adult Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Boryung Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fasting conditions in healthy adult volunteers, conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: BR3005, interventions name: BR3005-1, interventions name: BR3005-2, outcomesModule primaryOutcomes measure: AUCτ, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Center, H PLUS Yangji Hospital, status: RECRUITING, city: Seoul, state: Gwanakgu, zip: 08779, country: Korea, Republic of, contacts name: Seunghyun Kang, role: CONTACT, geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06289907, orgStudyIdInfo id: LH-BH-ADV-01, briefTitle: Hot Flash and Night Sweat Virtual Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-09, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Bonafide Health, class: INDUSTRY, collaborators name: Lindus Health, descriptionModule briefSummary: The purpose of this research study is to evaluate the effectiveness of the study product on vasomotor symptoms (VMS) and overall menopause symptoms in healthy women, who are perimenopausal or postmenopausal, and aged 40 - 65., conditionsModule conditions: Menopause, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Decentralized, double-blind, placebo-controlled, randomized, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Bonafide-HF3.0, interventions name: Placebo, outcomesModule primaryOutcomes measure: To determine the effects of the Study Product (SP) compared to placebo on hot flash symptoms, primaryOutcomes measure: To determine the effects of the SP compared to placebo on hot flash symptoms, primaryOutcomes measure: To determine the effects of the SP compared to placebo on hot flash symptoms, primaryOutcomes measure: To determine the effects of the SP compared to placebo on vasomotor symptoms, primaryOutcomes measure: To determine the effects of the SP compared to placebo on overall menopausal symptoms, primaryOutcomes measure: To determine the effects of the SP compared to placebo on overall menopausal symptoms, primaryOutcomes measure: To determine the effects of the SP compared to placebo on quality of life, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lindus Health, Inc., city: London, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06289894, orgStudyIdInfo id: BRY805-101, briefTitle: A Study of BRY805 in Participants With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: BioRay Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a phase 1 open label multicenter study to evaluate safety, tolerance and the maximum tolerance of BRY805 administered intravenously (IV) once every three weeks in participants with advanced solid tumors, so as to confirm the recommended phase 2 dose of BRY805 and obtain the preliminary efficacy information of participants with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BRY805 injection, outcomesModule primaryOutcomes measure: Occurrence of Drug Limited Toxicities (DLTs), primaryOutcomes measure: Type and incidence of Treatment-emergent adverse event (TEAEs) and serious adverse events (SAEs), secondaryOutcomes measure: BRY805 Serum Concentrations, secondaryOutcomes measure: Number of Participants with BRY805 Antibodies, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression-Free Survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shandong Tumor hospital, city: Jinan, state: Shandong, zip: 250117, country: China, contacts name: Jinming Yu, MD, role: CONTACT, phone: (+86)0531-67627156, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False |
protocolSection identificationModule nctId: NCT06289881, orgStudyIdInfo id: SIL-026-21, briefTitle: Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-02-04, primaryCompletionDateStruct date: 2025-03-11, completionDateStruct date: 2025-03-25, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Bio-innova Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 3 days washout period between the doses., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Sildenafill-Test product, interventions name: Sildenafill-Reference product, outcomesModule primaryOutcomes measure: Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t), primaryOutcomes measure: Maximal measured plasma concentration (Cmax), secondaryOutcomes measure: Number of subjects with adverse events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289868, orgStudyIdInfo id: DC-TR23-0222, secondaryIdInfos id: HAV-EU-11-23, type: OTHER, domain: Beckman Coulter, Inc, briefTitle: Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-05-27, completionDateStruct date: 2024-08-27, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Beckman Coulter, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and of the Access anti-HAV IgM assay as an aid in the laboratory diagnosis of acute or recent HAV infection, on the DxI 9000 Access Immunoassay Analyzer.This study will be used to obtain CE mark for both Access anti-HAV and anti- HAV IgM assays., conditionsModule conditions: HAV, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 1150, type: ESTIMATED, armsInterventionsModule interventions name: Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays, interventions name: Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays, outcomesModule primaryOutcomes measure: Access Anti-HAV diagnostic accuracy measured as sensitivity and specificity, primaryOutcomes measure: Access Anti-HAV IgM diagnostic accuracy measured as sensitivity and specificity, eligibilityModule sex: ALL, minimumAge: 2 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cerba Xpert, city: Frepillon, zip: 95740, country: France, contacts name: Chloé Puisney, PhD, role: CONTACT, phone: 06.30.15.34.65, email: [email protected], geoPoint lat: 49.05216, lon: 2.20528, locations facility: Eurofins Biomnis, city: Ivry-sur-Seine, zip: 94208, country: France, contacts name: Catherine Coignard, MD, role: CONTACT, phone: +33 149 59 63 37, email: [email protected], geoPoint lat: 48.81568, lon: 2.38487, hasResults: False |
protocolSection identificationModule nctId: NCT06289855, orgStudyIdInfo id: Parkinson's disease, briefTitle: Impulse Control Disorder Among Parkinson's Disease Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about impulse control disorders in Parkinson's disease patients.The main question: it aims to answer:* Detect Relative frequency of impulse control disorder among Parkinson's disease patients* Detect Relation between impulse control disorders, and other non motor and motor symptoms in Parkinson's disease patients, using clinical, neurophysiological and radiological assessment, conditionsModule conditions: Parkinson's Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: MDS-UPDRS, outcomesModule primaryOutcomes measure: number of patients with impulse control disorder among Parkinson's disease patients, secondaryOutcomes measure: percent of cognition affection, gait affection among patients with impulse control disorder among Parkinson's disease patients, secondaryOutcomes measure: volume of cortex and basal ganglia in patients with impulse control disorder among Parkinson's disease patients, secondaryOutcomes measure: cortical excitability and inhibition inpatients with impulse control disorder among Parkinson's disease patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06289842, orgStudyIdInfo id: ZU-IRB #9697, briefTitle: Accelerated Theta Burst Stimulation for Treatment of Suicidality in Depressed Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: The objective of this study is to investigate efficacy of accelerated theta burst stimulation (TBS) in suicidal reduction in patients with unipolar and bipolar depression, conditionsModule conditions: Suicide and Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Transcranial Magnetic Stimulation MagPro R30 with the MCF-B70 figure-of-eight coil (MagVenture, Denmark), outcomesModule primaryOutcomes measure: Change in suicidal ideation and behaviors as measured by Columbia Suicide Severity Rating Scale (C-SSRS), secondaryOutcomes measure: Change from baseline Montgomery-Åsberg Depression Rating Scale (MADRS) Score, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zagazig University, status: RECRUITING, city: Zagazig, zip: 44519, country: Egypt, contacts name: Medhat M Bassiony, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: Usama M Youssef, Professor, role: SUB_INVESTIGATOR, contacts name: Ghada M Salah El-Deen, Professor, role: SUB_INVESTIGATOR, contacts name: Hayam M El-Gohary, Professor, role: SUB_INVESTIGATOR, contacts name: Alaa E Zayed, Ass.Lecturer, role: SUB_INVESTIGATOR, geoPoint lat: 30.58768, lon: 31.502, hasResults: False |
protocolSection identificationModule nctId: NCT06289829, orgStudyIdInfo id: 4-2023-1605, briefTitle: The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2025-07-29, completionDateStruct date: 2025-07-29, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion, and the newly developed benzodiazepine, remimazolam, is gaining attention as one of them. Remimazolam has rapid onset and recovery times, hemodynamic stability, and is often co-administered with opioids like remifentanil for more effective LMA insertion. This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain, one of the recently developed LMAs, during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose. Starting with an initial concentration of remifentanil of 3.0 μg/mL, the success or failure of LMA insertion will determine the dosage for the next subject. Data will be collected from a total of 60 patients, and subsequent analysis will be conducted., conditionsModule conditions: Adult, Laryngeal Masks, Remimazolam, Remifentanil, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 67, type: ESTIMATED, armsInterventionsModule interventions name: remifentanil of the assigned dose, interventions name: Ambu Auragain for airway management, outcomesModule primaryOutcomes measure: Success/failure of LMA insertion on the first attempt, secondaryOutcomes measure: Difficulty of LMA insertion, secondaryOutcomes measure: Optimality of the LMA insertion based on the administered remifentanil dose, secondaryOutcomes measure: The number of attempts required for successful LMA insertion and whether intubation was performed., secondaryOutcomes measure: Air leak volume during positive-pressure ventilation, secondaryOutcomes measure: Systolic blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Patient State Index (PSI), secondaryOutcomes measure: Severity of hoarseness, secondaryOutcomes measure: Severity of coughing, secondaryOutcomes measure: Severity of sore throat, secondaryOutcomes measure: Diastolic blood pressure, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Severance Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Darhae Eum, Assistant Clinical Professor, role: CONTACT, phone: 82-2-2228-2431, email: [email protected], geoPoint lat: 37.566, lon: 126.9784, hasResults: False |
protocolSection identificationModule nctId: NCT06289816, orgStudyIdInfo id: 28/01/2023, briefTitle: Spleen Preserving Surgery for Splenic Hydatidosis: A Cohort Study on Short and Long-Term Outcomes, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2021-06-30, completionDateStruct date: 2021-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Yarmouk University, class: OTHER, descriptionModule briefSummary: This retrospective cohort study examines the effectiveness of minimally invasive spleen-preserving surgeries compared to total splenectomy for treating primary splenic hydatidosis in Jordan. Covering 18 patients from January 2015 to June 2021, the research highlights similar recurrence rates between both surgical approaches, emphasizing the benefits of spleen preservation in maintaining immune function and reducing septic risks, particularly in pediatric patients., conditionsModule conditions: Spleen-Preserving Surgery, conditions: Echinococcus Granulosus Infection, conditions: Hydatid Disease, conditions: Minimally Invasive Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Minimally Invasive Surgery, outcomesModule primaryOutcomes measure: Incidence of Postoperative Short-Term Complications, primaryOutcomes measure: Incidence of Postoperative Long-Term Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anas Aljaiuossi, city: Irbid, zip: 22110, country: Jordan, geoPoint lat: 32.55556, lon: 35.85, hasResults: False |
protocolSection identificationModule nctId: NCT06289803, orgStudyIdInfo id: Huadong Hospital of FudanU, briefTitle: The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: Aim of the study: To evaluate the value of Probe Confocal Laser Endomicroscopy (PCLE) in surgery for pancreatic tumor.Methods:Patients who are diagnosed with pancreatic tumor based on preoperative radiographic findings and will undergo radical resection are included in this clinical study. PCLE will be used in surgery to identify tumor is malignant or not, and surgeons will decide procedures of surgery based on outcomes of PCLE. In this present study, clinical trials will be divided into two phases. In the first phase, based on the definitive postoperative pathologic diagnosis, characteristic imaging structures that were collected by PCLE will be identified and primary diagnostic imaging criteria for pancreatic cancer would be developed. In the second phase, this criterion will be used for rapid intraoperative diagnosis of pancreatic cancer and predicting status of resection margin. In addition, accuracy of PCLE will be verified based on postoperative pathologic reports., conditionsModule conditions: Pancreatic Cancer, conditions: Diagnosis, conditions: Pancreatoduodenectomy, conditions: Distal Pancreatectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients diagnosed with pancreatic tumours will undergo surgical resection, and PCLE will be used for identifying the behaviour of tumours (benign or malignant neoplasms) and predicting the status of resection margin., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: probe confocal laser endomicroscopy, outcomesModule primaryOutcomes measure: diagnostic efficacy, secondaryOutcomes measure: Rate of R0 resection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huadong Hospital affiliated to Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Chunjing Li, M.S, role: CONTACT, phone: 14790068967, email: [email protected], contacts name: Chongyi Jiang, M.D, role: CONTACT, phone: +8618101802916, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06289790, orgStudyIdInfo id: 16/BW/2023', briefTitle: Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-11-07, completionDateStruct date: 2024-11-07, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups, conditionsModule conditions: Thoracic Surgery, Video-Assisted, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Erector Spinae Plane (ESP) block, interventions name: Lignocaine, outcomesModule primaryOutcomes measure: pain score on numerical rating score, primaryOutcomes measure: cumulative opioid dose, secondaryOutcomes measure: incidence of severe hypotension, secondaryOutcomes measure: incidence of nausea and vomiting, secondaryOutcomes measure: incidence of priuritis, secondaryOutcomes measure: incidence of local anaesthetic systemic toxicity symptoms, secondaryOutcomes measure: intra-operative cumulative opioid dose, secondaryOutcomes measure: time to discharge from hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Medical Institute of the Ministry of the Interior and Administration, city: Warsaw, state: Mazowieckie, zip: 02-507, country: Poland, contacts role: CONTACT, phone: 722 14 50, phoneExt: (47), email: [email protected], contacts name: Antoni Okniński, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Iwona Pikto-Pietkiewicz, MD, role: SUB_INVESTIGATOR, geoPoint lat: 52.22977, lon: 21.01178, hasResults: False |
protocolSection identificationModule nctId: NCT06289777, orgStudyIdInfo id: aortic remodeling, briefTitle: Aortic Remodeling After Endovascular Management of Type B Aortic Dissection., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair., conditionsModule conditions: Type B Aortic Dissection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: TEVAR, outcomesModule primaryOutcomes measure: Analysis of aortic remodeling, primaryOutcomes measure: technical success, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, city: Asyut, zip: 71515, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False |
protocolSection identificationModule nctId: NCT06289764, orgStudyIdInfo id: 7/02/2024/131, briefTitle: The Effect of Aromatherapy Application With Bergamot and Grapefruit Essential Oils on PMS, acronym: Aromatherapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Esra ÖZER, class: OTHER, collaborators name: KTO Karatay University, descriptionModule briefSummary: Aromatherapy is;the science of using highly concentrated essential oils or essences distilled from plants to take advantage of their therapeutic properties. Essential oils or essences are obtained from various parts of plants (root, leaf, flower, bark, fruit) and used therapeutically for physical and psychological well-being.Premenstrual syndrome (PMS) is a health problem characterized by the periodic occurrence of physical, cognitive, emotional and behavioral symptoms during the luteal phase of the menstrual cycle, ending with the onset of menstruation or with the alleviation of symptoms within a few days after the onset of menstruation. It is reported that approximately 80-95% of women complain of PMS complaints.Although the use of aromatherapy in womens health is widespread, there is no study comparing bergamot and grapefruit essential oils. The aim of this study was to determine the effect of aromatherapy with bergamot and grapefruit essential oils on premenstrual syndrome and menstrual symptoms., conditionsModule conditions: Premenstrual Syndrome-PMS, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Bergamot Essential Oil, interventions name: Grapefruit Essential Oil, interventions name: Sweet almond oil, outcomesModule primaryOutcomes measure: Premenstrual syndrome scale (PMS), secondaryOutcomes measure: Menstrual Symptom Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ankara Medipol Unıversty, status: RECRUITING, city: Ankara, state: Altındağ, zip: 06000, country: Turkey, contacts name: Esra ÖZER, Asisst. Prof., role: CONTACT, phone: +905433630475, email: [email protected], contacts name: Şerife İrem DÖNER, research assistant, role: SUB_INVESTIGATOR, contacts name: Hafize DAĞ TÜZMEN, lecturer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06289751, orgStudyIdInfo id: NACI-CerV-004, briefTitle: Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2031-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), collaborators name: Women Hospital, School of Medicine, Zhejiang University, collaborators name: Southwest Hospital, China, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: Qilu Hospital of Shandong University, collaborators name: Beijing Friendship Hospital, collaborators name: Tianjin Medical University, collaborators name: West China Second University Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: Gansu Provincial Maternal and Child Health Care Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Shengjing Hospital, descriptionModule briefSummary: This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients., conditionsModule conditions: Cervical Cancer, conditions: Neoadjuvant Chemoimmunotherapy, conditions: Radical Hysterectomy, conditions: Fertility Preservation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a multicentre, single-arm, phase 2 trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Paclitaxel-albumin, interventions name: Cisplatin, interventions name: Extrafascial hysterectomy, outcomesModule primaryOutcomes measure: Percentage of patients meeting ConCerV criteria, secondaryOutcomes measure: Objective Response Rate, ORR, secondaryOutcomes measure: Proportion of patients requiring postoperative adjuvant therapy, secondaryOutcomes measure: Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.0, secondaryOutcomes measure: the surgical complication, secondaryOutcomes measure: Pathologic Complete Response, secondaryOutcomes measure: Overall survival, OS, secondaryOutcomes measure: progression-free survival, PFS, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Gang Chen, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Jing Chen, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Gang Chen, role: PRINCIPAL_INVESTIGATOR, contacts name: Kezhen Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06289738, orgStudyIdInfo id: ICF in Takayasu Arteritis, briefTitle: ICF in Takayasu Arteritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-03-25, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: The aim was to analyze the problem in patients with Takayasu Arteritis based on the International Classification of Functioning, Disability and Health.The sample of our study will consist of individuals between the ages of 18-65 who have been diagnosed with Takayasu Arteritis by rheumatologists and are followed by Pamukkale University Rheumatology Clinic., conditionsModule conditions: Takayasu Arteritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: ICF, outcomesModule primaryOutcomes measure: 6 open-ended questions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elif Gur Kabul, status: RECRUITING, city: Uşak, country: Turkey, contacts name: Elif Gur Kabul, Assistant Professor, role: CONTACT, phone: 00.90.2582964282, phoneExt: 4282, email: [email protected], geoPoint lat: 38.67351, lon: 29.4058, hasResults: False |
protocolSection identificationModule nctId: NCT06289725, orgStudyIdInfo id: IRB-VN01002-23932, briefTitle: Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ly Hoa Anh Minh, class: OTHER, descriptionModule briefSummary: The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response., conditionsModule conditions: Chronic Hepatitis b, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: antiviral treatment, outcomesModule primaryOutcomes measure: Serological response for HBeAg, secondaryOutcomes measure: Virological response, otherOutcomes measure: Biochemical response, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital 1, status: RECRUITING, city: Ho Chi Minh City, country: Vietnam, contacts name: Minh Hoa Anh Ly, role: CONTACT, phone: 0902352622, email: [email protected], geoPoint lat: 10.82302, lon: 106.62965, locations facility: City Children's Hospital, status: RECRUITING, city: Ho Chi Minh City, country: Vietnam, contacts name: Minh Hoa Anh Ly, role: CONTACT, email: [email protected], geoPoint lat: 10.82302, lon: 106.62965, hasResults: False |
protocolSection identificationModule nctId: NCT06289712, orgStudyIdInfo id: APHP231660, briefTitle: Evaluation of the Ablation of Hepatic Lesions by Electroporation, acronym: EVALHEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-23, primaryCompletionDateStruct date: 2025-05-23, completionDateStruct date: 2025-05-23, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: Inria Team MONC, descriptionModule briefSummary: Irreversible electroporation is a curative treatment for cancerous liver lesions, performed on deep-seated tumors that are not eligible for surgical resection or percutaneous thermal ablation.The EVALHEP project aims to develop criteria for evaluating the effectiveness of the treatment based on imaging, mathematical models, and numerical simulations to assist radiologists who perform these complex procedures., conditionsModule conditions: Liver Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlate 3D numerical simulations of the IRE electric field with patient imaging follow-up, secondaryOutcomes measure: Calculation of the tumor coverage rate by the various electric field isolines at different relevant values (for example, three-dimensional isolines between 300 and 700V.cm-1 will be simulated numerically)., secondaryOutcomes measure: Correlation of recovery rate with treatment outcome and local recurrence during clinical follow-up, secondaryOutcomes measure: Identification and assessment of imaging biomarkers (radiomics-based) using numerical simulation and post-therapeutic imaging for treatment response evaluation., secondaryOutcomes measure: Digital resolution of electrical potential and tissue conductivity values from test pulses at the start of the procedure., secondaryOutcomes measure: Develop software solutions potentially usable in real-time and tailored for clinical use., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service d'imagerie diagnostique et interventionnelle tri-site des HUPSSD, status: RECRUITING, city: Bobigny, zip: 93009, country: France, contacts name: Olivier SUTTER, role: CONTACT, phone: 01 72 40 00 12, email: [email protected], geoPoint lat: 48.9, lon: 2.45, hasResults: False |
protocolSection identificationModule nctId: NCT06289699, orgStudyIdInfo id: WARD-CSS international 1251, briefTitle: Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Christian S. Meyhoff, class: OTHER, collaborators name: Rigshospitalet, Denmark, descriptionModule briefSummary: The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction., conditionsModule conditions: User Experience, conditions: Postoperative Complications, conditions: Acute Medical Conditions, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, secondaryOutcomes measure: Technical feasibility, secondaryOutcomes measure: Alert relay to smartphones, secondaryOutcomes measure: Response to alerts, secondaryOutcomes measure: Patients experiences from being monitored with wCSVM., secondaryOutcomes measure: Relevance of alarms, secondaryOutcomes measure: Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day, secondaryOutcomes measure: Frequency of delivered alarms on respiration rate (RR) pr patient pr day, secondaryOutcomes measure: Frequency of delivered alarms on heart rate (HR) pr patient pr day, secondaryOutcomes measure: Frequency of delivered alarms on blod pressure (BP) pr patient pr day, secondaryOutcomes measure: Overall score of user satisfaction from use of WARD24/7 app, secondaryOutcomes measure: Subscale MAUQ scores, secondaryOutcomes measure: Monitoring practices prior to the wCVSM, otherOutcomes measure: Cumulative duration of SpO2<88% and SpO2 < 85%, otherOutcomes measure: Cumulative duration of respiratory rate ≤ 5 min-1 and Respiratory rate > 24 min-1, otherOutcomes measure: Cumulative duration of Heart rate > 130 min-1 and Heart rate ≤ 30 min-1, otherOutcomes measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg and Systolic blood pressure > 220 mmHg o, otherOutcomes measure: Cumulative duration of Circulatory failure, otherOutcomes measure: Cumulative duration of Systolic blood pressure ≤ 90 mmHg AND Heart rate >110 min-1 OR heart rate < 50 bpm AND/OR SpO2 < 92% o, otherOutcomes measure: Cumulative duration of Hypoventilation: RR < 11 AND SpO2 < 88%, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Cleveland Clinic Foundation, General Anesthesiology, status: NOT_YET_RECRUITING, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Daniel Sessler, MD, role: CONTACT, contacts name: Daniel Sessler, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedizin, Klinik und Poliklinik für Anästhesiologie, status: NOT_YET_RECRUITING, city: Hamburg, zip: 20246, country: Germany, contacts name: Bernd C Saugel, MD, Dr. Med., role: CONTACT, contacts name: Bernd C Saugel, MD, Dr. Med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.57532, lon: 10.01534, locations facility: University Medical Center Groningen, Department of Anesthesiology, status: NOT_YET_RECRUITING, city: Groningen, zip: 9700, country: Netherlands, contacts name: Marjolein Haveman, TP, role: CONTACT, contacts name: Marjolein Haveman, TP, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.21917, lon: 6.56667, locations facility: St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin, status: RECRUITING, city: Trondheim, zip: 7006, country: Norway, contacts name: Erlend Skraastad, MD, PhD, role: CONTACT, contacts name: Erlend Skraastad, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 63.43049, lon: 10.39506, locations facility: Liverpool University Hospitals NHS Foundation Trust, status: NOT_YET_RECRUITING, city: Liverpool, zip: L7 8YE, country: United Kingdom, contacts name: Ingeborg Welters, Dr. Med., role: CONTACT, contacts name: Ingeborg Welters, Dr. Med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.41058, lon: -2.97794, hasResults: False |
protocolSection identificationModule nctId: NCT06289686, orgStudyIdInfo id: C.2023.080, briefTitle: MIRROR Project 44 - Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Brooke Army Medical Center, class: FED, collaborators name: Sparta Biopharma, collaborators name: Musculoskeletal Injury Rehabilitation Research for Operational Readiness, descriptionModule briefSummary: Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair., conditionsModule conditions: Rotator Cuff Tears, conditions: Rotator Cuff Injuries, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Rotator cuff repairs with BioEnthesis augmentation, interventions name: Rotator cuff repairs without BioEnthesis augmentation, outcomesModule primaryOutcomes measure: Rates of re-tear, secondaryOutcomes measure: Change in the Visual Analogue Scale (VAS) from before surgery to after surgery, secondaryOutcomes measure: Change in the return to activities of daily living (ADL) from before surgery to after surgery, secondaryOutcomes measure: Change in the Concomitant medications (ConMeds) from before surgery to after surgery, secondaryOutcomes measure: Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery, secondaryOutcomes measure: Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery, secondaryOutcomes measure: Change in the Constant-Murley Score from before surgery to after surgery, secondaryOutcomes measure: Change in the shoulder immobilization status from before surgery to after surgery, secondaryOutcomes measure: Change in strength measurements from before surgery to after surgery, secondaryOutcomes measure: Change in range of motion measurements from before surgery to after surgery, secondaryOutcomes measure: Number of medical events/adverse events after surgery, secondaryOutcomes measure: Cumulative number of steroid injections after surgery, secondaryOutcomes measure: Number of unscheduled visits after surgery, secondaryOutcomes measure: Number of for-cause imaging procedures, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Walter Reed National Military Medical Center, status: NOT_YET_RECRUITING, city: Bethesda, state: Maryland, zip: 20889, country: United States, contacts name: Kelly Kilcoyne, MD, role: CONTACT, phone: 301-295-2441, email: [email protected], geoPoint lat: 38.98067, lon: -77.10026, locations facility: Brooke Army Medical Center, status: RECRUITING, city: San Antonio, state: Texas, zip: 78234, country: United States, contacts name: Andrew Sheean, MD, role: CONTACT, phone: 210-916-1280, email: [email protected], geoPoint lat: 29.42412, lon: -98.49363, hasResults: False |
protocolSection identificationModule nctId: NCT06289673, orgStudyIdInfo id: INITIALL, secondaryIdInfos id: NCI-2024-01659, type: REGISTRY, domain: NCI Clinical Trial Registration Program, briefTitle: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2034-05, completionDateStruct date: 2039-05, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: St. Jude Children's Research Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Leukemia (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.Primary Objectives* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.* To develop a central database of genomic and clinical findings.Secondary Objectives* To assess event free and overall survival data of patients enrolled on this study., conditionsModule conditions: Acute Lymphoblastic Leukemia, conditions: Lymphoblastic Lymphoma, conditions: Mixed Phenotype Acute Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 850, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, interventions name: Vincristine, interventions name: Daunorubicin, interventions name: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine), interventions name: Methotrexate, interventions name: Cytarabine, outcomesModule primaryOutcomes measure: Sufficient phenotypic and/or genomic data necessary for therapeutic protocol assignment by Day 8 (completion of INITIALL therapy)., primaryOutcomes measure: Complete data within the INITIALL database, secondaryOutcomes measure: Event Free Survival (EFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: United States, Tennessee St. Jude Children's Research Hospital, city: Memphis, state: Tennessee, zip: 38105, country: United States, contacts name: Seth E. Karol, MD, role: CONTACT, phone: 866-278-5833, email: [email protected], contacts name: Seth E. Karol, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False |
protocolSection identificationModule nctId: NCT06289660, orgStudyIdInfo id: PED-TB22, briefTitle: Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-22, primaryCompletionDateStruct date: 2033-01-02, completionDateStruct date: 2033-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide., conditionsModule conditions: Tuberculosis Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Epidemiology of Tuberculosis, eligibilityModule sex: ALL, minimumAge: 1 Week, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, state: Firenze, zip: 50139, country: Italy, contacts name: Luisa Galli, role: CONTACT, email: [email protected], geoPoint lat: 43.77925, lon: 11.24626, locations facility: Ospedale Pediatrico Giovanni XXIII, status: RECRUITING, city: Bari, country: Italy, contacts name: Desiree Caselli, role: CONTACT, email: [email protected], geoPoint lat: 41.11148, lon: 16.8554, locations facility: Ospedale di Belluno, status: RECRUITING, city: Belluno, country: Italy, contacts name: Giangiacomo Nicolini, role: CONTACT, email: [email protected], geoPoint lat: 46.14262, lon: 12.2156, locations facility: Università di Bologna, status: RECRUITING, city: Bologna, country: Italy, contacts name: Marcello Lanari, role: CONTACT, email: [email protected], geoPoint lat: 44.49381, lon: 11.33875, locations facility: IRCCS Istituto Giannina Gaslini, status: RECRUITING, city: Genova, country: Italy, contacts name: Elio Castagnola, role: CONTACT, email: [email protected], geoPoint lat: 44.40478, lon: 8.94438, locations facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore, Policlinico, status: RECRUITING, city: Milano, country: Italy, contacts name: Samantha Bosis, MD, role: CONTACT, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale Luigi Sacco, status: RECRUITING, city: Milano, country: Italy, contacts name: Vania Giacomet, role: CONTACT, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, locations facility: Policlinico di Modena, status: RECRUITING, city: Modena, country: Italy, contacts name: Barbara Maria Bergamini, role: CONTACT, email: [email protected], geoPoint lat: 44.64783, lon: 10.92539, locations facility: Università Federico II, status: RECRUITING, city: Napoli, country: Italy, contacts name: Andrea Lo Vecchio, role: CONTACT, email: [email protected], geoPoint lat: 40.85216, lon: 14.26811, locations facility: Ospedale dei Bambini "G.Di Cristina", status: RECRUITING, city: Palermo, country: Italy, contacts name: Claudia Colomba, MD, role: CONTACT, email: [email protected], geoPoint lat: 38.13205, lon: 13.33561, locations facility: Ospedale di Parma, status: RECRUITING, city: Parma, country: Italy, contacts name: Susanna Maria Roberta Esposito, role: CONTACT, email: [email protected], geoPoint lat: 44.79935, lon: 10.32618, locations facility: IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: Gian Luigi Marseglia, role: CONTACT, email: [email protected], geoPoint lat: 45.19205, lon: 9.15917, locations facility: Azienda Ospedaliero Universitaria Pisana, status: RECRUITING, city: Pisa, country: Italy, contacts name: Diego Peroni, role: CONTACT, email: [email protected], geoPoint lat: 43.70853, lon: 10.4036, locations facility: Azienda USL Toscana Centro, status: RECRUITING, city: Prato, country: Italy, contacts name: Per Luigi Vasarri, role: CONTACT, email: [email protected], geoPoint lat: 43.8805, lon: 11.09699, locations facility: IRCCS Ospedale Pediatrico Bambin Gesù, status: RECRUITING, city: Roma, country: Italy, contacts name: Laura Lancella, role: CONTACT, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Universitario Agostino Gemelli IRCCS, status: RECRUITING, city: Roma, country: Italy, contacts name: Danilo Buonsenso, MD, role: CONTACT, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale Regina Margherita, status: RECRUITING, city: Torino, country: Italy, contacts name: Silvia Garazzino, role: CONTACT, email: [email protected], geoPoint lat: 45.07049, lon: 7.68682, hasResults: False |
protocolSection identificationModule nctId: NCT06289647, orgStudyIdInfo id: 19-28923B, secondaryIdInfos id: 5UG1EY030833, type: NIH, link: https://reporter.nih.gov/quickSearch/5UG1EY030833, briefTitle: Azithromycin Reduction to Reach Elimination of Trachoma B, acronym: ARRET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2029-08-31, completionDateStruct date: 2029-08-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, collaborators name: National Eye Institute (NEI), descriptionModule briefSummary: The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution., conditionsModule conditions: Trachoma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double (Investigator, Outcomes Assessor), whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100000, type: ESTIMATED, armsInterventionsModule interventions name: Azithromycin, outcomesModule primaryOutcomes measure: Ocular chlamydia measured in a population-based sample of 0-9 year-old children, secondaryOutcomes measure: Infectious load of chlamydia among 0-9-year-old children infected with ocular chlamydia, secondaryOutcomes measure: Conjunctival inflammation, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 9 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of California, San Francisco, city: Kindu, state: Maniema, country: Congo, The Democratic Republic of the, geoPoint lat: -2.94373, lon: 25.92237, hasResults: False |
protocolSection identificationModule nctId: NCT06289634, orgStudyIdInfo id: Pending, briefTitle: The Influence of Sound on Stress, Anxiety, and Mood, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Medgar Evers College, The City University of New York, class: OTHER, descriptionModule briefSummary: Multiple studies have highlighted music's ability to evoke diverse emotional states. Past research reveals that factors like musical elements, and the environment impact how people respond emotionally to music. For instance, faster tempos tend to heighten arousal, while minor key compositions evoke more arousal compared to major key compositions. In efforts to induce specific emotions post-stress, the research found that both pleasant and sad music aided stress recovery. Similarly, other researchers noted that positively rated music was more effective in reducing stress than negatively rated music, especially low arousal compositions over high arousal ones. Several studies focused on applying music to reduce stress and anxiety. In addition to man-made musical tones, the positive impact of natural surroundings on emotional state has been widely explored. A psycho-evolutionary viewpoint was offered, suggesting that humans have evolved in natural settings, making us inherently attuned to them physically and psychologically. A non-threatening natural environment, rich in aesthetically pleasing elements like visible escape routes, greenery, and water, tends to reduce stress and generate interest. In this study, the researchers are exploring how different sounds-man-made instrumental music versus natural sounds-affect stress, anxiety, and mood among the students of Medgar Evers College. Using an experimental approach, the researchers will assess pretest stress levels (via the perceived stress scale (PSS), anxiety (generalized anxiety disorder (GAD-7), and mood (four-dimensional mood scale (4DMS) among a sample of students. After randomly dividing them into two groups, each group will listen to one of the designated sounds (man-made music or nature sounds) for 30 minutes daily over 15 days. The researchers will then have them retake the stress, anxiety, and mood scales for post-test comparison. Statistical analysis (mixed ANOVA) will help to compare scores within and between groups. Ultimately, this study aims to determine the influence of tonal input on stress and anxiety levels among students, crucial given the significant stress they often experience., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Man-made sounds, interventions name: Natural sounds, outcomesModule primaryOutcomes measure: Stress, primaryOutcomes measure: Anxiety, primaryOutcomes measure: Mood, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289621, orgStudyIdInfo id: 2024P000420, secondaryIdInfos id: K01TW012180, type: NIH, link: https://reporter.nih.gov/quickSearch/K01TW012180, briefTitle: Brief Transdiagnostic Treatment for Anxiety Disorders and Post-traumatic Stress Disorder (PTSD) in South Africa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: University of Stellenbosch, collaborators name: Fogarty International Center of the National Institute of Health, collaborators name: Harvard Medical School (HMS and HSDM), descriptionModule briefSummary: The purpose of this study is to examine the use of a brief transdiagnostic treatment for anxiety disorders and (post-traumatic stress disorder (PTSD) in South Africa. The intervention will be delivered by non-specialist providers (e.g., nurses) in primary care clinics. The brief intervention group will be compared to an enhanced standard care control group., conditionsModule conditions: Anxiety Disorders, conditions: Post-traumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a Type 1 hybrid-effectiveness implementation trial. Study participants are randomized into the brief transdiagnostic treatment for anxiety disorders and post-traumatic stress disorder (PTSD) or an enhanced standard care control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: False Safety Behavioral Elimination Treatment (FSET), interventions name: Enhanced Standard Care, outcomesModule primaryOutcomes measure: Structured Clinical Interview for the DSM-5 (SCID-5), primaryOutcomes measure: Clinician-Administered PTSD Scale for the DSM-5 (CAPS), primaryOutcomes measure: Work Social Adjustment Scale (WSAS), primaryOutcomes measure: General Anxiety Disorder-7 (GAD-7), primaryOutcomes measure: Beck Anxiety Inventory (BAI), primaryOutcomes measure: Safety Aid Scale (SAS), secondaryOutcomes measure: Post-traumatic Disorder Checklist (PCL-5 PTSD Checklist (PCL-5), secondaryOutcomes measure: Patient Health Questionnaire - 9 (PHQ-9), secondaryOutcomes measure: Beck Depression Inventory (BDI), secondaryOutcomes measure: Anxiety Sensitivity Index -3, otherOutcomes measure: Life Events Checklist (LEC), otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06289608, orgStudyIdInfo id: ID_2024, briefTitle: Bruxism and Underlying Psichological Factors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Salamanca, class: OTHER, descriptionModule briefSummary: The aim of this study was o determine the relationship between self-reported bruxism (SB) and some psychological factors (i.e: Anxiety State-Trait; Stress Reactivity Index, Beck Depression Inventory). A consecutive sample of 101 patients that reported at least 2 of the 6 items of Bruxism self-reported index, were explored clinically for quantifying the number and severity of worn teeth, and also the severe and location of the muscular pain according to an standardized inventory., conditionsModule conditions: Bruxism, conditions: Muscular Disorders, Atrophic, conditions: Temporomandibular Joint Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Depression Level, primaryOutcomes measure: Stress Level, primaryOutcomes measure: Anxiety, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Odontológica de la Universidad de Salamanca, status: RECRUITING, city: Salamanca, zip: 37007, country: Spain, contacts name: JAVIER MONTERO, DDS, role: CONTACT, phone: 619429971, email: [email protected], geoPoint lat: 40.96882, lon: -5.66388, hasResults: False |
protocolSection identificationModule nctId: NCT06289595, orgStudyIdInfo id: Pro00134382, briefTitle: Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-03, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: PBM Healing International Limited, class: INDUSTRY, descriptionModule briefSummary: Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain., conditionsModule conditions: Orthodontic, conditions: Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: PBM Ortho device, outcomesModule primaryOutcomes measure: Level of Pain, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bio Dental Clinic Ashiya, city: Ashiya, country: Japan, geoPoint lat: 34.72807, lon: 135.30264, locations facility: Sawa Dental Clinic, city: Kasugai, country: Japan, geoPoint lat: 35.24762, lon: 136.97229, locations facility: Soejima Dental Clinic, city: Kitakyushu, country: Japan, geoPoint lat: 33.85181, lon: 130.85034, locations facility: Higashimachigran Dental Clinic, city: Kumamoto, country: Japan, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Tsujimura Dental Clinic, city: Tanabe, country: Japan, geoPoint lat: 33.73333, lon: 135.36667, locations facility: IXI Family Dental Clinic, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, locations facility: Miki Dental Clinic, city: Tokyo, country: Japan, geoPoint lat: 35.6895, lon: 139.69171, hasResults: False |
protocolSection identificationModule nctId: NCT06289582, orgStudyIdInfo id: R24-004, briefTitle: Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: Michael J. Fox Foundation for Parkinson's Research, descriptionModule briefSummary: The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval.Primary Objectives* To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers.* To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.Secondary Objectives* To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes.* To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes* To acquire safety data following injection of \[18F\]DPA-714, conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: [F-18]DPA714 administration IV, outcomesModule primaryOutcomes measure: Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UAB, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: Evan Hudson, BS, role: CONTACT, phone: 205-934-6499, email: [email protected], contacts name: Jonathan McConathy, MD,PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False |
protocolSection identificationModule nctId: NCT06289569, orgStudyIdInfo id: PRO00037243, briefTitle: Home Tele Rehabilitation Therapy for Vascular Dementia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2026-03-14, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: The Methodist Hospital Research Institute, class: OTHER, descriptionModule briefSummary: To determine whether the home telerehabilitation therapy is feasible and lessens caregiver burden in chronic stroke patients with and without vascular dementia (VaD), conditionsModule conditions: Dementia, Vascular, conditions: Stroke Sequelae, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Self-report measures will be not blinded, assessors will be blinded to treatment phase (SOC or telerehabilitation), enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Home telerehabilitation therapy, outcomesModule primaryOutcomes measure: Burden Scale for Family Caregivers, primaryOutcomes measure: Adverse events, secondaryOutcomes measure: Fugl-Meyer Upper extremity assessment, secondaryOutcomes measure: Wolf Motor Function Test (WMFT), otherOutcomes measure: Exercise log, otherOutcomes measure: Stroke Impact Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289556, orgStudyIdInfo id: TEMP0001, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False |
protocolSection identificationModule nctId: NCT06289543, orgStudyIdInfo id: BVU-ESTELOGLU, briefTitle: Preoperative Oral Carbohydrate on Gastric Emptying, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: The current preoperative fasting guidelines recommend, applying preoperative carbohydrate solution 2 hours before the operation to minimize prolonged fasting time potential negative effects and improve patient comfort. Fasting after midnight before the operation day is a widespread practice. The major obstacle to preoperative carbohydrate solutions becoming prevalent and extremely long fasting time is the limited product; which is proven safe and efficient, and unavailable in several countries. In this study, our objective is to analyze the gastric volume, preoperative anxiety, stress response, postoperative insulin resistance, and postoperative nausea and vomiting by utilizing a low osmolality oral carbohydrate solution prepared with ginger and melissa., conditionsModule conditions: Vomit Aspiration, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Preoperative carbohydrate solution, outcomesModule primaryOutcomes measure: Gastric volume, secondaryOutcomes measure: preoperative anxiety, secondaryOutcomes measure: postoperative nausea and vomiting, secondaryOutcomes measure: thirst, hunger, fatigue, dry mouth, secondaryOutcomes measure: Postoperative Pain Score, secondaryOutcomes measure: postoperative insulin resistance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezmialem University, status: RECRUITING, city: Istanbul, state: Fatih, country: Turkey, contacts name: Kazim Karaaslan, role: CONTACT, phone: +905055213865, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-01-01, uploadDate: 2024-01-24T06:51, filename: Prot_SAP_000.pdf, size: 439034, hasResults: False |
protocolSection identificationModule nctId: NCT06289530, orgStudyIdInfo id: 2023XAGG0070-1, briefTitle: Association Between Perioperative Blood and Interstitial Fluid Glucose Level and Clinically Relevant Postoperative Pancreatic Fistula in Different Pancreatic Surgeries, acronym: CR-POPF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: This observational study was conducted in patients undergoing elective pancreaticoduodenectomy or distal pancreatectomy. It mainly answers the following two main questions:1. What are the risk factors for clinically relevant postoperative pancreatic fistula in different pancreatic surgeries?2. What is the correlation between perioperative blood and interstitial fluid glucose level and clinically relevant postoperative pancreatic fistula in different pancreatic surgeries？Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed., conditionsModule conditions: Postoperative Pancreatic Fistula, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: Clinically relevant postoperative pancreatic fistula, secondaryOutcomes measure: Bile leakage, secondaryOutcomes measure: Chyle leak, secondaryOutcomes measure: Postpancreatectomy hemorrhage, secondaryOutcomes measure: Abdominal infection, secondaryOutcomes measure: Delayed gastric emptying, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College, status: RECRUITING, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: LING LAN, MD, role: CONTACT, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06289517, orgStudyIdInfo id: 68Ga-Her2-affibody, briefTitle: PET Imaging of 68Ga-Her2-affibody in Tumors With High Her2 Expression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, descriptionModule briefSummary: This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors., conditionsModule conditions: Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 68Ga-Her2-affibody, outcomesModule primaryOutcomes measure: The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer, secondaryOutcomes measure: The dosimetry of 68Ga-Her2-affibody, secondaryOutcomes measure: Quantitative evaluation of 68Ga-Her2-affibody, secondaryOutcomes measure: Correlation with pathological expression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Lei Yin, Dr., role: CONTACT, phone: +861083575252, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06289504, orgStudyIdInfo id: NN9838-4694, secondaryIdInfos id: U1111-1295-4056, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2024-11-16, completionDateStruct date: 2024-11-16, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will look at how CagriSema affects the blood levels of atorvastatin and warfarin. The study will look at the levels of warfarin and atorvastatin in the blood before the participant starts taking CagriSema and if this changes after the participant has taken CagriSema. The study will also investigate the effect of warfarin before and after the participant takes CagriSema and assess if the injection site affects the level of CagriSema in the blood. The study will last for about 8 months., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cagrilintide, interventions name: Semaglutide, interventions name: Atorvastatin, interventions name: Warfarin, outcomesModule primaryOutcomes measure: AUC0-72hours,atorv,SD: Area under the atorvastatin plasma concentration-time curve from time 0 to 72 hours after a single dose of atorvastatin without CagriSema exposure and at CagriSema steady state, primaryOutcomes measure: AUC0-168hours,S-war,SD: Area under the S-warfarin plasma concentration-time curve from time 0 to 168 hours after a single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: AUC0-∞,atorv,SD: Area under the atorvastatin plasma concentration curve from time 0 to infinity after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: Cmax,atorv,SD: Maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: tmax,atorv,SD: Time to maximum observed atorvastatin plasma concentration after single dose of atorvastatin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: AUC0-∞,S-war,SD: Area under the S-warfarin plasma concentration curve from time 0 to infinity after single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: Cmax,S-war,SD: Maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: tmax,S-war,SD: Time to maximum observed S-warfarin plasma concentration after single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: iAUCINR,0-168hours: Incremental area under the INR-curve from 0 to 168 hours after single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: INRmax: Maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: tINRmax: Time to maximum observed INR response after single dose of warfarin without CagriSema exposure and at CagriSema steady state, secondaryOutcomes measure: Rac,0-168hours,Cagri: The ratio of the area under the cagrilintide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose, secondaryOutcomes measure: Rac,0-168hours,Sema: The ratio of the area under the semaglutide plasma concentration curve from 0 to 168 hours after the 4th dose of CagriSema to the area under the plasma concentration curve from 0 to 168 hours after the 1st dose, secondaryOutcomes measure: AUC0-168hours, 4th dose Cagri: Area under the cagrilintide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema, secondaryOutcomes measure: AUC0-168hours,4th dose Sema: Area under the semaglutide plasma concentration curve from 0 to 168 hours after 4th dose of CagriSema, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Altasciences Company Inc., status: RECRUITING, city: Mount-Royal, state: Quebec, zip: H3P 3P1, country: Canada, geoPoint lat: 45.51675, lon: -73.64918, hasResults: False |
protocolSection identificationModule nctId: NCT06289491, orgStudyIdInfo id: 2024P000544, briefTitle: Randomized Trial of Hydrus Microstent Versus Goniotomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Massachusetts Eye and Ear Infirmary, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the comparative efficacy and safety of Hydrus Microstent, incisional goniotomy, and excisional goniotomy when combined with cataract surgery in patients with mild and moderate open-angle glaucoma. The main questions it aims to answer are:* How do the intraocular pressure lowering effects of these three microinvasive glaucoma surgeries compare?* How do the safety profiles of these three microinvasive glaucoma surgeries compare?Participants will be randomized to one of these three microinvasive glaucoma surgeries in combination with cataract surgery., conditionsModule conditions: Glaucoma, conditions: Glaucoma, Open-Angle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 243, type: ESTIMATED, armsInterventionsModule interventions name: Hydrus Microstent, interventions name: Incisional goniotomy, interventions name: Excisional goniotomy, outcomesModule primaryOutcomes measure: Intraocular pressure, primaryOutcomes measure: Intraocular pressure-lowering medications, secondaryOutcomes measure: Surgical complications, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289478, orgStudyIdInfo id: 0151/67, briefTitle: Efficacy and Safety of Retrograde Intraarticular Injection Via Drain Tube, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Elderly Patients With Femoral Neck Fractures Undergoing Cementless Bipolar Hemiarthroplasty - a Randomized Controlled Trial, acronym: TXA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: King Chulalongkorn Memorial Hospital, class: OTHER, descriptionModule briefSummary: The goal of this Randomized controlled trial is to evaluate in household ambulatory, elderly patients sustaining femoral neck fracture who are subjected to be treat with cementless bipolar hemiarthroplasty. The main questions it aims to answer are:* The efficacy in reducing blood transfusion for topical tranexamic acid administration* The safety of tranexemic acid, topically usedAs having undergone bipolar hemiarthroplasty surgery, participants will either receive retrograde intraarticular tranexamic acid injection via drain tube, or topical soaking administration.Researchers will compare, with standard procedure (procedure), whether topically administered tranexamic acid would reduce rate of blood transfusion., conditionsModule conditions: Femoral Neck Fracture, conditions: Bipolar Hemiarthroplasty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Topical tranexamic acid administration, outcomesModule primaryOutcomes measure: Rate of blood transfusion, secondaryOutcomes measure: Volume of blood transfusion, secondaryOutcomes measure: Calculated blood loss, secondaryOutcomes measure: Any adverse events, secondaryOutcomes measure: In-hospital mortality, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, city: Bangkok, zip: 10330, country: Thailand, contacts name: Kanyakorn Riewruja, role: CONTACT, phone: +66-95-864-4447, email: [email protected], contacts name: Kanyakorn Riewruja, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06289465, orgStudyIdInfo id: IstanbulBU, briefTitle: Examination of Pain, Posture, Physical and Mental Status in Seasonal Hazelnut Workers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule briefSummary: The collection of hazelnuts grown in our country provides a great source of employment for local people and seasonal workers. However, geographical conditions in hazelnut growing areas, challenging variable weather conditions in August and insufficient number of workers create a disadvantageous environment for seasonal workers.In this study, it was aimed to investigate the effects of working conditions on mental status, fatigue, pain severity and postures (posture disorders, developmental delays, etc.) of young adults working in Giresun during the hazelnut picking season in comparison with the group living in the same sociodemographic and cultural environment but not working as seasonal workers., conditionsModule conditions: Agricultural Workers' Diseases, conditions: Posture, conditions: Pain, conditions: Depression, conditions: Fatigue, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: McGill Melzack Questionnaire, primaryOutcomes measure: PhysioPrint Mobile Application, primaryOutcomes measure: Checklist Individual Strength Questionnaire, secondaryOutcomes measure: Beck Depression Inventory, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 34 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Bilgi University, city: Istanbul, zip: 34060, country: Turkey, contacts name: Furkan Çakır, M.Sc., role: CONTACT, phone: 2123115432, phoneExt: +90, email: [email protected], geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06289452, orgStudyIdInfo id: IVB102-101, briefTitle: Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: InnoVec Biotherapeutics Inc., class: INDUSTRY, collaborators name: Peking Union Medical College Hospital, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS., conditionsModule conditions: Retinoschisis, conditions: Retinal Disease, conditions: Retinal Degeneration, conditions: Eye Diseases, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: IVB102 Injection, interventions name: IVB102 Injection, interventions name: IVB102 Injection, outcomesModule primaryOutcomes measure: Incidence of DLTs, primaryOutcomes measure: Incidence of AEs, primaryOutcomes measure: Incidence of SAEs, secondaryOutcomes measure: Visual function, secondaryOutcomes measure: OCT imaging, secondaryOutcomes measure: ERG parameters, eligibilityModule sex: MALE, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06289439, orgStudyIdInfo id: 2024.05.25, briefTitle: Effect of Green Tea Supplementation in Older Adult Women, acronym: GTAW, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Valladolid, class: OTHER, collaborators name: Sanidad de Castilla y León, collaborators name: Instituto de Neurociencia de Castillas y Leon, descriptionModule briefSummary: Introduction: One of the consequences of aging is the decrease in physical performance which can affect the quality of life of older people. Although physical exercise is beneficial in improving this problem, older women do not seem to benefit as much as men. In this sense, the use of ergonomic aids by women could compensate for these issues. Thus, green tea has shown beneficial effects on physical performance in athletes through, among others, improving blood flow and vasodilation, mitochondrial respiration, calcium management, glucose and amino acid uptake, lipid oxidation, modulation of muscle damage, antioxidant effect, and anabolic and catabolic hormones, activation of the hypothalamic-pituitary-adrenal axis, etc. Therefore, the deterioration of physical performance and quality of life of green tea.Objective: To analyze the effect of supplementation with 1 g/day green tea extract (500 mg of polyphenols) for 10 weeks on quality of life values, physical performance (grip strength, walking speed, and resistance), and health biomarkers (biochemical, hematological, and hormonal) in women over 60 years of age who follow a physical training program.Methods: A total of 20 female volunteers between 60 and 73 years old (age: 65.9±4.58 years, BMI: 25.09±3.24 and body fat percentage: 32.54±6.39) who followed a physical activity adapted to their age and abilities are the members of this study. The volunteers were divided into two groups: placebo (CG; n = 10) and supplemented with 1 g/day of green tea (GI; n = 10). Different physical tests were performed (grip strength, walking speed and resistance) and the quality of life questionnaire (WHOQOL-BREF) was passed and health biomarkers (biochemical, hematological, and hormonal) were analyzed at the beginning (T1) and at the end of the 10 weeks of intervention (T2)., conditionsModule conditions: Female, conditions: Older Adults, conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel group placebo-controlled randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Green tea (Camellia sinensis) 1000 mg as extract, interventions name: Placebo, outcomesModule primaryOutcomes measure: Creatine kinase (CK), primaryOutcomes measure: Lactate dehydrogenase (LDH), secondaryOutcomes measure: Myoglobin (Mb), secondaryOutcomes measure: Alanine Aminotransferase (ALT), secondaryOutcomes measure: Aspartate Aminotransferase (AST), secondaryOutcomes measure: Interleukin 6 (IL-6), secondaryOutcomes measure: C-reactive protein (PCR), secondaryOutcomes measure: Testosterone, secondaryOutcomes measure: Cortisol, secondaryOutcomes measure: Miostatin (GDF8), secondaryOutcomes measure: advanced oxidation protein products (AOPP), secondaryOutcomes measure: lipid peroxidation (LPO), secondaryOutcomes measure: Oxygen radical absorption (ORAC), secondaryOutcomes measure: Total antioxidant status (TAS), secondaryOutcomes measure: Total antioxidant capacity (TAC), secondaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF), eligibilityModule sex: FEMALE, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Health Sciences, University of Valladolid Soria Campus, status: RECRUITING, city: Soria, zip: 42004, country: Spain, contacts name: Diego Fernández Lázaro, Vice Dean, role: CONTACT, phone: +34658073375, email: [email protected], geoPoint lat: 41.76401, lon: -2.46883, hasResults: False |
protocolSection identificationModule nctId: NCT06289426, orgStudyIdInfo id: KU3339, briefTitle: Online Yoga for Improving the Well-being of Desk-based Workers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-08-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Kingston University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of an 8-week online yoga intervention in improving the well-being and productivity of desk-based workers. The main questions it aims to answer are:* How effective is an 8-week online yoga intervention in improving the well-being (mental and physical) and productivity (work engagement and job performance) of the yoga group compared with passive controls?* Are there any differences in well-being and work-related measures between the yoga and control groups?Participants in the yoga group will practice yoga three days a week for 8 weeks and will be compared with a wait-listed control group, which will continue with the usual routine for 8 weeks. Researchers will evaluate the impact of yoga on the well-being and productivity of desk-based workers., conditionsModule conditions: Perceived Stress, conditions: Depression, conditions: Anxiety, conditions: Mindfulness, conditions: Self-Compassion, conditions: Compassion, conditions: Work Engagement, conditions: Productivity, conditions: Heart Rate Variability, conditions: Mental Wellbeing, conditions: Musculoskeletal Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Yoga, outcomesModule primaryOutcomes measure: Perceived Stress Scale, primaryOutcomes measure: PROMIS-Anxiety Short form, primaryOutcomes measure: The Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS), primaryOutcomes measure: The Mindful Attention Awareness Scale (MAAS), primaryOutcomes measure: The Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), primaryOutcomes measure: Self-Compassion Scale Short Form (SCS-SF), primaryOutcomes measure: The Compassion Scale (CS), primaryOutcomes measure: Uterecht Work Engagment Scale-Short Form (UWES -9), primaryOutcomes measure: Work Ability Index (WAI), primaryOutcomes measure: Center for Epidemiologic Studies Short Depression Scale (CES-D-R 10), primaryOutcomes measure: Heart Rate Variability (HRV), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vipin Wadhen, status: RECRUITING, city: London, zip: KT12EE, country: United Kingdom, contacts name: VIPIN WADHEN, MPhil, role: CONTACT, phone: 07308468129, email: [email protected], geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06289413, orgStudyIdInfo id: KCHRRF_ADiPOSE_0027, briefTitle: Autonomic Dysfunction in Patients Following Bariatric Surgery: The ADiPOSE Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Kansas City Heart Rhythm Research Foundation, class: OTHER, collaborators name: Kansas City Heart and Rhythm Institute, Overland Park, KS, collaborators name: Bariatric and Metabolic Specialists, Overland Park, KS, descriptionModule briefSummary: Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS., conditionsModule conditions: Autonomic Dysfunction, conditions: Orthostatic Intolerance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Development of AD/OI after BS, outcomesModule primaryOutcomes measure: To assess the prevalence of and characterize outcome of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Menorah Medical Center, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66209, country: United States, contacts name: Donita Atkins, role: CONTACT, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Bariatric and Metabolic Specialists, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66211, country: United States, contacts name: Nicole Fearing, MD, role: CONTACT, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Kansas City Heart Rhythm Institute - Roe Clinic, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66211, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Overland Park Regional Medical Center, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66215, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Centerpoint Medical Center Clinic, status: RECRUITING, city: Independence, state: Missouri, zip: 64057, country: United States, contacts name: Donita Atkins, role: CONTACT, geoPoint lat: 39.09112, lon: -94.41551, locations facility: Centerpoint Medical Center, status: RECRUITING, city: Independence, state: Missouri, zip: 64057, country: United States, contacts name: Donita Atkins, role: CONTACT, geoPoint lat: 39.09112, lon: -94.41551, locations facility: Research Medical Center Clinic, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64032, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Medical Center, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64032, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, hasResults: False |
protocolSection identificationModule nctId: NCT06289400, orgStudyIdInfo id: KaratayUOAS, briefTitle: Magnetic Field Application in Patellofemoral Pain Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: KTO Karatay University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to examine the effect of magnetic field application used in the treatment of patellofemoral pain., conditionsModule conditions: Pain, Knee, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Magnetic field application, interventions name: Conventional treatment, outcomesModule primaryOutcomes measure: Visual Analogue Scale (VAS), primaryOutcomes measure: 36-Item Short Form Survey (SF-36), primaryOutcomes measure: Manual Muscle Test, primaryOutcomes measure: The Lower Extremity Functional Scale (LEFS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: KTO Karatay University, status: RECRUITING, city: Konya, country: Turkey, contacts name: Osman Karaca, PhD, role: CONTACT, phone: +90 444 1251, phoneExt: 7845, email: [email protected], geoPoint lat: 37.87135, lon: 32.48464, hasResults: False |
protocolSection identificationModule nctId: NCT06289387, orgStudyIdInfo id: MMDEF001, briefTitle: Combining Gene Variants to Improve Risk Prediction for Metabolic (Dysfunction)- Associated Fatty Liver Disease and Its Progression to Cirrhosis in Indian Individuals With Type 2 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-10, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Medanta, The Medicity, India, class: OTHER, descriptionModule briefSummary: Type 2 diabetes and metabolic (dysfunction)-associated fatty liver disease (MAFLD) often exist together. The prevalence of MAFLD is about 15-30% in healthy people and around 60-70% in people with type 2 diabetes. Moreover, type 2 diabetes accelerates the progression of liver disease in MAFLD.MAFLD is a spectrum of liver conditions, ranging from simple fatty liver (low risk for progression), progressing to steatohepatitis (MASH) with no or mild fibrosis, advanced liver fibrosis, cirrhosis, and hepatocellular carcinoma. Although diabetes is the strongest predictor of advanced fibrosis in MAFLD, however, only a small proportion of people with type 2 diabetes and MAFLD (about 5-7%) develop a clinically significant liver disease, but the burden of MAFLD is such that even a small proportion of patients developing cirrhosis will lead to a huge strain on the health care system in India. MAFLD is predicted to be the leading indication for liver transplantation in coming years. At present, MAFLD/MASH is the second most common indication for liver transplantation in the USA as well as in India.The question is why around 5-7% patients amongst MAFLD population develop fibrosis and cirrhosis. A growing body of evidence suggest that the disease develops because of a complex process in which several factors, including genetic susceptibility and environmental insults, are involved. There are several gene variants that have been incriminated in the development and progression of MAFLD. The most common genes associated with MAFLD are PNPLA3, TM6SF2, GCKR, and MBOAT7. The loss-of-function gene variant HSD17B13 seems to protect from NAFLD. There are a few studies from India about the role of PNPLA3 and TM6SF2 in MAFLD. However, these studies used USG for the diagnosis of MAFLD, which does not provide any information regarding fibrosis of the liver. The data regarding other three genetic variants are scarce from Indian individuals., conditionsModule conditions: Type2diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Role of the PNPLA3, TM6SF2, GCKR, MBOAT7 and HSD17B13 genetic variants in the development and progression of MASLD., secondaryOutcomes measure: Correlation between body fat percentage (DEXA-measured) and the genetic variants, secondaryOutcomes measure: Correlation between lean body mass (as measured by DEXA) and the genetic variants, secondaryOutcomes measure: Correlation between bone mineral content (DEXA-measured) and the genetic variants, secondaryOutcomes measure: Correlation between fibrosis-4 score (FIB-4) and the genetic variants, secondaryOutcomes measure: Correlation between MASLD fibrosis score (NFS) and the genetic variants, secondaryOutcomes measure: Correlation between serum creatinine levels (eGFR) and the genetic variants, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medanta Division of Endocrinology & Diabetes, status: RECRUITING, city: Gurgaon, state: Haryana, zip: 122001, country: India, contacts name: Surender, PhD, role: CONTACT, phone: 0124141414, phoneExt: 6596, email: [email protected], geoPoint lat: 28.4601, lon: 77.02635, hasResults: False |
protocolSection identificationModule nctId: NCT06289374, orgStudyIdInfo id: 23HH8340, briefTitle: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery, acronym: LABS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Cancer Research UK, descriptionModule briefSummary: Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis., conditionsModule conditions: Oesophageal Adenocarcinoma, conditions: Gastric Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Biosample collection, outcomesModule primaryOutcomes measure: Salivary microbial biomarkers to predict treatment response and long-term prognosis, secondaryOutcomes measure: Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment, secondaryOutcomes measure: Quality of life measure up to 2 years following cancer surgery using validated questionnaires, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Bhamini Vadhwana, role: CONTACT, contacts name: Professor George Hanna, PhD FRCS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False |
protocolSection identificationModule nctId: NCT06289361, orgStudyIdInfo id: IMEA 070, briefTitle: Cohort IMEA 070 -Lenacapavir Compassional, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba, class: OTHER, collaborators name: Saint-Louis Hospital, Paris, France, collaborators name: Bichat Hospital, collaborators name: Saint Antoine University Hospital, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, descriptionModule briefSummary: Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023, conditionsModule conditions: HIV Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 58, type: ESTIMATED, outcomesModule primaryOutcomes measure: proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection, secondaryOutcomes measure: incidence of side effects and laboratory abnormalities on LEN treatment, secondaryOutcomes measure: evolution of HIV-1 or HIV-2 RNA over time, secondaryOutcomes measure: evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time, secondaryOutcomes measure: Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0), secondaryOutcomes measure: Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hopital Zobda Quitman, city: Fort-de-France, state: Martinique, zip: 97261, country: France, contacts name: Ornella OC CABRAS, PhD, role: CONTACT, phone: +33.5.96.55.23.01, email: [email protected], contacts name: Ornella OC CABRAS, PhD, role: PRINCIPAL_INVESTIGATOR, locations facility: Hopital Avicenne, city: Bobigny, zip: 93000, country: France, contacts name: Frederic FM MECHAI, MD, role: CONTACT, phone: +33.1.48.95.54.21, email: [email protected], contacts name: Frederic FM MECHAI, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.9, lon: 2.45, locations facility: Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses, city: Bordeaux, zip: 33000, country: France, contacts name: Pauline PP PERREAU, role: CONTACT, phone: 33.5.57.82.11.03, email: [email protected], contacts name: Arnaud AD DESCLAUX, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Hopital Saint-Andre, city: Bordeaux, zip: 33075, country: France, contacts name: Sabrina SC CALDATO, role: CONTACT, phone: +33.5.56.79.57.33, email: [email protected], contacts name: Fabrice FB BONNET, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: Hopital Raymond Poincare, city: Garches, zip: 92380, country: France, contacts name: Rezak RM MAHREZ, role: CONTACT, phone: +33.1.47.10.46.65, email: [email protected], contacts name: Pierre PT DE TRUCHIS, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.84226, lon: 2.18232, locations facility: C.H.D de Vendee, city: La Roche Sur Yon, zip: 85925, country: France, contacts name: Hélène HP PELERIN, role: CONTACT, phone: +33.2.51.44.65.72, email: [email protected], contacts name: Philippe PP PERRE, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.66667, lon: -1.43333, locations facility: André Mignot Hospital, city: Le Chesnay, zip: 78150, country: France, contacts name: Marie-Charlotte MCDC DE CARNE, MD, role: CONTACT, phone: +33.1.39.63.88.56, email: [email protected], contacts name: Marie-Charlotte MCDC DE CARNE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.8222, lon: 2.12213, locations facility: Centre Hospitalier Bretagne Sud - Hôpital du Scorff, city: Lorient, zip: 56100, country: France, contacts name: Jérémie JP PASQUIER, MD, role: CONTACT, phone: +33.2.97.06.74.86, email: [email protected], contacts name: Jérémie JP PASQUIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.75, lon: -3.36667, locations facility: CHU de Nice, city: Nice, zip: 06200, country: France, contacts name: Sophie SB BREAUD, role: CONTACT, phone: +33 4 92 03 90 90, email: [email protected], contacts name: David DC CHIRIO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: Hôpital Hotel Dieu, city: Paris, zip: 75004, country: France, contacts name: Valérie VLB LE BAUT, role: CONTACT, phone: +33.1.42.34.81.65, email: [email protected], contacts name: Jean-Paul JPV VIARD, PHD, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hopital Saint Antoine, city: Paris, zip: 75012, country: France, contacts name: Rym RM MONARD, role: CONTACT, phone: +33 1 86 69 71 21, email: [email protected], contacts name: Karine KL LACOMBE, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales, city: Paris, zip: 75013, country: France, contacts name: Malikhone MC CHANSOMBAT, role: CONTACT, phone: +33.1.42.16.01.74, email: [email protected], contacts name: Sophie SS SEANG, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hopital Necker, city: Paris, zip: 75015, country: France, contacts name: Elisabete EGP GOMES PIRES, role: CONTACT, phone: +33.1.44.49.2719, email: [email protected], contacts name: Carole CL LOUISIN, role: CONTACT, phone: +33.1.44.49.55.72, contacts name: Claudine CD DUVIVIER, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Bichat Hospital, city: Paris, zip: 75018, country: France, contacts name: ZELIE JULIA, role: CONTACT, phone: 40257057, phoneExt: 331, email: [email protected], contacts name: ROLAND LANDMAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Delafontaine, city: Saint-Denis, zip: 93200, country: France, contacts name: Awa AN N'DIAYE, role: CONTACT, phone: +33.1.42.35.61.40, phoneExt: 6809, email: [email protected], contacts name: Naomie NS SAYRE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.93326, lon: 2.36666, locations facility: Hopital Foch, city: Suresnes, zip: 92150, country: France, contacts name: Amina AF FADLI, role: CONTACT, phone: +33.1.46.25.11.73, email: [email protected], contacts name: David DZ ZUCMAN, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.87143, lon: 2.22929, hasResults: False |
protocolSection identificationModule nctId: NCT06289348, orgStudyIdInfo id: APHP230240, secondaryIdInfos id: 2023-A00970-45, type: REGISTRY, domain: ID-RCB, briefTitle: Announcement of Rare Metabolic Diseases in Systematic Newborn Screening: the Phenylketonuria Experience., acronym: ANNPHE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The aims of this collaborative, interdisciplinary research project are to understand and describe the psychological impact of the announcement of a rare, serious disease present since birth and detected in the context of the systematic neonatal screening (DNS), in terms of the parents' experience, but also on the part of the medical team, in order to improve its process and the support it provides for the announcement of the diagnosis., conditionsModule conditions: Phenylketonuria, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: socio-psychological questionnaire, interventions name: revised event impact scale (IER-S), interventions name: Non directive interview, interventions name: Stern interview, interventions name: semi-directive interview, outcomesModule primaryOutcomes measure: Psychological process linked to the announcement of inherited metabolic disease for the parents, primaryOutcomes measure: Psychological impact of the announcement of an inherited metabolic disease on the doctors' experience, primaryOutcomes measure: Measuring awareness of inherited metabolic diseases detected by midwives, secondaryOutcomes measure: Measure of the impact of the announcement on parents, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Necker Enfants Malades, city: Paris, zip: 75015, country: France, contacts name: Pascale DELONLAY, MD, PhD, role: CONTACT, phone: +33 1 44 49 48 52, email: [email protected], geoPoint lat: 48.85341, lon: 2.3488, hasResults: False |
protocolSection identificationModule nctId: NCT06289335, orgStudyIdInfo id: HCDrIMPrieto anaesthesia, briefTitle: Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-05, primaryCompletionDateStruct date: 2021-09-05, completionDateStruct date: 2022-01-03, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Hospital Central "Dr. Ignacio Morones Prieto", class: OTHER, descriptionModule briefSummary: Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia., conditionsModule conditions: Postanesthetic Excitement, conditions: Cesarean Section, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: saline solution, outcomesModule primaryOutcomes measure: Period of time, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hospital Central Dr. Ignacio Morones Prieto, city: San Luis Potosí, zip: 78290, country: Mexico, geoPoint lat: 22.14982, lon: -100.97916, hasResults: False |
protocolSection identificationModule nctId: NCT06289322, orgStudyIdInfo id: EU101136769-CLIN1, briefTitle: AI4HOPE Dementia Pain Assessment Pilot Study 1, acronym: AI4HOPE1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-07, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, collaborators name: University College Cork, collaborators name: University of Leeds, collaborators name: Fundacion Intras, collaborators name: Universidade do Porto, collaborators name: University Medical Centre Maribor, descriptionModule briefSummary: The pilot study will develop and test a standardized assessment toolkit that will provide conclusive information with a tolerable burden for cognitively impaired patients with dementia., conditionsModule conditions: Dementia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Feasibility study, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Digital toolkit for assessment, outcomesModule primaryOutcomes measure: Feasibility and acceptability of toolkit, primaryOutcomes measure: Accuracy of toolkit assessments, secondaryOutcomes measure: Effect of pain /distress interventions, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289309, orgStudyIdInfo id: N41/DBS/001142, briefTitle: NerveTrend vs. NerveAssure in Prevention of Recurrent Laryngeal Nerve Injury During Thyroid Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Marcin Barczynski, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare two distinct modes of NIM Vital application in thyroid surgery: NerveTrend vs. NerveAssure mode with respect to prevalence of early postoperative RLN injury.The hypothesis explored in this study is that NerveTrend mode may be not inferior than NerveAssure mode in intraoperative identification of impending neural injury and in prognostication of postoperative glottis function in monitored bilateral thyroid surgery. Hence, NerveTrend mode may be considered a bridge between i-IONM and NerveAssure modes, and particularly in health care environments with limited financial resources it can be considered a substantial step forward representing a modern alternative to the NerveAssure technique.A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each).The primary outcome measure is prevalence of recurrent laryngeal nerve (RLN) injury (%) on postoperative day 1 assessed by direct laryngoscopy., conditionsModule conditions: Thyroid Diseases, conditions: Surgery, conditions: Recurrent Laryngeal Nerve Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, randomized study with 2 arms: NeveTrend vs. NerveAssure mode (n=132 patients and 264 nerves at risk, each). Patients referred to the Department of Endocrine Surgery, Jagiellonian University Medical College in Krakow, for first-time thyroid surgery from March 1, 2024 onwards will be registered. Eligible patients with either benign or malignant thyroid disease will be assessed for the study. The study protocole has been approved by the Institutional Review Board (Bioethics Committee of the Jagiellonian University)., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Both participants and outcomes assessor will be blinded to the respective group assignment., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Neuromonitoring of the recurrent laryngeal nerves, outcomesModule primaryOutcomes measure: Prevalence of recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy, secondaryOutcomes measure: Positive predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy, secondaryOutcomes measure: Negative predictive value (%) of introperative neuromonitoring of recurrent laryngeal nerves in prognostication of postoperative glottis function assessed by direct laryngoscopy, secondaryOutcomes measure: Prevalence of permanent recurrent laryngeal nerve injury (%) assessed by direct laryngoscopy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Endocrine Surgery, Jagiellonian University College of Medicine, status: RECRUITING, city: Krakow, zip: 31-202, country: Poland, contacts name: Marcin Barczynski, MD, PhD, role: CONTACT, phone: +48602375939, email: [email protected], contacts name: Marcin Barczynski, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False |
protocolSection identificationModule nctId: NCT06289296, orgStudyIdInfo id: MCT, briefTitle: Medium Chain Fatty Acids and Ketones, acronym: MCFA, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-09-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, descriptionModule briefSummary: 16 participants were randomized to complete two seven-day intervention periods with twice-daily consumption of Medium-chain fatty acids (MCT) or long-chain fatty acids (LCT) oil. Before and after each intervention, participants completed a five-hour experimental day evaluating the response to a first intake of the MCT or LCT oils (pre MCT or LCT), which was repeated after the intervention period of daily intake (post MCT or LCT) (Fig. The intervention periods were separated by a 2-4-week washout period., conditionsModule conditions: Diet, Healthy, conditions: Health, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A parallel crossover design, in which a group of lean and a group of obese participants are allocated to complete two seven-day intervention periods with twice daily consumption of either medium-chain fatty acids or long-chain fatty acids., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ACTUAL, armsInterventionsModule interventions name: Fatty acid intake in lean and obese males, outcomesModule primaryOutcomes measure: Ketone bodies in plasma, eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Copenhagen, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False |
protocolSection identificationModule nctId: NCT06289283, orgStudyIdInfo id: Theodor Bilharz Research Ins., briefTitle: Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Cancer Tissues From Male Patients and Urine of Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder, acronym: Cancer bladder, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Theodor Bilharz Research Institute, class: OTHER, descriptionModule briefSummary: Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis and new treatment strategies for bladder cancer., conditionsModule conditions: Urinary Bladder Neoplasms, conditions: Microtia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: Urine samples and tissue samples: Samples will be collected in clean leak-proof containers without disinfectant or detergent residue and with tight-fitting leak-proof lids and preserved in a refrigera, outcomesModule primaryOutcomes measure: To characterize the microbiota in health and bladder cancer, and may lead to new prevention, diagnosis and treatment strategies for bladder cancer, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Theodor Bilharz Research Institute, city: Cairo, zip: 12411, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06289270, orgStudyIdInfo id: Microbiota and bladder cancer, briefTitle: Microbiota in Urine and Urothelium Can be a Factor for Induction of Urinary Bladder Cancer. The Study Will Examine Urine and Bladder Tissues From Egyptian Male Patients and Controls Using Whole Genomic Sequencing Techniques and 16S rRNA. The Aim is to Elucidate Role of Microbiota in Bladder Cancer., acronym: Cancer bladder, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Theodor Bilharz Research Institute, class: OTHER, descriptionModule briefSummary: Microbes inhabiting the urinary tract that are playing an important role in maintenance of health and the development of diseases and bladder cancer. There is correlation between initiation of bladder cancer and microbes. Urine and bladder tissues from healthy individuals and patients with bladder cancer were analyzed using 16S rRNA sequencing, results show abundant phylum. Next-generation sequencing technologies will be applied with whole genomic and 16S ribosomal RNA gene sequencing for microbiota profiling in urine and bladder tissue of male healthy individuals and patients with bladder cancer. Results will lead to prevention, diagnosis, and new treatment strategies for bladder cancer., conditionsModule conditions: Microbiota in Patients With Urinary Bladder Carcinoma in Urine and Cancer Tissues, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: To characterize the microbiota in male patients with bladder cancer., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Theodor Bilharz Research Institute, status: NOT_YET_RECRUITING, city: Cairo, state: Giza, zip: 12411, country: Egypt, contacts name: Mohamed M Wishahi, MD, role: CONTACT, phone: +201222247437, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, locations facility: Theodor Bilharz Research Institute, status: RECRUITING, city: Cairo, zip: 12411, country: Egypt, contacts name: Mohamed M Wishahi, MD, role: CONTACT, phone: +201222247437, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06289257, orgStudyIdInfo id: VitDAndEndomet, briefTitle: Association of Vitamin D Level and Its Receptor With Endometriosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Khon Kaen University, class: OTHER, descriptionModule briefSummary: Endometriosis, a condition where endometrial-like tissue grows outside the uterus, often occurs due to retrograde menstruation, where menstrual blood flows backward through the fallopian tubes into the pelvic cavity. This tissue can then implant and grow within the pelvic peritoneum. The survival of these ectopic implants leads to chronic inflammation, adhesion formation, and scarring of surrounding tissues, including the ovaries and fallopian tubes. Symptoms include cyclic pelvic pain, dysmenorrhea, dyspareunia, and infertility.Ectopic endometrial tissue survival is not attributed to mutations but rather epigenetic changes. Studies have linked this phenomenon to genes such as KRAS (Kirsten Rat Sarcoma Virus Oncogene), involved in cell proliferation and survival. Dysregulated KRAS activity can lead to increased production of MMP-2 and MMP-9 proteins, implicated in angiogenesis and tissue invasion, facilitating the spread of endometrial tissue.Vitamin D has been shown to modulate immune function and reduce inflammation. Studies suggest that vitamin D deficiency may exacerbate endometriosis symptoms and severity. However, evidence regarding the efficacy of vitamin D supplementation in managing endometriosis symptoms is mixed.One study found that long-term intake of vitamin D-rich foods was associated with an 18% lower risk of developing endometriosis. Additionally, vitamin D deficiency has been correlated with increased expression of mutated KRAS in colorectal cancer patients, suggesting a potential link between vitamin D status and genetic abnormalities in disease progression.Further research is needed to fully understand the relationship between vitamin D deficiency and endometriosis severity, particularly in specific populations like the Thai population., conditionsModule conditions: Endometriosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D level, interventions name: Vitamin D receptor, outcomesModule primaryOutcomes measure: Vitamin D level, secondaryOutcomes measure: rASRM, secondaryOutcomes measure: Vitamin D receptor, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University, city: Khon Kaen, zip: 40000, country: Thailand, contacts name: Vitet Layanun, Doctor of Medicine, role: CONTACT, phone: +66850663130, email: [email protected], contacts name: Vitet Layanun, Doctor of Medicine, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 16.44671, lon: 102.833, hasResults: False |
protocolSection identificationModule nctId: NCT06289244, orgStudyIdInfo id: 6597, briefTitle: Correlation Between Muscle Strength and Thickness in Critically Ill Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-06, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, class: OTHER, descriptionModule briefSummary: Mechanical ventilation (MV) is associated with adverse outcomes in ventilated patients, and impact of MV-induced diaphragm changes are still unclear.The objective of this prospective observational study is to assess muscle thickness and strength, specifically in limb muscles such as the quadriceps, among critically ill patients who undergo extended mechanical ventilation during their Intensive Care Unit (ICU) stay.The primary inquiries this study seeks to address are:* Is there an association between muscle thickness and strength in the limbs of critically ill patients undergoing prolonged MV?* How much thickness and strength variation can be expected in respiratory and limb muscles in critically ill patients undergoing prolonged MV?, conditionsModule conditions: Critical Illness, conditions: Muscle Weakness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, interventions name: Muscle strength measurement, outcomesModule primaryOutcomes measure: Correlation between quadriceps strength and thickness, secondaryOutcomes measure: Quadriceps strength, secondaryOutcomes measure: Quadriceps thickness, secondaryOutcomes measure: Diaphragm thickness, secondaryOutcomes measure: Diaphragm strength, secondaryOutcomes measure: Time to reach the sitting position, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, zip: 20122, country: Italy, contacts name: Veronica Rossi, MSc, role: CONTACT, email: [email protected], geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06289231, orgStudyIdInfo id: AWFiS/2023_5_PE, briefTitle: The Use of Artificial Intelligence (AI) for Gait Analysis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Gdansk University of Physical Education and Sport, class: OTHER, descriptionModule briefSummary: The main purpose of this study will be to assess the consistency and reliability of measurements made using the Vicon three-plane gait analysis device (Vicon Motion Capture System Ltd, Oxford, UK) and a mobile application based on image recognition technology with the help of artificial intelligence., conditionsModule conditions: Gait, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Gait analysis by the Vicon system, primaryOutcomes measure: Gait analysis by the mobile image recognition application, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Gdansk University of Physical Education and Sport, city: Gdańsk, state: Pomorskie, zip: 80-336, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False |
protocolSection identificationModule nctId: NCT06289218, orgStudyIdInfo id: Treating knee osteoarthritis, briefTitle: Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-25, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The purpose of this study will be to compare the combined effect of using Kinesio taping versus interferential current with an exercise program on knee pain, function, knee range of motion, knee muscle strength, and functional mobility in chronic knee osteoarthritis., conditionsModule conditions: Knee Osteoarthritis, 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: 48, type: ESTIMATED, armsInterventionsModule interventions name: interferential current, interventions name: kinesio taping, interventions name: exercise, outcomesModule primaryOutcomes measure: knee flexion range of motion, primaryOutcomes measure: knee extension range of motion, primaryOutcomes measure: quadriceps muscle strength, primaryOutcomes measure: The Western Ontario and McMaster Universities Osteoarthritis Index, primaryOutcomes measure: Timed up and go test, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289205, orgStudyIdInfo id: 60/IRB/SLMC/SWL, briefTitle: "Comparing Methotrexate Usage Techniques to Prevent Proliferative Vitreoretinopaty After Retinal Detachment Vitrectomy", statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University of Health Sciences Lahore, class: OTHER, descriptionModule briefSummary: This clinical trial, involving participants with rhegmatogenous retinal detachment, aims to compare Methotrexate Usage Techniques in preventing Proliferative Vitreoretinopathy (PVR) after vitrectomy. The study will evaluate the development of PVR, retinal detachment recurrence, and improvement in visual acuity. Participants will undergo retinal detachment surgery using the vitrectomy technique and will be divided into two groups. One group will receive Methotrexate infusion during surgery, while the other will receive repeated Methotrexate injections post-surgery. The researcher will analyze and compare outcomes between the two groups., conditionsModule conditions: Proliferative Vitreoretinopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Using lottery methods patients will be divided into two groups with 60 subjects in each group. Group 1 will be regarded as control group and per operative methotrexate infusion will be used by mixing 75 mg of methotrexate into one litre of BSS solution. Group 2 will be regarded as the study group and will receive 500 µg of intra-silicon oil methotrexate at the end of the surgery and then at 1st, 2nd, 3rd, 4th and 6th post operative weeks., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: This will be a single-blind study in which the subjects will be unaware of the intervention. Blinding will be maintained by ensuring that subjects are unaware of the dosing regimens they are receiving., whoMasked: PARTICIPANT, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate, outcomesModule primaryOutcomes measure: Development of Proliferative Vitreoretinopathy (PVR), primaryOutcomes measure: Recurrence of Retinal Detachment, secondaryOutcomes measure: Visual Acuity Improvement, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sahiwal Medical College & Teaching Hospital, Sahiwal, Pakistan, status: RECRUITING, city: Sahiwal, state: Punjab, zip: 57000, country: Pakistan, contacts name: Ahmad Z Jamil, FCPS,FRCS, role: CONTACT, phone: +923334853851, email: [email protected], geoPoint lat: 30.66667, lon: 73.1, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-24, uploadDate: 2024-02-24T14:05, filename: Prot_SAP_000.pdf, size: 182492, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-24, uploadDate: 2024-02-24T14:06, filename: ICF_001.pdf, size: 185782, hasResults: False |
protocolSection identificationModule nctId: NCT06289192, orgStudyIdInfo id: IRB00396489, briefTitle: Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Maryland Cigarette Restitution Fund, descriptionModule briefSummary: To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention., conditionsModule conditions: Tobacco Dependence, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: C-Raven Virtual Tobacco Cessation Counseling, interventions name: Nicotine Replacement Product, interventions name: Community Health Worker, interventions name: Lung Cancer Screening, outcomesModule primaryOutcomes measure: Acceptability and Feasibility, secondaryOutcomes measure: Readiness to quit smoking as assessed by The Readiness Ruler, secondaryOutcomes measure: Number of Participants that Uptake nicotine replacement therapy, secondaryOutcomes measure: Continued use of nicotine replacement therapy, secondaryOutcomes measure: Number of quit attempts, secondaryOutcomes measure: Number of participants than maintain cessation, secondaryOutcomes measure: Number of participants that uptake Quit Line services, secondaryOutcomes measure: Participant engagement with community health worker as assessed by number of CHW interactions, secondaryOutcomes measure: Participant satisfaction as assessed by study team survey, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chase House Apartments, city: Baltimore, state: Maryland, zip: 21201, country: United States, contacts name: Jeanne Clark, MD, role: CONTACT, phone: 410-614-1135, email: [email protected], contacts name: Alejandra Ellison-Barnes, MD, role: CONTACT, phone: 4106141135, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Monument East, city: Baltimore, state: Maryland, zip: 21202, country: United States, contacts name: Jeanne Clark, MD, role: CONTACT, phone: 410-614-1135, email: [email protected], contacts name: Alejandra Ellison-Barnes, MD, role: CONTACT, phone: 4106141135, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, locations facility: Johns Hopkins University School of Medicine, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Jeanne Clark, MD, role: CONTACT, phone: 410-614-1135, email: [email protected], contacts name: Alejandra Ellison-Barnes, MD, role: CONTACT, phone: 4106141135, email: [email protected], geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06289179, orgStudyIdInfo id: Thyroid and cortisol in sepsis, briefTitle: Thyroid and Cortisol Hormone Response to Sepsis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-02-20, completionDateStruct date: 2026-10-25, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Thyroid and cortisol hormone response to sepsis, conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 114, type: ESTIMATED, outcomesModule primaryOutcomes measure: Pattern of cortisol level and thyroid function response to sepsis in ICU, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289166, orgStudyIdInfo id: STSP-0601-04, briefTitle: Safety and Efficacy of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Staidson (Beijing) Biopharmaceuticals Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitor., conditionsModule conditions: Hemophilia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: STSP-0601 for Injection, outcomesModule primaryOutcomes measure: Incidence of adverse events, primaryOutcomes measure: Proportion of successfully treated bleeding episodes, secondaryOutcomes measure: Proportion of successfully treated bleeding episodes, secondaryOutcomes measure: Proportion of bleeding episodes received salvage treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Changcheng Zheng, role: CONTACT, phone: 13956961162, email: [email protected], geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Affiliated Hospital of Chongqing Medical University, status: NOT_YET_RECRUITING, city: Chongqing, state: Chongqing, zip: 400000, country: China, contacts name: Shu Chen, role: CONTACT, phone: 13983420188, email: [email protected], geoPoint lat: 29.56278, lon: 106.55278, locations facility: Fujian Medical University Affiliated Union Medical College Hospital, status: NOT_YET_RECRUITING, city: Fuzhou, state: Fujian, zip: 350005, country: China, contacts name: Fenge Yang, role: CONTACT, phone: 13635250168, email: [email protected], geoPoint lat: 26.06139, lon: 119.30611, locations facility: Lanzhou University First Hospital, status: NOT_YET_RECRUITING, city: Lanzhou, state: Gansu, zip: 730000, country: China, contacts name: Yaming Xi, role: CONTACT, phone: 13919110815, email: [email protected], geoPoint lat: 36.05701, lon: 103.83987, locations facility: Southern Medical University Southern Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Jing Sun, role: CONTACT, phone: 13316202696, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Second People's Hospital, status: NOT_YET_RECRUITING, city: Shenzhen, state: Guangdong, zip: 518000, country: China, contacts name: Xin Du, role: CONTACT, phone: 13602523722, email: [email protected], geoPoint lat: 22.54554, lon: 114.0683, locations facility: Guizhou Medical University Affiliated Hospital, status: NOT_YET_RECRUITING, city: Guiyang, state: Guizhou, zip: 550000, country: China, contacts name: Jishi Wang, role: CONTACT, phone: 13312233711, email: [email protected], geoPoint lat: 26.58333, lon: 106.71667, locations facility: Harbin First Hospital Hematology Tumor Research Center, status: NOT_YET_RECRUITING, city: Harbin, state: Heilongjiang, zip: 150000, country: China, contacts name: Jun Ma, role: CONTACT, phone: 0451-84883471, geoPoint lat: 45.75, lon: 126.65, locations facility: Henan Cancer Hospital, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450000, country: China, contacts name: Hu Zhou, role: CONTACT, phone: 13939068863, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, locations facility: Xiangya Hospital of Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410000, country: China, contacts name: Jie Peng, role: CONTACT, phone: 13974802938, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: Nanjing University School of Medicine Affiliated Gulou Hospital, status: NOT_YET_RECRUITING, city: Nanjing, state: Jiangsu, zip: 210000, country: China, contacts name: Rongfu Zhou, role: CONTACT, phone: 13605142342, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: The First Affiliated Hospital of Nanchang University, status: NOT_YET_RECRUITING, city: Nanchang, state: Jiangxi, zip: 330038, country: China, contacts name: Ruibin Huang, role: CONTACT, phone: 13970006820, email: [email protected], geoPoint lat: 28.68396, lon: 115.85306, locations facility: The first hospital of Jilin University, status: NOT_YET_RECRUITING, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Sujun Gao, role: CONTACT, phone: 158430732085, email: [email protected], geoPoint lat: 43.88, lon: 125.32278, locations facility: Shengjing Hospital Affiliated to China Medical University, status: NOT_YET_RECRUITING, city: Shenyang, state: Liaoning, zip: 110000, country: China, contacts name: Wei Yang, role: CONTACT, phone: 18940259033, email: [email protected], geoPoint lat: 41.79222, lon: 123.43278, locations facility: Affiliated Hospital of Qingdao University, status: NOT_YET_RECRUITING, city: Qingdao, state: Shandong, zip: 266000, country: China, contacts name: Zhongguang Cui, role: CONTACT, phone: 18661809137, email: [email protected], geoPoint lat: 36.06488, lon: 120.38042, locations facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xuefeng Wang, role: CONTACT, phone: 18917762601, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, locations facility: Xi'an Central Hospital, status: NOT_YET_RECRUITING, city: Xi'an, state: Shanxi, zip: 710000, country: China, contacts name: Yanping Song, role: CONTACT, phone: 13572973308, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, locations facility: West China Hospital of Sichuan University, status: NOT_YET_RECRUITING, city: Chengdu, state: Sichuan, zip: 610000, country: China, contacts name: Yuping Gong, role: CONTACT, phone: 15680990805, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, locations facility: Hospital of Hematology, Chinese Academy of Medical Sciences, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lei Zhang, role: CONTACT, phone: 022-23909095, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, locations facility: The Second Affiliated Hospital of Kunming Medical University, status: NOT_YET_RECRUITING, city: Kunming, state: Yunnan, zip: 650000, country: China, contacts name: Zeping Zhou, role: CONTACT, phone: 18788571605, email: [email protected], geoPoint lat: 25.03889, lon: 102.71833, hasResults: False |
protocolSection identificationModule nctId: NCT06289153, orgStudyIdInfo id: 23-01182, briefTitle: Internal Bracing Following ACL Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-26, completionDateStruct date: 2025-08-26, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with quadriceps graft with and without internal bracing., conditionsModule conditions: ACL Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Arthrex Internal Brace, interventions name: ACL Reconstruction, outcomesModule primaryOutcomes measure: Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation, primaryOutcomes measure: Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation, primaryOutcomes measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation, primaryOutcomes measure: Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation, primaryOutcomes measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation, primaryOutcomes measure: Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False |
protocolSection identificationModule nctId: NCT06289140, orgStudyIdInfo id: BIOPTERO2, briefTitle: Oral Bioavailability of a New Formulation of Pterostilbene Cocrystal in Comparison With Its Free Form (BIOPTERO2), acronym: BIOPTERO2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Fundació Eurecat, class: OTHER, collaborators name: Circe, S.L., descriptionModule briefSummary: The goal of this interventional study is to to evaluate the oral bioavailability of the crystallized form of pterostilbene (ccPT) compared to its commercial free base form (pterostilbene (PT) in healthy volunteers. The main question it aims to answer are:• Do the crystallized forms of pterostilbene (ccPT) using two different encapsulation methods exhibit greater bioavailability than its commercial free base form (PT)?Participants will attend to four visits: a preselection visit (V0), a visit for the first postprandial study (V1), a visit for the second postprandial study (V2) after one-week washing period and a visit for the third postprandial study (V3) after another one week washing period.Researchers will analyze the three postprandial assays to determine which type of ccPT encapsulation provides the highest bioavailability compared to the commercial free base form (PT)., conditionsModule conditions: Biological Availability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Pterostilbene cocrystal (ccPT) - Gelatin capsule, interventions name: Pterostilbene free form (PT), interventions name: Pterostilbene cocrystal (ccPT) - Gastro-resistant capsule, outcomesModule primaryOutcomes measure: Bioavailability of Pterostilbene calculated by area under the curve (AUC 0-24) of plasma pterostilbene levels, both free and total., secondaryOutcomes measure: Area under the curve (AUC 0-inf) of plasma pterostilbene levels, both free and total., secondaryOutcomes measure: Relative bioavailability of plasma pterostilbene levels (Frel)., secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Time for maximum plasma concentration (Tmax), secondaryOutcomes measure: Half-life (T1/2)., eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundació Eurecat, city: Reus, zip: 43204, country: Spain, contacts name: Antoni Caimari, PhD, role: CONTACT, phone: 0034 977 300 431, email: [email protected], contacts name: Anna Crescenti, PhD, role: CONTACT, phone: 0034 977 300 431, email: [email protected], geoPoint lat: 41.15612, lon: 1.10687, hasResults: False |
protocolSection identificationModule nctId: NCT06289127, orgStudyIdInfo id: GO 22/595, briefTitle: Test Properties of Lower Quarter Y-Balance Test: Effect of Verbal Instructions and Focus Techniques, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-20, primaryCompletionDateStruct date: 2023-02-02, completionDateStruct date: 2023-11-10, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The Lower Quadrant Y-Balance Test (LQYBT) is a landmark test used in assessing lower extremity performance, determining risk factors for injury, and making return-to-sport decisions. Studies have shown that the individual's focus of attention affects balance. The literature, has shown that the use of external focus is more effective than the use of internal focus in the execution of a movement.Consistent with these findings, the use of an external focus instruction during the LQYBT may lead to achieve more realistic and a higher performance outcome than the test result with standard instructions. The primary aim of this study was to investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT. The secondary aim was to investigate the reliability of the different instructions and focus tests we used for the LQYBT.Hypothesis of the study that test performance can be further enhanced by differentiating the instructions and focus techniques. A more effective assessment of individual performance may help us to make a more realistic decision to return to sport., conditionsModule conditions: Healthy, conditions: Attention Disturbances, conditions: Physical Stress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2, type: ACTUAL, armsInterventionsModule interventions name: Lower Quarter Y Balance Test, outcomesModule primaryOutcomes measure: Investigate the effects of using different instructions and focusing techniques on test performance on the LQYBT., secondaryOutcomes measure: Investigate the reliability of the different instructions and focus tests we used for the LQYBT., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, city: Ankara, state: Sıhhıye, zip: 06430, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False |
protocolSection identificationModule nctId: NCT06289114, orgStudyIdInfo id: S-20220005, briefTitle: Predictive Utility of a Short-term Improvement in Objectively Measured Physical Activity in Rheumatoid Arthritis (PUSIPA), acronym: PUSIPA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-09-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Hospital of South West Jutland, class: OTHER, descriptionModule briefSummary: SUMMARY Background: Several studies have shown physical activity (PA) to be inversely correlated to disease activity in rheumatoid arthritis (RA) patients. However, it is unclear whether improved PA leads to lower disease activity or if low disease activity predicts improved PA in rheumatoid arthritis patients. Furthermore, it is unknown how fibromyalgia (FM) affects this interaction.Objective(s): Our primary objective will be to compare the effect of an immediate improvement in physical activity after one week on the proportion of RA patients achieving low disease activity after 12 weeks of biological treatment. Furthermore, we will explore whether the presence of concomitant FM affects this clinical response (i.e., interaction between FM status and PA response).Design: A prospective cohort study in the form of a target-trial attempting to address a causal question comparing the outcome among the participants with an immediate improvement in physical activity, relative to individuals without.Setting and patients: Biologically naive RA patients initiating biological treatment are consecutively enrolled. PA is quantified by accelerometry one week prior to, one week after, and after 3 months of biological treatment.Sample size: 100 RA patients starting biological therapy is planned enrolled in the study.Measurements: RA patients will be divided into two groups depending on their improvement in physical activity after onset of biological treatment. The percentage of time spent in moderate-to-vigorously physical activity (MVPA) i.e., the percentage of time a patient is in motion \[walking, running, bicycling, or swimming\] is measured prior to, one week, and approximately 3 months after biological treatment onset, respectively. The MVPA ratio (MVPA After biological treatment/MVPA Before biological treatment) will divide patients enabling a contrast between two groups: Those with high improvement considering MVPA (after 1 week; the upper tertile of MVPA ratio of the sample) and those without. Treatment response (achieving a disease activity score \< 3.2) after approximately 3 months from baseline will be analyzed as the contrast between groups., conditionsModule conditions: Rheumatoid Arthritis, conditions: Fibromyalgia, Secondary, conditions: Fatigue, conditions: Physical Inactivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: MVPA ratio before and after biological therapy, primaryOutcomes measure: Disease activity score (DAS), secondaryOutcomes measure: Fibromyalgia, secondaryOutcomes measure: Fatigue, otherOutcomes measure: Physical activity scores on questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Esbjerg Hospital, status: RECRUITING, city: Esbjerg, zip: 6700, country: Denmark, contacts name: Philip R Lage-Hansen, MD, role: CONTACT, phone: +4530114582, email: [email protected], geoPoint lat: 55.47028, lon: 8.45187, hasResults: False |
protocolSection identificationModule nctId: NCT06289101, orgStudyIdInfo id: IRB00422008, secondaryIdInfos id: R21HD112617, type: NIH, link: https://reporter.nih.gov/quickSearch/R21HD112617, briefTitle: text4FATHER R21: Social Media - Efficacy Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), descriptionModule briefSummary: This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being., conditionsModule conditions: Fathers, conditions: Mobile Health, conditions: Nuclear Family, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: text4FATHER, outcomesModule primaryOutcomes measure: Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC), primaryOutcomes measure: Karitane Parenting Confidence Scale (KPCS), primaryOutcomes measure: Fathering Self-Efficacy Scale (FSES), primaryOutcomes measure: Father Engagement Scale (FES), primaryOutcomes measure: The Co-Parenting Relationship Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Hospital, city: Baltimore, state: Maryland, zip: 21287, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False |
protocolSection identificationModule nctId: NCT06289088, orgStudyIdInfo id: E-10840098-772.02-4659, briefTitle: The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance, acronym: lumbosacral, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-05-04, completionDateStruct date: 2024-05-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain., conditionsModule conditions: Orthosis, conditions: Low Back Pain, Postural, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single group, crossover study, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: First Intervention, interventions name: Second Intervention, interventions name: Third Intervention, outcomesModule primaryOutcomes measure: Visual Analog scale, primaryOutcomes measure: Orthosis comfort score, primaryOutcomes measure: Functional Reach Test (FRT), primaryOutcomes measure: Pedobarographic evaluation, primaryOutcomes measure: Y balance test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False |
protocolSection identificationModule nctId: NCT06289075, orgStudyIdInfo id: 23-1096-retro, briefTitle: PrognostICate- Study:Prognostication of ICU- and Ventilator- Days Over the Next Years Until 2040, acronym: PrognostICate, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: University Hospital of Cologne, class: OTHER, collaborators name: Johann Wolfgang Goethe University Hospital, collaborators name: Monash University, collaborators name: The Alfred, collaborators name: Albert Einstein College of Medicine, collaborators name: Montefiore Hospital, descriptionModule briefSummary: The Objective of our retrospective multicenter- study is to forecast ICU length of stay (ICULOS) and length of mechanical ventilation (LOMV) in ICU patients of different groups (regarding gender, age group, medical vs surgical admission) worldwide for the next years up to the year of 2040 using statistical forecasting models and historical, national and international ICU databases and population databases., conditionsModule conditions: ICU Admission, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10000000, type: ESTIMATED, armsInterventionsModule interventions name: Intensive Care Unit (ICU) treatment, outcomesModule primaryOutcomes measure: Length of mechanical ventilation, primaryOutcomes measure: Length of ICU stay, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 120 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06289062, orgStudyIdInfo id: NACI-CERV-005, briefTitle: Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2030-12-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: Women Hospital, School of Medicine, Zhejiang University, collaborators name: Third Military Medical University, collaborators name: Beijing Friendship Hospital, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: Tianjin Medical University, collaborators name: West China Second University Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: Qilu Hospital of Shandong University, collaborators name: Gansu Cancer Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Shengjing Hospital, collaborators name: Anhui Provincial Cancer Hospital, descriptionModule briefSummary: This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, PFS and OS., conditionsModule conditions: Cervical Cancer, conditions: Neoadjuvant Chemoimmunotherapy, conditions: Fertility Preservation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab, interventions name: Cisplatin, interventions name: Nab paclitaxel, interventions name: biopsy, outcomesModule primaryOutcomes measure: Pathologic complete response, secondaryOutcomes measure: The negative conversion of HPV, secondaryOutcomes measure: Pregnancy rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Preterm birth rate, secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: Surgical complications, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score, secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Kezhen Li, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Jing Chen, role: CONTACT, phone: 086-027-8362, email: [email protected], contacts name: Kezhen Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Gang Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False |
protocolSection identificationModule nctId: NCT06289049, orgStudyIdInfo id: HREBA.CC-24-0021, briefTitle: Heavy Strength Training in Head and Neck Cancer Survivors, acronym: LIFTING2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, descriptionModule briefSummary: Despite improvements in treatments, head and neck cancer survivors (HNCS) still endure acute and chronic side effects such as loss of muscular strength, limitations in physical functioning, fatigue, and swallowing difficulties that impact quality of life (QoL) and limit return to work. Light-to-moderate intensity strength training (LMST) has been shown to improve some side effects. Heavy lifting strength training (HLST) may further improve outcomes in some populations, however, only one small pilot study has focused on HNCS. The LIFTING 2 trial will be the first to examine the feasibility and effects of a HLST program versus no exercise in HNCS., conditionsModule conditions: Head and Neck Neoplasms, conditions: Head and Neck Cancer, conditions: Head and Neck Squamous Cell Carcinoma, conditions: Head and Neck Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: Participants and investigators will not be blinded to group assignment given the nature of the intervention., enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Experimental, outcomesModule primaryOutcomes measure: Recruitment rate, primaryOutcomes measure: Adherence to a heavy lifting strength training program, primaryOutcomes measure: Completion of maximal strength testing, primaryOutcomes measure: Followup assessment rate, primaryOutcomes measure: Safety, secondaryOutcomes measure: Muscular Strength, secondaryOutcomes measure: Cancer Specific Quality of Life, secondaryOutcomes measure: Fear of Cancer Recurrence, secondaryOutcomes measure: Symptom Burden, secondaryOutcomes measure: Perceived Stress, secondaryOutcomes measure: Self-Esteem, secondaryOutcomes measure: Sleep Habits, secondaryOutcomes measure: Malnutrition Status, secondaryOutcomes measure: Swallowing Abilities, secondaryOutcomes measure: Shoulder Range of Motion, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Handgrip Strength, secondaryOutcomes measure: Physical Function, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alberta, city: Edmonton, state: Alberta, country: Canada, contacts name: Stephanie Ntoukas, role: CONTACT, email: [email protected], contacts name: Kerry Courneya, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False |
protocolSection identificationModule nctId: NCT06289036, orgStudyIdInfo id: H2020206632, briefTitle: Prognosis in Subacute Ischemic Stroke Using Multimodal Imaging, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Hebei Medical University, class: OTHER, descriptionModule briefSummary: We enrolled patients with subacute IS, associated with moderate-to-severe stenosis of the unilateral cervical internal carotid artery, who underwent 4D ASL. Perfusion levels and collateral circulation were compared between groups with favorable prognosis (modified Rankin scale \[mRS\] ≤ 2) and poor prognosis (mRS \> 2)., conditionsModule conditions: The Levels of Cerebral Perfusion and Collateral Circulation in Patients With Subacute Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 28, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Modified Rankin Scale（mRS） score after 3 months of onset, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 88 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital of Hebei Medical University, city: Shijia Zhuang, state: Hebei, country: China, geoPoint lat: 34.17775, lon: 109.84894, hasResults: False |
protocolSection identificationModule nctId: NCT06289023, orgStudyIdInfo id: NCC1278, briefTitle: HA-WBRT-SIB for Brain Metastasis of Lung Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2020-01-01, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, class: OTHER, descriptionModule briefSummary: Patients with lung cancer and brain metastases undergo HA-WBRT-SIB using image-guided radiotherapy, receiving a total dose of 30-36 Gy delivered in 18-20 fractions to the whole brain (CTV), while the dose to the GTV is boosted to 44 Gy-52 Gy in 18-20 fractions, five times a week. The optimal mean dose (Dmean) to the bilateral hippocampus should optimally be ≤ 8 Gy, with a mandatory maximum dose (Dmax) to the hippocampus not exceeding 10 Gy; the preferred Dmean to the hippocampus PRV should optimally be ≤ 9 Gy, while the mandatory Dmax to the hippocampus PRV should be ≤ 12 Gy. The HVLT-R immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment., conditionsModule conditions: Lung Neoplasm, conditions: Brain Metastases, conditions: Simultaneous Integrated Boost, conditions: Hippocampal Avoidance, conditions: Cognitive Function, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: HA-WBRT-SIB, outcomesModule primaryOutcomes measure: OS, secondaryOutcomes measure: PFS, secondaryOutcomes measure: iPFS, secondaryOutcomes measure: HVLT-R learning score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College, city: Beijing, state: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06289010, orgStudyIdInfo id: 7354E, briefTitle: Neural Mechanisms of Family-Focused Treatment for Youth Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Boston University Charles River Campus, class: OTHER, collaborators name: Massachusetts Institute of Technology, descriptionModule briefSummary: The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are:* What are differences between depressed and non-depressed participants on baseline neural and parenting indicators?* Do baseline neural and parenting indicators predict response to FFT-CD?* Does change in parenting and neural functioning mediate change in depression from baseline to follow-up?Participants will:* complete baseline clinical measures* complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR)* undergo a 12-session course of FFT-CD* complete follow up evaluations and neuroimaging, conditionsModule conditions: Childhood Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Family-Focused Treatment for Childhood-Depression (FFT-CD), outcomesModule primaryOutcomes measure: Depression Treatment Response, primaryOutcomes measure: Children's Self Report of Depressive Symptoms, secondaryOutcomes measure: Depression Remission, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Boston University, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Martha C Tompson, PhD, role: CONTACT, phone: 617-358-4584, email: [email protected], contacts name: Natalie Marr, BS, role: CONTACT, phone: 6173539610, email: [email protected], contacts name: Martha C Tompson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Athinoula A. Martinos Imaging Center at Massachusetts Institute of Technology, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: John DE Gabrieli, PhD, role: CONTACT, phone: 617-253-8946, email: [email protected], contacts name: John DE Gabrieli, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.37787, lon: -71.062, hasResults: False |
protocolSection identificationModule nctId: NCT06288997, orgStudyIdInfo id: TFYuan_tACS, briefTitle: tACS Intervention for Methamphetamine Addiction, acronym: tACS for MUD, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-21, primaryCompletionDateStruct date: 2023-05-09, completionDateStruct date: 2023-11-09, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Shanghai Mental Health Center, class: OTHER, descriptionModule briefSummary: A growing body of evidence suggests a wide range of brain areas are critical for regulating cognitive control over decisions and involving in drug related cue processing. Previous studies have demonstrated that transcranial alternating current stimulation (tACS) over prefrontal cortex reduces craving for meth dependences. In this study, the investigators investigated whether a current level of 15mA with a patented frequency of 77.5Hz tACS intervention of prefrontal cortex cortices in methamphetamine addiction could reduce the subjective craving and improve the cognitive abilities., conditionsModule conditions: Methamphetamine-dependence, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 23, type: ACTUAL, armsInterventionsModule interventions name: transcranial alternating current stimulation, interventions name: sham tACS, outcomesModule primaryOutcomes measure: Changes of Cue-induced craving, secondaryOutcomes measure: Changes of cognition: behavioral inhibition, secondaryOutcomes measure: Changes of cognition: choice under ambiguity, secondaryOutcomes measure: changes of neural mechanism, secondaryOutcomes measure: Changes of depression status, secondaryOutcomes measure: Changes of anxiety status, secondaryOutcomes measure: Changes of sleep status, secondaryOutcomes measure: Changes of impulsivity, secondaryOutcomes measure: event-related potential in passive viewing task, otherOutcomes measure: side effect measurements, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantanghe Addiction Rehab Center, city: Beijing, state: Beijing, zip: 100054, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False |
protocolSection identificationModule nctId: NCT06288984, orgStudyIdInfo id: NFEC-2024-061, briefTitle: Effects of rTMS on Respiratory Function and Gut Microbiota in Patients With Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Impaired respiratory function may occur after brain injury, and will progress to restricted respiratory dysfunction without early intervention. At present, there is a lack of effective treatment options for respiratory dysfunction. Repetitive Transcranial Magnetic Stimulation(rTMS) is a non-invasive, painless and non-invasive neuroregulatory technique. In healthy people, rTMS applied to the respiratory motor cortex induces a contralateral respiratory muscle response. However, whether rTMS can improve respiratory function in patients with brain injury remains unclear. gut microbiota can affect muscle function and mass, and animal experiments have shown that probiotics can increase skeletal muscle mass and grip strength in mice. On the other hand, studies have found that rTMS can improve the nutritional status of patients with vegetative state by regulating the structure of gut microbiota. However, it remains unclear whether rTMS can improve respiratory muscle function in patients with brain injury by regulating gut microbiota. Therefore, the investigators intend to apply rTMS to the respiratory motor cortex to observe whether rTMS can improve respiratory function and reduce the incidence of pneumonia in patients with brain injury, and to observe the role of gut microbiota in this process., conditionsModule conditions: Brain Injuries, conditions: Respiratory Function Impaired, conditions: Gut Microbiota, 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: 74, type: ESTIMATED, armsInterventionsModule interventions name: active rTMS, interventions name: sham rTMS, outcomesModule primaryOutcomes measure: Diaphragm thickness, primaryOutcomes measure: Thickening fraction, secondaryOutcomes measure: Diaphragm mobility, secondaryOutcomes measure: Surface EMG of diaphragm, secondaryOutcomes measure: Forced vital capacity(FVC), secondaryOutcomes measure: Forced expiratory volume at one second（FEV1）, secondaryOutcomes measure: Peak expiratory flow (PEF), secondaryOutcomes measure: Maximum voluntary ventilation (MVV), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288971, orgStudyIdInfo id: IRCCS FSM, briefTitle: Personalized Innovative Intervention Pathways to Promote EF in Children With CP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: University of Pisa, collaborators name: University of Florence, collaborators name: Anastasis Società Cooperativa Sociale, descriptionModule briefSummary: Cerebral palsy (CP) is an umbrella term, covering a group of disorders of movement and posture. It is now accepted that CP represents much more than a disorder of movements considering the frequent association with a broad range of impairments, including cognitive impairments. In general, multiple clinical characteristics that define and determine different functional profiles. Several studies on children with unilateral and bilateral CP have been shown that, despite the overall preserved intellectual functioning, there are specific neuropsychological impairments distinguishing the two forms, including deficits in different Executive Functions (EF) components. Executive Functions (EFs) represent a complex cognitive domain consisting of a set of top-down functions essential for adaptive goal-directed behaviour, allowing to formulate, plan, and organise ideas, cope with challenges and novelties, resist temptations and stay focused. EF represents general domain abilities transversal to several cognitive processes and underling different daily life activities and school learning skills. Empowering EF becomes therefore crucial in children with CP both to strengthen specific functional EF weaknesses and to achieve far transfer effects on other compromised domains, such as motor planning, academic skills,and/or visuospatial processing. To pursue this, the EF training needs to be integrated into the complex and multidisciplinary care context promoting innovative intervention methodologies based on scientific evidence. Recent researches and clinical practice, carried out in our Institute, supports the effectiveness of innovative interventions on EF using new technologies in typical and atypical development, such as Self-adapting web based softwares, Game-based tools or Educational Robotics. Literature suggests these technologies allow to promote timely intervention within a user-friendly context, while respecting the key criteria of evidence-based neuropsychological rehabilitation, both reducing hospitalisation times and supporting interest and motivation for participation. The primary aim of this study is to evaluate the applicability of technological intervention integrated with psychomotor activities to promote EF and then secondary to measure the effect on the functional profile of children with CP, including motor planning, visuo-spatial processing and learning skills, evaluating both short-term (T2) and long-term changes (T3)., conditionsModule conditions: Executive Functions in Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Self-adaption web-based software for the rehabilitation of EF and visuo-spatial abilities, interventions name: Tele-rehabilitation of EF and specific cognitive processes underlying academic skills, interventions name: Game-based tools for the rehabilitation of EF and motor planning, outcomesModule primaryOutcomes measure: changes in score of inhibition subtest at the NEPSY-II, secondaryOutcomes measure: changes in score of the sustained attention subtest at the Leiter-3, secondaryOutcomes measure: changes in score of Developmental Test of Visual-Motor Integration (VMI), secondaryOutcomes measure: changes in score of MOXO-continuous performance test, secondaryOutcomes measure: changes in score of Corsi block-tapping subtest at the BVS-corsi, secondaryOutcomes measure: changes in score of Behaviour Rating Inventory of Executive Function (BRIEF-P/2) for parents, secondaryOutcomes measure: changes in score of RAN (rapid automatized naming) subtest at the rapid automatized naming and visual search of colours, figures and numbers test., secondaryOutcomes measure: changes in score of reading and text comprehension task at the ALCE, secondaryOutcomes measure: changes in score of reading and writing task at the DDE-2, secondaryOutcomes measure: changes in score of digit span forwards and backwards subtest at the BVN 5-11 and BVN 12-18, secondaryOutcomes measure: changes in score of Go/No-Go and N-back 1 subtest at the teleFE, secondaryOutcomes measure: changes in score of verbal fluency subtest at the NEPSY-II, secondaryOutcomes measure: changes in score of Test of Visual Perception and Visuo-motor Integration (TPV), secondaryOutcomes measure: changes in score of Praxic and Motor Coordination Skills-2nd Edition (APCM-2), secondaryOutcomes measure: changes in score of Movement Assessment Battery for Children - Second Edition (Movement ABC-2), secondaryOutcomes measure: changes in score of Synthetic scale for the evaluation of writing in developmental age (BHK test), eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, city: Pisa, zip: 56128, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False |
protocolSection identificationModule nctId: NCT06288958, orgStudyIdInfo id: Fondazione Stella Maris, briefTitle: Quality of Life in Children With Cerebral Palsy, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-04-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, descriptionModule briefSummary: Cerebral Palsy (CP) is an umbrella term that defines a group of permanent disorders of movement and posture, happening during the developing foetal or infant brain. In addition to the main motor symptoms, other clinical disturbances are associated. CP represents a clinical condition with an impact in Quality Of Life (QOL) and social participation, as reported in different countries. QOL is a multidimensional construct defined as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns" (WHOQOL, 1998).In order to best capture the peculiarities of CP, specific questionnaires were carried out to analyse the QOL in this clinical population. The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) is an internationally recognized CP-specific instrument based on the International Classification of Functioning, Disability and Health (ICF) framework. Many studies have used this instrument, showing a lower QOL in children with CP compared to their typical developing peers. In literature, several studies have shown that children with CP are at risk of experiencing activity limitations and participation restriction and which can potentially affect their QOL. Participation in daily-life activities, defined as a person's "involvement in a life situation," and participation restriction, characterised as "problems an individual may experience in involvement in life situations" (ICF, World Health Organization, 2001). Studies aimed at describing participation in daily-life activities in CP have consistently found lower frequencies and fewer activities in children and adolescents with CP. In order to gain an overall picture of the QOL and participation of children and adolescents with CP, several studies underline the importance of analysing other background factors, such as motor and cognitive functioning, pain perception, and individual characteristics.The present study aims to deeper understand the perception of QOL and social participation in a group of Italian children with CP, as reported by their parents, using two commonly used questionnaires in the CP population (CP-QOL and PEM-CY). In addition, this study aims to explore the roles of specific clinical variables, such as motor function and cognitive level, on parental perceptions of QOL, in the development of QOL and participation., conditionsModule conditions: Unilateral and Bilateral Cerebral Palsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Quality of Life and social participation in Italian children with CP, outcomesModule primaryOutcomes measure: Score of CP-QOL Child questionnaire, secondaryOutcomes measure: Score of PEM-CY questionnaire, secondaryOutcomes measure: Scores of Wechsler Intelligence scales, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Fondazione Stella Maris, city: Pisa, zip: 56128, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False |
protocolSection identificationModule nctId: NCT06288945, orgStudyIdInfo id: Dry eye syndrome, briefTitle: Effect of an Educational Program on Health-related Outcomes of Patients With Dry Eye Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-15, primaryCompletionDateStruct date: 2023-09-14, completionDateStruct date: 2023-09-14, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: Dry eye syndrome (DES) is a widespread ocular disease affecting the general population. It is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. Therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with DES including the severity of symptoms related to DES and their influence on visual-related functions, conditionsModule conditions: Dry Eye Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Educational Program, outcomesModule primaryOutcomes measure: ocular irritation symptoms associated with Dry eye syndrome and their effect on functions related to vision, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Nursing, Alexandria university, city: Alexandria, country: Egypt, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False |
protocolSection identificationModule nctId: NCT06288932, orgStudyIdInfo id: NIBD/IRB-263/08-2023, briefTitle: Outcome Study of Conventional Steroids vs. Steroids Combined With Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: National Institute of Blood and Marrow Transplant (NIBMT), Pakistan, class: OTHER_GOV, descriptionModule briefSummary: Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome., conditionsModule conditions: Immune Thrombocytopenia Purpura, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study will comprise the newly diagnosed patients of Immune thrombocytopenia purpura aged 5-60 year. Patients will be included in this trial, with a 1:1 ratio among the two group patients will be in each group. One group will receive steroids alone and the other will receive steroids and MMF., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Mycophenolate Mofetil (MMF) Treatment, outcomesModule primaryOutcomes measure: Platelet count monitoring, secondaryOutcomes measure: Assessment of Health-Related Quality of Life questionnaire, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 60 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: National Institute of Blood Diseases and Bone Marrow Transplantation, status: RECRUITING, city: Karachi, state: Sindh, zip: 75300, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False |
protocolSection identificationModule nctId: NCT06288919, orgStudyIdInfo id: 2023-IMPLHYGIENE, briefTitle: Erythritol vs Ultrasonic Scaler Prophylaxis Systems on Dental Implants With Crowns Made by Different Materials, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-10, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Pavia, class: OTHER, descriptionModule briefSummary: The aim of the study is to assess which prophylaxis methods is the most suitable for peri-implant hygiene between erythritol and ultrasonic scaler with peek inserts.A randomized clinical trial will be conducted on the patient. Patients will be randomly divided into two groups:* Erythritol group: erythritol with a particle size of \~14 µm will be used for 5 seconds (AIRFLOW® PLUS EMS)* Ultrasonic scaler group: a piezoelectric handpiece with peek inserts (Mini Piezon EMS; PI EMS) will be used.Different subgroups will be defined according to the material of the dental crown of the related implant.The oral hygiene session will be carried out every 6 months (2-years follow-up; 6 sessions), after instruction and motivation of the patient, completion of the clinical chart with the recording of the Probing Depth (evaluation in mm of the peri-implant sulcus taken by a periodontal probe; 4 surfaces of the gingival margin are detected: vestibular, palatal/lingual, mesial, distal), Bleeding on Probing and Plaque Index., conditionsModule conditions: Dental Implant Failed, conditions: Peri-implant Mucositis, conditions: Peri-Implantitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Erythritol prophylactic powders, interventions name: Ultrasonic scaler with peek inserts, outcomesModule primaryOutcomes measure: Probing Depth (PD), primaryOutcomes measure: Bleeding on Probing (BoP), primaryOutcomes measure: Plaque Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia, city: Pavia, state: Lombardy, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False |
protocolSection identificationModule nctId: NCT06288906, orgStudyIdInfo id: ASTER Study, briefTitle: Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems, acronym: ASTER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This is a physician-initiated, observational, monocentric, retrospective and prospective Study. The study is intended to assess the feasibility of mechanical thrombectomy of caval and iliofemoral veins according to normal clinical practice in adult patients with symptomatic acute or subacute ileofemoral or caval deep vein thrombosis objectively diagnosed with CT scan imaging., conditionsModule conditions: Thrombosis, Venous, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: mechanical thrombectomy of caval and iliofemoral veins, outcomesModule primaryOutcomes measure: Rate of Technical success, primaryOutcomes measure: Number of Participants presenting Bleeding, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: San Raffaele Hospital, city: Milano, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False |
protocolSection identificationModule nctId: NCT06288893, orgStudyIdInfo id: DEU-2001, briefTitle: SHEN211 Tablets for the Treatment of Mild and Moderate Novel Corona Virus Infections (COVID-19), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: JKT Biopharma Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Randomized, double-blind, placebo-controlled, multicenter phase II clinical study of SHEN211 tablets, conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized 2:1 to experimental and placebo arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: SHEN211 Tablets, interventions name: Placebo for SHEN211 Tablets, outcomesModule primaryOutcomes measure: Change from baseline in SARS-CoV-2 viral load at each time point, secondaryOutcomes measure: Time of recovery, secondaryOutcomes measure: Time to response, secondaryOutcomes measure: Time to negative, secondaryOutcomes measure: Percentage of subjects with disappearance of clinical symptoms, secondaryOutcomes measure: Change in COVID-19 symptom score, secondaryOutcomes measure: Ct value change from baseline, secondaryOutcomes measure: Change from baseline in chest CT scan (optional), secondaryOutcomes measure: Percentage of Subjects Progressed, secondaryOutcomes measure: Percent of Subjects Who Died, secondaryOutcomes measure: Safety Assessment Results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shenzhen Third People 's Hospital, city: Shenzhen, state: Guangdong, zip: 518112, country: China, contacts name: Hongzhou Lu, ph.D, role: CONTACT, phone: 0755-61232898, email: [email protected], contacts name: Ximin Meng, role: CONTACT, phone: 0755-61222333, phoneExt: 16565, email: [email protected], contacts name: Hongzhou Lu, ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, hasResults: False |
protocolSection identificationModule nctId: NCT06288880, orgStudyIdInfo id: kilis_4, briefTitle: Impact of Earthquake Trauma on Nurses' Compassion Fatigue: A Study From Kahramanmaraş, Turkey, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Kilis 7 Aralik University, class: OTHER, collaborators name: Hasan Kalyoncu University, descriptionModule briefSummary: This study investigates the impact of earthquake trauma on compassion fatigue among nurses working in emergency services following the devastating earthquakes on 6 February 2023, in Kahramanmaraş, Turkey. These earthquakes, with magnitudes of approximately 7.7 and 7.6, affected 11 provinces and resulted in over 50,000 deaths and 100,000 injuries, placing emergency service nurses at the forefront of dealing with the aftermath and trauma. The concept of compassion fatigue, characterised by a reduced capacity for empathy after repeated exposure to traumatic events, is a significant concern for nurses who have been directly involved in the care of earthquake victims. This study aims to explore the extent of earthquake trauma and compassion fatigue among these nurses, examining the relationship between these two conditions and their long-term effects. Given the limited research on post-traumatic stress disorder and compassion fatigue among emergency service nurses, this study seeks to contribute valuable insights into the psychological impacts of disaster response on healthcare professionals. The hypotheses tested aim to better understand the risks and psychological burdens faced by nurses in the wake of such natural disasters., conditionsModule conditions: Earthquake, conditions: Compassion Fatigue, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: Section 1: Demographic Information Form, primaryOutcomes measure: Section 2: Post-Earthquake Trauma Level Determination Scale, primaryOutcomes measure: Section 3: Compassion Fatigue Short Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Islam Elagöz, city: Kilis, zip: 79100, country: Turkey, contacts name: islam elagöz, role: CONTACT, contacts name: Aynur koyuncu, role: CONTACT, geoPoint lat: 36.71611, lon: 37.115, hasResults: False |
protocolSection identificationModule nctId: NCT06288867, orgStudyIdInfo id: FMASU MD28/2024, briefTitle: A 12 Months Prospective Study Comparing Functional Outcome Scores in Hip Arthroscopic Labral Repair Versus Debridement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: This study aims to address hip labral tears and compare between arthroscopic labral repair versus debridement., conditionsModule conditions: Hip Injuries, conditions: Acetabular Labral Tear, conditions: Femoro Acetabular Impingement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Arthroscopic Labral Repair, interventions name: Arthroscopic Labral Debridement, outcomesModule primaryOutcomes measure: Change from baseline in Hip Function, as measured by Hip Outcome Score (HOS), primaryOutcomes measure: Change from baseline in Hip Function, as measured by Harris Hip Score (HHS), primaryOutcomes measure: Change from baseline in Pain, as measured by the Visual Analogue Scale (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University, city: Cairo, country: Egypt, contacts name: Karim A Salem, MD, role: CONTACT, phone: 1000017388, phoneExt: +20, email: [email protected], geoPoint lat: 30.06263, lon: 31.24967, hasResults: False |
protocolSection identificationModule nctId: NCT06288854, orgStudyIdInfo id: 66222, briefTitle: Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer With Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rajavithi Hospital, class: OTHER_GOV, descriptionModule briefSummary: * Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer* Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo, conditionsModule conditions: Weight Gain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: olanzapine vs placebo, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: weight gain each group, outcomesModule primaryOutcomes measure: Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False |
protocolSection identificationModule nctId: NCT06288841, orgStudyIdInfo id: TJMZ2023-008, briefTitle: Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-11-29, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University General Hospital, class: OTHER, descriptionModule briefSummary: With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients., conditionsModule conditions: Pharmacological Action, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Ropivacaine injection, interventions name: Bupivacaine liposome, outcomesModule primaryOutcomes measure: NRS pain score within 72 hours after surgery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University General Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300052, country: China, contacts name: Ning Luo, role: CONTACT, phone: 13622098703, email: [email protected], geoPoint lat: 39.14222, lon: 117.17667, hasResults: False |
protocolSection identificationModule nctId: NCT06288828, orgStudyIdInfo id: IRB0569/66, briefTitle: The Efficacy of Aerobic Exercise Training on Autonomic Nervous System and Endothelial Function in Patients With Compensated Cirrhosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: King Chulalongkorn Memorial Hospital, class: OTHER, collaborators name: Chulalongkorn University, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of a 16-week aerobic exercise regimen on the autonomic nervous system and endothelial function in patients with compensated cirrhosis who maintain sedentary lifestyles. The primary research question is:1) What effect does 16 weeks of aerobic exercise have on changes in the autonomic nervous system and endothelial function in cirrhotic patients?Additionally, the secondary research questions are:1. How does a 16-week aerobic exercise program influence changes in muscle mass, muscle strength, and physical performance in cirrhotic patients?2. Is there a correlation between muscle mass and parameters of the autonomic nervous system in cirrhotic patients?Participants in the intervention group will undergo 150 minutes of moderate aerobic exercise per week for 16 weeks, accompanied by a personalized nutritional plan (1.2 grams of protein per kilogram of ideal body weight per day and a calorie intake of 35 kilocalories per kilogram of ideal body weight per day). The control group will solely receive nutritional guidance and maintain their sedentary lifestyle. The researchers will compare outcomes between these two groups., conditionsModule conditions: Cirrhosis, conditions: Aerobic Exercises, conditions: Lifestyle Modification, conditions: Endothelial Function, conditions: Autonomic Nervous System, conditions: Autonomic Dysfunction, conditions: Heart Rate Variability, conditions: Flow Mediated Dilation, conditions: Sarcopenia, conditions: Physical Activity, conditions: Physical Functional Performance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise, interventions name: Nutrition consultant, outcomesModule primaryOutcomes measure: Autonomic function test: Heart rate variability (HRV), primaryOutcomes measure: Endothelial function test: Flow mediated dilation (FMD) in % FMD change, secondaryOutcomes measure: Physical function, secondaryOutcomes measure: Muscle mass change, secondaryOutcomes measure: Muscle strength change, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of medicine, King Chulalongkorn Memorial Hospital, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06288815, orgStudyIdInfo id: TUH oral fluid TKA, briefTitle: Oral Fluid vs IV Fluid After Primary TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-10, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Thammasat University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.The main question it aims to answer is:Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?, conditionsModule conditions: Osteoarthritis, Knee, conditions: Total Knee Arthroplasty, conditions: Oral Fluid Replacement, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Oral fluid, interventions name: IV fluid, outcomesModule primaryOutcomes measure: Time to stand and walk, secondaryOutcomes measure: Time up and go, secondaryOutcomes measure: Incidence of oliguria, secondaryOutcomes measure: Incidence of nausea/vomiting, secondaryOutcomes measure: Urine specific gravity, secondaryOutcomes measure: the levels of certain electrolytes, secondaryOutcomes measure: the levels of creatinine, secondaryOutcomes measure: the levels of blood urea nitrogen (BUN)., secondaryOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Thammasat University, status: RECRUITING, city: Khlong Luang, state: Pathum Thani, zip: 12120, country: Thailand, contacts name: Yot Tanariyakul, M.D., role: CONTACT, phone: 663930257, email: [email protected], contacts name: Nattapol Tammachote, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False |
protocolSection identificationModule nctId: NCT06288802, orgStudyIdInfo id: 04-2023-200647, briefTitle: Study of Wilms Tumors Among Patients of Shefa Al-Orman Children Cancer Hospital, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-06-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: South Egypt Cancer Institute, class: OTHER, collaborators name: Shefa Al-orman Children Cancer Hospital, collaborators name: Assiut University, descriptionModule briefSummary: The goal of this cross sectional observational study is to determine the percentage of Wilms tumors among pediatric cancers at Shefa Al-Orman Children Cancer Hospital from june 2020 to june 2024,to study the outcome of patients with Wilms tumor treated according to SIOP Umbrella protocol during the study period and to study the treatment related complications during therapy according to common terminology criteria of adverse events version 5.0 (CTCAE Version 5.0)., conditionsModule conditions: Wilms Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Overall-survival (OS), secondaryOutcomes measure: Event-free survival (EFS), eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shefa Al-orman Children Cancer Hospital, status: RECRUITING, city: Luxor, country: Egypt, contacts name: Mahmoud Elzembely, MD, role: CONTACT, phone: +201146703107, email: [email protected], geoPoint lat: 25.69893, lon: 32.6421, hasResults: False |
protocolSection identificationModule nctId: NCT06288789, orgStudyIdInfo id: SFI-TR, briefTitle: Turkish Validity and Reliability of the Social Frailty Index, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-03-20, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Pamukkale University, class: OTHER, descriptionModule briefSummary: The aim was to examine the validity and reliability of the Social Frailty Index in Turkish among older adults. 65 years and above older adults will be included included in the study. Older adults who agree to participate in the study will first be administered the Hodkinson Mental Test. Those who score 6 points and above will be included in the study. To evaluate the validity of the \"Social Frailty Index\", Social Inclusion Scale, Older people\'s quality of life-brief (OPQOL-brief) and Lubben Social Network Scale will be applied to the participants. To determine the reliability of the \"Social Frailty Index\", older adults who do not receive any treatment will be tested and re-tested at one-week intervals., conditionsModule conditions: Elderly, conditions: Frailty, conditions: Quality of Life, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 186, type: ACTUAL, armsInterventionsModule interventions name: Social Frailty Index, outcomesModule primaryOutcomes measure: Social Frailty Index, secondaryOutcomes measure: Socıal Inclusıon Scale, secondaryOutcomes measure: Older people's quality of life-brief (OPQOL-brief), secondaryOutcomes measure: Lubben Social Network Scale, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elif Gur Kabul, city: Usak, state: Merkez, zip: 64200, country: Turkey, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False |
protocolSection identificationModule nctId: NCT06288776, orgStudyIdInfo id: SOD/ERB/2023/22-04, briefTitle: Efficacy of Azadirachta Indica Based Herbal Mouthwash in Treating the Tooth Hypersensitivity, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-04-30, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Pakistan Institute of Medical Sciences, class: OTHER_GOV, descriptionModule briefSummary: Type of study: Single-blinded clinical trial to evaluate the effectiveness of Azadirachta indica based Herbal mouthwash to treat the tooth sensitivity in patients.Participants aged 20 years and above having Gingival Index score 3 will be included in the study. Their tooth sensitivity will be checked initially and then they will be given Herbal based mouthwash for 3 months. Again, their tooth sensitivity shall be checked after 3 months., conditionsModule conditions: Tooth Sensitivity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: In this study, participants will be selected by consecutive non-random sampling technique., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Single-blinded study where participant will be masked., enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: Herbal based mouthwash, outcomesModule primaryOutcomes measure: Toothsensitivity declination with herbal based mouthwash, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Afsheen Mansoor, city: Islamabad, zip: 44080, country: Pakistan, geoPoint lat: 33.72148, lon: 73.04329, hasResults: False |
protocolSection identificationModule nctId: NCT06288763, orgStudyIdInfo id: SC220192, briefTitle: Nerve Transfer to Improve Function in High Level Tetraplegia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: University of Michigan, collaborators name: University of Calgary, collaborators name: The Methodist Hospital Research Institute, collaborators name: University of Pennsylvania, collaborators name: University of Utah, collaborators name: Stanford University, collaborators name: University of Miami, collaborators name: Johns Hopkins University, collaborators name: University of Alberta, descriptionModule briefSummary: The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.Participants will:* undergo standard of care pre- and post-op testing and study exams* complete pre- and post-questionnaires* undergo standard of care nerve transfer surgeries* follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months* attend therapy at local therapist for up to 2 years postop., conditionsModule conditions: Cervical Spinal Cord Injury, conditions: Tetraplegia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Elbow Dynamometry, primaryOutcomes measure: Spinal Cord Independence Measure, primaryOutcomes measure: Motor strength in medical research council grade (MRC), primaryOutcomes measure: Electrodiagnosis (Nerve Conduction Study and Electromyography, secondaryOutcomes measure: Canadian Outcomes Performance Measure (COPM), secondaryOutcomes measure: Capabilities of Upper Extremity Questionnaire (CUE-Q), secondaryOutcomes measure: Modified Ashworth Scale (MAS), secondaryOutcomes measure: Spinal Cord Injury Quality of LIfe Questionnaire, secondaryOutcomes measure: International SCI Pain Basic Dataset (ISCIPBDS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, status: NOT_YET_RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, contacts name: Adrian Valladarez, role: CONTACT, phone: 650-381-4257, email: [email protected], contacts name: Anthony Bet, role: CONTACT, phone: 650-683-5823, email: [email protected], contacts name: Thomas J Wilson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.42411, lon: -122.16608, locations facility: University of Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: George Jimsheleishvili, MD, role: CONTACT, phone: 305-243-4781, email: [email protected], contacts name: Patricia Graham, role: CONTACT, phone: 305-243-5119, email: [email protected], contacts name: Stephen S Burks, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Allan Levi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Johns Hopkins University, status: NOT_YET_RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Aston King, role: CONTACT, phone: 667-306-8862, email: [email protected], contacts name: Bronwyn Slobogean, role: CONTACT, email: [email protected], contacts name: Sami Tuffaha, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Allan Belzberg, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Savannah Solomon, role: CONTACT, phone: 734-936-7010, email: [email protected], contacts name: Yamaan Saadeh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Washington University in St. Louis, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Linda Koester, role: CONTACT, phone: 314-362-7368, email: [email protected], contacts name: Wilson Z. Ray, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Lora Assi, role: CONTACT, phone: 267-254-4745, email: [email protected], contacts name: Leah Coghlan, role: CONTACT, phone: 215-341-5864, email: [email protected], contacts name: Eric Zager, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Houston Methodist, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Amber Behne, role: CONTACT, phone: 346-238-6424, email: [email protected], contacts name: Sergio Ibarra Cortez, role: CONTACT, phone: 346-238-2494, email: [email protected], contacts name: Amir Faraji, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: University of Utah, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Kirstianna Lombardi, role: CONTACT, phone: 801-585-9821, email: [email protected], contacts name: Douglas Gibula, role: CONTACT, email: [email protected], contacts name: Mark Mahan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: University of Calgary - Alberta Health Services, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 2T9, country: Canada, contacts name: Ish Bains, role: CONTACT, phone: 403-944-4334, email: [email protected], contacts name: Rajiv Midha, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: University of Alberta, status: NOT_YET_RECRUITING, city: Edmonton, state: Alberta, zip: T6G 2E1, country: Canada, contacts name: Mith Rajshekar, PhD, role: CONTACT, email: [email protected], contacts name: Andrew Jack, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False |
protocolSection identificationModule nctId: NCT06288750, orgStudyIdInfo id: sdllycyyqx001, briefTitle: Protective Effect of Indocyanine Green Fluorescence Imaging Technology on Parathyroid Glands During Total Thyroidectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Shandong Linglong Yingcheng Hospital, class: NETWORK, descriptionModule briefSummary: Accurate identification and evaluation of the parathyroid glands (PGs) intraoperatively is critical to reduce the incidence of postoperative hypoparathyroidism after total thyroidectomy. Near-infrared fluorescence imaging (NIFI), including the autofluorescence (AF) and indocyanine green fluorescence (ICGF) imaging, is a promising technique to protect PGs. This study aimed to assess whether the combined use of AF and ICGF could reduce the incidence of postoperative hypoparathyroidism and improve the identification and evaluation of PGs during total thyroidectomy., conditionsModule conditions: Total Thyroidectomy, conditions: Parathyroid Function Low Adverse Event, conditions: Parathyroid Glands--Diseases, conditions: Indocyanine Green, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Indocyanine Green, interventions name: No indocyanine green, outcomesModule primaryOutcomes measure: Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast, secondaryOutcomes measure: Central lymph node dissetion (CLND), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Shandong Linglong Yingcheng Hospital, status: RECRUITING, city: Yantai, state: Shandong, zip: 264000, country: China, contacts name: Xuan Qiu, MD, role: CONTACT, phone: 8618354280081, email: [email protected], contacts name: Ni Wang, MD, role: CONTACT, phone: 8618705353551, email: [email protected], geoPoint lat: 37.47649, lon: 121.44081, hasResults: False |
protocolSection identificationModule nctId: NCT06288737, orgStudyIdInfo id: 54335073, briefTitle: Assessing Patient Engagement in Keratoconus Clinical Research, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: This study aims to investigate the influences behind patient choices regarding involvement, discontinuation, or re-engagement in keratoconus clinical trials. Uncovering these factors is essential to enhance the relevance and efficacy of future research endeavors.In essence, this trial aims to deepen understanding of the factors influencing participation in keratoconus clinical trials. Elevating participation rates could expedite the development of innovative treatments for this challenging condition., conditionsModule conditions: Keratoconus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients who decide to join in a keratoconus clinical trial, primaryOutcomes measure: Number of keratoconus patients who remain in clinical trial until completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/[email protected], geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-23, uploadDate: 2024-02-23T11:13, filename: ICF_000.pdf, size: 73995, hasResults: False |
protocolSection identificationModule nctId: NCT06288724, orgStudyIdInfo id: NatIntensive, briefTitle: MOdifiable facTors to Improve VentilAtion ThErapy in ICU, acronym: MOTIVATE-ICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Nat Intensive Care Surveillance - MORU, class: OTHER, collaborators name: D'Or Institute for Research and Education, collaborators name: University of Oxford, collaborators name: Wellcome Trust, collaborators name: Makerere University, descriptionModule briefSummary: ABSTRACT Introduction: Invasively ventilated patients in low and middle-income countries (LMICs) experience significantly higher mortality compared to those in High income countries (HICs). Direct application of HIC strategies to LMICs maybe ineffective due to context-specific challenges. This study aims to leverage the Intensive Care Registry of Uganda (ICRU) to identify ICU structural and process-related modifiable factors that impact patient outcomes in a low income country.Methods: The MOTIVATE-ICU is a prospective multicentre observational study in invasively ventilated patients. It involves a registry-embedded component examining patient- and process-related factors and a cross-sectional survey on ICU organizational structures. Inclusion criteria encompass patients aged ≥ 15 years undergoing IMV in Ugandan ICUs. Primary outcomes are ICU mortality, ICU length of stay (LOS), and duration of ventilation. Secondary outcomes include ventilator-associated complications, non-pulmonary organ support. tTracheostomy outcomes will be explored in a pre-planned substudy. Factors potentially associated with outcomes will be categorized into two groups; non-modifiable factors and potentially modifiable. Non-modifiable factors will include patient-related factors like age, comorbidities and illness severity; potentially modifiable factors include processes of care (e.g. sedation levels) and ICU organizational structure (e.g. staffing patterns). Multilevel multivariable logistic regression will be utilized to study associations, with both patient and ICU level fixed effects considered.Ethics and Dissemination: Given its observational nature, this study seeks a waiver for patient individual informed consent. Data anonymization ensures patient privacy. Following the principles of the Declaration of Helsinki, relevant ethical approvals will be acquired. Study findings will be disseminated through conferences and peer-reviewed journals., conditionsModule conditions: Critical Illness, conditions: Invasive Mechanical Ventilation, conditions: ICU Mortality, conditions: Developing Countries, conditions: Risk Factors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 625, type: ESTIMATED, outcomesModule primaryOutcomes measure: ICU mortality, primaryOutcomes measure: ICU Length of Stay, primaryOutcomes measure: Duration of mechanical ventilation, secondaryOutcomes measure: Duration of non-pulmonary organ support, secondaryOutcomes measure: ICU-Free days, secondaryOutcomes measure: Ventilator-free days, secondaryOutcomes measure: Ventilator-associated Pneumonia, secondaryOutcomes measure: Tracheobronchitis, secondaryOutcomes measure: Non-infectious Pulmonary complication, secondaryOutcomes measure: Readmission, secondaryOutcomes measure: Unplanned extubations, secondaryOutcomes measure: Tracheostomy related outcomes, eligibilityModule sex: ALL, minimumAge: 15 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False |
protocolSection identificationModule nctId: NCT06288711, orgStudyIdInfo id: CHRBSS #STUDY00002538, secondaryIdInfos id: R01DA057308, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA057308, briefTitle: Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2027-08-31, completionDateStruct date: 2027-11-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Vermont, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD., conditionsModule conditions: Opioid Use Disorder, conditions: Posttraumatic Stress Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Prolonged exposure therapy, interventions name: Financial incentives, interventions name: Treatment as usual, outcomesModule primaryOutcomes measure: Prolonged exposure therapy session attendance, primaryOutcomes measure: Prolonged exposure therapy completion, primaryOutcomes measure: Change in posttraumatic stress disorder symptom severity - clinician rated, secondaryOutcomes measure: Change in non-prescribed drug use - objective, secondaryOutcomes measure: Change in non-prescribed drug use - self-reported, secondaryOutcomes measure: Change in opioid craving, secondaryOutcomes measure: Medications for opioid use disorder treatment retention, secondaryOutcomes measure: Prolonged exposure therapy acceptability, secondaryOutcomes measure: Satisfaction with prolonged exposure therapy delivered via telemedicine, secondaryOutcomes measure: Prolonged exposure therapy homework adherence, secondaryOutcomes measure: Change in posttraumatic stress disorder symptom severity - self-reported, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Vemont, status: RECRUITING, city: Burlington, state: Vermont, zip: 05401, country: United States, contacts name: Kelly R Peck, Ph.D., role: CONTACT, phone: 802-656-9610, email: [email protected], geoPoint lat: 44.47588, lon: -73.21207, hasResults: False |
protocolSection identificationModule nctId: NCT06288698, orgStudyIdInfo id: 53955721, briefTitle: Understanding Patient Engagement Trends in TBI Clinical Research, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Clinical trials, specifically focused on TBI, are crucial in assessing the safety and efficacy of new treatments. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation.The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients., conditionsModule conditions: TBI, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of TBI patients who decide to enroll in a clinical research, primaryOutcomes measure: Rate of TBI patients who remain in clinical trial to trial completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/[email protected], geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-23, uploadDate: 2024-02-23T11:01, filename: ICF_000.pdf, size: 69900, hasResults: False |
protocolSection identificationModule nctId: NCT06288685, orgStudyIdInfo id: 73/256, secondaryIdInfos id: 73/256, type: OTHER, domain: Police General Hospital, briefTitle: Percutaneous Trigger Finger Release Concomitant Steroid Injection Versus Percutaneous Trigger Finger Release Alone, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-11, primaryCompletionDateStruct date: 2024-01-23, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Police General Hospital, Thailand, class: OTHER, descriptionModule briefSummary: Background:Percutaneous A1 pulley release is a cost-effective and straightforward procedure with outcomes comparable to open A1 pulley release. Postoperative pain is a prevalent concern. Corticosteroid injection is a common nonoperative treatment for trigger finger, providing favorable outcomes but associated with a notable risk of recurrence. Numerous studies have explored the combined approach of percutaneous trigger finger release with corticosteroid injection. However, to date, there is no report on early postoperative results.Objective:To conduct a comparative analysis of early postoperative outcomes between percutaneous A1 pulley release with steroid injection and percutaneous A1 pulley release alone.Study Design \& Methods:This study constitutes a randomized controlled trial involving patients with trigger finger who underwent percutaneous release surgery from October 2023 to January 2024. A total of 38 patients were enrolled, with 18 assigned to the percutaneous A1 pulley release with steroid injection group and 20 to the percutaneous A1 pulley release alone group. Postoperative assessments included pain scores using the Visual Analog Scale (VAS), evaluation of quality of life through the QuickDASH score (qDASH), patient satisfaction, and complications., conditionsModule conditions: Trigger Finger, conditions: Percutaneous A1 Pulley Release, conditions: Steroid Injection, conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients diagnosed with trigger finger, aged 18 years or older, and classified under Quinell's grade 2, 3, or 4, were included in the study \[ \]. Recruitment took place at the Outpatient Orthopedic Department of the Police General Hospital between October 2023 and January 2024. Exclusion criteria encompassed individuals with a history of prior hand surgery, Dupuytren's disease, type 1 diabetes, previous phalangeal fractures, recent steroid injection within the last month, and autoimmune diseases., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Group allocation and Randomization:Patients were enrolled and randomized into two groups, percutaneous A1 pulley release with steroid injection (Group A) and percutaneous A1 pulley release alone (Group B), by utilizing computer generate randomization and the results were put in opaque sealed envelopes. Informed consent was obtained from all participants, and surgeries were performed by the same surgeon (WJ)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 38, type: ACTUAL, armsInterventionsModule interventions name: percutaneous A1 pulley release, interventions name: Triamcinolone, outcomesModule primaryOutcomes measure: postoperative pain score, secondaryOutcomes measure: hand function by quickDASH, secondaryOutcomes measure: patients satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Police General Hospital, city: Bangkok, state: Pathumwan, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False |
protocolSection identificationModule nctId: NCT06288672, orgStudyIdInfo id: 1002, briefTitle: IBS Skin Patch Test Food Allergy Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-15, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: IBS-80, LLC, class: INDUSTRY, descriptionModule briefSummary: Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \"true\" avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \"sham\" avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants with IBS are patch tested to 80 type 4 food allergens. Those with questionable or positive patch test reactions are randomized to follow a patch test-directed avoidance diet or a sham diet (avoidance of foods to which the patch tests showed no reaction) for 16 weeks. Upon conclusion of the avoidance diet, participants complete a brief questionnaire to assess their response to the avoidance diet., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The true or sham avoidance diet for each participant is randomly assigned by the study administrator. Assignments will not be made available to participants until after their study completion or to investigators until all 250 participants have completed the study and the results have been analyzed., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: True avoidance diet, interventions name: Sham avoidance diet, outcomesModule primaryOutcomes measure: Post-Avoidance Diet Relative IBS Symptom Global Assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Adult and Pediatric Dermatology, status: RECRUITING, city: Marlborough, state: Massachusetts, zip: 01752, country: United States, contacts name: Christy Williams, MD, role: CONTACT, phone: 508-460-9613, email: [email protected], contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: [email protected], contacts name: Christy Williams, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.34593, lon: -71.55229, locations facility: Adult and Pediatric Dermatology, status: RECRUITING, city: Westford, state: Massachusetts, zip: 01886, country: United States, contacts name: Christy Williams, MD, role: CONTACT, phone: 508-460-9613, email: [email protected], contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: [email protected], contacts name: Christy Williams, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.57926, lon: -71.43784, locations facility: Allergy & Asthma Care of New York, status: NOT_YET_RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Clifford Bassett, MD, role: CONTACT, phone: 212-260-6078, email: [email protected], contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: [email protected], contacts name: Clifford Bassett, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Modern Dermatology NYC, status: RECRUITING, city: New York, state: New York, zip: 10016, country: United States, contacts name: Kathryn Frew, MD, role: CONTACT, phone: 929-533-1797, email: [email protected], contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: [email protected], contacts name: Kathryn Frew, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, locations facility: North Wales Dermatology, PLLC, status: RECRUITING, city: North Wales, state: Pennsylvania, zip: 19454, country: United States, contacts name: Michael B Stierstorfer, MD, role: CONTACT, phone: 215-699-1929, email: [email protected], contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: [email protected], contacts name: Michael B Stierstorfer, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.21094, lon: -75.27823, locations facility: Shepherd Allergy, status: RECRUITING, city: Barboursville, state: West Virginia, zip: 25504, country: United States, contacts name: Meagan Shepherd, MD, role: CONTACT, phone: 304-733-3333, email: [email protected], contacts name: Sally Iles, BSN, MBA, role: CONTACT, phone: 617-922-1130, email: [email protected], contacts name: Meagan Shepherd, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.40953, lon: -82.29459, hasResults: False |
protocolSection identificationModule nctId: NCT06288659, orgStudyIdInfo id: KY2024-050, briefTitle: aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial, acronym: ASTIM-MT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Huashan Hospital, class: OTHER, descriptionModule briefSummary: ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage., conditionsModule conditions: Aneurysmal Subarachnoid Hemorrhage, conditions: Intracranial Pressure Increase, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 368, type: ESTIMATED, armsInterventionsModule interventions name: Intraventricular intracranial pressure monitoring, outcomesModule primaryOutcomes measure: The rate of good neurological functional prognosis, secondaryOutcomes measure: The rate of good neurological functional prognosis, secondaryOutcomes measure: The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E), secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Incidence of VP shunt-related hydrocephalus, secondaryOutcomes measure: Incidence of Delayed Cerebral Ischemia, secondaryOutcomes measure: Incidence of epilepsy, otherOutcomes measure: Incidence of intracranial infection, otherOutcomes measure: Incidence of bleeding from puncture site, otherOutcomes measure: Incidence of poor healing in surgical incisions, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Neurosurgery, Huashan Hospital, Fudan University, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xuehai Wu, Ph.D., role: CONTACT, phone: +8613764880571, email: [email protected], geoPoint lat: 31.22222, lon: 121.45806, hasResults: False |
protocolSection identificationModule nctId: NCT06288646, orgStudyIdInfo id: ROMEO 101712, briefTitle: Using Infrared Spectroscopy to Analyze Volatile Organic Compounds (VOCs) in the Breath of Patients With Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-24, primaryCompletionDateStruct date: 2024-04-24, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Picomole Inc, class: INDUSTRY, collaborators name: Vitalite Health Network, descriptionModule briefSummary: The goal of this clinical trial is to compare breath samples from patients with lung cancer, those with stable lung nodules, and individuals without lung cancer. The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer.Participants will be asked to provide one breath sample, and two if they get treated. They will also be asked to fill out a questionnaire about their background and medical history., conditionsModule conditions: Lung Cancer, conditions: Non Small Cell Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Differences in Breath Spectra of Lung Cancer, Stable Pulmonary Nodules, and Controls, secondaryOutcomes measure: Differences in breath spectra of patients with lung cancer before and after treatment, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vitalite Health Network, status: RECRUITING, city: Moncton, state: New Brunswick, zip: E1C 8X3, country: Canada, contacts name: Nada Hammami, role: CONTACT, phone: 506-869-7391, email: [email protected], contacts name: Marcel Mallet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.09454, lon: -64.7965, hasResults: False |
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